Documentation. secutrial Export Formats. Valid for Version 4.7 As of

Transcription

1 Documentation secutrial Export Formats Valid for Version 47 As of interactive Systems, Berlin 2014

2 Documentation secutrial 47 Export Formats Table of Contents 1 Introduction 5 New features in secutrial Export Options 5 Description 7 Project and Centre 7 Visit 7 Patients 7 Format 7 Included data 8 Data handling 10 Filter data records10 Send Export after Search 11 2 Export Model Standard (non-rectangular) structure12 22 Rectangular structure13 3 SAS-Format Introduction Data types 15 Date Formats 15 Other Data Types 16 Labels 17 Code Lists 17 Images 17 Numbers SAS Format Problems 18 4 SPSS Format Introduction Data types 19 Date formats 19 Code Lists 20 Images 20 Numbers 21 5 CSV & Text Formats Introduction Data types 22 Date Formats 22 Code Lists 23 Images 24 Numbers 24 6 Table descriptions visitplan /vp (Project visit plan)25 62 visitplanforms / vpfs (Forms shown in visits)26 63 forms / fs (Forms) questions / qs (Questions) items / is (Items) centres / ctr (Centres) casenodes / cn (Patient information)29 68 atcasenodes / atcn (Patient information history)30 As of by ias

3 Documentation secutrial 47 Export Formats 69 atcasevisitplans / atcvp (Patient visit plan history) queries / qac (Queries) comments / cts (Comments) sdv / sdv (Source Data Verification) atsdv / atsdv (Source Data Verification audit trail) miv / miv (Missing Values) atmiv / atmiv (Missing Values audit trail) mnp : ecrf Data atmnp : Audit Trail ecrf emnp : Sub-Documents atemnp : Audit Trail Subdocuments images / img (Images) data formnumbers 52 7 CDISC ODM Introduction ODM Data structure 53 Omitted information53 Artifical study elements 54 Audit Trail 54 Queries and Comments54 Hidden data 55 secutrial and CDISC 55 Date Formats secutrial Vendor Schema Extension58 74 Structure summary Element description: General information62 <ODM> Element description: Project setup63 <Study> 63 <StudyName> 63 <StudyDescription> 63 <ProtocolName> 63 <MetaDataVersion>63 <Protocol> 64 <StudyEventRef>64 <StudyEventDef>64 <FormRef> 65 <FormDef> 65 <Description> 65 <ItemGroupRef> 66 <ItemGroupDef> 66 <ItemRef> 67 <Alias> 67 <ItemDef> 68 <CodeListRef> 68 <CodeList> 69 <CodeListItem> 69 <TranslatedText>69 77 Element description: Participant administration69 As of by ias

4 Documentation secutrial 47 Export Formats <AdminData> 69 <User> 70 <LocationRef> 70 <Location> 71 <SignatureDef> Element description: Clinical data71 <ClinicalData> 71 <SubjectData> 72 <Annotation> - Subject 72 <StudyEventData> 73 <FormData> 73 <AuditRecord> 74 <Signature> 74 <Annotation> 74 <ItemGroupData>75 <Annotation> 75 <ItemDataTyped>76 <ItemData> 76 <ImageData> 77 <ImageFileData> 77 <Annotation> 77 <Annotations> 78 8 Appendix A-1: SAS program example79 9 Appendix A-2: SAS format (=code lists) example118 10Appendix B: SPSS syntax example126 11Appendix C: CDISC ODM v13 example214 As of by ias

5 Documentation secutrial 47 Export Formats 1 Introduction Data stored through the secutrial DataCapture may be exported to external files in various formats from the ExportSearchTool The export is started by the user and generated asynchronous on the server The file containing the exported data is at first stored on the application server This file is encrypted for the intermediate storage using a five digit random TAN (transaction number) which is only known to the person who started the export After completion of the export, the data file can be downloaded from the server using the TAN for access As the export generation is done asynchronous, you can start several exports, logout and login later to download the results To get informed when the exports are finished you can be notified by All data of the patients entered in the ecrfs are exported Further related data may be exported using the available options in the ExportSearchTool The data may be exported in various formats These are: SAS SPSS CSV / text files CDISC ODM All exported data are delivered as zip files to minimize download time These files have to be unpacked be - fore they may be imported into the required application The zip-files contain a varying amount of files: CDISC ODM v13 (XML): 6-9 files (1 *xml for the data and 5-8 *xsd file for description of formats) SAS: 1 *sas, 1 *_fmtsas file, all tables in separate files named *dat in the subdirectory "dat" SPSS: 1 *sps file, all tables in separate files named *txt in the subdirectory "dat" CSV and text-format: all tables in separate files (forms and subforms, according audit trails-tables additionally casenodes, forms, items, questions, visit plan, visit forms, centres, queries, comments, sdv, separate table with reference values [some might be missing according to the chosen export options]) Images If the project setup and the chosen option ( Included data: project setup ) includes separate image data as collected with an image item all exported files are included into a separate "patientimages" folder (with further substructure) The names and path of the included files are listed in the exported "images" table Images and image items are not included in the rectangular export format New features in secutrial 47 A new table is exported for the new Missing Values (MV) function 11 Export Options Several options can be set to define which data are to be exported The range of options varies if the export is started directly or on the result of a search It depends further on the project configuration and selected ex - port format The selected options are included on a html page into the export zip file As of by ias

6 Documentation secutrial 47 Export Formats Image 1: All possible options for export (format SAS) The filter for data records can be hidden from view if not needed As of by ias

7 Documentation secutrial 47 Export Formats Description You can enter a short description for your export This entry is optional It shall help to distinguish the generated exports in the download or history list If you omit this information (or in older exports) the list of selected centre is displayed Project and Centre The project and centres for which the data should be exported must be selected The displayed options depend on the role and assignment of the user If the export is started as a search result only the found patients are included and the options for project and centre selection are disabled Visit The data could be restricted for the included visits Normally the whole visit plan is included but that could be restricted to include only the first or last visit (calculated individually for each patient regardless of visit type) or a single visit type could be selected If the single visit is repeated in a patients visit plan, all visits of this type will be exported ecrfs of adverse events or general patient status are always included Patients The patient data to be exported may be restricted to valid patients Valid patients are all those patients who are participating in the study and have not been dismissed from the study for reasons such as withdrawal from the study, death, etc This is stored in the patient status: The patient status could have been set to "dead", "frozen" or "anonymized" None of those patients will be exported if you choose the option "Valid pa - tients" but will be included with the option "All patients" If you start an export after a search or from the display of a historical search result only the displayed patients will be exported without further check for centres or status (see below) Patients which are to be deleted completely or from the selected project will never be exported regardless of the chosen options Format There are 6 different export formats available: CDISC ODM v13 format (xml) SAS format SPSS format CSV format for MS ExcelCSV data Text file with fixed field lengths Depending on the chosen format more options are available to specify it: For normal CSV format the field separator and encloser could be assigned, in the MS Excel format the tabulator is used as separator and double quotes as encloser For the SAS and SPSS format additional files describing the data and starting the import in the statistical ap - plication are created These files are intended to be executed in the evaluation program to load all exported data in one or two steps For both CSV formats and the text file the handling of the code list could be specified The reference values could either be exported in a separate file or the codes could be directly replaced by the coded value in the same (form) table In the CDISC format some additional information could be included into the export by choosing the "with sec - utrial Extensions" option The format of the single data item could be chosen between the current 13 and the older 12 ODM format For further information see chapter: "CDISC ODM 13 As of by ias

8 Documentation secutrial 47 Export Formats Rectangular table For SAS, SPSS, CSV and TXT the rectangular format can be choosen For each patient there will be exactly one data row with all forms Repeated data eg forms shown in multiple visits will be exported as repeated columnsthe repetition will be indicated be appropriate column names (see table description in section 621 data below) With this format all code lists are automatically included in the data table for CSV and TXT format For the explanation of the column names there are always one or two additional tables included in the ex - port The visitplan (vp) explaines the used visit IDsThe formnames (fa) are only needed in the SAS format and describes the replacement of the tablenames with numbers, necessary because of the column name length restriction in this program Shorten table names Normally all names (standard and ecrf tables) are appended by the project model suffix and the timestamp of the export, eg "casenode_tpx_ csv" For SAS tables the timestamp is only appended to the included *dat files, not to the table names itself For the SAS, SPSS, CSV and TXT format the option "shorten table names" can be selected In this case the standard tables are exported with only short names Names of ecrf tables are abbreviated by removing the "mnp" and project model suffix from the table name The prefix for audit trail and subform tables will be maintained WARNING: The uniqueness of table names is only guaranteed for normal table names Only choose the shortening option if the table names of the forms will not conflict with the standard names described in this document or the data will be corrupted during export! In the rectangular export format this option removes the timestamp from the name and shortens the names of the additional explanation tables The project abbreviation remains Included data Patient identifier In all export files patients are identified by the internal unique patient identifier (=DB-primary key) Along with this identifier, the pseudonym and the additional identification code (=AID) to identify the patient in the export data may be exported The possible choices depend on the project usage of these identifiers Centre information Centre information may be included in the export data The centre is exported in a separate table, containing the name of the centre and the country For CDISC export this option is always enabled to create valid ODM files The participant information is now included with the document edit meta information (see below) Project setup A short description of the defined forms of the selected project including the project visit plan can be exported by choosing this option For CDISC export this option is always enabled to create valid ODM files This option is not available for rectangular export formats Queries and Comments Queries and Comments may be included in the export data This option is not available for rectangular export formats Source Data Verification (SDV) The validation of the electronic data against the original source is stored in two separate tables (one for the current form data and one for the audit trail) which can be exported by choosing this option The SDV status of each document is included into the export even if this option is not chosen In the CDISC format the SDV status is added either as an additional attribute (with ias extension) or as separate annotations (without ias extension) This option is only available if the usage of SDV is configured for the selected project This option is not available for rectangular export formats As of by ias

9 Documentation secutrial 47 Export Formats Missing Values (MV) The markup of missing values is stored in two separate tables (one for the current form data and one for the audit trai) which can be exported by chossing this option, the audit trail MV table only when the audit trail option is additionaly selected The markup of missing values is not exported within CDISC format This option is only available if the usage of MV is configured for the selected project This option is not available for rectangular export formats Audit Trail A complete audit trail may be exported along with the valid current patient data This option is not available for rectangular export formats Double Data Entry This option is only displayed for projects which uses double data entry Normally only the original records where the double data entry comparison has been finished are exported You can choose to include the duplicates (in the DataCapture visible from the original audit trail) or the double records before finished comparison to be included into export This option is not available for rectangular export formats Images If any image item is included into the project setup these option let you include the original (uploaded), the displayed (web) and/or the thumbnail image to the export Besides the image description table which is always exported, the option included the separate image files into the export These files are exported in the separate "patientimages" folder This option is not available for rectangular export formats Images and image items are not exported in the rectangular format E-Signature and validation Some information about the e-signature including the signature-validity of every ecrf may be included in the export data The validation is done during the time of the export A new algorithm for creating e-signatures has been introduced in secutrial 31 to handle problems with signing subforms The algorithm version is stored in each document to allow the validation of both (old and new) types of e-signatures If the validation option has been choosen, this version is exported too This option is only available if the usage of e-signature is configured for the selected project Form data of hidden fields Instead of the deletion of items, questions or complete ecrfs with the risk of non-tolerable data-loss these elements can be marked as "hidden" in the FormBuilder Even visit forms, not shown in any visit are treated as hidden Hidden elements will not be displayed in the DataCapture for collecting and dis - play of data but the data are preserved in the database and can still be exported (per selection for each export) and evaluated If the export option include hidden data is selected for export of SAS / SPSS / CSV or TXT format, even the data related to hidden fields will be exported If any element in a project is marked as "hidden" the description of the project-setup contains an additional column for this property The hidden data of the form description, queries, comments, sdv or forms will be marked as hidden in a therefore introduced column hidden, resp mnphide in form data tables In the CDISC format the form description and queries and comments on hidden elements are only exported if this option is chosen Here the "hidden" property is exported as an annotation to the ecrf data The form data are filtered as chosen by this option NOTE: It is not possible to export any data of visit forms not shown in any visit with the rectangular format because with this structure all forms must be assigned to a distinct visit to create the distinct columns! Form items Since secutrial 43 it can be selected weather the complete ecrfs or only selected items shall be exported Non-displayed (=hidden) items can only be selected if the option Form data of hidden fields has been selected Single items, formgroups, forms or formfamilies can be selected At least one item must be selected to start an export with item selection As of by ias

10 Documentation secutrial 47 Export Formats In the non-rectangular export only those tables will be exported, that includes one of the selected items This option is not selectable for the CDISC format For this format the complete project setup will always be exported Form meta data The meta information about form and patient status, document editing an ecrf-structure can be in- or excluded from the export This can reduce the amount of additional columns if this information is not needed for data evaluation The specific description of the columns belonging to the meta categories can be found in the online help or in the annotations of the mnp* and data table descriptions below Data handling Unselected checkbox The value of unselected checkboxes can exported as 0 (as in previous versions) or null In either cases it is not possible to distinguish between not stored ecrf with checkbox and stored ecrf with unselected checkbox values Date / time items To allow the handling of ecrf date / time items as real dates during evaluation it is now possible to let this value be exported in real date format Because most evaluation software only accept complete dates and times, not given parts has be completed with a default value The default can be specified here For further details about the exported date and time formats in the selected export format see the appropriate sections about Date formats Randomization If the project configuration includes the configurable randomization with blinding and the participant has the unblinding export right, there is an option to unblind the randomization during export With this option selected the additional randomization columns in the casenode table (or the additional RANDOM form in the CDISC ODM format) will include the random groups whereas the normal randomization form items will always be exported the blinded randomization value The unblinding will be logged in the export history Filter data records The included ecrfs are filtered by these options A data row (one stored ecrf) will not be exported if the attributes stored in the congruent mnp-document (eg "form is complete") are not the same as specified in the filter options The default value - no check means not to filter by this option The filter checks all options with an AND qualifier The options and values are: Completion status: no check / empty / partly filled / completely filled Validation: no check / without / with warning Validation: no check / without / with error Review A: no check / no / yes Review B: no check / no / yes Freeze (by system): no check / no / yes Comment status: no check / without / with comment Query status: no check / open / answered / resolved Query Source Data Verification: no check / not done / in progress / verified with errors / not necessary / verified The filter applies to the current data in the ecrfs, if the audit trail option has been choosen, all audit trail records for all exported current records are exported Therefore the actual status information of the audit trails records can be different from the filter selection As of by ias

11 Documentation secutrial 47 Export Formats Send You can be notified if the export has been finished If your contact is already known in secutrial the address field will be pre-filled 12 Export after Search Additionally search results can be exported The data selection options "project" and "centre" are therefore not available, because the subjects whose data are to be exported are determined before the export is star - ted on the result of the search Only patients displayed in the search result will be exported That means the applied filters on the search result will apply on the export too On the other hand all forms matching the export filter will be exported the data is not restricted to that included in the search form Patients, who shall be deleted completely or in the chosen project, will never be exported As of by ias

12 Documentation secutrial 47 Export Formats 2 Export Model This section describes all possible tables and columns that SAS export files may contain Some tables and columns are optional, see chapter: "Export Options" 21 Standard (non-rectangular) structure For reasons of simplification, some tables in secutrial are joined into one table Like this, the secutrial database model is transformed to a more flat model The following picture illustrates the exported tables in a table-relationship model A table is shown with its keys and major columns The number of tables of entities <tablename>, <sub-tablename> and "<at-tablename>", "<at-sub-tablename>" depends on the project (study) Some of the tables could be omitted for an export depending on chosen export configuration The columns in the <tablename> entities vary depending on the fact, if the ecrf has been collected during a normal visit, an adverse event or directly connected to the casenode The exact declaration for these three categories can be found in the table descriptions The structuring into administrative data, study setup and ecrf data is only an informal structure concerning the table contents This structure is not explicitly found in the export casenode mnppid <pk> mnpctrid <fk> centre mnpctrid <pk> Administrative Data Study Setup visitplan vpform forms questions items mnpvisid <pk> mnpvisid <fk> formid <fk> formid <pk> formtablename fgid <pk> formid <fk> ffid <pk> fgid <fk> ffcolname ecrf Data <tablename> mnpdocid <pk> mnppid <fk> mnpvisid<fk> (ffcolname) <sub-tablename> mnpsubdocid <pk> mnpdocid <fk> (ffcolname) <at-tablename> mnpdocid <fk> mnpatdocid <pk> mnppid <fk> mnpvisid <fk> (ffcolname) <at-sub-tablename> mnpatsubdocid mnpatdocid fgid <fk> (ffcolname) <pk> <fk> queries mnpdocid <fk> ffid <fk> ffcolname mnpqueryid comments mnpdocid <fk> ffid <fk> ffcolname mnpcommentid Image 2: Structure of the exported data in the standard (non-rectangular) format The black arrows depict the relationships between the tables The orange arrows indicate the content relations to the table and column names from the form setup to the ecrf data As of by ias

13 Documentation secutrial 47 Export Formats 22 Rectangular structure In the rectangular export format all casenode and ecrf data are exported into a single data table For each patient there is exactly one data row The tables structure of single ecrfs are then concatenated Re - peated display of forms, like ecrf shown in several visits, are then appended as additional columns The form types are concatenated in the sequence: 1 visit forms 2 casenode forms 3 adverse event forms 4 image forms Patient visits are sorted by visit type as defined in the project visit plan Visit repetitions are in immediate suc - cession Visit groups or treatment arms are neglected in the export For each visit all shown forms are included Adverse events and follow-ups are repeated and counted according creation, starting with 1 For each followup all adverse event forms are included regardless if they are shown for a single patient (adverse event forms may be filtered according the is SAE property of the single event) Image forms are also repeated and counted according creation per image form The assignment to patients visit or follow-up are only indicated by the export of the corresponding mnpcvpid (=primary key of the patientvisit) or mnpfuid (primary key of the adverse event follow up) If both key columns are empty then the image form was assigned to the patient directly According to the form definition the user defined items are listed for each form To distinguish the columns from separate ecrfs the columns are prepanded by an appropriate name prefix Subforms are repeated as often as the maximal number for each export The item repetitions are marked by appending repetition indizes (see below) Scheme of column names for visit forms Example v21_1_mnptp0table_column[_1_1] Visit: listed by primary key, here with visitid = 21 Visit repetition: 1 Table: mnptp0table ('mnp' + project scheme + user entered value), for SAS format the tablesnames are replaced by a number to avoid too long column names The replacement is documented in the formnumbers table Column: column name as defined per user (ecrf item) or meta data (see table descriptions) Optional for sub forms: ID of Repetitiongroup-question and number of repetition Scheme of column names for casenode forms Example c_mnptp0table_column[_1_1] Table: mnptp0table ('mnp' + project scheme + user entered value) Column: column name as defined per user (ecrf item) or meta data Optional for sub forms: ID of Repetitiongroup-question and number of repetition Scheme of column names for adverse event forms Example: a1_3_mnptp0table_column[_1_1] Adverse event number: counted by existance per patient, here = 1 Repetition/Followup: counted by existance per patient, here = 3 Table: mnptp0table ('mnp' + project scheme + user entered value) Column: column name as defined per user (ecrf item) or meta data Optional for sub forms: ID of Repetitiongroup-question and number of repetition Scheme of column names for image forms Example i5_mnptp0table_column[_1_1] Image form: repetition: 5 Table: mnptp0table ('mnp' + project scheme + user entered value) Column: column name as defined per user (ecrf item) or meta data Optional for sub forms: ID of Repetitiongroup-question and number of repetition If the option shorten table names have been selected, the mnptp0 part of the form names are removed from the column names As of by ias

14 Documentation secutrial 47 Export Formats If an ecrf is not stored or created for a single patient the corresponding columns are empty The structure of the complete table may differ depending on the included patient data: only the maximal number or repeti - tions in the exported data, not in the complete project data, are displayed For the explanation of the visit-ids in the column names the standard table visitplan is additionaly included in the export In the SAS format the form table names are replaced by a simple form number To explain the re - placement an additional table formnumbers is exported too data ecrf Data Study Setup mnpcnid mnpctrid mnpptnid mnpcs0 v21_1_mnpdocid v21_1_mnpptnid <cl> v21_1_mnpcvpid v21_1_mnpvispdt v21_1_(ffcolname) a1_1_mnpdocid a1_1_mnpptnid a1_1_mnpfuid a1_1_mnpaedt a_1_(ffcolname) i1_mnpdocid i1_mnpptnid i1_mnpcvpid i1_mnpfuid i1_mnpfs0 i1_(ffcolname) <pk> <cl> <cl> <cl> <cl> <cl> <cl> visitplan mnpvisid <pk> formnumbers formnumber formtablename mnpdocid mnpptnid mnpfs0 (ffcolname) <cl> <cl> Image 3: Structure of the exported data in the rectangular The orange arrows indicate the content relations to the name parts of the column names from the setup to the ecrf data The table formnumbers is only exported in the SAS format, for all other formats the respective table names are used directly as part of the column names As of by ias

15 Documentation secutrial 47 Export Formats 3 SAS-Format 31 Introduction By selecting the appropriate export format, all data are exported in a SAS compatible format At least two files are created for the export, one containing table meta-data and clinical data definition, the other containing the code lists The naming convention for these files is: the file name is an abbreviation of the project name with the file extension "sas The code lists file has the additional naming extension "*_fmtsas" The sas file contains all data descriptions, the data records are separate files All names of tables in the export have the name of table as they are stored in the secutrial database These data tables are included in a separate directory "dat" and have the file extension "dat" The names follow the convention: the prefix 'at' for audit records the prefix 'mnp' for normal data records, the prefix 'emnp' for repetition data records the project abbreviation, eg 'tp0' a representative short table name, eg 'persondata' The naming of these files follows the naming convention described above, extended with the project abbreviation and the timestamp of the export, similar to the naming of the entire zipped download file These names are referenced in the sas script file This naming convention avoids mixing data from different exports Some older SAS versions only allow table names with eight characters In order to achieve this, the coding convention prefixes apart from the prefix at and 'e'' (subforms) may be omitted from the export names, by using the export option "shorten table names" The data descriptions have INPUT and ATTRIB definitions of all variables The INPUT label defines the name of all variables in the record and the start position and the end position of data in the record All alphanumerical fields are identified with a dollar-sign ($) before the start position Date field input definitions are characterized by starting with an at-sign (@) followed by the start position of the date and then the field name The ATTRIB attributes contain a label for each variable, format details for code list elements, format and informat details for date variables In the rectangulare export format there are exactly three data files: data, visitplan and formnumbers The project abbreviation is always appended to the data files, an additional timestamp is appended if the option shorten tablenames has not been selected 32 Data types Date Formats All date fields edited in the ecrfs (ias date components) are stored as strings in the database with the format YYYYMMDDHHMISS YYYY is a four digit year value, eg 1956 MM is a month as number (01 for January 12 for December) DD is the day of the month HH is the time in 24 hours MI is the minute value of the time SS is the second s value of the time Other system generated dates are stored in a real data format in the database SAS has no data type for date times that is capable to specify the time zone Two types of SAS date formats are used: DATETIME20 and DATE9 These formats are used to represent all internal dates stored in the system, such as last edit date, creation date, etc The time zone of all exported dates and datetimes is specified in the configuration file of the secutrial installation As of by ias

16 Documentation secutrial 47 Export Formats It is possible to export the item dates as real dates Then they will be exported similar to the system generated date and times For the display in SAS the FORMAT for these variables are specified to simulate the input display in the ecrfs The real date formats are listed in the second row for each ias date component If exporting as real date all values not entered in the ecrf are replaced by the defaults given during export start It is not therefore not possible to distinguish if a user has left a minor part of a non-checked date item empty or if the part could not be entered because of the item type Type ias Format SAS INFORMAT SAS FORMAT Format Description Example Date (eg visit date) DATE11 DATE9 DD-MMM-YYYY 28-MAY-2004 Datetime ias date components ias calculated date time intervals (eg last edit date) DATETIME20 DATETIME20 DD-MMM-YYYY:HH:MI:SS YYYY $4 YYYY 2004 DATE11 YEAR4 DD-MMM-YYYY MM-YYYY $6 YYYYMM MAY-2004:11:58:03 DATE11 MONYY7 DD-MMM-YYYY 01-MAY-2004 DD-MM-YYYY $8 YYYYMMDD DD-MM-YYYY HH:MM DATE11 DATE9 DD-MMM-YYYY 28-MAY-2004 $12 YYYYMMDDHHMI DATETIME20 DATETIME20 DD-MMM-YYYY:HH:MI:SS HH:MM $4 HHMI 1158 TIME8 HHMM5 HH:MI:SS 11:58:00 HH:MM:SS $6 HHMISS TIME8 TIME8 HH:MI:SS 11:58:03 MM:SS $4 MISS 5803 TIME8 TIME8 HH:MI:SS 00:58:03 Y $4 YYYY 0052 Y-M $6 YYYYMM Y-M-D $8 YYYYMMDD MAY-2004:11:58:00 Y-M-D-H-M $12 YYYYMMDDHHMI H-M $12 YYYYMMDDHHMI H-M-S $14 YYYYMMDDHHMISS M-S $14 YYYYMMDDHHMISS Because there are no display type for minutes and seconds only, this item type is formatted as a complete time if exported as real date Because of the three-letter month abbreviation it is possible to select the language for the date format Probably most SAS installation will need the date-language in english Other Data Types Other used SAS data types are Strings ($8, $10, $20, $40 $100) and Numbers (4 == 4 digits) The investigator data will be exported as code lists In the rectangular data the centre and country information are also exported as code lists, in the standard format this information is exported in a separate table As of by ias

17 Documentation secutrial 47 Export Formats Most status data are exported as bit values which may be seen as Boolean values The value 1 indicates that the bit is set and that the status is "valid" or "true" Status values "0" or NULL indicate that the bit is not set and that the corresponding status is "false" The meaning of all bit values are stored in the appropriate code list The data lines all have fixed length fields Between each pair of fields, one field is left empty This makes it easier to assess the file Position rules with the variable names are provided as comments in the data file if configured via configuration file This again is just a convenience to be able to examine the file manually Labels Every table and each item of the form (which build the variable parts of the variables) have assigned a label taken from the form (=ecrf) declaration as done in the secutrial FormBuilder The label of the whole ecrf is taken from the form name (the displayed name in the matrix) The label of each item is made up of the item label If this is not set, the question label is used If this label is not set either, the unique label as for the search is used, which must be set at least Code Lists Code lists are exported to a separate file with the name extension 'fmt' The reference of which field has which code list is defined in the FORMAT value of the ATTRIB specifiers The following items are exported as code lists: Status values These are most binary values which only have one key/value pair for the value "1" Some status values are coded by a small amount of values Checkbox values Checkboxes may only be set or not set, like a binary value In the data table, the value 1 represents "set" The coding of the value is stored in the code lists, and quite like the binary status values, may only have two key/value pair The standard value is "yes" or "no" Per export option it is possible to export the non-set state as null (unset column = spaces) Drop down selections All choices of the drop down are coded in the code list Radio-button choices All choices of a radio-button group are coded in the code list Query, answer, comment, sdv code lists The type of the annotation to an ecrf Investigators All investigators referenced in export data are coded in code lists These are only exported if investigator and centre data are to be exported at all Centre and country names These are only exported for the rectangular format Images With the image component files of any format can be uploaded to the server This function is intended to be used to collect associated images to a study Therefore besides storing the uploaded file on the server the system tries to generate a web image for display on the ecrf and a thumbnail for compressed display All three images (if existent) can be included into the export and will be stored into a separate image folder As an ecrf item the image will be exported as a reference to the separate table "images" containing some information about the image as origin name, file size, file type, upload date and user who uploaded the image In the rectangular format image items and image data are not included, even if all items has been selected Numbers In secutrial there are integer (without) and double (with decimal digits) number items These items will be exported with the specified input precision Score number fields are exported with the length of 22 digits The actual length of the calculated score num - ber is nevertheless be the same as displayed length in the DataCapture and depends on the calculation al - gorithm and item configuration The used decimal digit character can be defined by specifying the number format language in the export options As of by ias

18 Documentation secutrial 47 Export Formats 33 SAS Format Problems Problem: Data lines in SAS longer than 256 are truncated at 256 bytes and an error may be generated see [ To avoid this problem SAS advise to follow one of two options: Place data in an external file and specify this file in the INFILE statement This allows the LRECL (logical record length, the maximum length of a record) to be specified The appropriate length of each statement is calculated by secutrial Alternatively, split the data lines, so that each line contains less than 256 bytes This is not possible if the data fields themselves are longer then 256 bytes, for example with queries, answers and comments However, data of lines that are longer than 256 bytes may be wrapped to the next line This is indicated in the input statement of the SAS file by the line pointer control character "/" Because text areas in secutrial can consist of more than the allowed length, only the first option is implemented since secutrial 20 Since SAS version 91 it is possible to disable the option QuoteLenMax in the fmt script (export option Ignore warnings for 262 character length ) Because the code list labels are originally not defined in SAS but in various secutrial places, they could exceed the SAS limitations As of by ias

19 Documentation secutrial 47 Export Formats 4 SPSS Format 41 Introduction The SPSS export consists of different files in one zip file with a similar structure as the SAS export One *sps syntax file describes the imported tables and columns and a "dat" folder contains the csv-data files The data files are simple csv-format as described in the next chapter The single columns are enclosed in double quotation marks and are separated by single commas In the data files the column names are listed in the first line which is omitted during the syntax execution but can be used for manual inspections In the syntax files the columns are labelled with the specified text for the SAS export (see table description for details) or the item labels as defined in the FormBuilder for the ecrf layout 42 Data types The medical data entered into the ecrfs are exported either as whole or rational number with defined length or as text The length of text depends on the input field The meta data information such as visit plan date or save timestamps are exported as real dates or datetimes The length of number data are either defined by the number of the form item field for standard number fields or by constants used for coding values Date formats It is possible to export the item dates as real dates Then they will be exported similar to the system generated date and times For the display in SPSS for these variables FORMATS are specified to simulate the input display in the ecrfs The real date formats are listed in the second row for each ias date component If exporting as real date all values not entered in the ecrf are replaced by the defaults given during export start Therefore it is not possible to distinguish if a user has left a minor part of a non-checked date item empty or if the part could not be entered because of the item type Type ias Format SPSS INFORMAT SPSS FORMAT Format Description Example Date (eg visit date) DATE DATE9 DD-MMM-YYYY 28-MAY-2004 The time zone of all exported dates and datetimes is specified in the configuration file of the secutrial installation Datetime ias date components (eg last edit date) DATETIME DATETIME20 DD-MMM-YYYY HH:MI:SS 28-MAY :58:03 YYYY A4 YYYY 2004 DATE MOYR9 DD-MMM-YYYY MM-YYYY A6 YYYYMM DATE MOYR9 DD-MMM-YYYY 01-MAY-2004 DD-MM-YYYY A8 YYYYMMDD DD-MM-YYYY HH:MM DATE DATE11 DD-MMM-YYYY 28-MAY-2004 A12 YYYYMMDDHHMI DATETIME DATETIME18 DD-MMM-YYYY HH:MI:SS 28-MAY :58:00 HH:MM A4 HHMI 1158 TIME TIME5 HH:MI:SS 11:58:00 HH:MM:SS A6 HHMISS TIME TIME8 HH:MI:SS 11:58:03 MM:SS A4 MISS 5803 TIME TIME8 HH:MI:SS 00:58:03 As of by ias

20 Documentation secutrial 47 Export Formats Type ias Format SPSS INFORMAT SPSS FORMAT Format Description Example ias calculated date time intervals Y A4 YYYY 0052 Y-M A6 YYYYMM Y-M-D A8 YYYYMMDD Y-M-D-H-M A12 YYYYMMDDHHMI H-M A12 YYYYMMDDHHMI H-M-S A14 YYYYMMDDHHMISS M-S A14 YYYYMMDDHHMISS Because there are no display type for minutes and seconds only, this item type is formatted as a complete time if exported as real date There is no FORMATS type in SPSS for year only, so this item type is format - ted similar to the month-year item Because of the three-letter month abbreviation it is possible to select the language for the date format Probably most SPSS installation will need the date-language in english Code Lists Coded values such as radio button, popup, lookups, checkboxes as well as status values and participant references are exported as coded values with defined value labels containing all corresponding possible values The following items are exported as code lists: Status values (F20) These are most binary values which only have one key/value pair for the value "1" Some status values are coded by a small amount of values The length for this fields are F20 Checkbox values (F20) Checkboxes may only be set or not set, like a binary value In the data table, the value 1 represents "set" The coding of the value is stored in the code lists, and quite like the binary status values, may only have two key/value pair The standard value are "yes" and "no" Drop down selections (F100) All choices of the drop down are coded in the code list Radio-button choices (F100) All choices of a radio-button group are coded in the code list Query, answer, comment, sdv status code lists (F20) The type of the annotation to an ecrf Investigators (F100) All investigators referenced in export data are coded in code lists These are only exported if investigator and centre data are to be exported at all Centre and country names (F100) These are only used for the rectangular format Images With the image component files of any format can be uploaded to the server This function is intended to be used to collect associated images to a study Therefore besides storing the uploaded file on the server the system tries to generate a web image for display on the ecrf and a thumbnail for compressed display All three images (if existent) can be included into the export and will be stored into a separate image folder As an ecrf item the image will be exported as a reference to the separate table "images" containing informations about the image as origin name, file size, file type, upload date and user who uploaded the image In the recangular format image items and image data are not included, even if all items has been selected As of by ias

21 Documentation secutrial 47 Export Formats Numbers The number format in SPSS depends on the system locale of the SPSS installation As this could be set during the import it would change the setting permanently So the number format can be chosen before the ex - port creation in secutrial independently of the module or project configuration to match the SPSS system used for evaluation As of by ias

22 Documentation secutrial 47 Export Formats 5 CSV & Text Formats 51 Introduction The CSV-Format (Character Separated Values) is a very flexible export format, and many systems support their import: Microsoft Excel, OpenOfficeorg Calc, Oracle, SPSS A disadvantage of this format against SAS and CDISC is that no meta-data such as labels and descriptions of fields may be exported The CSV and Text formats are described together here They only vary slightly in the formatting of the data lines Three export selections are available for these formats: CSV Format for MS Excel CSV Data Text files with fixed field lengths Image 4: Possible encloser types for the CSV export format The CSV formats use variable field lengths The data fields are enclosed with field enclosure characters and are delimited by another character The MS-Excel format uses a tabulator "(Tabulator)" as field separator and double quotation marks as field enclosure characters In the CSV data format these delimiters may be altered (see possible selection as shown above) In the text file format with fixed field lengths, all fields are exported with fixed field lengths and no field delimiters are used, similar to the SAS dat-file format Each table is exported to a separate file The file name has the name of the table Reference values may be exported to separate tables or to the same table When exported to the same table, the code is replaced If exported to a separate file, they are all exported to one file, with the naming convention cl_ + project abbreviation Column names may be exported these will be exported to the first line of each file 52 Data types Date Formats It is possible to export the item dates as real dates Then they will be exported similar to the system generated date and times The real date formats are listed in the second row for each ias date component It is not possible to specify a distinct display format in CSV or TXT files This has to be done manually in the used software if desired If exporting as real date all values not entered in the ecrf are replaced by the defaults given during export start It is not therefore not possible to distinguish if a user has left a minor part of a non-checked date item empty or if the part could not be entered because of the item type Type ias Format Format Description Example Date (eg visit date) YYYY-MM-DD The time zone of all exported dates and datetimes is specified in the configuration file of the secutrial installation Datetime (eg last edit date) YYYY-MM-DD HH:MI:SS :58:03 YYYY YYYY 2004 As of by ias

23 Documentation secutrial 47 Export Formats Type ias Format Format Description Example ias date components ias calculated date time intervals YYYY-MM-DD MM-YYYY YYYYMM DD-MMM-YYYY DD-MM-YYYY YYYYMMDD DD-MMM-YYYY DD-MM-YYYY HH:MM YYYYMMDDHHMI DD-MMM-YYYY HH:MI:SS :58:03 HH:MM HHMI 1158 HH:MI:SS 11:58:00 HH:MM:SS HHMISS HH:MI:SS 11:58:03 MM:SS MISS 5803 HH:MI:SS 00:58:03 Y YYYY 0052 Y-M YYYYMM Y-M-D YYYYMMDD Y-M-D-H-M YYYYMMDDHHMI H-M YYYYMMDDHHMI H-M-S YYYYMMDDHHMISS M-S YYYYMMDDHHMISS Code Lists Code lists could be exported to a separate file with the name "cl_" + project-abbreviation if the option separ - ate table is chosen Otherwise the db-values of code lists would be replaced by the referenced (label-) val - ues during export The three columns contain information about "column", "code", and "value" The column is described by table name + "" + column name The code consists of the db-value to be interpreted, and the value represents the meaning of the code The following item types are referenced in the code list: Binary status values These only have one key/value pair for the value "1 Status values for status with more than one option Checkbox values Checkboxes may only be set or not set, like a binary value In the data table, the value "1" represents "set" The coding of the value is stored in the code lists and like the binary status values may only have two key/value pair The value is "yes" or "no" possibly appended by label following the checkbox display in the form Drop down selections All choices of the drop down are coded in the code list Radio-button choices All choices of a radio-button group are coded in the code list Queries, sdv: The type of annotation to an ecrf Investigators All investigators referenced in export data are coded in code lists These are only exported if investigator and centre data are to be exported If an item references a lookup table and the reference values are exported into separate files the values of the lookup table are referenced by this lookup table name in contrast to simple code list values of radio but - As of by ias

24 Documentation secutrial 47 Export Formats tons which are referenced by table- and column name of the item The information which lookup table has to be used for an item is given in the "lookuptablename" column of the item-description With the rectangular table format the option separate table cannot be chosen and all values will be directly exported inline in the data table Images With the image component files of any format can be uploaded to the server This function is intended to be used to collect associated images to a study Therefore besides storing the uploaded file on the server the system tries to generate a web image for display on the ecrf and a thumbnail for compressed display All three images (if existent) can be included into the export and will be stored into a separate image folder As an ecrf item the image will be exported as a reference to the separate table "images" containing some information about the image as origin name, file size, file type, upload date and user who uploaded the image In the rectangular format image items and image data are not included, even if all items has been selected Numbers The number format can be chosen before the export creation in secutrial independently of the module or project configuration to match the software system used for evaluation As of by ias

25 Documentation secutrial 47 Export Formats 6 Table descriptions The following table description generally applies in structure and content to the SAS, SPSS and the CSV / TXT formats The Label descriptions are only applicable for the SAS or SPSS export format The SAS Length/ Format description is only applicable for the SAS export format The SPSS Format descriptions are only applicable for the SPSS export format For simple CSV or TXT format only the variable names are exported and even that only if the corresponding option ( column names ) has been chosen 61 visitplan /vp (Project visit plan) This table is exported if the option "Project setup" was included The primary key of the visit ( mnpvisid ) is referenced in every visit related ecrf This table is always exported in the rectangular format as an explanation for the the column visit numbers In the productive area the visitplan of the current, productive project and all archived project versions are ex - ported, the version information is included in the last two columns In the setup area these columns will be empty Only if a project has just been set to released but the release has not been performed the version in - formation of the next productive version is included there Variable Label SAS Length/ Format SPSS Format Description mnpvisid Visit-ID 10 F100 Identifier of the visit Used in ecrf Data as reference to the Visit Plan visitnumber Visit sequence 10 F40 Sequence of visit creation visittype Type of visit 2 [clvt] F20 Type of visit (scheduled/unscheduled, type of date check) [ 0 = 'fixed' 1 = 'flexible' 2 = 'unscheduled' 3 = 'free'] previsid Preceding visit-id 10 F100 Reference to the preceding visit (needed for calculation of visit date) visitday minusoffset plusoffset Time lag to preceding visit (days) Possible negative time frame (days) Possible positive time frame (days) 10 DATE11 The visit plan date is calculated by the date from the preceding visit (see above) and this time lag 10 F100 For some visit types it is possible to give a time frame around the calculated visit day where a visit is allowed This defines the days before the visit plan date 10 F100 For some visit types it is possible to give a time frame around the calculated visit day where a visit is allowed This defines the days past the visit plan date visitarm Treatment arm $100 A100 Name of the treatment arm if this visit is dedicated to an arm visitgroup Visit group $100 A100 Name of the visit group if this visit is included into a (repeated) visit group 1 hidden hidden in DataCapture 2 [clhd] F20 A status setting indicating that this visit is hidden in the DataCapture [ 0 = 'no' 1 = 'yes'] visitlabel Visit label $50 A50 Visit label that is shown in the patients matrix (DataCapture) mnpvsno Version number 10 F100 Version number of project (will only be set in productive area) As of by ias

26 Documentation secutrial 47 Export Formats Variable Label SAS Length/ Format SPSS Format Description mnpvslbl Version label $30 A30 Version label of project (will only be set in productive area) 1: Hidden fields This variable is only exported if there are any hidden fields in the project and the option "Form data of hidden fields" has been chosen 62 visitplanforms / vpfs (Forms shown in visits) This table is exported if the option "Study setup" was included It only consists of the two foreign keys of visit and form, indicating which form is presented in which visit This can be used to check if every presented form is stored for a patient Variable Label SAS Length/ SPSS Format Description Format mnpvisid Visit-ID 10 F100 Identifier of the visit Used in ecrf Data as reference to the Visit Plan formid Form-ID 10 F100 Identifier of the Form-Definition 63 forms / fs (Forms) All forms are exported to one table This is exported if the option "Project setup" was included An ecrf in secutrial is based on a form definition which is set up in the FormBuilder and stored in the database too A short form setup description is exported too in three tables: "forms", "questions" and "items" The ecrf setup is structured hierarchically: 'form' <-->> 'question' <-->> 'item' One ecrf is described with one form (and stored into one db table) The questions are mainly for layout purpose but connect also to the subforms The items itself reflects the single db column In queries and comments the items are referenced by id and Colum name For subforms the question-id of the parent-repetition is exported to distinguish between double referenced subforms in the same parent form (eg medication in the morning and medication in the evening, recorded in one form "medication") The 'hidden' column is only present for projects which contain at least one 'hidden' element (either form, question or item) In the productive area the forms of the current, productive project and all archived project versions are expor - ted, the version information is included in the last two columns In the setup area these columns will be empty Only if a project has just been set to released but the release has not been performed the version in - formation of the next productive version is included there The variables for forms are: Variable Label SAS Length [Format] SPSS Format Description formid Form-ID 10 F100 Unique identifier of the form formtablename DB table name $24 A24 The table name for the form-data This table name is used in the export as the (part) filename too 1 hidden hidden in DataCapture 2 [clhd] fornname Form name (as in matrix) F20 A status setting indicating that this form is hidden in the DataCapture [ 0 = 'no' 1 = 'yes'] $200 A100 This name is used in the patient matrix to identify an ecrf Most times it will be the same as the title of the opened ecrf As of by ias

27 Documentation secutrial 47 Export Formats Variable Label SAS Length SPSS Format Description [Format] formfamily Form family name $100 A100 Name of the form family as displayed in the matrix sequence Form sequence in form family 2 ddetype DDE form type 2 [cldde] 10 F100 Sequence of form in the form family This field is used for numerical sorting F20 A flag indicating that this form is used as a double data entry form [ 0 = 'normal form' 1 = 'DDE form' ] mnpvsno Version number 10 F100 Version number of project (will only be set in productive area) mnpvslbl Version label $30 A30 Version label of project (will only be set in productive area) 1: Hidden fields This variable is only exported if there are any hidden fields in the project and the option "Form data of hidden fields" has been chosen 2: Double Data Entry This variable is only exported if there is any double data entry form in the project 64 questions / qs (Questions) This table is exported if the option "Project setup" was included Questions are the intermediate level between forms and items This level is used in secutrial mostly for layout purpose Often it does contain the question text of the ecrf The 'hidden' column is only present for projects which contains at least on 'hidden' element (either form, question or item) The variables for questions are: Variable Label SAS Length [Format] SPSS Format Description fgid Question-ID 10 F100 Unique identifier for the question This ID is referenced in the QAC table formid Form-ID 10 F100 Identifier of the form, foreign key to the forms table sequence Question sequence in form 1 hidden hidden in DataCapture 2 [clhd] fglabel Question label (or unique label for search) 10 F100 Sequence of question in the form as used for sorting This may not be filled or may not simply be incremented This field is nevertheless used for numerical sorting F20 A status setting indicating that this form is hidden in the DataCapture [ 0 = 'no' 1 = 'yes'] $200 A200 The text of the question in the form If this is not set, the unique label for search is used (which must be set at least in the FormBuilder) fgid Question-ID 10 F100 Unique identifier for the question This ID is referenced in the QAC table formid Form-ID 10 F100 Identifier of the form, foreign key to the forms table sequence Question sequence in form 10 F100 Sequence of question in the form as used for sorting This may not be filled As of by ias

28 Documentation secutrial 47 Export Formats Variable Label SAS Length [Format] subformtablename Sub-form DB table name SPSS Format Description or may not simply be incremented This field is nevertheless used for numerical sorting $24 A24 The table name for the subform data This column is only filled for repetition form groups 1: Hidden fields This variable is only exported if there are any hidden fields in the project and the option "Form data of hidden fields" has been chosen 65 items / is (Items) This table is exported if the option "Study setup" was included All Items are exported to one table One item corresponds to a single data field in the ecrf Sometimes the textual descriptions are stored in the question label (see above) therefore the exported label could be the same as the label of the question itself The 'hidden' column is only present for projects which contains at least on 'hidden' element (either form, question or item) The variables for items are: Variable Label SAS Length [Format] SPSS Format Description ffid Item-ID 10 F100 Unique identifier for the item fgid Question-ID 10 F100 Identifier for the question, foreign key to questions This ID is referenced in the QAC table sequence Item sequence in question 10 F100 Sequence of items in the question as used for sorting This may not be filled or may not simply be incremented This field is nevertheless used for numerical sorting ffcolname DB column name $32 A32 Identifier of the form, foreign key to the forms table 1 hidden hidden in DataCapture 2 [clhd] fflabel Item label (or question label or unique label for search) F20 A status setting indicating that this form is hidden in the DataCapture [ 0 = 'no' 1 = 'yes'] $1500 A1500 The text of the question in the form If this is not set, the question label or at least the unique label for search is used (which must be set in the FormBuilder) lookuptable name of lookup table $30 A30 If the column refers to it the name of the Lookup table is inscribed 2 ddecomp Comparison type for DDE 2 [clddecomp] F20 A status describing the type of comparison for DDE [ null/0 = 'compare' 1 = 'ignore' 2 = 'ignore case and whitespace' (only text) 3 = 'compare including hash values' (only images)] 1: Hidden fields This variable is only exported if there are any hidden fields in the project and the option "Form data of hidden fields" has been chosen As of by ias

29 Documentation secutrial 47 Export Formats 2: Double Data Entry This variable is only exported if there is any double data entry form in the project 66 centres / ctr (Centres) This table is exported if it is chosen to export "Investigator and centre" option All centres of the project are exported The primary key of the centre "mnpctrid" is then referenced in every casenode The variables for centres are: Variable Label SAS Length [Format] SPSS Format Description mnpctrid Centre-ID 10 F100 The identifier of the centre mnpctrname Centre name $100 A100 The name of the centre mnpcname Country name $200 A200 The name of the country 67 casenodes / cn (Patient information) This table contains the basic information about the exported patients Various casenode identifiers may be exported, if they are available in the system Each patient is identified with a unique primary key The participant referenced here is the person responsible for the patient inclusion into the given project (needed for payment) A patient pseudonym or an additional identifier (=AID) also uniquely identifies a patient This need not be ex - ported though The selection option for this depends on the project configuration Patients with the status set to "to-be-deleted" will never be exported Patients with the status "delete pseud - onym" will be exported if the option "all patients" have been chosen Otherwise these patients will be omitted too The casenode table will be extended with the columns of the configurable randomization items as defined in the project If the column names are not unique across the project the column names will be prefixed with the table name The variables for casenode are: Variable Label SAS Length [Format] SPSS Format Description mnppid Patient-ID 10 F100 Identifies each patient uniquely This identifier is a unique number which each patient record receives automatically and can not be altered mnppsd mnpaid mnplabid Patient pseudonym Patient identifier Patient identifier 0 mnpptnid Participant-ID 10 [cltn] $20 A20 The random patient pseudonym This identifier may not be exported $20 A20 An alternative patient identifier which may be entered when the patient is stored This identifier may not be exported $20 A20 An alternative patient identifier which is given when the patient is created This identifier may not be exported F100 The identifier of the user who entered the patient into the project Investigators are exported as code lists and the identifier is the key of the code list 1 mnpctrid Centre-ID 10 F100 The identifier of the centre This information is not exported if centre data are not to be exported Centres are exported as separate tables and this identifier is the primary key of that table 2 mnpcs0 Case status 0 2 [clcs_0x] 2 mnpcs1 Case status 1 2 [clcs_1x] F20 A status setting indicating that the patient record is not valid [ 1 = 'not shown'] F20 A status setting indicating that the patient record As of by ias

30 Documentation secutrial 47 Export Formats Variable Label SAS Length [Format] 2 mnpcs2 Case status 2 2 [clcs_2x] 2 mnpcs3 Case status 3 2 [clcs_3x] 2 mnpcs4 Case status 4 2 [clcs_4x] 2 mnpcs5 Case status 5 2 [clcs_5x] 2 mnpcs6 Case status 6 2 [clcs_6x] 2 mnpcs7 Case status 7 2 [clcs_7x] SPSS Format Description has been marked as being anonymized (no pseudonym) [ 1 = 'delete Pseudonym'] F20 A status setting indicating that the patient record data is frozen and may not be changed This status is not used at the moment therefore it is not distinguished from the next [ 1 = 'data frozen'] F20 A status setting indicating that the patient record has been frozen automatically, set by rule [ 1 = 'data frozen'] F20 A status setting indicating that the patient has deceased [ 1 = 'deceased'] F20 A status setting indicating that the patient data in this project is frozen and may not be changed [ 1 = 'Project: data frozen] F20 A status setting indicating that the patient data in this project will be deleted [ 1 = 'Project: to be deleted'] F20 A status setting stating that no new visits may be added for this patient in this project [ 1 = 'Project: closed visit plan'] 3 visitstartdateentry date DATE11 DATE11 Date of patient entry into the project Base for the calculation of the patients visit plan 4 random Label of the randomization item $100 A100 Randomization similar to the form table with the randomization button item Depending on project setup there may be multiple columns of this type The columns includes either the randomization number or the randomization group depending on blinding of the project and choosen export option 0: Investigator information This variable is only exported if the export option form meta data "Document editing" has been chosen 1: Centre information This variable is only exported if the export option "Centre information" has been chosen 2: Patient status This variable is only exported if the export option form meta data "patient status" has been chosen 3: Structure information This variable is only exported if the export option form meta data "structure information" has been chosen 4: Randomization information This variable(s) is (are) only exported if the project contains any configurable randomization The variable name and label of this information depends on the definition of the randomization button item 68 atcasenodes / atcn (Patient information history) The audit trail tables of the patient visit plans are divided into two tables: 'atcn' and 'atcvp' which are exported with the "Audit trail" option For casenodes the entry dates could be changed to adjust the base of the visit plan As of by ias

31 Documentation secutrial 47 Export Formats Variable Label SAS Length SPSS Format Description [Format] mnppid Patient-ID 10 F100 Identifies each patient uniquely This identifier is a unique number which each patient record receives automatically and can not be altered oldvisitstartdate Old entry date DATE11 DATE11 Former entry date before change of visit plan newvisitstartdate New entry date DATE11 DATE11 New date after the change of visit plan 0 mnpptnid Participant-ID 10 [cltn] F100 The identifier of the user who made the change of the entry date Investigators are exported as code lists and the identifier is the key of the code list 1 mnppusid Patientuser-ID 10 F100 Patient ID if the patient has made the change instead of the participant, references the mnppid from the casenode table changedate Date of change DATETIME20 DATETIME20 Timestamp of change changereason Reason for change $200 A200 Reason given by user 0: Investigator information This variable is only exported if the export option form meta data "Document editing" has been chosen 1: Patientuser These variable is only exported if the export option "Investigator and centre information" has been chosen and the project uses the PSD workflow In that case either participant or patient could have made one entry In that case for each line either participant or patientuse will be set, not both 69 atcasevisitplans / atcvp (Patient visit plan history) The audit trail tables of the patients case visit plans are divided into two tables: 'atcn' and 'atcvp' which are exported with the "Audit trail" option Patient visits could be changed in the planned visit date or - for un - scheduled visits - in the visit type Variable Label SAS Length SPSS Format Description [Format] mnppid Patient-ID 10 F100 Identifies each patient uniquely This identifier is a unique number which each patient record receives automatically and can not be altered mnpcvpid Patient visit-id 10 F100 Unique identifier for the visit of a patient If the visit has been deleted, this column is empty oldmnpvispdt old planned date of visit DATE11 DATE11 Former plan date before change of visit plan newmnpvispdt New planned date of visit DATE11 DATE11 New plan date after the change of visit plan If the visit has been deleted, this column is empty oldmnpvisid Old visit-id 10 F100 If the type of an unscheduled visit was changed, this is the former visit type newmnpvisid New visit-id 10 F100 If the type of an unscheduled visit was changed, this is the new visit type If the visit has As of by ias

32 Documentation secutrial 47 Export Formats Variable Label SAS Length [Format] SPSS Format Description been deleted, this column is empty oldmnpvisno Old patient-visit number 10 F100 The patient-visits are counted in the sequence of their creation, starting with 1 The counting is independently for the scheduled and unscheduled visits Unscheduled visits are counted individually be type If a visit type was changed, the absolute numbers and sequences have to be adjusted The former number is stored here newmnpvisno New patient-visit number 10 F100 The patient-visits are counted in the sequence of their creation, starting with 1 The counting is independently for the scheduled and unscheduled visits Unscheduled visits are counted individually be type If a visit type was changed, the absolute numbers and sequences have to be adjusted The new number is stored here If the visit has been deleted, this column is empty 0 mnpptnid Participant-ID 10 [cltn] F100 The identifier of the user who made the change of the visit Investigators are exported as code lists and the identifier is the key of the code list 0 mnppusid Patientuser-ID 10 F100 Patient ID if the patient has 1 made the change instead of the participant, references the mnppid from the casenode table changedate Date of change DATETIME20 DATETIME20 Timestamp of change changereason Reason for change $200 A200 Reason given by participant 0: Investigator information This variable is only exported if the export option form meta data "Document editing" has been chosen 1: Patientuser This variable is only exported if the project uses the PSD workflow In that case either participant or patient could have made one entry In that case for each line either participant or patientuse will be set, not both 610 queries / qac (Queries) This table is exported if it is chosen to export "queries and comments" option Queries and comments are annotations to the ecrfs Each ecrf may have multiple queries and com - ments One query can consist of many questions and answers At least a query is resolved with a final remark At least resolved queries consist of one question, one answer and one final remark Queries are placed upon single items in the form The variables for queries are: As of by ias

33 Documentation secutrial 47 Export Formats Variable Label SAS Length SPSS Format Description [Format] mnppid Patient-ID 10 F100 The unique patient identifier associating a query record to a patient record mnpdocid Document-ID 10 F100 Unique identifier of the ecrf to which this annotation has been added As queries could be added on normal items or item in subforms, this is either the mnpdocid from the outer form or the mnpsubdocid from the inner form ffid Item-ID 10 F100 Identifier for the item, foreign key to table "items" ffcolname DB column name $32 A32 Column name of the item 2 hidden hidden in DataCapture 2 [clhd] F20 A status setting indicating that this query is hidden in the DataCapture because either item, question, form or visit is hidden [ 0 = 'no' 1 = 'yes'] qacdate Date of entry DATETIME20 DATETIME20 The date when the annotation was edited mnpqueryid Query-ID 10 F100 Unique identifier of a query This field indicates which answer belongs to which question 1 querytype Query Type (Manual or Automatic) querystatus Query Status (Calculated Status) qacstatus QAC Status (type of query-entry) $1 A1 The type indicates if the query is the result of an automatically check (via discrepancies) or entered directly into the form [A = 'Automatical' M = 'Manual'] 2 [clqa] 2 [clqa] 0 mnpptnid Participant-ID 10 [cltn] F20 The result status of the actual sequence of queries and answers (= the status of the last query-entry) If the query is based on an automatic check (type="a"), then the final resolve could be marked for a new check The last option is only available if the setup includes the discrepancies handling (DTM) [ 0 = 'no entry' 1 = 'Query' 2 = 'Answer' 4 = 'Resolved' 8 = 'Resolved and check again'] F20 The status of the single query entry The type is the same as the result status of the whole query (see above) F100 The identifier of the user Investigators are exported as code lists and the identifier is the key of the code list qaccontent Content $1000 A1000 The content of the annotation 0: Investigator information This variable is only exported if the export option form meta data "Document editing" has been chosen 1: DTM This variable is only exported if the setup of secutrial includes the discrepancies handling (DTM) As of by ias

34 Documentation secutrial 47 Export Formats 2: Hidden fields This variable is only exported if there are any hidden fields in the project and the option "Form data of hidden fields" has been chosen 611 comments / cts (Comments) This table is exported if it is chosen to export "queries and comments" option Comments are annotations to the ecrfs Each ecrf may have multiple comments The comments are single, unrelated remark to single items The variables for Comments are: Variable Label SAS Length [Format] SPSS Format Description mnppid Patient-ID 10 F100 The unique patient identifier associating a comment record to a patient record mnpdocid Document-ID 10 F100 Unique identifier of the ecrf to which this annotation has been added As comments could be added on normal items or item in subforms, this is either the mnpdocid from the outer form or the mnpsubdocid from the inner form ffid Item-ID 10 F100 Identifier for the item, foreign key to table "items" ffcolname DB column name $32 A32 Column name of the item 1 hidden hidden in Data- Capture 2 [clhd] F20 A status setting indicating that this comment is hidden in the DataCapture because either item, question, form or visit is hidden [ 0 = 'no' 1 = 'yes'] qacdate Date of entry DATETIME20 DATETIME20 The date when the annotation was edited mnpcommentid Comment-ID 10 F100 Unique identifier of a Comment 0 mnpptnid Participant-ID 10 [cltn] F100 The identifier of the user Investigators are exported as code lists and the identifier is the key of the code list qaccontent Content $1000 A1000 The content of the annotation 0: Investigator information This variable is only exported if the export option form meta data "Document editing" has been chosen 1: Hidden fields This variable is only exported if there are any hidden fields in the project and the option "Form data of hidden fields" has been chosen 612 sdv / sdv (Source Data Verification) This table is exported when the selected project has this function configured and the corresponding export option was chosen For every item there could be an entry in this table stating the state of SDV If there is no entry, the item has the default status "not done" If the value of an SDV for an item or form has changed, the old values will be transferred in to the SDV audit trail table (see down) Variable Label SAS Length SPSS Format Description [Format] mnppid Patient-ID 10 F100 The unique patient identifier associating a comment record to a patient record mnpdocid Document-ID 10 F100 Unique identifier of the ecrf on which the SDV has been performed As SDV could be As of by ias

35 Documentation secutrial 47 Export Formats Variable Label SAS Length [Format] SPSS Format Description done on normal items or item in subforms, this is either the mnpdocid from the outer form or the mnpsubdocid from the inner form ffid Item-ID 10 F100 Identifier for the item, foreign key to table "items" ffcolname DB column name $32 A32 Column name of the item 1 hidden hidden in Data- Capture 2 [clhd] F20 A status setting indicating that this query is hidden in the DataCapture because either item, question, form or visit is hidden [ 0 = 'no' 1 = 'yes'] sdvdate Date of entry DATETIME20 DATETIME20 The date when the SDV was performed mnpfssdv Status SDV 2 [clfssdv] 0 mnpptnid Participant-ID 10 [cltn] F20 Status of the referenced item [ 1 = 'not done' 2 = 'not necessary' 4 = 'not possible' 8 = 'deferred' 16 = 'in progress' 32 = 'verified' 64 = 'verified with errors' ] F100 The identifier of the user Investigators are exported as code lists and the identifier is the key of the code list 0: Investigator information This variable is only exported if the export option form meta data "Document editing" has been chosen 1: Hidden fields This variable is only exported if there are any hidden fields in the project and the option "Form data of hidden fields" has been chosen 613 atsdv / atsdv (Source Data Verification audit trail) This table is exported when the selected project has this function configured and the SDV and audit trail export option was chosen For every item there could be an entry in this table stating the former state of SDV If there is no entry, the item has the default status "not done" Variable Label SAS Length SPSS Format Description [Format] mnppid Patient-ID 10 F100 The unique patient identifier associating a comment record to a patient record mnpatdocid ATDocument-ID 10 F100 Unique identifier of the audit trail ecrf on which the SDV has been performed As SDV could be done on normal items or item in subforms, this is either the mnpdocid from the outer form or the mnpsubdocid from the inner form ffid Item-ID 10 F100 Identifier for the item, foreign key to table "items" ffcolname DB column name $32 A32 Column name of the item 1 hidden hidden in Data- Capture 2 [clhd] F20 A status setting indicating that this query is hidden in the DataCapture because either item, question, form or visit is hidden [ 0 = 'no' As of by ias

36 Documentation secutrial 47 Export Formats Variable Label SAS Length [Format] SPSS Format 1 = 'yes'] Description sdvdate Date of entry DATETIME20 DATETIME20 The date when the SDV was performed mnpfssdv Status SDV 2 [clfssdv] 0 mnpptnid Participant-ID 10 [cltn] F20 Status of the referenced item [ 1 = 'not done' 2 = 'not necessary' 4 = 'not possible' 8 = 'deferred' 16 = 'in progress' 32 = 'verified' 64 = 'verified with errors' ] F100 The identifier of the user This information is not exported if investigator data are not to be exported Investigators are exported as code lists and the identifier is the key of the code list 0: Investigator information This variable is only exported if the export option form meta data "Document editing" has been chosen 1: Hidden fields This variable is only exported if there are any hidden fields in the project and the option "Form data of hidden fields" has been chosen 614 miv / miv (Missing Values) This table is exported when the selected project has this function configured and the corresponding export option was chosen For every item there could be an entry in this table stating the state of Missing Values If there is no entry, the item has the default status "Value exists" If the value of an MV for an item has changed, the old values will be transferred in to the MV audit trail table (see down) Variable Label SAS Length [Format] SPSS Format Description mnppid Patient-ID 10 F100 The unique patient identifier associating a comment record to a patient record mnpdocid Document-ID 10 F100 Unique identifier of the ecrf on which the MV has been set As MV could be done on normal items or item in subforms, this is either the mnpdocid from the outer form or the mnpsubdocid from the inner form ffid Item-ID 10 F100 Identifier for the item, foreign key to table "items" ffcolname DB column name $32 A32 Column name of the item 1 hidden hidden in DataCapture 2 [clhd] F20 A status setting indicating that this query is hidden in the DataCapture because either item, question, form or visit is hidden [ 0 = 'no' 1 = 'yes'] editdate Date of entry DATETIME20 DATETIME20 The date when the MV was performed mivstatus Status MV 2 [clmiv] F20 Status of the referenced item, label depends on project configuration [ 2 = 'Value not collected' 3 = 'Other reason for missing value' 4 = 'Value not collected due to rule' ] As of by ias

37 Documentation secutrial 47 Export Formats Variable Label SAS Length [Format] mivstatustext Other reason for MV SPSS Format Description $250 A250 Other reason for missing value (freetext entry of user) May only be exported if project configured to use this MV status 1: Hidden fields This variable is only exported if there are any hidden fields in the project and the option "Form data of hidden fields" has been chosen 615 atmiv / atmiv (Missing Values audit trail) This table is exported when the selected project has this function configured and the MV and audit trail export option was chosen For every item there could be an entry in this table stating the former state of MV If there is no entry, the item has the default status "Value exists" Variable Label SAS Length SPSS Format Description [Format] mnppid Patient-ID 10 F100 The unique patient identifier associating a comment record to a patient record mnpatdocid ATDocument-ID 10 F100 Unique identifier of the audit trail ecrf on which the SDV has been performed As SDV could be done on normal items or item in subforms, this is either the mnpdocid from the outer form or the mnpsubdocid from the inner form ffid Item-ID 10 F100 Identifier for the item, foreign key to table "items" ffcolname DB column name 1 hidden hidden in Data- Capture $32 A32 Column name of the item 2 [clhd] F20 A status setting indicating that this query is hidden in the DataCapture because either item, question, form or visit is hidden [ 0 = 'no' 1 = 'yes'] editdate Date of entry DATETIME20 DATETIME20 The date when the MV was performed mivstatus Status MV 2 [clmiv] mivstatustext Other reason for MV F20 Status of the referenced item, label depends on project configuration [ 2 = 'Value not collected' 3 = 'Other reason for missing value' 4 = 'Value not collected due to rule' ] $250 A250 Other reason for missing value (freetext entry of user) May only be exported if project configured to use this MV status 1: Hidden fields This variable is only exported if there are any hidden fields in the project and the option "Form data of hidden fields" has been chosen 616 mnp : ecrf Data The ecrf tables have names following the naming convention for short and long names described above The audit records are stored in separate tables, and these have the same name as the table along with a constant prefix 'at' The audit tables have the same structure as the data tables, with an additional new primary key The original document is referenced by the original primary key As of by ias

38 Documentation secutrial 47 Export Formats The variable ecrfs have fixed and varying schema Each ecrf table has the same fixed variables The varying variables are ecrf dependent The labels of the varying schema are taken from the form definition as made in the FormBuilder If the item label is set, this is used directly If no item label is set, the question label is used instead If this is not set either, the unique label for search of the question is used, which must be set at least If the item is the number part of a unit group, the standard unit is appended in brackets to the label Four types of ecrf record sets exist: 1 Data belonging to the casenode, independent of a visit These ecrfs just have a reference to the patient casenode 2 Data collected during patient visits These ecrfs contain visit details Each visit is identified by a visit-id All records of one patient in the same visit have the same visit-id For each patient the visits are numbered according creation sequence 3 Data of Adverse Events and Serious Adverse Events These ecrfs contain details of the Adverse Event and Follow-up For each patient the adverse events are numbered according creation sequence 4 Data of image forms could be created without study plan and related to either patient directly or every single visit or adverse event follow-up These forms depend on corresponding templates in the project setup and are therefore not necessarily included into every study Some of the standard variables depend on the selected options for export These are commented in the descriptions of the variables Only a few variables depend on the overall project configuration as made in the FormBuilder or on the general setup of secutrial These variables are explicitly stressed in the descriptions below (The order of description is approximately the order of export) Some ecrf variables are only exported for special types of forms These variables are marked by numbers explained below Variable Label SAS Length SPSS Format Description [Format] mnppid Patient-ID 10 F100 The unique patient identifier associating an ecrf record to a patient record mnpdocid Document-ID 10 F100 Each ecrf document record has a unique document identifier ddeduplicatedid Document-ID of the duplicate document for DDE dderealdid Document-ID of the real document for DDE 10 F100 Document-ID of the duplicate document for DDE (only set if this is the original document) This column is only exported, if the project configuration includes the DDE function 10 F100 Document-ID of the real document for DDE (only set if this is the duplicate document) This column is only exported if the project configuration includes the DDE function 0 mnplastedit Date of last edit DATETIME20 DATETIME20 Date when record was last edited (=saved) 0 mnpptnid Participant-ID 10 [cltn] F100 The identifier of the user who (last) saved the form Investigators are exported as code lists and the identifier is the key of the code list 0 mnppusid Patientuser-ID 10 F100 Patient ID if the patient has made the change instead of the participant, references the mnppid from the casenode table This column is only exported if the project configuration includes the PSD function 1v mnpvisid Visit-ID 10 F100 Identifier of the visit to which the ecrf belongs This is the identifier for the common variables of the case visit plan 1v mnpcvpid Patient visit-id 10 F100 Unique identifier for each patient visit 1v mnpvisno Patient visit number 10 F100 Individual number of visit for the given casenode This number is calculated during the creation of the visit, it does As of by ias

39 Documentation secutrial 47 Export Formats 1v mnpvgrno Variable Label SAS Length [Format] 1v mnpvispdt 1v mnpvisfdt 1a mnpaeid 1a mnpaedate 1a mnpaeno 1a mnpaefuid 1a mnpaefudt 1i mnpcrtdt 1i mnpcrtpt 1i mnpcrtpusid Patient visit group number Planned date of visit Date of first data entry in visit Adverse Event- ID Adverse Event date Adverse Event casenumber Adverse Event Follow-up-ID Adverse Event Follow-up date Document create date Document creator (participant) Document creator (patientuser) 2 mnpfs0 Form status (Review A) 2 mnpfs1 Form status (Review B) 2 mnpfs2 Form status (Freeze) 2 mnpfs3 Form status (System-Freeze) SPSS Format Description not necessarily reflect the temporal sequence of visits Scheduled and unscheduled visits are counted independently Unscheduled visits are counted separate for each type 10 F100 Individual number of repeating of group if the current visit is included in a (repeated) visit group DATE11 DATE11 The planned date of the visit For a fixed visit this date is predefined by the visit plan For flexible, free and unscheduled visits this date is entered during the creation of a new visit by the participant DATETIME20 DATETIME20 The date of first data entry Normally this should be the real date of visit 10 F100 Unique identifier of an Adverse Event DATETIME20 DATETIME20 The date when the Adverse Event occurred 10 F100 Individual number of the Adverse Event for the given casenode This number is calculated during the creation of an Adverse Event, it does not necessarily represent the temporal order of events 10 F100 The ID of a follow-up to the Adverse Event DATETIME20 DATETIME20 The date when the patient data was collected for the follow-up DATETIME20 10 [cltn] DATETIME20 The date of the creation of this document F100 The user who creates this document This information is not exported if investigator data are not to be exported Investigators are exported as code lists and the identifier is the key of the code list 10 F100 The patientuser who creates this document This is the Patient ID if the patient has made the change instead of the participant, references the mnppid from the casenode table This column is only exported if the project configuration includes the PSD function 2 [clfs_0x] 2 [clfs_1x] 2 [clfs_2x] 2 [clfs_3x] F20 A status stating that the record has been reviewed with review level 1 [ 1 = 'medical reviewed(a)'] F20 A status stating that the record has been reviewed with review level 2 [ 1 = 'data reviewed(b)'] F20 A status stating that the record is manually frozen and data may no longer be altered [ 1 = 'manually frozen'] F20 A status stating that the record is frozen by system and data may no longer be altered As of by ias

40 Documentation secutrial 47 Export Formats Variable Label SAS Length [Format] 2 mnpfcs0 Form completion status 2 mnpfcs1 Validation status (error) 2 mnpfcs2 Validation status (warning) 2 mnpfcs3 Data entry complete status 2 mnpfsqa Form status Queries 2 mnpfsct Form status Comments 2 [clfs_0x] 2 [clfs_1x] 2 [clfs_2x] 2 [clfs_3x] 2 [clfqa] 2 [clct] 2 mnpfssdv Form status SDV 2 [clfssdv] 2 mnpfsdde Form status DDE 2 [clfsdde] SPSS Format Description [ 1 = 'rule based frozen'] F20 A status indicating that the completion status of a record [ 0 = 'empty' 2 = 'partially completed' 4 = 'completed'] F20 A status stating that validation errors are stored in the record [ 1 = 'with error'] F20 A status indicating that confirmation warnings are stored in the record [ 1 = 'with warning'] F20 A status indicating the data entry on this record is completed Further changes are only possible if queries are made This status is only exported, if the project configuration includes the DEC workflow F20 A status stating if any query or answered query is set on this record If the status is set to 'Query' there is at least one open query on this record If the status is set to 'Answer' than all existing queries on this record has been answered [0 = '' 1 = 'with open query' 2 = 'with answered query' 4 = 'all queries resolved'] F20 A status stating if any comment has been made on this record [1 = 'with comment'] F20 A status stating the progress of source data verification This status is only exported, if the project configuration includes the SDV function [ 1 = 'not done' 2 = 'not necessary' 4 = 'not possible' 8 = 'deferred 16 = 'in progress' 32 = 'verified' 64 = 'verified with errors'] F20 A status describing the progress of the double data entry (DDE) This status is only exported, if the project configuration includes the DDE function [ 0 = 'DDE comparison finished' 1 = 'entry in progress' 2 = 'entry completed' 3 = 'ignore' (duplicate)] As of by ias

41 Documentation secutrial 47 Export Formats Variable Label SAS Length [Format] 3 mnphide hidden in Data- Capture 2 [clhd] SPSS Format Description F20 A status setting indicating that this document is hidden in the DataCapture because either form or visit is hidden, or form is currently not shown in visit This column is only exported if the project includes any hidden element [ 0 = 'no' 1 = 'yes'] 4 siguser Signature user $200 A200 Textual representation of the user: TNTITEL+TNVORNAME + TNNACHNAME (of table PARTI- CIPANT) Only for validation purposes 4 sigtext Signature text $30 A30 This is the textual description of the action leading to data storing It is the same signature text that the user was presented during the signature process It has been stored textually in the database as presented 0 sigstatus Signature status $2 F20 Numerical description of the action leading to data storing This flag is always set, independent of any necessary e-signature Meaning of values: [ 1 = data edited 2 = review A 3 = review B 4 = comment 5 = query asked 6 = query answered 7 = data freeze 8 = data unfreeze 9 = sdv (only with SDV) 10 = revoke review A 11 = query resolved 12 = data entry complete (only DEC) 13 = modify data (only DEC) 14 = manual freeze 15 = data import 16 = revoke entry complete (only DEC) 19 = DDE entry 20 = DDE entry completed 21 = DDE entry reopened 22 = DDE comparison finished 23 = DDE entry corrected ] 4 sigvalid Signature validity $10 A10 Validity of signature This is only exported if chosen by option 4 sigversion Signature algorithm version 0 sigreason Reason for modification [ valid invalid not signed ] 2 F20 Numerical type of signature algorithm version [0 = signature made before 31 1 = signature made since 31 2 = signature made since 40 ] $200 A200 Manually entered reason for modification of data after setting the "data entry complete" status Required only for this action This column is only exported if the project configuration includes the As of by ias

42 Documentation secutrial 47 Export Formats Variable Label SAS Length [Format] SPSS Format DEC workflow Description 0 mnpvsno Version number 10 F100 Version number of the project with which the ecrf was stored (will only be set in productive area) 0 mnpvslbl Version label $30 A30 Version label of the project with which the ecrf was stored (in the setup area this is a timestamp of the last project setup editing) 0: Document edit information This variable is only exported if the export option form meta data "Document editing" has been chosen 1: Structure information These variables are only exported if the export option form meta data Structure has been chosen v: Visit or image ecrf Visit ecrfs additionally have these variables of the Case Visit Plan of every patient The labels of the visits and other meta-data are exported in a separate table, see [section Visit Plan] As image ecrfs could be related to either patient, single visits or adverse event follow-ups these tables will have all possible visit columns too a: Adverse Event or image ecrf Adverse Events are occasions when a patient visits the physician for a medical reason outside of the regular visit plan of the trial (according GCP: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment ) The indication of the irregular visit, for example flu, is the Adverse Event All further irregular visits to the physician for the same indication are follow-ups to the initial Adverse Event As image ecrfs could be related to either patient, single visit or adverse event follow-up these tables will have all possible adverse event columns too i: Image ecrf Image ecrfs did not follow a study plan They can be created using the predefined forms by every participant with the edit right and can be related to patient, visit or adverse event follow-up These variables define the creator (participant) and creation date 2: Form status These variables are only exported if the export option form meta data status has been chosen 3: Hidden fields This variable is only exported if there are any hidden fields in the project and the option "Form data of hidden fields" has been chosen 4: E-Signature and validation This variables are only exported if the e-signature is used and the option E-signature with validation has been chosen 617 atmnp : Audit Trail ecrf The tables of the audit trail are similar to the normal ecrf tables Additionally, they have an own primary key "mnpatdocid" The reference to the original document is made via the "mnpdocid" Variable Label SAS Length SPSS Format Description [Format] mnpdocid Document-ID 10 F100 The original ecrf document record unique document identifier mnpatdocid ATDocument-ID 10 F100 The unique identifier for the audit trail As of by ias

43 Documentation secutrial 47 Export Formats Variable Label SAS Length [Format] SPSS Format document itself Description 618 emnp : Sub-Documents Image 5: Example of a repetition group with a subform In this case there are no other items in the outer form ecrfs may contain repetition fields, which may have several values in one ecrf An example is an ecrf with medication A patient often takes more than one type of medication, and these may be recorded using repetition fields A repetition itself may contain many fields, in the medication example it might be the Registered trademark, the Dose and Continuing it is taken These data are stored and exported in separate tables, which contain a reference to the main ecrf Sub-document tables have the naming convention that all table names start with an 'e' for extended If short names are to be used, the prefix is omitted from the table name Variable Label SAS Length [Format] SPSS Format Description mnppid Patient-ID 10 F100 The unique patient identifier associating an ecrf record to a patient record mnpdocid Parent document-id 10 F100 The reference to the main (parent) document mnpsubdocid Subdocument-ID 10 F100 Unique identifier of the subdocument fgid Question-ID of Repetition 10 F100 Unique identifier of the repetition-question of the parent document position Position in Repetition 10 F100 Position in the repetition of the parent document starting with "0" 619 atemnp : Audit Trail Subdocuments The audit trail tables of the subforms are exported in a similar way In contrast to the audit trail of the normal ecrfs, the subdocuments do not reference the original subdocument but instead reference the outer audit trail document This is necessary because if a repetition was deleted prior to saving, there would be no original subdocument to refer to Therefore the audit trail of the subdocuments contains a new primary key and a new reference to the parent document Variable Label SAS Length [Format] SPSS Format Description mnppid Patient-ID 10 F100 The unique patient identifier associating an ecrf record to a patient record mnpatdocid Parent ATDocument-ID 10 F100 The identifier of the main (parent) audit trail document As of by ias

44 Documentation secutrial 47 Export Formats Variable Label SAS Length SPSS Format Description [Format] mnpatsubdocid ATSubdocument-ID 10 F100 The unique identifier for the audit trail subdocument itself fgid Question-ID of Repetition 10 F100 Unique identifier of the repetition-question of the parent (at)document position Position in Repetition 10 F100 Position in the repetition of the parent (at)document starting with "0" 620 images / img (Images) If there are any images included into the ecrf data either in normal or special image forms, the image refer - ences in the ecrf data are resolved in this separate image table If the binary images are included into the export, the corresponding file name and file status columns are appended to this table (see below) The binary data are included in an "patientimages" folder inside the zip Variable Label SAS Length SPSS Format Description [Format] mnpimgid Image-ID 10 F100 The unique identifier for the image This ID is referenced in the ecrf tables uploadedfilename Uploaded file $500 A500 This is the original name from the client before the upload As this is not necessarily unique all files are renamed on the server and for export contenttype Content type $40 A40 Type of file as given by the uploading browser imagesize Image size (bytes) 22 F220 File size measured in bytes uploaddate Date of upload DATETIME20 DATETIME20 Timestamp of upload 0 mnpptnid Participant-ID 10 [cltn] F100 The identifier of the user who uploaded the image This information is not exported if investigator data are not to be exported Investigators are exported as code lists and the identifier is the key of the code list 0 mnppusid Patientuser-ID 10 F100 Patient ID if the patient has made the upload instead of the participant, references the mnppid from the casenode table This column is only exported if the project configuration includes the PSD function 1 originalfile Original file name $100 A100 The file name of the uploaded file on the server resp in the export 1 originalstatus Status of original file $15 A15 The status of the included original file If the file is nonexistent this is an error for the original file as this should always exist [ valid invalid nonexistent] 2 webfile Web file name $100 A100 For the display on the ecrf in the system a reduced web image could have been created during upload if possible for the uploaded file type 2 webstatus Status of web file $15 A15 The status of the included web file As the creation of a web image depends on file type a nonexistent web As of by ias

45 Documentation secutrial 47 Export Formats Variable Label SAS Length [Format] SPSS Format Description image could be valid Possible values: [ valid invalid nonexistent ] 3 thumbnailfile Thumbnail file name $100 A100 For the display on report of patient matrix in the system a small thumbnail image could have been created during the upload if possible for the uploaded file type 3 thumbnailstatusstatus of thumbnail file $15 A15 The status of the included thumbnail file As the creation of a thumbnail image depends on file type a nonexistent web image could be valid Possible values: [ valid invalid nonexistent ] 0: Investigator information This variable is only exported if the export option form meta data "Document editing" has been chosen 1: Original These variables are exported if the export option "Original files" has been chosen 2: Web These variables are exported if the option "Web files" has been chosen 3: Thumbnail These variables are exported if the option "Thumbnail files" has been chosen 621 data This table is exported for the rectangular export format # Variable Label SAS Length [Format] Patient SPSS Format CSV /TXT Length Description mnppid Patient-ID 10 F Identifies each patient uniquely This identifier is a unique number which each patient record receives automatically and can not be altered 1 mnppsd Patient pseudonym $20 A20 20 The random patient pseudonym This identifier need not be exported 1 mnpaid Patient identifier $20 A20 20 An alternative patient identifier which may be entered when the patient is stored This identifier need not be exported 1 mnplabid Patient identifier $20 A20 20 An alternative patient identifier 0 mnpptnid Participant-ID 10 [cltn] F The identifier of the user who entered the patient into the project Investigators are exported as code lists and the identifier is the As of by ias

46 Documentation secutrial 47 Export Formats # Variable Label SAS Length [Format] SPSS Format CSV /TXT Length Description key of the code list CSV/TXT: full name of the participant, Centre 2 mnpctrid Centre-ID 10 F The identifier of the centre CSV/TXT: name of the centre 2 mnpcid Country name $100 A The identfier of the country CSV/TXT: The name of the country Patient status 3 mnpcs0 Case status 0 2 [clcs_0x] 3 mnpcs1 Case status 1 2 [clcs_1x] 3 mnpcs3 Case status 3 2 [clcs_3x] 3 mnpcs4 Case status 4 2 [clcs_4x] 3 mnpcs5 Case status 5 2 [clcs_5x] 3 mnpcs7 Case status 7 2 [clcs_7x] F20 30 A status setting indicating that the patient record is not shown in the DataCaptureThis status can be set by rule anonymize patient or in the AdminTool [ 1 = 'not shown'] F20 30 A status setting indicating that the patient record has been marked as being anonymized (no pseudonym) [ 1 = 'deleted Pseudonym'] F20 30 A status setting indicating that the patient record has been frozen This status can be set by rule 'freeze patient' or in the Admin- Tool [ 1 = 'data frozen'] F20 30 A status setting indicating that the patient has deceased This status can be set by rule 'patient deceased' or in the AdminTool [ 1 = 'deceased'] F20 30 A status setting indicating that the patient data in this project is frozen and may not be changed This status can be set by rule 'freeze casenode' or in the AdminTool [ 1 = 'Project: data frozen] F20 30 A status setting stating that no new visits may be added for this patient in this project This status can be set by rule 'freeze following forms' or in the AdminTool [ 1 = 'Project: closed visit plan'] 4 visitstartdate Entry date DATE11 DATE11 10 Date of patient entry into the project Base for the calculation of the patients visit plan random Label of the randomization item $100 A Randomization similar to the form table with the randomization button item There may be multiple columns of this type The columns includes either the ran- As of by ias

47 Documentation secutrial 47 Export Formats # Variable Label SAS Length [Format] SPSS Format CSV /TXT Length Description domization number or the randomization group depending on blinding of the project and choosen export option This column(s) is(are) only exported if the configurable randomization is used in the project Form data Scheme of column names for visit forms (example) v12_1_mnpxytable_mnpdocid Visit: listed by primary key, here with visitid = 21 Visit repetition: 1 Table: mnptp0table ('mnp' + project scheme + user entered value), for SAS format the tablesnames are replaced by a number to avoid too long column names The replacement is documented in the formnumbers table Column: column name as defined per user (ecrf item) or meta data (see table descriptions) Optional for sub forms: ID of Repetitiongroup-question and number of repetition Scheme of column names for casenode forms (example) c_mnpxytable_mnpdocid Table: mnptp0table ('mnp' + project scheme + user entered value) Column: column name as defined per user (ecrf item) or meta data Optional for sub forms: ID of Repetitiongroup-question and number of repetition Scheme of column names for adverse event forms (example) a1_3_mnpxytable_mnpdocid Adverse event number: counted by existance per patient, here = 1 Repetition/Followup: counted by existance per patient, here = 3 Table: mnptp0table ('mnp' + project scheme + user entered value) Column: column name as defined per user (ecrf item) or meta data Optional for sub forms: ID of Repetitiongroup-question and number of repetition Scheme of column names for image forms (example) i5_mnpxytable_mnpdocid Image form: repetition: 5 Table: mnptp0table ('mnp' + project scheme + user entered value) Column: column name as defined per user (ecrf item) or meta data Optional for sub forms: ID of Repetitiongroup-question and number of repetition The following columns are repeated for each form mnpdocid Document-ID 10 F Each ecrf document record has a unique document identifier Document edit 0 mnplastedit Date of last edit DATETIME20 DATETIME20 18 Date when record was last edited (=saved) 0 mnpptnid Participant-ID 10 [cltn] F The identifier of the user who created the form Investigators are exported as code lists and the identifier is the key of the code As of by ias

48 Documentation secutrial 47 Export Formats # Variable Label SAS Length [Format] SPSS Format CSV Description /TXT Length list CSV/TXT: Full name of participant 0 mnppusid Patientuser-ID 10 F Patient ID if the patient has made the change instead of the participant, references the mnppid from the casenode table If set this is the same ID as the current patient This column is only exported if the project configuration includes the PSD function 0 sigstatus Signature status $2 F20 2 Numerical description of the action leading to data storing This flag is always set, independent of any necessary e-signature Meaning of values: [ 1 = data edited 2 = review A 3 = review B 4 = comment 5 = query asked 6 = query answered 7 = data freeze 8 = data unfreeze 9 = sdv (only with SDV) 10 = revoke review A 11 = query resolved 12 = data entry complete (only DEC) 13 = modify data (only DEC) 14 = manual freeze 15 = data import 16 = revoke entry complete (only DEC) 0 sigreason Reason for modification 19 = DDE entry 20 = DDE entry completed 21 = DDE entry reopened 22 = DDE comparison finished 23 = DDE entry corrected ] $200 A Manually entered reason for modification of data after setting the "data entry complete" status Required only for this action This column is only exported if the project configuration includes the DEC workflow 0 0mnpvsno Version number 10 F Version number of project (will only be set in productive area) 0 mnpvslbl Version label $30 A30 30 Version label of project (will only be set in productive area) Signature validation 5 siguser Signature user $200 A Textual representation of the user: TNTITEL+TNVORNAME + TNNACHNAME (of table PARTI- CIPANT) Only for validation purposes As of by ias

49 Documentation secutrial 47 Export Formats # Variable Label SAS Length [Format] SPSS Format CSV /TXT Length Description 5 sigtext Signature text $30 A30 30 This is the textual description of the action leading to data storing It is the same signature text that the user was presented during the signature process 5 sigvalid Signature validity $10 A10 10 Validity of signature This is only exported if chosen by option 10sigversion Structure Signature algorithm version [ valid invalid not signed ] 2 F20 2 Numerical type of signature algorithm version [0 = signature made before 31 1 = signature made since 31 2 = signature made since 40 ] 4vmnpcvpid Patient visit-id 10 F Unique identifier for each patient visit 4vmnpvisno Visit number 10 F Individual number of visit for the given casenode This number is calculated during the creation of the visit, it does not necessarily reflect the temporal sequence of visits Scheduled and unscheduled visits are counted independently Unscheduled visits are counted separate for each type 4vmnpvispdt Planned date of visit DATE9 DATE11 10 The planned date of the visit For a fixed visit this date is predefined by the visit plan For flexible, free and unscheduled visits this date is entered during the creation of a new visit by the participant 4vmnpvisfdt Date of first data entry in visit DATETIME20 DATETIME20 18 The date of first data entry Normally this should be the real date of visit 4a mnpaeid Adverse Event-ID 10 F Unique identifier of an Adverse Event 4amnpaedate Adverse Event date DATETIME20 DATETIME20 18 The date when the Adverse Event occurred 4amnpaeno 4amnpaefuid 4amnpaefudt 4i mnpcrtdt Adverse Event casenumber Adverse Event Follow-up-ID Adverse Event Follow-up date Document create date 10 F Individual number of the Adverse Event for the given casenode This number is calculated during the creation of an Adverse Event, it does not necessarily represent the temporal order of events 10 F The ID of a follow-up to the Adverse Event DATETIME20 DATETIME20 18 The date when the patient data was collected for the follow-up DATETIME20 DATETIME20 18 The date of the creation of this document 4i mnpcrtpt Document creator 10 F The user who creates this docu- As of by ias

50 Documentation secutrial 47 Export Formats # Variable Label SAS Length [Format] SPSS Format CSV /TXT Length Description (participant) [cltn] ment This information is not exported if investigator data are not to be exported Investigators are exported as code lists and the identifier is the key of the code list CSV/TXT: full name of participant 4i mnpcrtpusid Document creator (patientuser) Form status 6 mnpfs0 Form status (Review A) 6 mnpfs1 Form status (Review B) 6 mnpfs2 Form status (Freeze) 6 mnpfs3 Form status (System-Freeze) 6 mnpfcs0 Form completion status 6 mnpfcs1 Validation status (error) 6 mnpfcs2 Validation status (warning) 6 mnpfcs3 Data entry complete status 10 F The patientuser who creates this document This is the current Patient ID if the patient has made the change instead of the participant This column is only exported if the project configuration includes the PSD function 2 [clfs_0x] 2 [clfs_1x] 2 [clfs_2x] 2 [clfs_3x] 2 [clfs_0x] 2 [clfs_1x] 2 [clfs_2x] 2 [clfs_3x] 6 mnpfsqa Form status Queries 2 [clfqa] F20 30 A status stating that the record has been reviewed with review level 1 [ 1 = 'medical reviewed(a)'] F20 30 A status stating that the record has been reviewed with review level 2 [ 1 = 'data reviewed(b)'] F20 30 A status stating that the record is manually frozen and data may no longer be altered [ 1 = 'manually frozen'] F20 30 A status stating that the record is frozen by system and data may no longer be altered [ 1 = 'rule based frozen'] F20 30 A status indicating that the completion status of a record [ 0 = 'empty' 2 = 'partially completed' 4 = 'completed'] F20 30 A status stating that validation errors are stored in the record [ 1 = 'with error'] F20 30 A status indicating that confirmation warnings are stored in the record [ 1 = 'with warning'] F20 30 A status indicating the data entry on this record is completed Further changes are only possible if queries are made This status is only exported, if the project configuration includes the DEC workflow F20 30 A status stating if any query or answered query is set on this record If the status is set to 'Query' there is at least one open query on this record If the status is set As of by ias

51 Documentation secutrial 47 Export Formats # Variable Label SAS Length [Format] 6 mnpfsct Form status Comments 2 [clct] 6 mnpfssdv Form status SDV 2 [clfssdv] SPSS Format CSV /TXT Length Description to 'Answer' than all existing queries on this record has been answered [0 = '' 1 = 'with open query' 2 = 'with answered query' 4 = 'all queries resolved'] F20 30 A status stating if any comment has been made on this record [1 = 'with comment'] F20 30 A status stating the progress of source data verification This status is only exported if the project configuration includes the SDV function [ 1 = 'not done' 2 = 'not necessary' 4 = 'not possible' 8 = 'deferred 16 = 'in progress' 32 = 'verified' 64 = 'verified with errors'] 6 mnpfsdde Form status DDE 2 [clfsdde] 7 mnphide Hidden in DataCapture F20 30 A status describing the progress of the double data entry (DDE) This status is only exported if the project configuration includes the DDE function [ 0 = 'DDE comparison finished' 1 = 'entry in progress' 2 = 'entry completed' 3 = 'ignore' (duplicate)] $2 F20 30 Status determines if the form was hidden explicitly This status is only exported if the project configuration includes any hidden element Form content data according project definition According to the form definition the user defined items are listed for each form Subforms are repeated as often as the maximal number for each export The item repetitions are marked by appending repetition indizes 0: Participant and edit information These variables are only exported if the export option form meta data "Document editin" has been chosen 1: Patient Identifier Additional pseudonyms Add-ID, Lab-ID if used in the project and selected for export 2: Centre information These variables are only exported if the option centre information has been selected 3: Patient status These variables are only exported if the option patient status has been selected As of by ias

52 Documentation secutrial 47 Export Formats 4: Structure information These variables are only exported if the export option form meta data Structure has been chosen v: Visit or image ecrf Visit ecrfs additionally have these variables of the Case Visit Plan of every patient The labels of the visits and other meta-data are exported in a separate table, see [section Visit Plan] As image ecrfs could be related to either patient, single visits or adverse event follow-ups these tables will have all possible visit columns too a: Adverse Event or image ecrf Adverse Events are occasions when a patient visits the physician for a medical reason outside of the regular visit plan of the trial The indication of the irregular visit, for example flu, is the Adverse Event All further irregular visits to the physician for the same indication are follow-ups to the initial Adverse Event As image ecrfs could be related to either patient, single visit or adverse event follow-up these tables will have all possible adverse event columns too i: Image ecrf Image ecrfs did not follow a study plan They can be created using the predefined forms by every participant with the edit right and can be related to patient, visit or adverse event follow-up These variables define the creator (participant) and creation date 5: E-Signature and validation This variables are only exported if the e-signature is used and the option E-signature with validation has been chosen 6: Form status These variables are only exported if the export option form meta data status has been chosen 7: Hidden fields This variable is only exported if there are any hidden fields in the project and the option "Form data of hidden fields" has been chosen NOTE: It is not possible to export form data of visit forms not shown in any visit with the rectangular export format! 622 formnumbers This table is only exported for the rectangular SAS format Here the form table names in the column names are replaced by simple numbers in the sequence of occurrence in export To map the numbers to the table names this information is given in a separate table Variable Label SAS Length/ Format SPSS Format Description formid Form-ID 10 F100 Identifier of the Form-Definition This may not be the same ID as in the non-rectangular setup definition formtablename DB table name $100 A100 Table name as given in the project setup definition As of by ias

53 Documentation secutrial 47 Export Formats 7 CDISC ODM Introduction CDISC, the Clinical Database Interchange Standards Consortium, has developed several XML standards for the interchange of clinical data The Operational Data Model (ODM) represents data that can be transferred among different systems during clinical trials or be used for archival storage The format is vendor-independ - ent and system-neutral Study meta-data, study data and administrative data can be exported In the productive ExportSearchTool the audit trail will be exported with all existing MetaDataVersions of the exported project and corresponding ClinicalData elements 72 ODM Data structure ODM v13 has the following main sections: Study allows the representation of various studies in one file It contains the protocol and form-setup definitions The following sub-elements of "Study" are exported: GlobalVariables contains the study name MetaDataVersion contains setup information regarding the study, including definitions of the visits, the ecrfs associated with each visit, the information collected on each ecrf, and code lists For each project version as created by a project release a corresponding MetaDataVersion element is exported when the export option "with Audit Trail" has been selected AdminData includes administrative data such as references to the investigators and the trial centres Also signature definitions are exported here ClinicalData contains the collected data items of the study In the "ClinicalData" section, all study data is included The data is represented according to the hierarchy for each subject (StudyEventData, FormData, Item- GroupData, ItemData), which in turn is equivalent to the meta-data hierarchy (StudyEvent, Form, Item- Group, Item) If the exported data include the audit trail then for each exported MetaDataVersion a corresponding ClinicalData element is exported if there has been any data changes in that setup version In CDISC and secutrial the wording for some elements are different Both notations could be used in the following description Some of the elements are listed below: secutrial project patient centre location CDISC study subject location address Omitted information The following sections are not included in the secutrial 47 ODM v13 export: ReferenceData gives information about the validity of data, such as value ranges not necessarily study-specific Association for annotations across different elements ds:signature for signing the xml document itself Do not mix up with the signature applied to an ecrf! The latter is documented with the "Signature" element As of by ias

54 Documentation secutrial 47 Export Formats Besides the matching problems mentioned below some setup information are omitted in the export They may be included into future versions of secutrial setup information about non stored forms (as used for printing or display only) rules and checks, including error messages measurement units for number fields Artifical study elements There are some articifical study elements introduced by secutrial to allow the export of meta information, that are related to the ecrfs but not directly entered: Study event random: RANDOM The assigned random group or random number of a patient is exported as an additional study event with a single Form element, including a single ItemData element and one Item element for each randomisation button The random button-items themselves are additionally exported as normal ecrf item data If unblinding during export has been selected than only the data in the artifical random form is unblinded Form visit date: FVMI Because the visit date can be changed independent from any ecrf handling, a separate form for this date is used The transactions of this form reflect the editing of the visit plan in the DataCapture ItemGroup patient identifier: FGSUBJID It was requested to include the patient pseudonym as an additional item into each ecrf form So a new ItemData and Item element has been created for this As the pseudonyms cannot change, this item is only inlcuded in the first INSERT transaction Normally the Pat-ID is used as the pseudonym If this is not used in the project for patient identification or the participant has no role right to see this, either the Add-ID or the Lab-ID is used, depending on project and role configuration ItemGroup form status: FGFS The different form status are included in a separate form group on the beginning of each form For every single status (see table description for mnp-tables above), an own Item element FFFS is created These elements are included into every transaction ItemGroup form saved timestamp: FGMNP The time stamp of ecrf editing is included as a separate ItemGroup element with a single Item FFMN- PLASTEDIT element These elements are also included into every transaction Audit Trail The secutrial -CDISC export is build as a single import file into other systems In contrast to the other export formats of secutrial the audit trail is not handled with separate files (or tables) but with subsequent transactions to the same FormData element The transaction type of the first statement is set to "Insert" whereas the subsequent entries to the same ecrf are set to "Update" The current data of the ecrf is the last transaction In the productive ExportSearchTool all existing project versions are exported as separate MetaDataVersion definitions and corresponding ClinicalData elements So every ecrf transaction is exported with the related Meta DataVersion element (=project version), with which the transaction was made If no audit trail is exported all transactions are of type "Insert" Queries and Comments Queries and comments are exported as annotations to the single item data If the "typed data format" has been chosen than the AnnotationID is given as an attribute of the ItemData<Type> element, the annotation itself will be listed in the Annotations element With the "untyped data format" the Annotation will be included directly as a sub element of the ItemData element If no audit trail is exported the complete list of queries and comments are added to the current data (=last transaction) with the transaction type set to "Insert" if the format of the data is untyped In this case the complete list of queries and comments will therefore be exported (if the option is chosen) even if the audit trail is As of by ias

55 Documentation secutrial 47 Export Formats omitted If the audit trail is included the particular query or comment entry is added to the correct particular transaction In this case the element UserEntry will not be added to the annotation (if ias extension has been selected), because the user of the form data is responsible for the annotation too If the typed data format is chosen and the audit trail is omitted, than only those queries and comments will be exported that has been added as the last transaction to the data Hidden data As it is not allowed to delete any collected (productive) data, in secutrial it is possible to hide single items, item groups(=questions) or forms from view in the DataCapture if this information shall not be collected any longer This data could be included into an export If the ias extensions are used than hidden data are denoted by the attribute "ias:hidden" in the study definition of the FormData, ItemGroupData or ItemData elements Without the ias extension this data is flagged up by annotations added to the hidden data element (FormData, ItemGroupData or ItemData) secutrial and CDISC There are some limitations in matching the data within secutrial data with the CDISC format: Signature, Queries/Comments and sequence of transactions The action of making a query or comment to the data in secutrial could include the e-signature Here the complete data of the made annotation and the referenced ecrf data are signed If the audit trail is omitted the annotation is not appended to the transaction statement where it was made, but all annotations are appended to the last (current) data but only if the untyped data format is chosen For typed data export only a query or comment appended as a last transaction could be exported (see below) So the e-signature is normally applied as a Signature element to a FormData element If all queries are appended to the single transaction for a snapshot export then the additional UserEntry is added when the ias extension has been chosen and the data is exported in the untyped data format To get a complete and exact impression of the query management we recommend using the typed data export with included audit trail Queries and Annotations For queries a series of related annotations belong to one discussion This fact is not reflected in the ODM definition In the ias extension therefore the QueryID element has been declared to allow the grouping of annotations by the same QueryID This query ID is displayed in the user interface of the secutrial DataCapture module As the comment IDs are displayed also, a corresponding CommentID element has been declared for that type of annotation too If the standard ODM version is used, only the AnnotationID indicates the grouping of related annotations by using the query ID as the first number part Transactions and AuditRecord If the audit trail is exported, the type of the ODM file is "transactional" and for every FormData element an AuditRecord element is given It contains the "ReasonForChange" where the content of the "sigtext" and optional "modifyreason" column is exported If the audit trail is not exported, no AuditRecord is given With multiple project setup versions and included audit trail multiple ClinicalData elements are exported Then the SubjectData and StudyEventData elements are included in different ClinicalData elements for the same patient and visit when the save of an ecrf has been done with different project versions Therefore subsequent listings of such elements have applied "Update" transactions But there could be no AuditRecords given as the elements are not changing themselves but the included elements are changing LocationRef in AuditRecord The AuditRecord element of each form has a mandatory location entry During the process of saving an ecrf in secutrial the participant and time are stored for the action, but not the information about location For the export the location of the patient is used here, as this should have been the location during editing However, as it is possible for patients to change their location (=centre) via the AdminTool this information may not represent the correct former centre Therefore this information is only added to the last transaction As of by ias

56 Documentation secutrial 47 Export Formats (Note: a location element in a web based application is as good as useless as a data entry could be made from all over the world and do not necessarily reflect the physical location of the data entry point) Roles In CDISC only three roles are defined without further information to the meaning of this definition A role can only be given directly to a participant In secutrial the role concept is quite sophisticated The roles are defined with dynamic rights concerning application functions A participant can have different roles dedicated to his participation in different centres (=locations) Therefore most times the role properties of participants will be left empty for export Only when participants are assigned directly to a project the role property will be set For matching this to the CDISC role specifications the role name in secutrial is literally compared to the CDISC role names If it does not match with any of these, the label "Other" is set Typed Item data and Annotations As it is only allowed to add a single AnnotationID attribute to an ItemData<Type> element there are some restrictions for this type of data format in the combination with other export options If the audit trail is omitted only a query or comment appended as a last transaction could be exported If hidden data are exported without ias extension it could be possible that the AnnotationID for the hidden flag could not be added to a hidden ItemData<Type> element if the affected item has another annotation like a query, comment or sdv entry For that case the more important information is added in the hierarchy: query > comment > sdv > hidden Included data Is it valid in the CDISC ODM definition to omit the part of the study definition or admin data as long as former ODM files are referenced in the PriorFileOID attribute of the ODM element where all administrative or study OID referenced in the current file are declared As it is not possible in the ExportSearchTool application design to guarantee that such a former file is available this option is not implemented in secutrial 47 to assure the generation of valid CDISC ODM files The former selectable option of including administrative and or setup data has therefore been disabled Images In contrast to all other items an uploaded image file contains more information than just a simple one-dimensional measurement In CDISC ODM there is no option to include such multi-dimensional item data Here we decided to export the (server-generated) filename as the most unique identifier for the image If the ias extension is chosen an additional ImageID allows to reference the separate information exported in the ImageData elements (following the principle of Annotations) Date Formats All date fields edited in the ecrfs (ias date components) are stored as strings in the database following the pattern YYYYMMDDHHMISS YYYY is a four digit year value, eg 1956 MM is a month in number starting with 01 for January and 12 for December DD is the day of the month HH is the hour value of the time (in 24 hours-cycle) MI is the minute value of the time SS is the second's value of the time Other system-generated dates are stored in a real date format in the database CDISC formats for date and time are compliant with ISO 8601 ODM demands the specification of the time zone "Datetime" is the only format that is specified with a time zone value ODM 12 defines: A missing time zone specification means that the relationship between the local clock and Universal Time is not known In secutrial time zone is specified within the configuration file (default is CET / CEST) Type ias Format CDISC Format Description Example (typed data) date DD-MM-YYYY date YYYY-MM-DD EffectiveDate=" " As of by ias

57 Documentation secutrial 47 Export Formats Type ias Format CDISC Format Description Example (typed data) ias date components ias checked date components ias date/time intervals compone nts DD-MM-YYYY HH:MM:SS (Z) datetime DDThh:mm:ssn+hh: mm timestamp YYYY-MM- <DateTimeStamp> T18:05: :00</DateTim estamp> YYYY partialdate YYYY <ItemDataPartialDate ItemOID="FFbirthdate_3">1974< /ItemDataPartialDate> MM-YYYY partialdate YYYY-MM <ItemDataPartialDate ItemOID="FFbirthdate_3"> </ItemDataPartialDate> DD-MM-YYYY partialdate YYYY-MM-DD <ItemDataPartialDate ItemOID="FFpregdate_5"> </ItemDataPartialDate> DD-MM-YYYY HH:MM partialdatetime YYYY-MM- DDThh:mm <ItemDataPartialDatetime ItemOID="FFpregdate_5"> T10:09</ItemDataPartialDatet ime> HH:MM partialtime hh:mm <ItemDataPartialTime ItemOID="FFbirthdate_3">10:09 </ItemDataPartialTime> HH:MM:SS partialtime hh:mm:ss <ItemDataPartialTime ItemOID="FFstopdate_7">20:17: 32</ItemDataPartialTime> MM:SS incompletedatetime mm:ss <ItemDataIncompleteDatetime ItemOID="FFstartdate_7"> T-:17:32</ItemDataIncompleteDa tetime> YYYY partialdate YYYY <ItemDataPartialDate ItemOID="FFbirthdate_3">1974< /ItemDataPartialDate> MM-YYYY partialdate YYYY-MM <ItemDataPartialDate ItemOID="FFbirthdate_3"> </ItemDataPartialDate> DD-MM-YYYY date YYYY-MM-DD <ItemDataDate ItemOID="FFpregdate_5"> </ItemDataDate> DD-MM-YYYY HH:MM partialdatetime YYYY-MM- DDThh:mm <ItemDataPartialDatetime ItemOID="FFpregdate_5"> T10:09</ItemDataPartialDatet ime> HH:MM partialtime hh:mm <ItemDataPartialTime ItemOID="FFbirthdate_3">10:09 </ItemDataPartialTime> HH:MM:SS time hh:mm:ss <ItemDataTime ItemOID="FFstopdate_7">20:17: 32</ItemDataTime> MM:SS incompletedatetime mm:ss <ItemDataIncompleteDatetime ItemOID="FFstartdate_7"> T-:17:32</ItemDataIncompleteDa tetime> Y durationdatetime PnY <ItemDataDurationDatetime ItemOID="ffscoredate">P54Y6M< /ItemDataDurationDatetime> Y-M Y-M-D Y-M-D-H-M H-M H-M-S PnYnM PnYnMnD PnYnMnDTnHnM PnYnMnDTnHnMnS As of by ias

58 Documentation secutrial 47 Export Formats Type ias Format CDISC Format Description Example (typed data) M-S The partial date and time types are new introduced in ODM v13 As the complete date or time information are only guaranteed in the secutrial checked date components with "YYYY-MM-DD" or "HH:MM:SS" format, all other components are declared partial with exception of the date component type "MM:SS" The new calculated date/time intervals are exported as date durations Be aware that they do not represent exact time length! As there is no time zone information in the ias ecrf date components this part is not exported in ecrf data 73 secutrial Vendor Schema Extension It is possible to extend the CDISC-export with vendor specific extensions This is done in secutrial with the schema definition in "iasxsd" The namespace "ias" is defined as This namespace is used to add secutrial -specific information to the export file The schema describes elements and attributes for: UserEntry (authorization for query and comments used in untyped data export without audit trail) QueryID (id of queries) CommentID (id of comments) Validation of e-signature Version of e-signature Hidden data SDV validation information Images This additional information can be chosen by selection the "include secutrial extensions" option for the CDISC-export format Since ODM v13 the standard xml definitions for namespaces and schemas are included with the files: xmlxsd xlinkxsd xmldsig-core-schemaxsd Since ODM v121 the schema description files are separated for the plain CDISC and vendor extension into separate files to allow more precise control over the sequence of elements The two ODM files are: ODM1-2-1-foundationxsd ODM1-2-1xsd The vendor extensions from secutrial are defined in three additional xsd files: ias-nsxsd ias-extensionxsd iasxsd In the ias schema the following attributes and elements are redefined in ias-extensionxsd: <?xml version="10" encoding="iso "?> <xs:schema targetnamespace=" xmlns=" xmlns:xs=" xmlns:ias=" elementformdefault="qualified" attributeformdefault="unqualified"> <xs:import namespace=" schemalocation="ias-nsxsd"/> <xs:redefine schemalocation="odm1-3-0xsd"> <!-- redefine here any attributegroup group defined by ODM schema --> <!-- 30: image element extension --> As of by ias

59 Documentation secutrial 47 Export Formats <xs:group name="subjectdataelementextension"> <xs:sequence> <xs:element ref="ias:imagedata" minoccurs="0" maxoccurs="unbounded"/> </xs:sequence> </xs:group> <!-- additional hidden attribute --> <xs:attributegroup name="formdefattributeextension"> <xs:attribute ref="ias:hidden"/> </xs:attributegroup> <xs:attributegroup name="itemgroupdefattributeextension"> <xs:attribute ref="ias:hidden"/> </xs:attributegroup> <xs:attributegroup name="itemdefattributeextension"> <xs:attribute ref="ias:hidden"/> </xs:attributegroup> <!-- redefine for SDV--> <xs:attributegroup name="formdataattributeextension"> <xs:attribute ref="ias:sdv"/> </xs:attributegroup> <xs:attributegroup name="itemdataattributeextension"> <xs:attribute ref="ias:sdv"/> <xs:attribute ref="ias:imagedataid"/> </xs:attributegroup> <xs:attributegroup name="itemdatastarattributeextension"> <xs:attribute ref="ias:sdv"/> <xs:attribute ref="ias:imagedataid"/> </xs:attributegroup> <!-- esignature validation --> <xs:group name="signatureelementextension"> <xs:sequence> <xs:element ref="ias:validity" minoccurs="0" maxoccurs="unbounded"/> <xs:element ref="ias:version" minoccurs="0" maxoccurs="unbounded"/> </xs:sequence> </xs:group> <!-- patient location, qac-description (user, id) --> <xs:group name="annotationelementextension"> <xs:sequence> <xs:element ref="ias:userentry" minoccurs="0" maxoccurs="unbounded"/> <xs:element ref="ias:queryid" minoccurs="0" maxoccurs="unbounded"/> <xs:element ref="ias:commentid" minoccurs="0" maxoccurs="unbounded"/> </xs:sequence> </xs:group> </xs:redefine> </xs:schema> with the basic definitions in ias-nsxsd: <?xml version="10" encoding="iso "?> <xs:schema targetnamespace=" xmlns=" xmlns:xs=" xmlns:odm=" xmlns:ias=" elementformdefault="qualified" attributeformdefault="unqualified"> <xs:simpletype name="filecheck"> <xs:restriction base="xs:string"> <xs:enumeration value="valid"/> <xs:enumeration value="invalid"/> <xs:enumeration value="nonexistent"/> </xs:restriction> </xs:simpletype> <xs:simpletype name="filetype"> <xs:restriction base="xs:string"> <xs:enumeration value="original"/> <xs:enumeration value="web"/> <xs:enumeration value="thumbnail"/> </xs:restriction> </xs:simpletype> <xs:attribute name="sdv" type="xs:decimal"/> <xs:attribute name="hidden" type="xs:boolean"/> <xs:element name="validity" type="xs:string"/> <xs:element name="version" type="odm:integer"/> <xs:attribute name="imagedataid" type="xs:idref"/ <!-- used for qac-description --> <xs:element name="userentry"> <xs:complextype> As of by ias

60 Documentation secutrial 47 Export Formats <xs:sequence> <xs:element ref="odm:userref"/> <xs:element ref="odm:datetimestamp"/> </xs:sequence> </xs:complextype> </xs:element> <xs:element name="queryid"> <xs:complextype> <xs:attribute name="value" type="odm:integer"/> </xs:complextype> </xs:element> <xs:element name="commentid"> <xs:complextype> <xs:attribute name="value" type="odm:integer"/> </xs:complextype> </xs:element> <!-- 30: ias extension for image data --> <xs:element name="imagefiledata"> <xs:complextype> <xs:attribute name="type" type="ias:filetype"/> <xs:attribute name="filename" type="xs:string"/> <xs:attribute name="filestatus" type="ias:filecheck"/> </xs:complextype> </xs:element> <xs:element name="imagedata"> <xs:complextype> <xs:sequence> <xs:element ref="ias:userentry" minoccurs="0" maxoccurs="1"/> <xs:element ref="ias:imagefiledata" minoccurs="0" maxoccurs="3"/> </xs:sequence> <xs:attribute name="id" type="xs:id" use="required"/> <xs:attribute name="uploadedfilename" type="xs:string" use="required"/> <xs:attribute name="contenttype" type="xs:string"/> <xs:attribute name="imagesize" type="xs:integer"/> </xs:complextype> </xs:element> </xs:schema> 74 Structure summary The general structure of the elements in the xml is listed here without respect to optional or multiple elements and attributes: <?xml?> <ODM> <Study> <GlobalVariables> <StudyName></StudyName> <StudyDescription/> <ProtocolName></ProtocolName> </GlobalVariables> <BasicDefinitions/> <MetaDataVersion> <Protocol> <StudyEventRef/> </Protocol> <StudyEventDef> <FormRef/> </StudyEventDef> <FormDef> <Description> <TranslatedText></TranslatedText> </Description> <ItemGroupRef/> </FormDef> <ItemGroupDef> <ItemRef/> <Alias/> </ItemGroupDef> <ItemDef> <TranslatedText></TranslatedText> <CodeListRef/> <Alias/> <CodeListDef> As of by ias

61 Documentation secutrial 47 Export Formats <CodeListItem> <TranslatedText></TranslatedText> </CodeListDef> </MetaDataVersion> </Study> <AdminData> <User> <LoginName></LoginName> <FullName></FullName> <FirstName></FirstName> <LastName></LastName> <Adress> <StreetName></StreetName> <City></City> <StateProv></StateProv> <PostalCode></PostalCode> <OtherText></OtherText> </Adress> < ></ > <Fax></Fax> <Phone></Phone> <LocationRef/> </User> <LocationDef> <MetaDataVersionRef/> </Location> <SignatureDef> <Meaning></Meaning> <LegalReason></LegalReason> </SignatureDef> </AdminData> <ClinicalData> <SubjectData> <InvestigatorRef/> <SiteRef/> <Annotation> <Comment></Comment> <Flag> <FlagValue></FlagValue> <FlagType></FlagType> </Flag> </Annotation> <StudyEventData> <FormData> <AuditRecord> <UserRef/> <LocationRef/> <DateTimeStamp></DateTimeStamp> <ReasonForChange></ReasonForChange> </AuditRecord> <Signature> <UserRef/> <LocationRef/> <SignatureRef/> <DateTimeStamp></DateTimeStamp> <ias:validity></ias:validity> <ias:version></ias:version> </Signature> <Annotation> <Comment></Comment> <Flag> <FlagValue></FlagValue> <FlagType></FlagType> </Flag> </Annotation> <ItemGroupData> <ItemData> <Annotation> <Comment></Comment> <Flag> <FlagValue></FlagValue> <FlagType></FlagType> </Flag> <ias:userentry> <UserRef/> <DateTimeStamp></DateTimeStamp> As of by ias

62 Documentation secutrial 47 Export Formats </ias:userentry> <ias:queryid/> <ias:commentid/> </Annotation> </ItemData> </ItemGroupData> <ItemGroupData> <ItemDataInteger></ItemDataInteger> </ItemGroupData> </FormData> </StudyEventData> <ias:imagedata> <ias:userentry> <UserRef/> <DateTimeStamp></DateTimeStamp> </ias:userentry> <ias:imagefiledata/> </ias:imagedata> </SubjectData> <Annotations> <Annotation> <Comment></Comment> <Flag> <FlagValue></FlagValue> <FlagType></FlagType> </Flag> <ias:userentry> <UserRef/> <DateTimeStamp></DateTimeStamp> </ias:userentry> <ias:queryid/> <ias:commentid/> </Annotation> </Annotations> </ClinicalData> </ODM> The description explains the attributes and content most of the used CDISC elements For each element the interpretation of the element in the CDISC export in relation to secutrial is explained first Then a short example is given whether there are any relevant attributes or body content, followed by a description of specific attributes The secutrial extensions are classified by the namespace "ias:" Elements with no further information are omitted from this description The notation "LB:TEXT" means that the element "TEXT" is translated via the secutrial LanguageBundle into the language of the secutrial installation (Mostly the verbalization of the element "TEXT" is crude English, it is only used as a short wildcard) For further details concerning sequence of elements and whether they are optional or mandatory, please refer to the CDISC ODM v13 documentation 75 Element description: General information <ODM> The ODM element is the frame of the whole export General information about schema and content are given here The export file object is identified with the FileOID which is built in secutrial by the TAN This is not necessarily unique for each and every file, but should suffice in combination with the creation date to distinguish the files <ODM xmlns=" xmlns:ds=" xmlns:xsi=" xmlns:ias=" xsi:schemalocation=" iasxsd" Description="Patients (All patients) User Data(yes) Audit- Trail(yes) Queries and Comments(yes) Pseudonym(yes) HiddenFields(yes) Esignature(yes) Validity(yes) SDV(yes)" FileType="Transactional" FileOID="secuTrialde/ST26/IAS1/10_ " CreationDateTime=" T15:14: :00" ODMVersion="13" Originator="interActive-Systems" SourceSystem="secuTrial" SourceSystemVersion="47"> xmlns:ias xsi:schemalocation Description secutrial namespace if the secutrial format extensions have been chosen reference and file for the secutrial vendor format extension textual compendium of selected export options As of by ias

63 Documentation secutrial 47 Export Formats FileType ["Transactional" "Snapshot"] fixed value, if the audit trail is included the type is "Transactional" FileOID ["secutrialde/" + customerdbprefix + "/" + customerschemamodelname + "/" + projectversionnumber + "_" + timestamp] unique identifier of export file build from the domain name of secutrial, the customer db-prefix, the project schema, the project version number and the timestamp of export CreationDateTime ODMVersion Originator SourceSystem SourceSystemVersion timestamp of the generation of the file ["13"] the secutrial version 47 implements the ODM version 13 To tell processing systems that the xsd schema is used in exchange for the dtd, this has to be added [customercustomername] Customer name owning the project ["secutrial"] version as specified in the sources and configuration file This is displayed in the browser title of each secutrial -application 76 Element description: Project setup <Study> The Study element describes the setup and administrative data of a study For multiple studies several Study elements could be contained in one file In secutrial only single projects (=studies) can be exported Only study elements used for collecting data are exported Plain informative objects like display forms or headlines are not exported <Study OID="IAS1"> OID [customerschemamodelname] The model name (=DB-scheme) name of the project The model name always uniquely identifies a study within a secutrial installation <StudyName> The body contains the name for the study as defined in the FormBuilder <StudyName>Teilprojekt</StudyName> <StudyDescription> This is a mandatory element, but as there is no complement in secutrial this field is left blank <ProtocolName> This is a mandatory element, but as there is no exact complement in secutrial this field is set to the model name of the exported project, too <ProtocolName>IAS1</ProtocolName> <MetaDataVersion> This is the current setup description for export This is matched with the project version information as defined in the FormBuilder Most of the information derives from the visit plan and the defined forms The whole export of the setup defines both a reference element and a definition for that reference Therefore the hierarchy is quite flat in contrast to the export of the study data itself In the productive area for every archive and current project version a MetaDataVersion element is exported In the setup area only the development version itself is given here <MetaDataVersion OID="IAS11" Name="Basisregister (10)"> OID [customerschemamodelname + "" + projectversionno] The identification is built from the model name and the version number of the project As of by ias

64 Documentation secutrial 47 Export Formats Name [projectformattedname] This is the label of the project combined from the project name and the version label In this form the project name is displayed in the Data- Capture status information (For development project from the setup-test area the version label displays the last project save-time For productive projects the label has been entered by the participant during the release) <Protocol> This is close to the visit plan defined in the FormBuilder Furthermore forms for capturing adverse event and patient status information are defined here, too These are only added, if forms of the type "AdverseEvent" and "Casenode" are actually defined as form families So the protocol includes all stored form presentation options of the secutrial patient matrix <StudyEventRef> This is the reference for an event as described above <StudyEventRef StudyEventOID="VISIT619" OrderNumber="1" Mandatory="Yes"/> <StudyEventRef StudyEventOID="AE" Mandatory="No"/> <StudyEventRef StudyEventOID="CN15" Mandatory="No"/> <StudyEventRef StudyEventOID="RANDOM" Mandatory="No"/> StudyEventOID OrderNumber Mandatory ["VISIT" + visitvisitid "AE" "CN" + formfamilyfyid "RANDOM"] The identification of a study event is a token for the kind of event (normal visit, adverse event or patient status information (= casenode families / "CN") As several visits can be defined in the visit plan of the project, it is most likely that there are multiple visit-events They are distinguished by the primary key of the secutrial visit-object added Patient status events are distinguished by the corresponding formfamily ID If a project does not declare form families for casenode or adverse event level, the appropriate study events are omitted The RANDOM event is an addition for the export of the configurable randomization [ i+1 ] The sequence of presentation the visits to the user, starting with 1 Events for status forms or adverse events have no ordering [ "Yes" "No" ] The scheduled visits which are created for the initial visit plan belong to the normal study progress and are therefore mandatory AEs do not necessarily occur neither must CN events contain forms that have to be filled Unscheduled visits are not mandatory too <StudyEventDef> This is the actual definition of a study event Each reference has a separate definition <StudyEventDef OID="VISIT619" Name="1 Visite" Repeating="Yes" Type="Scheduled" Category="fest"> <StudyEventDef OID="AE" Name="Adverse Event" Repeating="Yes" Type="Common"> <StudyEventDef OID="CN15" Name="Patientstatus" Repeating="No" Type="Unscheduled"> <StudyEventDef OID="RANDOM" Name="randomization" Repeating="No" Type="Unscheduled"> OID Name Repeating Type Category reference to StudyEventOID as defined in the StudyEventRef [visitvisitlabel projectcasenodefamilyffamilyname projectaefamilyffamilyname] name indication type of event as in description above for adverse events and casenode, the name of the respective form families are used For visits the visit label as displayed in the matrix is given If there is no label defined, the default from the language bundle is used [ "Yes" "No" ] Adverse events are repeating elements where the number of occurrence is undefined visits can differ here: if the visit plan as defined in the Form- Builder has no maximum number of visits or the number of defined visits is less than the maximum number of visits then the last defined visit is also repeating, same for unscheduled visits CN events are never repeating [ "Scheduled" "Unscheduled" "Common" ] Visits are scheduled or unscheduled (as defined in FB) adverse events are common patient status forms are exported as "CN" events are defined as unscheduled (the type for AE and CN events changed from last secutrial version!) [ visitvisittypelabel ] The type of the visit is given here This attribute is only given for visits As of by ias

65 Documentation secutrial 47 Export Formats <FormRef> Each stored form of a project setup which is no subform is referenced for a study event All visit forms are referenced in their corresponding visit ATTENTION: If a form for the type "Visit" is not referenced - any longer - in any visit and the audit trail is omitted, it will not be exported neither as definition nor the (possibly previous entered) form data In the CDISC ODM data model the study events does not represent any additional information besides the presented forms Especially the visit plan date could not be matched here Instead of the former attribute ex - tension secutrial 47 now exports an artificial form "FVMI" (= visit meta information) with only the subject identifier and visit plan date as included items The visit plan date is marked with the SDSVarName "VIS - ITDY" according the CDISC SDTM data model The possible history of the visit plan is exported as corresponding transactions to this form Additionaly the randomisation is exported as an artifical form FRANDOM that is included in the unscheduled CN StudyEvent element This randomisation form is included for any randomisation If there are Image forms will be referenced in each StudyEventDef element because the relation between such a form is not predefined in the setup and will be set during the first completion of the form <FormRef FormOID="mnptp4sonstiges" OrderNumber="1" Mandatory="No"/> FormOID OrderNumber Mandatory [ "FVMI" 'FRANDOM' "F" + formformtablename ] DB table name of the form as defined in the FormBuilder The artificial visit information form has the OID "FVMI" (=visit meta information), the artifical random form has the OID "FRAN- DOM" [ repetitionindex +1 ] This is the sequence of display in the visit This number is derived from the sorting of the forms in the visit (or adverse event or casenode) If there are non-stored forms in the visit, this number may be discontinuously Image forms will have no number as their presentation is not sorted [ "No" ] It is not possible in secutrial to force the user to fill in a form hence this attribute is always set to no <FormDef> <FormDef OID="mnptp4untersuchung" Name="Untersuchung" Repeating="No" ias:hidden="true"> <FormDef OID="mnptp4ae" Name="Adverse Event" Repeating="Yes"> OID Name Repeating ias:hidden ias:ddetype reference to FormOID as defined in FormRef [ formformname ] form display name as in the patient matrix [ "Yes" "No" ] For adverse events this property is set to "Yes" because the forms are filled in for each follow-up Also Image forms will have this property set to "Yes" All other forms have this value set to "No" [ "true" ] If a form has been hidden from the data collection but is included in the export (option "include hidden fields" and with the ias extension) then this attribute is added to the form definition [ "normal form" DDE form ] If the DDE function is used, single forms can be marked as used for double data entry <Description> This element could be included into a FormDef, ItemGroupDef or ItemDef element At the moment this is used in secutrial only for the FormDef element <Description> <TranslatedText xml:lang="de">bitte füllen Sie alle Felder nach genauer Befragung aus</translatedtext> </Description> xml:lang [ "de" "en" ] language as defined for the project (either directly in the project design, by the customer design or the application default At the moment secutrial allows either a German or English installation The form description is only available as entered in the FormBuilder most times this will be similar to the project language version As of by ias

66 Documentation secutrial 47 Export Formats text [ formformdescr ] informative text to be displayed beneath the form title <ItemGroupRef> The form hierarchy in secutrial works with an intermediate question between the DB-table as defined in a form and the DB-column as referenced in the item CDISC ODM uses a similar construction For each question an item group is defined The sequence of item groups represents the sequence in the form Additionally secutrial defines the document status information of each form This information is exported as an additional item group as CDISC ODM does not provide an appropriate element at form level CDISC recommends exporting the patient identifier as a separate item for monitoring errors and changes Because it is not possible to add items directly to patients, an artificial item group and item is added to each and every form to export this value This item group is only exported for the first transaction If neither the pseudonym nor the aid is selected for an individual export, this first item group is completely omitted The single item in this group contains the patient identification information as selected for export This information is marked as the SDSVarName "SUBJID" which references the external CDISC Submission Metadata Model (SMM) If both identifiers (pseudonym and aid) are selected, this field contains the pseudonym <ItemGroupRef ItemGroupOID="FGSUBJID" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FGVISITDY" Mandatory="Yes"/> <ItemGroupRef ItemGroupOID="FGFS" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FGMNP" Mandatory="Yes"/> <ItemGroupRef ItemGroupOID="FGRANDOM" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG1268" OrderNumber="10" Mandatory="No"/> ItemGroupOID [ "FGSUBJID" "FGVISITDY" "FGFS" "FGMNP" "FGRANDOM" "FG" + formgroupfgid ] The first item group in every form contains the patient pseudonym with the OID "FGSUBJID", the second the form status information this item group has the OID "FGFS" The artifical item group FGMNP contains the last save date of the form data The item group for the visit plan date has the OID "FGVIS- ITDY" The item group for the random form has the OID "FGRANDOM" For each other item group the prefix "FG" is used followed by the primary key of the secutrial question DB representation object form group OrderNumber [ i + 1 ] The sequence of appearance on the form this does not necessarily represent the exact position (as headlines are not exported at all) the additional item groups "FGFS", "FGVISITDY" and "FGSUBJID" has no number as these groups are not presented to the user but are only internally managed by the system Mandatory [ "Yes" "No" ] It is not possible in secutrial to force the user to fill in a question hence this attribute is normally set to "No" Only the visit day item group is set to "Yes" because this internal field is always given for each existing visit <ItemGroupDef> <ItemGroupDef OID="FGSUBJID" Name="patient identifier" Repeating="No" IsReferenceData="No"> <ItemGroupDef OID="FGVISITDY" Name="Geplantes Visitendatum" Repeating="No"> <ItemGroupDef OID="FGFS" Name="document status information" Repeating="No" IsReferenceData="No"> <ItemGroupDef OID="FGMNP" Name="saved" Repeating="No" IsReferenceData="No"> <ItemGroupDef OID="FGRANDOM" Name="randomization" Repeating="No"> <ItemGroupDef OID="FG1268" Name="Geburtsdatum" Repeating="No" IsReferenceData="No" ias:hidden="true" Domain= DM > <ItemGroupDef OID="FG1275" Name="Bisherige Behandlung" Repeating="Yes" IsReferenceData="No"> OID Name Repeating isreferencedata Reference to the ItemGroupOID as defined in the ItemGroupRef [ "patient identifier" "document status information" "saved" "randomization" formgroupfgquerylabel ] The first item group represents the patient identifier, the second the form status information and is labelled appropriately, the next item group consists of a single item with the save date of the form for a normal item group the unique label (for search) of the question is used [ "Yes" "No" ] For repetition groups this property is set to "Yes" all other question types are set to "No" in the data exported for this group for each repetition an Item- GroupData element is exported with a corresponding repeat key [ "No" ] This is always set to "No" as secutrial does not include references to external data As of by ias

67 Documentation secutrial 47 Export Formats ias:hidden Domain [ "true" ] If an item group has been hidden from the data collection but is included in the export (option "include hidden fields" and with the ias extension) then this attribute is added to the item group definition [ formgroupsdtmdomain ] references the CDISC Submission Metadata Model (SDTM) For content see CDISC definitions If an SDTM domain has been given for the item group definition it is exported as an additional attribute For greater flexibility this domain can be entered in freetext in the project setup definition Therefore it cannot be garantueed that the exported doamin is a real valid SDTM domain <ItemRef> The DB columns are represented as items both in CDISC ODM 121 and in secutrial The sequence of items within an item group is the same as within the form The items of subforms are directly included in the outer repetition group <ItemRef ItemOID="FFSUBJID" Mandatory="No"/> <ItemRef ItemOID="FFVISITDY" Mandatory="Yes"/> <ItemRef ItemOID="FFFS0" Mandatory="No"/> <ItemRef ItemOID="FFMNPLASTEDIT" Mandatory="Yes"/> <ItemRef ItemOID="FFRANDOMrandom1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF1921d1" OrderNumber="1" Mandatory="No"/> ItemOID [ fixed text "FF" + formfieldformgroupfgid + "" + formfieldffcolname ] The items in the additional form status item group as fixed id-names (see below) for normal form fields the id is built with the prefix "FF", the form group id and the DB column name of the item Item OIDs of the artifical elements: FFSUBJID patient identifier FFVISITDY visit plan date FFFCS0 completion status (code list) FFFCS1 validation status error FFFCS2 validation status warning FFFCS3 data entry complete (only if DEC is used in the project) FFFS0 review A status FFFS1 review B status FFFS2 freeze status FFFS3 system-freeze status FFFQA query status of document (code list) FFFCT comment status of document FFFSDV sdv status of document (only if SDV is used in the project) OrderNumber Mandatory FFMNPLASTEDIT FFRANDOMrandom1 timestamp for last edit of document column name of the randomization item in the artifical random form ("random1" is an example) [ i + 1 ] Sequence and position of items in an item group the additional items to define the form status have no number set as they are not displayed to the user but are only internally calculated by the system [ "Yes" "No" ] Normally items are set to "No" Only if there is a "mandatory" rule defined for this item this attribute is set to "Yes" Conditional mandatory fields are not marked this way <Alias> The alias element can be used to supply an additional meaning to the parent element For example it can be used for more complex SDMT annotations It is allowed in the ItemGroupDef and the ItemDef elements <Alias Context="SDTM" Name="Domain: DM Demographics"/> Context [ odmaliascontext ] freetext describing the interpretation context of the alias name Name [ odamailasname ] freetext describing the other name and meaning of the parent element As of by ias

68 Documentation secutrial 47 Export Formats <ItemDef> The item definition describes the kind of data collected in this column Further information about interpreting the data (like references to a code list) and the question presented on the form are given In secutrial the question for an item could be stored either on the item or on the item group (=question) level Hence the export in the CDISC-question element combines both possible texts Consequently, the translated text might be the same as the name of the surrounding item group <ItemDef OID="FFSUBJID" Name="Patientidentifikation" DataType="string" Length="20" SDSVar- Name="SUBJID"/> <ItemDef OID="FFVISITDY" Name="Geplantes Visitendatum" DataType="date" SDSVarName="VISITDY"/> <ItemDef OID="FFFS0" Name="Medizinischer Review (A)" DataType="integer" Length="2"/> <ItemDef OID="FFRANDOMrandom1" Name="random1" DataType="string" Length="100"/> <ItemDef OID="FF1921d1" Name="d1" DataType="date" SDSVarName="BRTHDTC"> <ItemDef OID="FF1925epcc2d" Name="epcc2d" DataType="string" Length="5" ias:hidden="true"> OID Name Reference to the ItemOID as defined in the ItemRef Either fixed name for the status from the LanguageBundle or the column name of the normal item (formfieldffcolname) DataType [ "integer" "float" "date" "partialdate" "time" "partialtime" "partialdatetime" "incompletedatetime" "string" ] For text fields, text areas and randomization items the DataType is set to "text" for scores, unit group-number fields and number fields with fractal portion the DataType is set to "float" for simple number fields and all fields with reference values such as checkboxes, radio buttons or lookup tables the DataType is set to "integer" For secutrial date components the data type depends on the displayed are normally partial or incomplete date, time or datetime types Only for checked date (ddmmyyyy) and checked time (hh:mi:ss) components real date and time data types could be used Length [ formfieldfieldlength formfieldfieldtypeffa + formfieldfieldtypeffb 2*formfieldfieldLength ] For text items the length-value equals the number of characters displayed in Unicode due to the xml-format of the file some Unicode characters might need more than one printing character to be represented for float items the length and significant digits are needed the length is calculated from the number of digits before and after the decimal point SignificantDigits [ formfieldfieldtypeffb ] Number of digits after the decimal point this one is required only for float items SDSVarName [ "SUBJID" "VISITDY" formfieldsdsvarname ] references the CDISC Submission Metadata Model (SDTM) For content see CDISC definitions At the moment the first two special variables are constantly used in secutrial for the items "FFSUBJID" and "FFVISITDY" For normal items the additional SDSVarName defined for the item is exported For greater flexibility this variable can be entered in freetext in the project setup definition Therefore it cannot be garantueed that the exported variable is a real valid SDTM variable ias:hidden [ "true" ] If an item has been hidden from the data collection but is included in the export (option "include hidden fields" and with the ias extension) then this attribute is added to the item definition ias:ddecomp [ "compare" "ignore completly" "ignore case and whitespace" (only text) "compare including hash values" (only images) ] If the DDE function is used, for the form each text and image item can configured how to be handled during DDE comparison <CodeListRef> <CodeListRef CodeListOID="CLclfcs_0"> <CodeListRef CodeListOID="CL1921rb2"/> <CodeListRef CodeListOID="CLlmnpias2tier"/> CodeListOID [ "CL" + fixedtext "CL" + formfieldformgroupfgid + formfieldffcolname "CL" + formfieldlookuptablename ] The id of a code list begins with the fixed prefix "CL" followed either by a fixed text for general code lists like form completion status or subject status for radio buttons or popup fields the code list id is built from the form group primary key and column name of the respective item for lookup fields the lookup table name is used Therefore multi-referenced lookup tables are exported only once as a code list As of by ias

69 Documentation secutrial 47 Export Formats <CodeList> Code lists are exported to interpret normal form item fields as well as standard status fields and annotation types <CodeList DataType="integer" OID="CLclfcs_0" Name="Ausfüllstatus"> <CodeList DataType="integer" OID="CL1921rb2" Name="rb2"> <CodeList DataType="integer" OID="CLlmnpias2tier" Name="Haustiere"> DataType OID Name [ "integer" "text" ] Code lists normally consist of integer values as codes Reference to the definition in CodeListRef [ fixed text formfieldffcolname formfieldlookupdescription lddescription ] The name of a code list depends on its type for standard code lists this is a fixed text as translated by the LanguageBundle For code lists for normal form fields the DB-column name is used for code lists of lookup tables this is the description stored in the corresponding lookup-description object <CodeListItem> The code list item is the representation of a single value and decoded value (=text) of a code list The de - code element displays the textual representation of the code <CodeListItem CodedValue="1" Rank="1> <TranslatedText xml:lang="de">männlich</translatedtext> CodedValue [ fixed value fvaluefvvalue lmnptablemnplid ] fixed value for status flag, stored database value for this option or primary key of lookup table entry Rank [ i + 1 ] sequence of presentation <TranslatedText> The translated text is used to display the question on a form or the code of a code list <TranslatedText xml:lang="de">männlich</translatedtext> <TranslatedText xml:lang="en">empty</translatedtext> xml:lang text [ "de" "en" ] language as defined for the project (either directly in the project design, by the customer design or the application default At the moment secutrial allows either a German or English installation, the standard code lists and items (form status) could be given in both languages the questions of the items or the code lists built of lookup tables or for normal form field items are only available as entered in the FormBuilder most times this will be similar to the installed language version [ LB: status value lmnptablemnpname fvaluefvlabel ] LanguageBundle label for status flag, displayed text of option or lookup entry 77 Element description: Participant administration The user specific data is exported in a user element The role of a user is exported as attribute UserType The ODM differs between four roles: UserType (Sponsor Investigator Lab Other) if the user has a role that is not equal to Sponsor, Investigator or Lab, the default role Other is set Due to the role architecture in secutrial, the role "Other" is likely to be used in most cases If a user is member in more than one location, the locations are exported as multiple references A role is only exported if the user has one role directly associated with the project or the user participates in exactly one centre In the first case all centres of this project are referenced as locations for this user The locations include all centres of the exported project, regardless if any participant or subject is included <AdminData> The user, location and signature definitions are included into this element which no further attributes given As of by ias

70 Documentation secutrial 47 Export Formats <User> A user element is the description of information connected with a user Most parts can be omitted if the fields are empty There might be two addresses, one for the private and one for the working postal address of a user The second one is distinguished by the clinic name in the "OtherText" element Either one or both may be omitted <User OID="USER262" UserType="Other"> <User OID="USER1"> <LoginName>susanne</LoginName> <FullName>Dipl biol Susanne Schneider</FullName> <FirstName>Susanne</FirstName> <LastName>Schneider</LastName> <Address> <StreetName>Dieffenbachstr 33c</StreetName> <City>Berlin</City> <StateProv>Deutschland</StateProv> <PostalCode>10967</PostalCode> </Address> <Address> <StreetName>An der Spree 1</StreetName> <City>Berlin</City> <StateProv>Deutschland</StateProv> <PostalCode>12345</PostalCode> <OtherText>Charite</OtherText> </Address> < >susanneschneider@interactive-systemsde</ > <Fax> </Fax> <Phone> </Phone> <LocationRef LocationOID="LOCATION263"/> </User> OID [ "USER" + participantptnid ] Fixed prefix followed by the primary key of the DB object participant UserType [ participantrolerolename "Other" ] Only set if the participant has a role directly associated with the project the role name is used if it matches textually the definition with one of the CDISC types otherwise the type "Other" is set LoginName [ participantlogin ] This is the unique login name the participants use to access the secutrial system FullName [ participantfullname ] This is built from the participant title, first name and surname FirstName [ participanttnvorname ] LastName [ participanttnnachname ] StreetName City StateProv PostalCode OtherText [ participanttnstrasse participantlocationstrasse + participantlocationhausnummer ] The first is the private address which is only given at all when this attribute is set the second attribute is used for the working address in secutrial the "location" is just the postal address, whereas the CDISC "location" is represented by the secutrial "centre" name! Only given if set [ participanttnort participantlocationstadt ] only given if set [ participantcountrycname participantlocationcountrycname ] only given if set [ participanttnplz participantlocationplz ] only given if set [ participantlocationklinikname ] If this parameter is set the address is the working address of the participant it should represent the name of the clinic or medical office <LocationRef> <LocationRef LocationOID="LOCATION263"/> LocationOID [ "LOCATION" + centrectrid ] fixed prefix followed by the primary key of the DB centre object As of by ias

71 Documentation secutrial 47 Export Formats <Location> The reference to the MetaDataVersion states that the location is not generally valid but belongs to a version of the system However, in secutrial only the name of locations (=centres) could change Once created neither the id could be changed nor can the location be deleted <Location OID="LOCATION364" Name="Hannover" LocationType="Site"> <MetaDataVersionRef StudyOID="IAS2" MetaDataVersionOID="IAS22" EffectiveDate=" "/> </Location> Name LocationType MetaDataVersionRef [ centreagname ] The name of the centre as defined in the AdminTool within secutrial all centre names have to be unique even across several projects (at least within one customer area of an installation) [ "Site" ] All centres in secutrial could technically be used for collecting data, so all are declared as "sites" reference to the last, current project version as described in the last exported MetaDataVersion element The effective date is the date of the file generation <SignatureDef> The Signature tag may be contained in a FormData element, ItemData element, ItemGroupData element, StudyEventData element, or SubjectData element In secutrial CDISC exports signatures are only applied to FormData elements The signature will only be exported, if the option E-Signature and validation has been selected An electronic signature applies to a collection of clinical data and indicates that a specific user accepts legal responsibility for this data (see 21 CFR Part 11) The signature identifies the person signing, the location of signing, the signature meaning (via the referenced SignatureDef), the date and time of signing, and an en - crypted hash value of the included data An electronic signature applies to the entity to which it is attached (in this case an electronic case report form) The signature covers all clinical data in that entity at the time of signing, including all clinical data in any sub-entities Thus, a signature on a form includes all clinical data at the form, item group, and item levels The feature for signing in secutrial is called "e-signature" It can be configured via the FormBuilder for which action a signature is required (saving data, reviewing a form, commenting data, freezing, etc) <SignatureDef OID="SIG0" Methodology="Electronic"> <Meaning>Daten eingegeben</meaning> <LegalReason>Daten eingegeben</legalreason> </SignatureDef> OID Methodology Meaning LegalReason [ "SIG" + i ] The signature definitions are built from all used signatures in the DB After the fixed prefix "SIG" an index of collection is used (So the OID could differ from export to export) [ "Electronic" ] Of the two possibilities for computer signatures (electronic or digital) in secutrial only the electronic signature is implemented [ DocumentStoredecodeSigstatus(documentsigstatus) ] Textual representation of the action the "sigstatus" is an integer representing every possible action resulting in form storing the decoding is done during the export, whereas the LegalReason was decoded during the action and stored textually in the DB The exported text here could change if the LanguageBundle or the used language has been changed [ documentsigtext ] Stored text for action this text was presented to the user during the sign action the same decoding is used as for the getting of "Meaning" This text is unchangeable 78 Element description: Clinical data <ClinicalData> The collected data of the study is exported in this part The study name and meta data version under which the export is performed is referenced here (this is not necessarily the version under which the data was col - lected) As of by ias

72 Documentation secutrial 47 Export Formats In secutrial the project version no and version label are stored in the form data, at least when they are set So it could be referenced for every form data with which project version the data has been collected In CDISC there is no appropriate reference for this So the reference to the correct "MetaDataVersionOID" is exported as a form annotation if given <ClinicalData StudyOID="IAS2" MetaDataVersionOID="IAS21"> <ClinicalData StudyOID="IAS2" MetaDataVersionOID="IAS22"> <SubjectData> As the form data of a single subject could be edited in different study meta data versions, the single patient could be listed more than once Therefore a transaction type is added to this element Because the element itself is not edited but only the included form data elements there is no direct audit record element attached here <SubjectData SubjectKey="SUBJECT345" TransactionType="Insert"> <InvestigatorRef UserOID="USER343"/> <SubjectData SubjectKey="SUBJECT345" TransactionType="Update"> <SiteRef LocationOID="LOCATION364"/> SubjectKey LocationRef SiteRef [ "SUBJECT" + patientpid ] After the prefix the primary key of the DB patient object is used This is unique across all studies and does not represent any identification information as presented to the user hence anonymised patients or exports without the pseudonym or additional id are still valid As data for the same subject could be edited in different study version a patient could be included in different clinical data elements In that case the subsequence listings have the transaction type set to "Update" Reference to the participant who entered the patient into the current project (either by creating a new patient in a registry or by adding the patient into a part-project This reference is only given in the first (Insert) transaction Reference to the centre the patient is dedicated This reference is only given in the last transaction <Annotation> - Subject For each patient, the information about his/her status (SeqNum=1) and the information about his/her status within the project (SeqNum=2) are always exported If the export of the pseudonym (SeqNum=3) and additional id (SeqNum=4) are also included depends on the export options If these fields are not filled in, an empty annotation is exported The type and value of these annotations are decoded by the specified, fixed code lists These subject annotations are only added to the last transaction representing the current subject status The annotations for the subject status (1 and 2) are only exported, if the option meta data option Patient status has been selected <Annotation SeqNum="1"> <Comment>active</Comment> <Flag> <FlagValue CodeListOID="CODELISTSubjectStatus">0</FlagValue> <FlagType CodeListOID="CODELISTSubjectType">0</FlagType> </Flag> </Annotation> Comment [ patientgetcumulatedpatientstatusstring(patientpatientenstatus) ] Textual representation of the whole patient status as given in the AdminTool <Annotation SeqNum="2"> <Comment>active</Comment> <Flag> <FlagValue CodeListOID="CODELISTSubjectStatus">0</FlagValue> <FlagType CodeListOID="CODELISTSubjectType">1</FlagType> </Flag> </Annotation> Comment [ patientgetcumulatedpatientstatusstring(casenodecnstatus) ] Textual representation of the casenode status as given in the AdminTool under project status As of by ias

73 Documentation secutrial 47 Export Formats <Annotation SeqNum="3"> <Comment>iwx616</Comment> <Flag> <FlagValue CodeListOID="CODELISTSubjectIdentifier">0</FlagValue> </Flag> </Annotation> Comment [ patientpseudonym ] This is what is named "patient PID" in the secutrial references it is used to reidentify patients within all the different secutrial applications this field is exported according to the selected export options if the project configuration claims to hide this field, it can not be selected for export in this case the annotation is omitted <Annotation SeqNum="4"> <Comment/> <Flag> <FlagValue CodeListOID="CODELISTSubjectIdentifier">1</FlagValue> </Flag> </Annotation> Comment [ patientaid ] Additional id for patients it can be empty depending on the project configuration if this field is not used in the project at all, it is not possible to be se - lected for export and this annotation will be omitted <StudyEventData> Visits, adverse events and the patient status matrix are handled as study events Therefore, each visit, each adverse event and the patient status matrix are exported as single study events The number or visit events depend on the visit plan of each patient As the form data of a single study event could be edited in different study meta data versions, the single event could be listed more than once Therefore a transaction type is added to this element Because the element itself is not edited but only the included form data elements there is no direct audit record element attached here <StudyEventData StudyEventOID="VISIT625" TransactionType="Insert"> <StudyEventData StudyEventOID="VISIT625" TransactionType="Update"> <StudyEventData StudyEventOID="AE" StudyEventRepeatKey="AE11" TransactionType="Insert"> <StudyEventData StudyEventOID="CN" TransactionType="Insert"> <StudyEventData StudyEventOID="RANDOM" TransactionType="Insert"> StudyEventRepeatKey [ casevisitplanvisitno + "" + (i+1) "AE" + adverseeventaeno + "" + (i+1) ] If the visit is defined as repeating, the stored visitno is exported this number is set during the creation of each individual visit regardless if this is a repeating visit or not therefore it is possible that it does not start with "1" for adverse events the aeno is used which is calculated during the creation of the individual adverse event if adverse events may be created independent from the temporal sequence, the order of time and repeat key may differ Therefore additional the repetition index is appended, similar to the building of a visit This should guarantee unique repeat keys even for merged patients <FormData> The audit trail of ecrfs is exported as a sequence of transactions to the same form data element The first element has the transaction type set to "Insert", every following element is set to "Update" Every child element will inherit the transaction type Only if a new item group or item element is declared in a subsequent meta data version element, the transaction type of an internal element could differ from the outer type Each transaction is listed in the clinical data element for the corresponding meta data version with which the form was saved (in former secutrial version indicated by an annotation) The form is the basic element for collecting data in secutrial For this reason the AuditRecord and Signature element are only appended to this ODM element To export additional information from secutrial to CDISC annotations are used The first annotation (SeqNum=1) displays the document-id One annotation (SeqNum=2) provides the action for storage this is the same information as in the SignatureElement As not necessarily all forms or actions have to be signed, the reason for saving is backed up here, too As of by ias

74 Documentation secutrial 47 Export Formats The last annotation (SeqNum=4) is exported if the option for checking the signature validity is selected (only available if the e-signature is configured in the project) <FormData FormOID="Fmnpias2komponenten" TransactionType="Insert"> <FormData FormOID="Fmnpias2komponenten" TransactionType="Update"> <FormData FormOID="Fmnpias2ae" FormRepeatKey="AE11FU1" TransactionType="Insert"> FormRepeatKey ["AE" + adverseeventaeno + "" + (i+1) + "FU"+ (j+1) ] If the form belongs to an adverse event, then it is declared as repeating In this case the ae event key with the follow-up repetition index is used as the repeat key <AuditRecord> <AuditRecord> <UserRef UserOID="USER384"/> <LocationRef LocationOID="LOCATION364"/> <DateTimeStamp> T15:03: :00</DateTimeStamp> <ReasonForChange>Query eingefügt</reasonforchange> <SourceID>mnpdid2mnpatdid3</SourceID> </AuditRecord> DateTimeStamp ReasonForChange SourceID [ documentmnpdate in ISO-format ] timestamp of storage, same content as in SignatureDateTimeStamp (see below) [ documentsigtext + ": " + documentmodifyreason ] reason for storage as defined by action This is stored textually in the field sigtext If the action requires signing, this text is presented to the user as legal reason (similar to signature element) For the action of data modification after the status "data entry complete" has been set (extended workflow) the participant has to supply a reason for changing data If this reason is set it is appended after the general text [ "mnpdid" + mnpdid "mnpdid" + mnpdid + "mnpatdid" + mnpatdid ] primary key of the tpxdocument and the attpxdocument for transactions from the audit trail <Signature> <Signature> <UserRef UserOID="USER343"/> <LocationRef LocationOID="LOCATION364"/> <SignatureRef SignatureOID="SIG0"/> <DateTimeStamp> T15:19: :00</DateTimeStamp> <ias:validity>gültig</ias:validity> <ias:version>0</ias:version> </Signature> ias:validity ias:version ["valid" "invalid" ] As it is possible that only some actions require an e-signature the "not signed" is an allowed state but then the Signature element is not appended at all The validation is done during export by new calculation of the hash value across the stored data and comparison with the stored hash value ["0" "1" "2" ] Displays the algorithm version with which the signature has been generated <Annotation> <Annotation SeqNum="1"> <Comment>Dokument-Nr 2-1</Comment> </Annotation> Comment [" Dokument-Nr " + documentmnpdid + " - " + position in audit trail ] Document-ID as presented in the DataCapture the included mnpdid is the primary key of the document object in the DB <Annotation SeqNum="2"> <Comment>Daten eingegeben</comment> <Flag> <FlagValue CodeListOID="CLsig">1</FlagValue> </Flag> </Annotation> As of by ias

75 Documentation secutrial 47 Export Formats Comment [ DocumentStoredecodeSigstatus(documentsigstatus) ] Textual representation of the value of the Flag (Could slightly differ to AuditRecordReasonForChange if the LanguageBundle has been updated during data collection The meaning should nevertheless be similar) <Annotation SeqNum="4"> <Comment>unsigniert</Comment> <Flag> <FlagValue CodeListOID="CLsigvalid">0</FlagValue> </Flag> </Annotation> Comment [ "not signed" "valid" "invalid" ] Status of the signature check: if the form has not been signed, the first option is used and the signature is not checked otherwise a "valid" flag indicates that a recalculation of the signature hash value produces the same result as the stored hash value and therefore the signature is valid <Annotation SeqNum="5"> <Comment>ausgeblendet</Comment> <Flag> <FlagValue CodeListOID="CLclhd">1</FlagValue> </Flag> </Annotation> Comment [!formisvisible ] Status of the 'hidden'-property: if set to "1" the form is hidden from view in the DataCapture for data collecting and display This annotation is only exported if at least one element of the project-setup is set to 'hidden', these elements shall be included in the export, the untyped data format is chosen and the export does not use the secutrial extensions (see above) For more limitation see chapter: Hidden data <Annotation SeqNum="6"> <Comment>DDE original document: 5281</Comment> </Annotation> Comment [ tpxdocumentdderealdid tpxdocumentddeduplicatedid ] Document-ID of the either the real document (if this is the duplicate) or of the duplicate (if this is the real document) of the Double Data Entry Which type of relation-id is used is described by the label Only exported if this is a DDE form <ItemGroupData> The item group is an organization component for data In secutrial this is matched to the form group level of the form setup Repetition groups with multiple subforms can be exported with a repeat key indicating the position of the subform in the repetition For these repetition groups the form group level of the contained subforms are ignored an all contained subform-items are exported as items in this repetition group <ItemGroupData ItemGroupOID="FG1923"> <ItemGroupData ItemGroupOID="FG1915" ItemGroupRepeatKey="0"> ItemGroupRepeatKey [ repetitionindex ] Position in the repetition of a subform <Annotation> <Annotation SeqNum="1"> <Comment>hidden</Comment> <Flag> <FlagValue CodeListOID="CODELISTclhd">1</FlagValue> </Flag> </Annotation> Comment [!formgroupisvisible ] If the form group is direct (property "hide") or indirect (by form) hidden from view in the DataCapture for data collecting and display This annotation is only exported if at least one element of the project-setup is set to 'hid - den' and these elements shall be included in the export and the export does not As of by ias

76 Documentation secutrial 47 Export Formats use the secutrial extensions (see above) For more limitation see chapter: Hidden data <ItemDataTyped> <ItemDataString ItemOID="FFSUBJID">ukb615</ItemDataString> <ItemDataInteger ItemOID="FFFS0">0</ItemDataInteger> <ItemDataDatetime ItemOID="FFMNPLASTEDIT"> T18:05: :00</ItemDataDatetime> <ItemDataDate ItemOID="FF1921d1"> </ItemDataDate> <ItemDataPartialTime ItemOID="FF1921d2">14:30</ItemDataPartialTime> <ItemDataInteger ItemOID="FF1921rb2">1</ItemDataInteger> <ItemDataAny ItemOID="FF1921s1" IsNull="Yes"/> <ItemDataDate ItemOID="FF1921d1" AnnotationID="Q11"> </ItemDataDate> IsNull ias:sdv ias:imagedataid text [ "Yes" ] If no value is stored (the DB column contains "null") this attribute is set these two attributes are mutually exclusive If this attribute is set than the type "ItemDataAny" is used [ sdvstatus-bit ] Status of the SDV for this item This attribute is only exported if the project uses SDV and the export includes the secutrial extension [ reference to the ImageData element ] The reference to the ImageDataElement which describes the image file(s) in more detail [ patientpseudnoym formstatus-bit mnplasteditdate valueof(mnprecord- valueforkey (formfieldffcolname) ] In this element the stored value for a column is given for simple number fields or text this is the exact DB value if the item definition references to a code list, this code list is used to decode the exported value if no value is stored (the DB column contains "null") this attribute is not set For the additional items for the form status any value other than "null" implies that the status described in this item is set checkbox values are recoded during export in secutrial the non-checked box is stored as "null" as this is a reasonable value it is exported as "0" (If it is crucial to distinguish whether the user has explicitly chosen to answer "no" or if he/she hasn't answered at all, another item type such as radio buttons should be used) All values are checked against the definition supplied in the item definition if a code list value is missing or the format does not match, the CDISC file is not valid <ItemData> <ItemData ItemOID="FF1921d1" Value=" "></ItemData> <ItemData ItemOID="FF1921d2" Value="1430 "></ItemData> <ItemData ItemOID="FF1921rb2" Value="1"></ItemData> <ItemData ItemOID="FF1921s1" IsNull="Yes"></ItemData> Value IsNull ias:sdv ias:imagedataid [ formstatus-bit timestamp valueof (mnprecordvalueforkey(formfieldffcolname) ] In this element the stored value for a column is given for simple number fields or text this is the exact DB value if the item definition references to a code list, this code list is used to decode the exported value if no value is stored (the DB column contains "null") this attribute is not set For the additional items for the form status any value other than "null" implies that the status described in this item is set checkbox values are recoded during export in secutrial the non-checked box is stored as "null" as this is a reasonable value it is exported as "0" (If it is crucial to distinguish whether the user has explicitly chosen to answer "no" or if he/she hasn't answered at all, another item type such as radio buttons should be used) All values are checked against the definition supplied in the item definition if a code list value is missing or the format does not match, the CDISC file is not valid [ "Yes" ] If no value is stored (the DB column contains "null") this attribute is set these two attributes are mutually exclusive [ sdvstatus-bit ] Status of the SDV for this item This attribute is only exported if the project uses SDV and the export includes the secutrial extension [ reference to the ImageData element ] The reference to the ImageDataElement which describes the image file(s) in more detail As of by ias

77 Documentation secutrial 47 Export Formats <ImageData> <ias:imagedata ID="mnpimgid79" uploadedfilename="dsc_0189jpg" contenttype="image/jpeg" imagesize="71130"> ID uploadedfilename contenttype imagesize [ "mnpimgid" + tpximagemnpimgid ] The unique identifier for this image, build with the primary key of the database object [ tpximageuploadedfilename ] The plain (without path) filename from the upload (=client filename) [ tpximagecontenttype ] The content specification as given from the browser during upload (=mime type) This could be used as a hint to specify the application for file handling [ tpximageimagesize ] The file size of the uploaded image measured in bytes <ImageFileData> <ias:imagefiledata type="original" filename="patientimages/5/75/75/ jpg" filestatus="valid"/> type filename filestatus [ "original" "web" "thumbnail" ] The type of the described file, this could either be the uploaded "original", the displayed "web" image on the ecrf or the minimized "thumbnail" [ tpximageoriginalfullpathexport txpimagewebfullpathexport tpximagethumbnailfullpathexport ] The name and path to the exported image file This is even set if the image does not exist All images are exported in a separate "patientimages" folder Inside this folder the images are evenly distributed into subfolders according patient id parts [ "valid" "invalid" "nonexistent" ] Status if the named file exists (is included into export), is valid (=unchanged since upload) or invalid (changed since upload) For original file a nonexistent file has to be treated as an error since the uploaded file has to exist Because even non-image files can be uploaded in secutrial nonexistent web- and thumbnail images are no error <Annotation> Queries and comments are exported as annotations to the item data In the comment the text entered by the user is given, whereas the flag value distinguishes between query and comment The flag type for queries defines the type of query entry The transaction type of these annotations is always set to "Insert" regardless of the transaction type of the enclosing item, item group or form When queries and comments are cumulatively appended to the last form transaction (when no audit trail is exported this is only possible for untyped data, see chapter: Queries and Comments), they do not correspond to the AuditRecord entry of the enclosing form To distinguish this information the secutrial extension for "ias:userentry" gives information about the user who made the annotation and the timestamp of this action If the audit trail is exported too the element "ias:userentry" is omitted for the query- and comments annotation because the user of the current form data transaction is responsible for the annotation too The "ias:queryid" is the query ID as displayed in the DataCapture It allows subsuming several query-entries to a single query (including the query, its answers, and finally the closing comment) Similar the comment ID is given in the "ias:commentid" element The attribute SeqNum only reflects the sequence of listing and has no further meaning <Annotation SeqNum="0"> <Comment>ausgeblendet</Comment> <Flag> <FlagValue CodeListOID="CLclhd">1</FlagValue> </Flag> </Annotation> Comment [!formfieldisvisible ] If set to "1" the form field is hidden from view in the Data- Capture for data collecting and display This annotation is only exported if at least one element of the project-setup is set to 'hidden' and these elements shall be included in the export and the export does not use the secutrial extensions For more limitation see chapter: "Hidden data" As of by ias

78 Documentation secutrial 47 Export Formats <Annotation SeqNum="1"> <Comment>Source Data Verification</Comment> <Flag> <FlagValue CodeListOID="CLclfssdv">2</FlagValue> </Flag> </Annotation> Comment [ sdvstatus for formfield in this mnprecord ] Status for the SDV of this item Is only exported if SDV is configured for the project and the export does not use the secutrial extension (see above) <Annotation SeqNum="2" TransactionType="Insert" ID="Q11"> <Comment>war das nicht eher noch einen Tag später?</comment> <Flag> <FlagValue CodeListOID="CLqact">1</FlagValue> <FlagType CodeListOID="CLclqa">1</FlagType> </Flag> <ias:queryid value="1"/> </Annotation> ID Comment ias:queryid [ "Q" + qaccontentqueryqueryid + "" + qaccontentqacid ] the ID is build with a fix prefix and the primary key of the query and the query entry This ID is only given in the typed data export where the item data annotations are exported in the separate element and referenced in the item data by this ID [ qaccontentqactext ] The free text entry of the user [ qaccontentqueryqueryid ] the query ID as displayed in the DataCapture By this ID the annotations which belong together could be identified If the ias extension is not used, the grouping of annotations is only indicated by the first number part of the annotation ID <Annotation SeqNum="1" TransactionType="Insert" ID="C12"> <Comment>Operationsbericht stehen noch aus</comment> <Flag> <FlagValue CodeListOID="CLqact">0</FlagValue> </Flag> <ias:commentid value="1"/> </Annotation> ID Comment ias:commentid [ "C" + qaccontentcommentcommentid + "" + qaccontentqacid ] the ID is build with a fix prefix and the primary key of the comment and the comment entry This ID is only given in the typed data export where the item data annotations are exported in the separate element and referenced in the item date element by this ID [ qaccontentqactext ] The free text entry of the user [ qaccontentcommentcommentid ] the comment ID as displayed in the DataCapture Only give with chosen ias extension <Annotations> If the typed data format is chosen than the annotations to single item data elements could not be added as sub elements Instead the AnnotationID is added as an item data attribute and all referenced annotations are listed separate in an Annotations element parallel to the subject data elements As a side effect this typed data export limits the number of annotations possibly made to a single item data transaction (see chapter: "Queries and Comments" and "Hidden data") So with adverse export options some annotations needed for complete overview of query management or status information may not be included in the CDISC export As of by ias

79 Documentation secutrial 47 Export Formats 8 Appendix A-1: SAS program example /* File created on (CEST) by User: susanne */ /* Data from Project Basisregister*/ /* Only Data from Centre 'Berlin' contained in export*/ DATA visitplan_ias1 (LABEL='Project visit plan') infile 'dat/visitplan_ias1_ dat' missover LRECL=114 input mnpvisid 1-10 visitnumber visittype previsid visitday minusoffset plusoffset visitlabel $ ATTRIB mnpvisid LABEL='Visit-ID' visitnumber LABEL='Visit sequence' visittype LABEL='Type of visit' FORMAT=clvt previsid LABEL='Preceding visit-id' visitday LABEL='Time lag to preceding visit (days)' minusoffset LABEL='Possible negative time frame (days)' plusoffset LABEL='Possible positive time frame (days)' visitlabel LABEL='Visit label' run /* == end of visitplan_ias1 == */ DATA visitplanforms_ias1 (LABEL='Forms in visit plan') infile 'dat/visitplanforms_ias1_ dat' missover LRECL=22 input mnpvisid 1-10 formid ATTRIB mnpvisid LABEL='Visit-ID' formid LABEL='Form-ID' run /* == end of visitplanforms_ias1 == */ DATA forms_ias1 (label='form') infile 'dat/forms_ias1_ dat' missover LRECL=352 input formid 1-10 formtablename $ hidden formname $ formfamily $ sequence ATTRIB formid LABEL='Form-ID' formtablename LABEL='DB table name' hidden LABEL='hidden in DataCapture' FORMAT=clhd formname LABEL='Form name (as in matrix)' formfamily LABEL='Form family name' sequence LABEL='Form sequence in form family' run /* == end of forms_ias1 == */ DATA questions_ias1 (label='questions') infile 'dat/questions_ias1_ dat' missover LRECL=237 input fgid 1-10 formid sequence hidden fglabel $ ATTRIB fgid LABEL='Question-ID' formid LABEL='Form-ID' sequence LABEL='Question sequence in form' hidden LABEL='hidden in DataCapture' FORMAT=clhd fglabel LABEL='Question label (or unique label for search)' As of by ias

80 Documentation secutrial 47 Export Formats run /* == end of questions_ias1 == */ DATA items_ias1 (label='items') infile 'dat/items_ias1_ dat' missover LRECL=1603 input ffid 1-10 fgid sequence ffcolname $ hidden fflabel $ lookuptable $ ATTRIB ffid LABEL='Item-ID' fgid LABEL='Question-ID' sequence LABEL='Item sequence in question' ffcolname LABEL='DB column name' hidden LABEL='hidden in DataCapture' FORMAT=clhd fflabel LABEL='Item label (or question label or unique label for search)' lookuptable LABEL='Name of lookup table' run /* == end of items_ias1 == */ DATA centres_ias1 (label='centres') infile 'dat/centres_ias1_ dat' missover LRECL=313 input mnpctrid 1-10 mnpctrname $ mnpcname $ ATTRIB mnpctrid LABEL='Centre-ID' mnpctrname LABEL='Centre name' mnpcname LABEL='Country name' run /* == end of centres_ias1 == */ DATA casenodes_ias1 (label='patient information') infile 'dat/casenodes_ias1_ dat' missover LRECL=88 input mnppid 1-10 mnppsd $ mnpptnid mnpctrid mnpcs mnpcs mnpcs mnpcs mnpcs mnpcs mnpcs mnpcs7 visitstartdate ATTRIB mnppid LABEL='Patient-ID' mnppsd LABEL='Patient pseudonym' mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpctrid LABEL='Centre-ID' mnpcs0 LABEL='Case status 0' FORMAT=clcs_0x mnpcs1 LABEL='Case status 1' FORMAT=clcs_1x mnpcs2 LABEL='Case status 2' FORMAT=clcs_2x mnpcs3 LABEL='Case status 3' FORMAT=clcs_3x mnpcs4 LABEL='Case status 4' FORMAT=clcs_4x mnpcs5 LABEL='Case status 5' FORMAT=clcs_5x mnpcs6 LABEL='Case status 6' FORMAT=clcs_6x mnpcs7 LABEL='Case status 7' FORMAT=clcs_7x visitstartdate LABEL='Entry date' INFORMAT=DATE9 FORMAT=DATE9 run /* == end of casenodes_ias1 == */ DATA atcasenodes_ias1 (label='patient information history') infile 'dat/atcasenodes_ias1_ dat' missover LRECL=262 input mnppid 1-10 As of by ias

81 Documentation secutrial 47 Export newvisitstartdate mnpptnid changedate changereason $ ATTRIB mnppid LABEL='Patient-ID' oldvisitstartdate LABEL='Old entry date' INFORMAT=DATE9 FORMAT=DATE9 newvisitstartdate LABEL='New entry date' INFORMAT=DATE9 FORMAT=DATE9 mnpptnid LABEL='Participant-ID' FORMAT=cltn changedate LABEL='Date of change' INFORMAT=DATETIME18 FORMAT=DATETIME20 changereason LABEL='Reason for change' run /* == end of atcasenodes_ias1 == */ DATA atcasevisitplans_ias1 (label='patient visit plan history') infile 'dat/atcasevisitplans_ias1_ dat' missover LRECL=317 input mnppid 1-10 mnpcvpid newmnpvispdt oldmnpvisid newmnpvisid oldmnpvisno newmnpvisno mnpptnid changedate changereason $ ATTRIB mnppid LABEL='Patient-ID' mnpcvpid LABEL='Patient visit-id' oldmnpvispdt LABEL='Old planned date of visit' INFORMAT=DATE9 FORMAT=DATE9 newmnpvispdt LABEL='New planned date of visit' INFORMAT=DATE9 FORMAT=DATE9 oldmnpvisid LABEL='Old visit-id' newmnpvisid LABEL='New visit-id' oldmnpvisno LABEL='Old patient-visit number' newmnpvisno LABEL='New patient-visit number' mnpptnid LABEL='Participant-ID' FORMAT=cltn changedate LABEL='Date of change' INFORMAT=DATETIME18 FORMAT=DATETIME20 changereason LABEL='Reason for change' run /* == end of atcasevisitplans_ias1 == */ DATA queries_ias1 (label='queries') infile 'dat/queries_ias1_ dat' missover LRECL=1117 input mnppid 1-10 mnpdocid ffid ffcolname $ qacdate mnpqueryid querytype $ querystatus qacstatus mnpptnid qaccontent $ ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' ffid LABEL='Item-ID' ffcolname LABEL='DB column name' qacdate LABEL='Date of entry' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpqueryid LABEL='Query-ID' querytype LABEL='Query type (manual or automatic)' querystatus LABEL='Query status (calculated status)' FORMAT=clqa qacstatus LABEL='QAC status (type of query-entry)' FORMAT=clqa mnpptnid LABEL='Participant-ID' FORMAT=cltn qaccontent LABEL='Content' run /* == end of queries_ias1 == */ As of by ias

82 Documentation secutrial 47 Export Formats DATA comments_ias1 (label='comments') infile 'dat/comments_ias1_ dat' missover LRECL=1108 input mnppid 1-10 mnpdocid ffid ffcolname $ qacdate mnpcommentid mnpptnid qaccontent $ ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' ffid LABEL='Item-ID' ffcolname LABEL='DB column name' qacdate LABEL='Date of entry' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpcommentid LABEL='Comment-ID' mnpptnid LABEL='Participant-ID' FORMAT=cltn qaccontent LABEL='Content' run /* == end of comments_ias1 == */ DATA sdv_ias1 (label='source Data Verification') infile 'dat/sdv_ias1_ dat' missover LRECL=100 input mnppid 1-10 mnpdocid ffid ffcolname $ sdvdate mnpfssdv mnpptnid ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' ffid LABEL='Item-ID' ffcolname LABEL='DB column name' sdvdate LABEL='Date of entry' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpfssdv LABEL='Status SDV' FORMAT=clfssdv mnpptnid LABEL='Participant-ID' FORMAT=cltn run /* == end of sdv_ias1 == */ DATA atsdv_ias1 (label='audit Trail Source Data Verification') infile 'dat/atsdv_ias1_ dat' missover LRECL=100 input mnppid 1-10 mnpatdocid ffid ffcolname $ sdvdate mnpfssdv mnpptnid ATTRIB mnppid LABEL='Patient-ID' mnpatdocid LABEL='ATDocument-ID' ffid LABEL='Item-ID' ffcolname LABEL='DB column name' sdvdate LABEL='Date of entry' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpfssdv LABEL='Status SDV' FORMAT=clfssdv mnpptnid LABEL='Participant-ID' FORMAT=cltn run /* == end of atsdv_ias1 == */ DATA mnpias1komponenten (label='basisdaten') infile 'dat/mnpias1komponenten_ias1_ dat' missover LRECL=1448 input mnppid 1-10 mnpdocid mnplastedit mnpptnid mnpvisid mnpcvpid mnpvisno As of by ias

83 Documentation secutrial 47 Export mnpvisfdt mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ eppc1 $ epcc2a $ epcc2b $ epcc2c $ epcc2d $ tier rasse farbe tier rasse farbe tier rasse farbe hb hb hb hb hb hb r1s r1s r1s r2s r2s r2s cb rb rrb cb rrb ugcb ug ugm ugt1 $ ugcb ugt2 $ ug ugm cb rb rrb pp score gz kz score text1 $ text2 $ zeit1 $ datum1 $ zeit2 $ datum2 $ ddd $ random1 $ hobbies haustier abcdefghijabcdefghij cb rb rrb pp As of by ias

84 Documentation secutrial 47 Export Formats score farbe hb hb hb bild bild ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-id' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9 FORMAT=DATE9 mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_kh hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_fs hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_cf hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_t hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_lv hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_iy r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_kx rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_jf rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_jq cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_fr rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_cp ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_bj ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ugt2 LABEL='Meßzeitpunkt - HHMI' ug1 LABEL='Messwert (g) - Number' ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_le cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_ip rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_kz rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_y pp1 LABEL='Popup - CODELIST' FORMAT=cl_lg score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (53) - Number' As of by ias

85 Documentation secutrial 47 Export Formats score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' ddd LABEL='IASStandardGroup Zeitfelder - YYYYMMDD' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a abcdefghijabcdefghij LABEL='Namenstest mit Regel - CODELIST' FORMAT=clcb cb4 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_cs rb3 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_dg rrb4 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_id pp2 LABEL='Popup - CODELIST' FORMAT=cl_ff score3 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' farbe LABEL='Lieblingsfarbe - CODELIST' FORMAT=cl_bh hb7 LABEL='Erste Reihe - CODELIST' FORMAT=cl_mh hb9 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_fm hb8 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_bq bild1 LABEL='Lieblingsbild' bild2 LABEL='und noch ein Bild' run /* == end of mnpias1komponenten == */ DATA atmnpias1komponenten (label='basisdaten (Audit-Records)') infile 'dat/atmnpias1komponenten_ias1_ dat' missover LRECL=1459 input mnppid 1-10 mnpdocid mnpatdocid mnplastedit mnpptnid mnpvisid mnpcvpid mnpvisno mnpvisfdt mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ eppc1 $ epcc2a $ epcc2b $ epcc2c $ epcc2d $ tier rasse farbe tier rasse farbe tier rasse farbe hb hb hb hb hb hb r1s r1s r1s As of by ias

86 Documentation secutrial 47 Export Formats r2s r2s r2s cb rb rrb cb rrb ugcb ug ugm ugt1 $ ugcb ugt2 $ ug ugm cb rb rrb pp score gz kz score text1 $ text2 $ zeit1 $ datum1 $ zeit2 $ datum2 $ ddd $ random1 $ hobbies haustier abcdefghijabcdefghij cb rb rrb pp score farbe hb hb hb bild bild ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-id' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9 FORMAT=DATE9 mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a As of by ias

87 Documentation secutrial 47 Export Formats rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_kh hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_fs hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_cf hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_t hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_lv hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_iy r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_kx rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_jf rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_jq cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_fr rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_cp ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_bj ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ugt2 LABEL='Meßzeitpunkt - HHMI' ug1 LABEL='Messwert (g) - Number' ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_le cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_ip rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_kz rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_y pp1 LABEL='Popup - CODELIST' FORMAT=cl_lg score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (53) - Number' score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' ddd LABEL='IASStandardGroup Zeitfelder - YYYYMMDD' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a abcdefghijabcdefghij LABEL='Namenstest mit Regel - CODELIST' FORMAT=clcb cb4 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_cs rb3 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_dg rrb4 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_id pp2 LABEL='Popup - CODELIST' FORMAT=cl_ff score3 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' farbe LABEL='Lieblingsfarbe - CODELIST' FORMAT=cl_bh hb7 LABEL='Erste Reihe - CODELIST' FORMAT=cl_mh hb9 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_fm hb8 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_bq bild1 LABEL='Lieblingsbild' bild2 LABEL='und noch ein Bild' run /* == end of atmnpias1komponenten == */ DATA mnpias1komponenten1 (label='komponenten 1') infile 'dat/mnpias1komponenten1_ias1_ dat' missover LRECL=1381 input mnppid 1-10 mnpdocid mnplastedit mnpptnid mnpvisid mnpcvpid mnpvisno mnpvisfdt As of by ias

88 Documentation secutrial 47 Export Formats mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ eppc1 $ epcc2a $ epcc2b $ epcc2c $ epcc2d $ tier rasse farbe tier rasse farbe tier rasse farbe hb hb hb hb hb hb r1s r1s r1s r2s r2s r2s cb rb rrb cb rrb ugcb ug ugm ugt1 $ ugcb ug ugm ugt2 $ cb rb rrb pp score gz kz score text1 $ text2 $ zeit1 $ datum1 $ zeit2 $ datum2 $ random1 $ hobbies haustier bild ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpvisid LABEL='Visit-ID' As of by ias

89 Documentation secutrial 47 Export Formats run mnpcvpid LABEL='Patient visit-id' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9 FORMAT=DATE9 mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_ku hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_jj hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_hg hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_hb hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_cv hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_mx r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_lx rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_ke rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_ib cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_en rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_co ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_lk ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ug1 LABEL='Messwert (g) - Number' ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_ck ugt2 LABEL='Meßzeitpunkt - HHMI' cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_kw rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_r rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_fy pp1 LABEL='Popup - CODELIST' FORMAT=cl_da score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (53) - Number' score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a bild1 LABEL='Bild-1' As of by ias

90 Documentation secutrial 47 Export Formats /* == end of mnpias1komponenten1 == */ DATA atmnpias1komponenten1 (label='komponenten 1 (Audit-Records)') infile 'dat/atmnpias1komponenten1_ias1_ dat' missover LRECL=1392 input mnppid 1-10 mnpdocid mnpatdocid mnplastedit mnpptnid mnpvisid mnpcvpid mnpvisno mnpvisfdt mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ eppc1 $ epcc2a $ epcc2b $ epcc2c $ epcc2d $ tier rasse farbe tier rasse farbe tier rasse farbe hb hb hb hb hb hb r1s r1s r1s r2s r2s r2s cb rb rrb cb rrb ugcb ug ugm ugt1 $ ugcb ug ugm ugt2 $ cb rb rrb pp score gz kz score text1 $ text2 $ As of by ias

91 Documentation secutrial 47 Export Formats zeit1 $ datum1 $ zeit2 $ datum2 $ random1 $ hobbies haustier bild ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-id' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9 FORMAT=DATE9 mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_ku hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_jj hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_hg hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_hb hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_cv hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_mx r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_lx rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_ke rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_ib cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_en rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_co ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_lk ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ug1 LABEL='Messwert (g) - Number' ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_ck ugt2 LABEL='Meßzeitpunkt - HHMI' cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_kw rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_r rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_fy pp1 LABEL='Popup - CODELIST' FORMAT=cl_da score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' As of by ias

92 Documentation secutrial 47 Export Formats gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (53) - Number' score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a bild1 LABEL='Bild-1' run /* == end of atmnpias1komponenten1 == */ DATA mnpias1roentgen (label='röntgenbilder') infile 'dat/mnpias1roentgen_ias1_ dat' missover LRECL=792 input mnppid 1-10 mnpdocid mnplastedit mnpptnid mnpvisid mnpcvpid mnpvisno mnpvisfdt mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ titel $ aufnahme $ beschreibung $ klinisch ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-id' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9 FORMAT=DATE9 mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' titel LABEL='Titel' aufnahme LABEL='Aufnahmedatum - YYYYMMDD' beschreibung LABEL='Beschreibung' As of by ias

93 Documentation secutrial 47 Export Formats klinisch LABEL='Klinisch auffällig? - CODELIST' FORMAT=cl_kv run /* == end of mnpias1roentgen == */ DATA atmnpias1roentgen (label='röntgenbilder (Audit-Records)') infile 'dat/atmnpias1roentgen_ias1_ dat' missover LRECL=803 input mnppid 1-10 mnpdocid mnpatdocid mnplastedit mnpptnid mnpvisid mnpcvpid mnpvisno mnpvisfdt mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ titel $ aufnahme $ beschreibung $ klinisch ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-id' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9 FORMAT=DATE9 mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' titel LABEL='Titel' aufnahme LABEL='Aufnahmedatum - YYYYMMDD' beschreibung LABEL='Beschreibung' klinisch LABEL='Klinisch auffällig? - CODELIST' FORMAT=cl_kv run /* == end of atmnpias1roentgen == */ DATA mnpias1score (label='score-test') infile 'dat/mnpias1score_ias1_ dat' missover LRECL=635 input mnppid 1-10 As of by ias

94 Documentation secutrial 47 Export Formats mnpdocid mnplastedit mnpptnid mnpvisid mnpcvpid mnpvisno mnpvisfdt mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ sb vr score score rb rb ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-id' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9 FORMAT=DATE9 mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' sb1 LABEL='horizontal radiobutton - CODELIST' FORMAT=cl_in vr1 LABEL='vertical radiobutton - CODELIST' FORMAT=cl_ek score LABEL='score berechnen - Number' score2 LABEL='score function - Number' rb1 LABEL='erste Frage - CODELIST' FORMAT=cl_cz rb2 LABEL='zweite Frage - CODELIST' FORMAT=cl_d run /* == end of mnpias1score == */ DATA atmnpias1score (label='score-test (Audit-Records)') infile 'dat/atmnpias1score_ias1_ dat' missover LRECL=646 input mnppid 1-10 mnpdocid mnpatdocid mnplastedit mnpptnid mnpvisid mnpcvpid mnpvisno mnpvispdt As of by ias

95 Documentation secutrial 47 Export mnpvisfdt mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ sb vr score score rb rb ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-id' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9 FORMAT=DATE9 mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' sb1 LABEL='horizontal radiobutton - CODELIST' FORMAT=cl_in vr1 LABEL='vertical radiobutton - CODELIST' FORMAT=cl_ek score LABEL='score berechnen - Number' score2 LABEL='score function - Number' rb1 LABEL='erste Frage - CODELIST' FORMAT=cl_cz rb2 LABEL='zweite Frage - CODELIST' FORMAT=cl_d run /* == end of atmnpias1score == */ DATA mnpias1bild (label='standard-bild') infile 'dat/mnpias1bild_ias1_ dat' missover LRECL=676 input mnppid 1-10 mnpdocid mnplastedit mnpptnid mnpvisid mnpcvpid mnpvisno mnpvisfdt mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs As of by ias

96 Documentation secutrial 47 Export Formats mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ farbe zahl wort $ bild ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-id' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9 FORMAT=DATE9 mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' farbe LABEL='Lieblingsfarbe - CODELIST' FORMAT=cl_brl zahl LABEL='Lieblingszahl - Number' wort LABEL='Lieblingswort' bild1 LABEL='Lieblingsbild' run /* == end of mnpias1bild == */ DATA atmnpias1bild (label='standard-bild (Audit-Records)') infile 'dat/atmnpias1bild_ias1_ dat' missover LRECL=687 input mnppid 1-10 mnpdocid mnpatdocid mnplastedit mnpptnid mnpvisid mnpcvpid mnpvisno mnpvisfdt mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ farbe As of by ias

97 Documentation secutrial 47 Export Formats zahl wort $ bild ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-id' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9 FORMAT=DATE9 mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' farbe LABEL='Lieblingsfarbe - CODELIST' FORMAT=cl_brl zahl LABEL='Lieblingszahl - Number' wort LABEL='Lieblingswort' bild1 LABEL='Lieblingsbild' run /* == end of atmnpias1bild == */ DATA mnpias1bild1 (label='standard-bild-2') infile 'dat/mnpias1bild1_ias1_ dat' missover LRECL=676 input mnppid 1-10 mnpdocid mnplastedit mnpptnid mnpvisid mnpcvpid mnpvisno mnpvisfdt mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ farbe zahl wort $ bild ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-id' As of by ias

98 Documentation secutrial 47 Export Formats mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9 FORMAT=DATE9 mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' farbe LABEL='Lieblingsfarbe - CODELIST' FORMAT=cl_bsi zahl LABEL='Lieblingszahl - Number' wort LABEL='Lieblingswort' bild1 LABEL='Lieblingsbild' run /* == end of mnpias1bild1 == */ DATA atmnpias1bild1 (label='standard-bild-2 (Audit-Records)') infile 'dat/atmnpias1bild1_ias1_ dat' missover LRECL=687 input mnppid 1-10 mnpdocid mnpatdocid mnplastedit mnpptnid mnpvisid mnpcvpid mnpvisno mnpvisfdt mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ farbe zahl wort $ bild ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-id' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9 FORMAT=DATE9 mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x As of by ias

99 Documentation secutrial 47 Export Formats mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' farbe LABEL='Lieblingsfarbe - CODELIST' FORMAT=cl_bsi zahl LABEL='Lieblingszahl - Number' wort LABEL='Lieblingswort' bild1 LABEL='Lieblingsbild' run /* == end of atmnpias1bild1 == */ DATA mnpias1status (label='patientenstatus') infile 'dat/mnpias1status_ias1_ dat' missover LRECL=1308 input mnppid 1-10 mnpdocid mnplastedit mnpptnid mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ eppc1 $ epcc2a $ epcc2b $ epcc2c $ epcc2d $ tier rasse farbe tier rasse farbe tier rasse farbe hb hb hb hb hb hb r1s r1s r1s r2s r2s r2s cb rb rrb cb rrb ugcb ug ugm ugt1 $ ugcb ug ugm ugt2 $ As of by ias

100 Documentation secutrial 47 Export Formats cb rb rrb pp score gz kz score text1 $ text2 $ zeit1 $ datum1 $ zeit2 $ datum2 $ random1 $ hobbies haustier ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_jn hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_hz hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_kq hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_hx hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_hs hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_mf r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_by rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_go rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_la cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_hh rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_ht ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_jx ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ug1 LABEL='Messwert (g) - Number' ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_bi ugt2 LABEL='Meßzeitpunkt - HHMI' cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_fa rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_if As of by ias

101 Documentation secutrial 47 Export Formats rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_eh pp1 LABEL='Popup - CODELIST' FORMAT=cl_ep score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (53) - Number' score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a run /* == end of mnpias1status == */ DATA atmnpias1status (label='patientenstatus (Audit-Records)') infile 'dat/atmnpias1status_ias1_ dat' missover LRECL=1319 input mnppid 1-10 mnpdocid mnpatdocid mnplastedit mnpptnid mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ eppc1 $ epcc2a $ epcc2b $ epcc2c $ epcc2d $ tier rasse farbe tier rasse farbe tier rasse farbe hb hb hb hb hb hb r1s r1s r1s r2s r2s r2s cb rb rrb cb rrb ugcb ug ugm ugt1 $ ugcb As of by ias

102 Documentation secutrial 47 Export Formats ug ugm ugt2 $ cb rb rrb pp score gz kz score text1 $ text2 $ zeit1 $ datum1 $ zeit2 $ datum2 $ random1 $ hobbies haustier ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_jn hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_hz hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_kq hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_hx hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_hs hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_mf r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_by rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_go rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_la cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_hh rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_ht ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_jx ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ug1 LABEL='Messwert (g) - Number' As of by ias

103 Documentation secutrial 47 Export Formats ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_bi ugt2 LABEL='Meßzeitpunkt - HHMI' cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_fa rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_if rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_eh pp1 LABEL='Popup - CODELIST' FORMAT=cl_ep score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (53) - Number' score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a run /* == end of atmnpias1status == */ DATA mnpias1ae (label='adverse Event') infile 'dat/mnpias1ae_ias1_ dat' missover LRECL=1379 input mnppid 1-10 mnpdocid mnplastedit mnpptnid mnpaeid mnpaedate mnpaeno mnpaefuid mnpaefudt mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ eppc1 $ epcc2a $ epcc2b $ epcc2c $ epcc2d $ tier rasse farbe tier rasse farbe tier rasse farbe hb hb hb hb hb hb r1s r1s r1s r2s r2s r2s cb rb As of by ias

104 Documentation secutrial 47 Export Formats rrb cb rrb ugcb ug ugm ugt1 $ ugcb ug ugm ugt2 $ cb rb rrb pp score gz kz score text1 $ text2 $ zeit1 $ datum1 $ zeit2 $ datum2 $ random1 $ hobbies haustier ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpaeid LABEL='Adverse Event-ID' mnpaedate LABEL='Adverse Event date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpaeno LABEL='Adverse Event case number' mnpaefuid LABEL='Adverse Event Follow-up-ID' mnpaefudt LABEL='Adverse Event Follow-up date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_kr hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_do hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_bw hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_lf hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_hn hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_cr r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb As of by ias

105 Documentation secutrial 47 Export Formats r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_gm rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_ee rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_gn cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_iv rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_br ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_dm ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ug1 LABEL='Messwert (g) - Number' ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_ft ugt2 LABEL='Meßzeitpunkt - HHMI' cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_ih rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_fv rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_s pp1 LABEL='Popup - CODELIST' FORMAT=cl_md score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (53) - Number' score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a run /* == end of mnpias1ae == */ DATA atmnpias1ae (label='adverse Event (Audit-Records)') infile 'dat/atmnpias1ae_ias1_ dat' missover LRECL=1390 input mnppid 1-10 mnpdocid mnpatdocid mnplastedit mnpptnid mnpaeid mnpaedate mnpaeno mnpaefuid mnpaefudt mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ eppc1 $ epcc2a $ epcc2b $ epcc2c $ epcc2d $ tier rasse farbe tier rasse farbe tier rasse farbe hb As of by ias

106 Documentation secutrial 47 Export Formats hb hb hb hb hb r1s r1s r1s r2s r2s r2s cb rb rrb cb rrb ugcb ug ugm ugt1 $ ugcb ug ugm ugt2 $ cb rb rrb pp score gz kz score text1 $ text2 $ zeit1 $ datum1 $ zeit2 $ datum2 $ random1 $ hobbies haustier ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpaeid LABEL='Adverse Event-ID' mnpaedate LABEL='Adverse Event date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpaeno LABEL='Adverse Event case number' mnpaefuid LABEL='Adverse Event Follow-up-ID' mnpaefudt LABEL='Adverse Event Follow-up date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c As of by ias

107 Documentation secutrial 47 Export Formats tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_kr hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_do hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_bw hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_lf hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_hn hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_cr r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_gm rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_ee rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_gn cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_iv rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_br ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_dm ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ug1 LABEL='Messwert (g) - Number' ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_ft ugt2 LABEL='Meßzeitpunkt - HHMI' cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_ih rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_fv rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_s pp1 LABEL='Popup - CODELIST' FORMAT=cl_md score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (53) - Number' score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a run /* == end of atmnpias1ae == */ DATA mnpias1sae1 (label='serious Adverse Event') infile 'dat/mnpias1sae1_ias1_ dat' missover LRECL=1379 input mnppid 1-10 mnpdocid mnplastedit mnpptnid mnpaeid mnpaedate mnpaeno mnpaefuid mnpaefudt mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ eppc1 $ epcc2a $ As of by ias

108 Documentation secutrial 47 Export Formats epcc2b $ epcc2c $ epcc2d $ tier rasse farbe tier rasse farbe tier rasse farbe hb hb hb hb hb hb r1s r1s r1s r2s r2s r2s cb rb rrb cb rrb ugcb ug ugm ugt1 $ ugcb ug ugm ugt2 $ cb rb rrb pp score gz kz score text1 $ text2 $ zeit1 $ datum1 $ zeit2 $ datum2 $ random1 $ hobbies haustier ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpaeid LABEL='Adverse Event-ID' mnpaedate LABEL='Adverse Event date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpaeno LABEL='Adverse Event case number' mnpaefuid LABEL='Adverse Event Follow-up-ID' mnpaefudt LABEL='Adverse Event Follow-up date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' As of by ias

109 Documentation secutrial 47 Export Formats sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_gt hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_lq hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_nj hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_ej hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_gi hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_gy r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_cm rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_fu rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_gv cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_he rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_hf ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_dx ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ug1 LABEL='Messwert (g) - Number' ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_f ugt2 LABEL='Meßzeitpunkt - HHMI' cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_fk rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_mp rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_nd pp1 LABEL='Popup - CODELIST' FORMAT=cl_bx score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (53) - Number' score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a run /* == end of mnpias1sae1 == */ DATA atmnpias1sae1 (label='serious Adverse Event (Audit-Records)') infile 'dat/atmnpias1sae1_ias1_ dat' missover LRECL=1390 input mnppid 1-10 mnpdocid mnpatdocid mnplastedit mnpptnid mnpaeid mnpaedate mnpaeno mnpaefuid mnpaefudt mnpfs mnpfs mnpfs mnpfs mnpfcs As of by ias

110 Documentation secutrial 47 Export Formats mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ eppc1 $ epcc2a $ epcc2b $ epcc2c $ epcc2d $ tier rasse farbe tier rasse farbe tier rasse farbe hb hb hb hb hb hb r1s r1s r1s r2s r2s r2s cb rb rrb cb rrb ugcb ug ugm ugt1 $ ugcb ug ugm ugt2 $ cb rb rrb pp score gz kz score text1 $ text2 $ zeit1 $ datum1 $ zeit2 $ datum2 $ random1 $ hobbies haustier ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpaeid LABEL='Adverse Event-ID' mnpaedate LABEL='Adverse Event date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpaeno LABEL='Adverse Event case number' mnpaefuid LABEL='Adverse Event Follow-up-ID' mnpaefudt LABEL='Adverse Event Follow-up date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x As of by ias

111 Documentation secutrial 47 Export Formats mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_gt hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_lq hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_nj hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_ej hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_gi hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_gy r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_cm rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_fu rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_gv cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_he rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_hf ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_dx ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb ug1 LABEL='Messwert (g) - Number' ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_f ugt2 LABEL='Meßzeitpunkt - HHMI' cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_fk rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_mp rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_nd pp1 LABEL='Popup - CODELIST' FORMAT=cl_bx score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (53) - Number' score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a run /* == end of atmnpias1sae1 == */ DATA mnpias1bilder (label='bilderformular mit besonders "langem Namen"') infile 'dat/mnpias1bilder_ias1_ dat' missover LRECL=803 input mnppid 1-10 As of by ias

112 Documentation secutrial 47 Export Formats mnpdocid mnplastedit mnpptnid mnpvisid mnpcvpid mnpvisno mnpvisfdt mnpaeid mnpaedate mnpaeno mnpaefuid mnpcrtdt mnpcrtpt mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ img bild bezeichnung $ img bild ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-id' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9 FORMAT=DATE9 mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpaeid LABEL='Adverse Event-ID' mnpaedate LABEL='Adverse Event date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpaeno LABEL='Adverse Event case number' mnpaefuid LABEL='Adverse Event Follow-up-ID' mnpaefudt LABEL='Adverse Event Follow-up date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpcrtdt LABEL='Document create date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpcrtpt LABEL='Document creator (participant)' FORMAT=cltn mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' img LABEL='Bild a' bild2 LABEL='Bild b' bezeichnung LABEL='Bezeichnung' img1 LABEL='Bild c' bild3 LABEL='Bild d' run /* == end of mnpias1bilder == */ As of by ias

113 Documentation secutrial 47 Export Formats DATA atmnpias1bilder (label='bilderformular mit besonders "langem Namen" (Audit-Records)') infile 'dat/atmnpias1bilder_ias1_ dat' missover LRECL=814 input mnppid 1-10 mnpdocid mnpatdocid mnplastedit mnpptnid mnpvisid mnpcvpid mnpvisno mnpvisfdt mnpaeid mnpaedate mnpaeno mnpaefuid mnpcrtdt mnpcrtpt mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ img bild bezeichnung $ img bild ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-id' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9 FORMAT=DATE9 mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpaeid LABEL='Adverse Event-ID' mnpaedate LABEL='Adverse Event date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpaeno LABEL='Adverse Event case number' mnpaefuid LABEL='Adverse Event Follow-up-ID' mnpaefudt LABEL='Adverse Event Follow-up date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpcrtdt LABEL='Document create date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpcrtpt LABEL='Document creator (participant)' FORMAT=cltn mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' img LABEL='Bild a' bild2 LABEL='Bild b' bezeichnung LABEL='Bezeichnung' img1 LABEL='Bild c' As of by ias

114 Documentation secutrial 47 Export Formats bild3 LABEL='Bild d' run /* == end of atmnpias1bilder == */ DATA mnpias1bilder1 (label='röntgen') infile 'dat/mnpias1bilder1_ias1_ dat' missover LRECL=770 input mnppid 1-10 mnpdocid mnplastedit mnpptnid mnpvisid mnpcvpid mnpvisno mnpvisfdt mnpaeid mnpaedate mnpaeno mnpaefuid mnpcrtdt mnpcrtpt mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ img aufnahme $ ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-id' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9 FORMAT=DATE9 mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpaeid LABEL='Adverse Event-ID' mnpaedate LABEL='Adverse Event date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpaeno LABEL='Adverse Event case number' mnpaefuid LABEL='Adverse Event Follow-up-ID' mnpaefudt LABEL='Adverse Event Follow-up date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpcrtdt LABEL='Document create date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpcrtpt LABEL='Document creator (participant)' FORMAT=cltn mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' img LABEL='erstes Bild' aufnahme LABEL='Aufnahme:' As of by ias

115 Documentation secutrial 47 Export Formats run /* == end of mnpias1bilder1 == */ DATA atmnpias1bilder1 (label='röntgen (Audit-Records)') infile 'dat/atmnpias1bilder1_ias1_ dat' missover LRECL=781 input mnppid 1-10 mnpdocid mnpatdocid mnplastedit mnpptnid mnpvisid mnpcvpid mnpvisno mnpvisfdt mnpaeid mnpaedate mnpaeno mnpaefuid mnpcrtdt mnpcrtpt mnpfs mnpfs mnpfs mnpfs mnpfcs mnpfcs mnpfcs mnpfcs mnpfsqa mnpfsct mnpfssdv siguser $ sigtext $ sigstatus sigvalid $ sigreason $ img aufnahme $ ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' FORMAT=cltn mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-id' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9 FORMAT=DATE9 mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpaeid LABEL='Adverse Event-ID' mnpaedate LABEL='Adverse Event date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpaeno LABEL='Adverse Event case number' mnpaefuid LABEL='Adverse Event Follow-up-ID' mnpaefudt LABEL='Adverse Event Follow-up date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpcrtdt LABEL='Document create date' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpcrtpt LABEL='Document creator (participant)' FORMAT=cltn mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x mnpfsqa LABEL='Form status Queries' FORMAT=clfqa mnpfsct LABEL='Form status Comments' FORMAT=clct mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' img LABEL='erstes Bild' aufnahme LABEL='Aufnahme:' As of by ias

116 Documentation secutrial 47 Export Formats run /* == end of atmnpias1bilder1 == */ DATA emnpias1medikament (label='medikament') infile 'dat/emnpias1medikament_ias1_ dat' missover LRECL=109 input mnppid 1-10 mnpdocid mnpsubdocid fgid position wirkstoff $ dosis einnahme $ ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Parent document-id' mnpsubdocid LABEL='Subdocument-ID' fgid LABEL='Question-ID of Repetition' position LABEL='Position in Repetition' wirkstoff LABEL='Wirkstoff' dosis LABEL='Dosis - Number' einnahme LABEL='Einnahmezeit - HHMI' run /* == end of emnpias1medikament== */ DATA atemnpias1medikament (label='medikament') infile 'dat/atemnpias1medikament_ias1_ dat' missover LRECL=109 input mnppid 1-10 mnpatdocid mnpatsubdocid fgid position wirkstoff $ dosis einnahme $ ATTRIB mnppid LABEL='Patient-ID' mnpatdocid LABEL='Parent ATDocument-ID' mnpatsubdocid LABEL='ATSubdocument-ID' fgid LABEL='Question-ID of Repetition' position LABEL='Position in Repetition' wirkstoff LABEL='Wirkstoff' dosis LABEL='Dosis - Number' einnahme LABEL='Einnahmezeit - HHMI' run /* == end of atemnpias1medikament== */ DATA images_ias1 (label='images') infile 'dat/images_ias1_ dat' missover LRECL=957 input mnpimgid 1-10 uploadedfilename $ contenttype $ imagesize uploaddate mnpptnid originalfile $ originalstatus $ webfile $ webstatus $ thumbnailfile $ webstatus $ ATTRIB mnpimgid LABEL='Image-ID' uploadedfilename LABEL='Uploaded file' contenttype LABEL='Content type' imagesize LABEL='Image size (bytes)' uploaddate LABEL='Date of upload' INFORMAT=DATETIME18 FORMAT=DATETIME20 mnpptnid LABEL='Participant-ID' As of by ias

117 Documentation secutrial 47 Export Formats originalfile LABEL='Original file name' originalstatus LABEL='Status of original file' webfile LABEL='Web file name' webstatus LABEL='Status of web file' thumbnailfile LABEL='Thumbnail file name' thumbnailstatus LABEL='Status of thumbnail file' run /* == end of images_ias1 == */ /* == end of file == */ As of by ias

118 Documentation secutrial 47 Export Formats 9 Appendix A-2: SAS format (=code lists) example proc format value cl_ku 3 = 'grün' 2 = 'blau' 1 = 'rot' value cllt_d 3 = 'Lesen' 1 = 'Sport' 2 = 'Faulenzen' value cl_co 0 = 'nein' 1 = 'ja' value cl_kx 0 = 'no einheit' 1 = 'yes einheit' value cl_cp 0 = 'nein' 1 = 'ja' value cl_kz 0 = 'nein' 1 = 'ja' 3 = 'grün' value cl_cs 0 = 'no einheit' 1 = 'yes einheit' value cl_cr 3 = 'grün' 1 = 'rot' 2 = 'blau' value cl_cv 3 = 'grün' 2 = 'blau' 1 = 'rot' value clcs_3x 1 = 'frozen' value cl_cz 3 = 'grün' 1 = 'rot' 2 = 'blau' value cl_d 3 = 'grün' 1 = 'rot' 2 = 'blau' value cl_le 1 = 'g' 2 = 'mol' value cl_lf 1 = 'rot' 3 = 'grün' 2 = 'blau' value cl_lg 1 = 'rot' 2 = 'blau' 3 = 'grün' value cl_da 1 = 'rot' 3 = 'grün' 2 = 'blau' value cl_lk 1 = 'g' 2 = 'mol' As of by ias

119 Documentation secutrial 47 Export Formats value cl_f 1 = 'g' 2 = 'mol' value cl_dg 3 = 'grün' 0 = 'nein' 1 = 'ja' value cl_lq 3 = 'grün' 2 = 'blau' 1 = 'rot' value cl_r 0 = 'nein' 1 = 'ja' value cl_s 0 = 'nein' 1 = 'ja' value cl_t 2 = 'blau' 1 = 'rot' 3 = 'grün' value cl_la 0 = 'nein' 1 = 'ja' value cl_lv 1 = 'rot' 2 = 'blau' 3 = 'grün' value cl_do 3 = 'grün' 1 = 'rot' 2 = 'blau' value cl_lx 0 = 'no einheit' 1 = 'yes einheit' value cl_y 1 = 'ja' 0 = 'nein' value clhd 0 = 'no' 1 = 'yes' value cl_dx 1 = 'g' 2 = 'mol' value clcs_4x 1 = 'deceased' value cl_md 2 = 'blau' 1 = 'rot' 3 = 'grün' value cl_dm 2 = 'mol' 1 = 'g' value cl_mf 3 = 'grün' 2 = 'blau' 1 = 'rot' value clfs_0x 1 = 'medical review (A)' value cl_ee 0 = 'nein' 1 = 'ja' As of by ias

120 Documentation secutrial 47 Export Formats value clqa 0 = '' 1 = 'open' 2 = 'answered' 4 = 'resolved' 8 = 'check again' value cl_ej 2 = 'blau' 1 = 'rot' 3 = 'grün' value cl_ek 5 = 'fünf' 2 = 'zwei' 4 = 'vier' 1 = 'eins' value cl_en 0 = 'no einheit' 1 = 'yes einheit' value cl_mx 1 = 'rot' 2 = 'blau' 3 = 'grün' value cl_brl 2 = 'blau' 3 = 'grün' 1 = 'rot' value clcs_5x 1 = 'Project: frozen' value cl_nd 0 = 'nein' 1 = 'ja' value clfs_1x 1 = 'data review (B)' value cl_fa 0 = 'no einheit' 1 = 'yes einheit' value cl_nj 1 = 'rot' 3 = 'grün' 2 = 'blau' value cllt_a 2 = 'Pferd' 3 = 'Hund' 1 = 'Katze' value cllt_b 6 = 'Araber' 7 = 'Perser' 4 = 'Hannoveraner' 1 = 'Schäferhund' 3 = 'Kurzhaar' 5 = 'Siam' 2 = 'Dackel' value cllt_c 14 = 'Schimmel' 15 = 'braun-schwarz' 11 = 'Palomino' 3 = 'tabby' 12 = 'rot' 1 = 'getigert' 5 = 'blau' 7 = 'weiß' 2 = 'braun' 4 = 'schwarz-weiß' 13 = 'braun' 16 = 'bunt' 8 = 'rot' As of by ias

121 Documentation secutrial 47 Export Formats 6 = 'braun' 9 = 'Rappe' 10 = 'schwarz' value cl_ff 3 = 'grün' 2 = 'blau' 1 = 'rot' value cl_fk 0 = 'no einheit' 1 = 'yes einheit' value cl_fm 2 = 'blau' 3 = 'grün' 1 = 'rot' value cl_ep 1 = 'rot' 3 = 'grün' 2 = 'blau' value cl_bsi 1 = 'rot' 2 = 'blau' 3 = 'grün' value cl_fs 2 = 'blau' 1 = 'rot' 3 = 'grün' value cl_ft 1 = 'g' 2 = 'mol' value cl_fu 1 = 'ja' 0 = 'nein' value cl_fv 0 = 'nein' 1 = 'ja' value clcs_6x 1 = 'Project: to be deleted' value cl_fy 0 = 'nein' 1 = 'ja' value cl_he 0 = 'no einheit' 1 = 'yes einheit' value clfs_2x 1 = 'manual freeze' value cl_gi 1 = 'rot' 2 = 'blau' 3 = 'grün' value cl_gm 0 = 'no einheit' 1 = 'yes einheit' value cl_gn 0 = 'nein' 1 = 'ja' value cl_go 1 = 'ja' 0 = 'nein' value cl_kv 1 = 'ja' 0 = 'nein' 3 = 'unklar' As of by ias

122 Documentation secutrial 47 Export Formats value cl_kw 0 = 'no einheit' 1 = 'yes einheit' value cl_gv 0 = 'nein' 1 = 'ja' value clcs_7x 1 = 'Project: visit plan closed' value clcb 0 = 'no' 1 = 'yes' value cl_eh 1 = 'ja' 0 = 'nein' value clfs_3x 1 = 'rulebased freeze' value clfssdv 1 = 'not done' 2 = 'not necessary' 4 = 'not possible' 8 = 'deferred' 16 = 'in progress' 32 = 'verified' 64 = 'verified with errors' value cl_hb 3 = 'grün' 2 = 'blau' 1 = 'rot' value cl_fr 0 = 'no einheit' 1 = 'yes einheit' value cl_hf 0 = 'nein' 1 = 'ja' value cl_hg 3 = 'grün' 1 = 'rot' 2 = 'blau' value cl_hh 0 = 'no einheit' 1 = 'yes einheit' value clfcs_1x 1 = 'with errors' value clct 0 = '' 1 = 'with comment' value cl_hn 3 = 'grün' 1 = 'rot' 2 = 'blau' value cl_hs 3 = 'grün' 2 = 'blau' 1 = 'rot' value cl_ht 1 = 'ja' 0 = 'nein' value cltn 1 = 'Dipl biol Susanne Schneider' 151 = 'Dr Ulrike Jonas' value cl_hx As of by ias

123 Documentation secutrial 47 Export Formats 2 = 'blau' 3 = 'grün' 1 = 'rot' value cl_hz 1 = 'rot' 3 = 'grün' 2 = 'blau' value clcs_0x 1 = 'not shown' value cl_ib 0 = 'nein' 1 = 'ja' value cl_id 0 = 'nein' 1 = 'ja' value clfcs_0x 0 = 'empty' 2 = 'partly filled' 4 = 'completely filled' value cl_if 1 = 'ja' 0 = 'nein' value cl_ih 0 = 'no einheit' 1 = 'yes einheit' value clfcs_2x 1 = 'with warnings' value cl_in 3 = 'drei' 2 = 'zwei' 1 = 'eins' value cl_ip 0 = 'no einheit' 1 = 'yes einheit' value cl_iv 0 = 'no einheit' 1 = 'yes einheit' value cl_gt 2 = 'blau' 3 = 'grün' 1 = 'rot' value cl_iy 1 = 'rot' 2 = 'blau' 3 = 'grün' value cl_mh 2 = 'blau' 3 = 'grün' 1 = 'rot' value cl_bi 2 = 'mol' 1 = 'g' value cl_gy 2 = 'blau' 1 = 'rot' 3 = 'grün' value clcs_1x 1 = 'delete pseudonym' value cl_jf 0 = 'nein' 1 = 'ja' As of by ias

124 Documentation secutrial 47 Export Formats value cl_mp 0 = 'nein' 1 = 'ja' value cl_jj 2 = 'blau' 1 = 'rot' 3 = 'grün' value clfcs_3x 1 = 'data entry complete' value cl_jn 3 = 'grün' 1 = 'rot' 2 = 'blau' value cl_bh 2 = 'blau' 3 = 'grün' 1 = 'rot' value cl_jq 1 = 'ja' 0 = 'nein' value cl_bj 1 = 'g' 2 = 'mol' value cl_bx 1 = 'rot' 2 = 'blau' 3 = 'grün' value clfqa 0 = 'without query' 1 = 'with open query' 2 = 'with answered query' 4 = 'all queries resolved' 8 = 'all queries resolved' value cl_jx 2 = 'mol' 1 = 'g' value cl_bq 3 = 'grün' 1 = 'rot' 2 = 'blau' value cl_br 0 = 'nein' 1 = 'ja' value clvt 0 = 'fixed' 1 = 'flexible' 2 = 'unscheduled' 3 = 'free' value cl_bw 2 = 'blau' 3 = 'grün' 1 = 'rot' value clcs_2x 1 = 'frozen' value cl_by 0 = 'no einheit' 1 = 'yes einheit' value cl_ke 0 = 'nein' 1 = 'ja' value cl_kh 2 = 'blau' 1 = 'rot' As of by ias

125 Documentation secutrial 47 Export Formats 3 = 'grün' value cl_cf 1 = 'rot' 2 = 'blau' 3 = 'grün' value cl_kq 3 = 'grün' 1 = 'rot' 2 = 'blau' value cl_kr 2 = 'blau' 1 = 'rot' 3 = 'grün' value cl_ck 2 = 'mol' 1 = 'g' value cl_cm 0 = 'no einheit' 1 = 'yes einheit' As of by ias

126 Documentation secutrial 47 Export Formats 10 Appendix B: SPSS syntax example * created (CEST) by susanne * * project 'Basisregister' * * centre 'Berlin' * GET DATA /TYPE = TXT /FILE = 'dat/visitplan_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnpvisid F100 visitnumber F40 visittype F20 previsid F100 visitday EDATE10 minusoffset F100 plusoffset F100 visitlabel A50 VARIABLE LABELS mnpvisid 'Visit-ID' visitnumber 'Visit sequence' visittype 'Type of visit' previsid 'Preceding visit-id' visitday 'Time lag to preceding visit (days)' minusoffset 'Possible negative time frame (days)' plusoffset 'Possible positive time frame (days)' visitlabel 'Visit label' VALUE LABEL visittype 0 'fixed' 1 'flexible' 2 'unscheduled' 3 'free' CACHE EXECUTE DATASET NAME visitplan_ias1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/visitplanforms_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnpvisid F100 formid F100 VARIABLE LABELS mnpvisid 'Visit-ID' formid 'Form-ID' CACHE EXECUTE DATASET NAME visitplanforms_ias1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/forms_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = formid F100 formtablename A24 As of by ias

127 Documentation secutrial 47 Export Formats hidden F20 formname A200 formfamily A100 sequence F100 VARIABLE LABELS formid 'Form-ID' formtablename 'DB table name' hidden 'hidden in DataCapture' formname 'Form name (as in matrix)' formfamily 'Form family name' sequence 'Form sequence in form family' VALUE LABEL hidden 0 'no' 1 'yes' CACHE EXECUTE DATASET NAME forms_ias1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/questions_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = fgid F100 formid F100 sequence F100 hidden F20 fglabel A200 VARIABLE LABELS fgid 'Question-ID' formid 'Form-ID' sequence 'Question sequence in form' hidden 'hidden in DataCapture' fglabel 'Question label (or unique label for search)' VALUE LABEL hidden 0 'no' 1 'yes' CACHE EXECUTE DATASET NAME questions_ias1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/items_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = ffid F100 fgid F100 sequence F100 ffcolname A32 hidden F20 fflabel A1500 lookuptable A30 VARIABLE LABELS ffid 'Item-ID' fgid 'Question-ID' sequence 'Item sequence in question' ffcolname 'DB column name' hidden 'hidden in DataCapture' fflabel 'Item label (or question label or unique label for search)' lookuptable 'Name of lookup table' As of by ias

128 Documentation secutrial 47 Export Formats VALUE LABEL hidden 0 'no' 1 'yes' CACHE EXECUTE DATASET NAME items_ias1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/centres_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnpctrid F100 mnpctrname A100 mnpcname A200 VARIABLE LABELS mnpctrid 'Centre-ID' mnpctrname 'Centre name' mnpcname 'Country name' CACHE EXECUTE DATASET NAME centres_ias1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/casenodes_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnppsd A20 mnpptnid F100 mnpctrid F100 mnpcs0 F20 mnpcs1 F20 mnpcs2 F20 mnpcs3 F20 mnpcs4 F20 mnpcs5 F20 mnpcs6 F20 mnpcs7 F20 visitstartdate EDATE10 VARIABLE LABELS mnppid 'Patient-ID' mnppsd 'Patient pseudonym' mnpptnid 'Participant-ID' mnpctrid 'Centre-ID' mnpcs0 'Case status 0' mnpcs1 'Case status 1' mnpcs2 'Case status 2' mnpcs3 'Case status 3' mnpcs4 'Case status 4' mnpcs5 'Case status 5' mnpcs6 'Case status 6' mnpcs7 'Case status 7' visitstartdate 'Entry date' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpcs0 1 'not shown' As of by ias

129 Documentation secutrial 47 Export Formats VALUE LABEL mnpcs1 1 'delete pseudonym' VALUE LABEL mnpcs2 1 'frozen' VALUE LABEL mnpcs3 1 'frozen' VALUE LABEL mnpcs4 1 'deceased' VALUE LABEL mnpcs5 1 'Project: frozen' VALUE LABEL mnpcs6 1 'Project: to be deleted' VALUE LABEL mnpcs7 1 'Project: visit plan closed' CACHE EXECUTE DATASET NAME casenodes_ias1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/atcasenodes_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 oldvisitstartdate EDATE10 newvisitstartdate EDATE10 mnpptnid F100 changedate DATETIME232 changereason A200 VARIABLE LABELS mnppid 'Patient-ID' oldvisitstartdate 'Old entry date' newvisitstartdate 'New entry date' mnpptnid 'Participant-ID' changedate 'Date of change' changereason 'Reason for change' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' CACHE EXECUTE DATASET NAME atcasenodes_ias1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/atcasevisitplans_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpcvpid F100 As of by ias

130 Documentation secutrial 47 Export Formats oldmnpvispdt EDATE10 newmnpvispdt EDATE10 oldmnpvisid F100 newmnpvisid F100 oldmnpvisno F100 newmnpvisno F100 mnpptnid F100 changedate DATETIME232 changereason A200 VARIABLE LABELS mnppid 'Patient-ID' mnpcvpid 'Patient visit-id' oldmnpvispdt 'Old planned date of visit' newmnpvispdt 'New planned date of visit' oldmnpvisid 'Old visit-id' newmnpvisid 'New visit-id' oldmnpvisno 'Old patient-visit number' newmnpvisno 'New patient-visit number' mnpptnid 'Participant-ID' changedate 'Date of change' changereason 'Reason for change' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' CACHE EXECUTE DATASET NAME atcasevisitplans_ias1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/queries_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 ffid F100 ffcolname A32 qacdate DATETIME232 mnpqueryid F100 querytype A1 querystatus F20 qacstatus F20 mnpptnid F100 qaccontent A1000 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' ffid 'Item-ID' ffcolname 'DB column name' qacdate 'Date of entry' mnpqueryid 'Query-ID' querytype 'Query type (manual or automatic)' querystatus 'Query status (calculated status)' qacstatus 'QAC status (type of query-entry)' mnpptnid 'Participant-ID' qaccontent 'Content' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL querystatus 1 'open' 2 'answered' 4 'resolved' 8 'check again' VALUE LABEL qacstatus As of by ias

131 Documentation secutrial 47 Export Formats 1 'open' 2 'answered' 4 'resolved' 8 'check again' CACHE EXECUTE DATASET NAME queries_ias1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/comments_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 ffid F100 ffcolname A32 qacdate DATETIME232 mnpcommentid F100 mnpptnid F100 qaccontent A1000 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' ffid 'Item-ID' ffcolname 'DB column name' qacdate 'Date of entry' mnpcommentid 'Comment-ID' mnpptnid 'Participant-ID' qaccontent 'Content' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' CACHE EXECUTE DATASET NAME comments_ias1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/sdv_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 ffid F100 ffcolname A32 sdvdate DATETIME232 mnpfssdv F20 mnpptnid F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' ffid 'Item-ID' ffcolname 'DB column name' sdvdate 'Date of entry' mnpfssdv 'Status SDV' mnpptnid 'Participant-ID' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfssdv As of by ias

132 Documentation secutrial 47 Export Formats 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' CACHE EXECUTE DATASET NAME sdv_ias1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/atsdv_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpatdocid F100 ffid F100 ffcolname A32 sdvdate DATETIME232 mnpfssdv F20 mnpptnid F100 VARIABLE LABELS mnppid 'Patient-ID' mnpatdocid 'ATDocument-ID' ffid 'Item-ID' ffcolname 'DB column name' sdvdate 'Date of entry' mnpfssdv 'Status SDV' mnpptnid 'Participant-ID' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' CACHE EXECUTE DATASET NAME atsdv_ias1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/mnpias1komponenten_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpvisid F100 mnpcvpid F100 mnpvisno F100 mnpvispdt EDATE10 mnpvisfdt DATETIME232 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 As of by ias

133 Documentation secutrial 47 Export Formats mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 eppc1 A120 epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F100 rasse1 F100 farbe1 F100 tier2 F100 rasse2 F100 farbe2 F100 tier3 F100 rasse3 F100 farbe3 F100 hb1 F100 hb2 F100 hb3 F100 hb4 F100 hb5 F100 hb6 F100 r1s1 F20 r1s2 F20 r1s3 F20 r2s1 F20 r2s2 F20 r2s3 F20 cb1 F20 rb1 F100 rrb1 F100 cb3 F20 rrb3 F100 ugcb1 F20 ug F220 ugm F100 ugt1 A4 ugcb2 F20 ugt2 A4 ug1 F220 ugm1 F100 cb2 F20 rb2 F100 rrb2 F100 pp1 F100 score1 F100 gz1 F30 kz1 F103 score2 F100 text1 A40 text2 A120 zeit1 A6 datum1 A8 zeit2 A4 datum2 A6 ddd A8 random1 A5 hobbies1 F100 haustier1 F100 abcdefghijabcdefghij F20 cb4 F20 rb3 F100 rrb4 F100 pp2 F100 score3 F100 farbe F100 hb7 F100 hb9 F100 hb8 F100 As of by ias

134 Documentation secutrial 47 Export Formats bild1 F100 bild2 F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-id' mnpvisno'visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' tier3 'a) Haustier' rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' rb1 'b) einfacher RadioButton' rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12 IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ugt2 'c) Meßzeitpunkt' ug1 'b) Messwert' ugm1 '13 IASUnitGroup' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (53)' score2 'c) Score über Zahlenfelder' text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' As of by ias

135 Documentation secutrial 47 Export Formats zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' ddd '16 IASStandardGroup Zeitfelder' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' abcdefghijabcdefghij 'Namenstest mit Regel' cb4 'a) einfache Checkbox' rb3 'b) einfacher RadioButton' rrb4 'c) Reset-Radiobutton' pp2 'e) Popup' score3 'f) Score über Auswahl-Optionen (Ganzzahlen)' farbe 'Lieblingsfarbe' hb7 'a) Erste Reihe' hb9 'b) Zweite Reihe' hb8 'c) Dritte Reihe' bild1 'a) Lieblingsbild' bild2 'b) und noch ein Bild' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' As of by ias

136 Documentation secutrial 47 Export Formats VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier2 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier3 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' As of by ias

137 Documentation secutrial 47 Export Formats 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb4 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau' VALUE LABEL r1s1 0 'no' 1 'yes' VALUE LABEL r1s2 0 'no' 1 'yes' VALUE LABEL r1s3 0 'no' 1 'yes' VALUE LABEL r2s1 0 'no' 1 'yes' VALUE LABEL r2s2 0 'no' 1 'yes' VALUE LABEL r2s3 0 'no' 1 'yes' VALUE LABEL cb1 0 'no' 1 'yes' VALUE LABEL rb1 1 'ja' 0 'nein' VALUE LABEL rrb1 1 'ja' 0 'nein' VALUE LABEL cb3 0 'no' 1 'yes' As of by ias

138 Documentation secutrial 47 Export Formats VALUE LABEL rrb3 1 'ja' 0 'nein' VALUE LABEL ugcb1 0 'no' 1 'yes' VALUE LABEL ugm 2 'mol' 1 'g' VALUE LABEL ugcb2 0 'no' 1 'yes' VALUE LABEL ugm1 2 'mol' 1 'g' VALUE LABEL cb2 0 'no' 1 'yes' VALUE LABEL rb2 1 'ja' 0 'nein' 3 'grün' VALUE LABEL rrb2 1 'ja' 0 'nein' VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hobbies1 1 'Sport' 2 'Faulenzen' 3 'Lesen' VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL abcdefghijabcdefghij 0 'no' 1 'yes' VALUE LABEL cb4 0 'no' 1 'yes' VALUE LABEL rb3 1 'ja' 0 'nein' 3 'grün' VALUE LABEL rrb4 1 'ja' 0 'nein' VALUE LABEL pp2 1 'rot' 3 'grün' 2 'blau' VALUE LABEL farbe 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb7 1 'rot' 3 'grün' 2 'blau' As of by ias

139 Documentation secutrial 47 Export Formats VALUE LABEL hb9 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb8 1 'rot' 3 'grün' 2 'blau' CACHE EXECUTE DATASET NAME mnpias1komponenten WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1komponenten_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnpatdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpvisid F100 mnpcvpid F100 mnpvisno F100 mnpvispdt EDATE10 mnpvisfdt DATETIME232 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 eppc1 A120 epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F100 rasse1 F100 farbe1 F100 tier2 F100 rasse2 F100 farbe2 F100 tier3 F100 rasse3 F100 farbe3 F100 hb1 F100 hb2 F100 hb3 F100 hb4 F100 hb5 F100 hb6 F100 r1s1 F20 r1s2 F20 r1s3 F20 r2s1 F20 r2s2 F20 r2s3 F20 cb1 F20 rb1 F100 As of by ias

140 Documentation secutrial 47 Export Formats rrb1 F100 cb3 F20 rrb3 F100 ugcb1 F20 ug F220 ugm F100 ugt1 A4 ugcb2 F20 ugt2 A4 ug1 F220 ugm1 F100 cb2 F20 rb2 F100 rrb2 F100 pp1 F100 score1 F100 gz1 F30 kz1 F103 score2 F100 text1 A40 text2 A120 zeit1 A6 datum1 A8 zeit2 A4 datum2 A6 ddd A8 random1 A5 hobbies1 F100 haustier1 F100 abcdefghijabcdefghij F20 cb4 F20 rb3 F100 rrb4 F100 pp2 F100 score3 F100 farbe F100 hb7 F100 hb9 F100 hb8 F100 bild1 F100 bild2 F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-id' mnpvisno'visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' As of by ias

141 Documentation secutrial 47 Export Formats tier3 'a) Haustier' rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' rb1 'b) einfacher RadioButton' rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12 IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ugt2 'c) Meßzeitpunkt' ug1 'b) Messwert' ugm1 '13 IASUnitGroup' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (53)' score2 'c) Score über Zahlenfelder' text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' ddd '16 IASStandardGroup Zeitfelder' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' abcdefghijabcdefghij 'Namenstest mit Regel' cb4 'a) einfache Checkbox' rb3 'b) einfacher RadioButton' rrb4 'c) Reset-Radiobutton' pp2 'e) Popup' score3 'f) Score über Auswahl-Optionen (Ganzzahlen)' farbe 'Lieblingsfarbe' hb7 'a) Erste Reihe' hb9 'b) Zweite Reihe' hb8 'c) Dritte Reihe' bild1 'a) Lieblingsbild' bild2 'b) und noch ein Bild' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' As of by ias

142 Documentation secutrial 47 Export Formats VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier2 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' As of by ias

143 Documentation secutrial 47 Export Formats VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier3 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb4 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau' As of by ias

144 Documentation secutrial 47 Export Formats VALUE LABEL r1s1 0 'no' 1 'yes' VALUE LABEL r1s2 0 'no' 1 'yes' VALUE LABEL r1s3 0 'no' 1 'yes' VALUE LABEL r2s1 0 'no' 1 'yes' VALUE LABEL r2s2 0 'no' 1 'yes' VALUE LABEL r2s3 0 'no' 1 'yes' VALUE LABEL cb1 0 'no' 1 'yes' VALUE LABEL rb1 1 'ja' 0 'nein' VALUE LABEL rrb1 1 'ja' 0 'nein' VALUE LABEL cb3 0 'no' 1 'yes' VALUE LABEL rrb3 1 'ja' 0 'nein' VALUE LABEL ugcb1 0 'no' 1 'yes' VALUE LABEL ugm 2 'mol' 1 'g' VALUE LABEL ugcb2 0 'no' 1 'yes' VALUE LABEL ugm1 2 'mol' 1 'g' VALUE LABEL cb2 0 'no' 1 'yes' VALUE LABEL rb2 1 'ja' 0 'nein' 3 'grün' VALUE LABEL rrb2 1 'ja' 0 'nein' VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hobbies1 As of by ias

145 Documentation secutrial 47 Export Formats 1 'Sport' 2 'Faulenzen' 3 'Lesen' VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL abcdefghijabcdefghij 0 'no' 1 'yes' VALUE LABEL cb4 0 'no' 1 'yes' VALUE LABEL rb3 1 'ja' 0 'nein' 3 'grün' VALUE LABEL rrb4 1 'ja' 0 'nein' VALUE LABEL pp2 1 'rot' 3 'grün' 2 'blau' VALUE LABEL farbe 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb7 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb9 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb8 1 'rot' 3 'grün' 2 'blau' CACHE EXECUTE DATASET NAME atmnpias1komponenten WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/mnpias1komponenten1_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpvisid F100 mnpcvpid F100 mnpvisno F100 mnpvispdt EDATE10 mnpvisfdt DATETIME232 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 As of by ias

146 Documentation secutrial 47 Export Formats mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 eppc1 A120 epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F100 rasse1 F100 farbe1 F100 tier2 F100 rasse2 F100 farbe2 F100 tier3 F100 rasse3 F100 farbe3 F100 hb1 F100 hb2 F100 hb3 F100 hb4 F100 hb5 F100 hb6 F100 r1s1 F20 r1s2 F20 r1s3 F20 r2s1 F20 r2s2 F20 r2s3 F20 cb1 F20 rb1 F100 rrb1 F100 cb3 F20 rrb3 F100 ugcb1 F20 ug F220 ugm F100 ugt1 A4 ugcb2 F20 ug1 F220 ugm1 F100 ugt2 A4 cb2 F20 rb2 F100 rrb2 F100 pp1 F100 score1 F100 gz1 F30 kz1 F103 score2 F100 text1 A40 text2 A120 zeit1 A6 datum1 A8 zeit2 A4 datum2 A6 random1 A5 hobbies1 F100 haustier1 F100 bild1 F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-id' mnpvisno'visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' As of by ias

147 Documentation secutrial 47 Export Formats mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' tier3 'a) Haustier' rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' rb1 'b) einfacher RadioButton' rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12 IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ug1 'b) Messwert' ugm1 '13 IASUnitGroup' ugt2 'c) Meßzeitpunkt' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (53)' score2 'c) Score über Zahlenfelder' text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' bild1 'Bild-1' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' As of by ias

148 Documentation secutrial 47 Export Formats 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' As of by ias

149 Documentation secutrial 47 Export Formats VALUE LABEL tier2 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier3 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' As of by ias

150 Documentation secutrial 47 Export Formats VALUE LABEL hb4 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau' VALUE LABEL r1s1 0 'no' 1 'yes' VALUE LABEL r1s2 0 'no' 1 'yes' VALUE LABEL r1s3 0 'no' 1 'yes' VALUE LABEL r2s1 0 'no' 1 'yes' VALUE LABEL r2s2 0 'no' 1 'yes' VALUE LABEL r2s3 0 'no' 1 'yes' VALUE LABEL cb1 0 'no' 1 'yes' VALUE LABEL rb1 1 'ja' 0 'nein' VALUE LABEL rrb1 1 'ja' 0 'nein' VALUE LABEL cb3 0 'no' 1 'yes' VALUE LABEL rrb3 1 'ja' 0 'nein' VALUE LABEL ugcb1 0 'no' 1 'yes' VALUE LABEL ugm 2 'mol' 1 'g' VALUE LABEL ugcb2 0 'no' 1 'yes' VALUE LABEL ugm1 2 'mol' 1 'g' VALUE LABEL cb2 0 'no' 1 'yes' VALUE LABEL rb2 As of by ias

151 Documentation secutrial 47 Export Formats 1 'ja' 0 'nein' VALUE LABEL rrb2 1 'ja' 0 'nein' VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hobbies1 1 'Sport' 2 'Faulenzen' 3 'Lesen' VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' CACHE EXECUTE DATASET NAME mnpias1komponenten1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1komponenten1_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnpatdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpvisid F100 mnpcvpid F100 mnpvisno F100 mnpvispdt EDATE10 mnpvisfdt DATETIME232 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 eppc1 A120 epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F100 rasse1 F100 farbe1 F100 tier2 F100 rasse2 F100 farbe2 F100 tier3 F100 rasse3 F100 farbe3 F100 hb1 F100 hb2 F100 hb3 F100 As of by ias

152 Documentation secutrial 47 Export Formats hb4 F100 hb5 F100 hb6 F100 r1s1 F20 r1s2 F20 r1s3 F20 r2s1 F20 r2s2 F20 r2s3 F20 cb1 F20 rb1 F100 rrb1 F100 cb3 F20 rrb3 F100 ugcb1 F20 ug F220 ugm F100 ugt1 A4 ugcb2 F20 ug1 F220 ugm1 F100 ugt2 A4 cb2 F20 rb2 F100 rrb2 F100 pp1 F100 score1 F100 gz1 F30 kz1 F103 score2 F100 text1 A40 text2 A120 zeit1 A6 datum1 A8 zeit2 A4 datum2 A6 random1 A5 hobbies1 F100 haustier1 F100 bild1 F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-id' mnpvisno'visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' tier3 'a) Haustier' As of by ias

153 Documentation secutrial 47 Export Formats rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' rb1 'b) einfacher RadioButton' rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12 IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ug1 'b) Messwert' ugm1 '13 IASUnitGroup' ugt2 'c) Meßzeitpunkt' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (53)' score2 'c) Score über Zahlenfelder' text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' bild1 'Bild-1' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 As of by ias

154 Documentation secutrial 47 Export Formats 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier2 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' As of by ias

155 Documentation secutrial 47 Export Formats 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier3 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb4 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau' VALUE LABEL r1s1 0 'no' 1 'yes' VALUE LABEL r1s2 0 'no' 1 'yes' VALUE LABEL r1s3 0 'no' 1 'yes' As of by ias

156 Documentation secutrial 47 Export Formats VALUE LABEL r2s1 0 'no' 1 'yes' VALUE LABEL r2s2 0 'no' 1 'yes' VALUE LABEL r2s3 0 'no' 1 'yes' VALUE LABEL cb1 0 'no' 1 'yes' VALUE LABEL rb1 1 'ja' 0 'nein' VALUE LABEL rrb1 1 'ja' 0 'nein' VALUE LABEL cb3 0 'no' 1 'yes' VALUE LABEL rrb3 1 'ja' 0 'nein' VALUE LABEL ugcb1 0 'no' 1 'yes' VALUE LABEL ugm 2 'mol' 1 'g' VALUE LABEL ugcb2 0 'no' 1 'yes' VALUE LABEL ugm1 2 'mol' 1 'g' VALUE LABEL cb2 0 'no' 1 'yes' VALUE LABEL rb2 1 'ja' 0 'nein' VALUE LABEL rrb2 1 'ja' 0 'nein' VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hobbies1 1 'Sport' 2 'Faulenzen' 3 'Lesen' VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' CACHE EXECUTE DATASET NAME atmnpias1komponenten1 WINDOW = FRONT As of by ias

157 Documentation secutrial 47 Export Formats GET DATA /TYPE = TXT /FILE = 'dat/mnpias1roentgen_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpvisid F100 mnpcvpid F100 mnpvisno F100 mnpvispdt EDATE10 mnpvisfdt DATETIME232 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 titel A60 aufnahme A8 beschreibung A120 klinisch F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-id' mnpvisno'visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' titel 'Titel' aufnahme 'Aufnahmedatum' beschreibung 'Beschreibung' klinisch 'Klinisch auffällig?' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' As of by ias

158 Documentation secutrial 47 Export Formats VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' VALUE LABEL klinisch 1 'ja' 0 'nein' 3 'unklar' CACHE EXECUTE DATASET NAME mnpias1roentgen WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1roentgen_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnpatdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpvisid F100 mnpcvpid F100 mnpvisno F100 mnpvispdt EDATE10 mnpvisfdt DATETIME232 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 As of by ias

159 Documentation secutrial 47 Export Formats mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 titel A60 aufnahme A8 beschreibung A120 klinisch F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-id' mnpvisno'visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' titel 'Titel' aufnahme 'Aufnahmedatum' beschreibung 'Beschreibung' klinisch 'Klinisch auffällig?' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 As of by ias

160 Documentation secutrial 47 Export Formats 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' VALUE LABEL klinisch 1 'ja' 0 'nein' 3 'unklar' CACHE EXECUTE DATASET NAME atmnpias1roentgen WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/mnpias1score_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpvisid F100 mnpcvpid F100 mnpvisno F100 mnpvispdt EDATE10 mnpvisfdt DATETIME232 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 sb1 F100 vr1 F100 score F100 score2 F100 rb1 F100 rb2 F100 VARIABLE LABELS mnppid 'Patient-ID' As of by ias

161 Documentation secutrial 47 Export Formats mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-id' mnpvisno'visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' sb1 'horizontal radiobutton' vr1 'vertical radiobutton' score 'score berechnen' score2 'score function' rb1 'erste Frage' rb2 'zweite Frage' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' As of by ias

162 Documentation secutrial 47 Export Formats 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' VALUE LABEL sb1 1 'eins' 2 'zwei' 3 'drei' VALUE LABEL vr1 1 'eins' 2 'zwei' 5 'fünf' 4 'vier' VALUE LABEL rb1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL rb2 1 'rot' 3 'grün' 2 'blau' CACHE EXECUTE DATASET NAME mnpias1score WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1score_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnpatdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpvisid F100 mnpcvpid F100 mnpvisno F100 mnpvispdt EDATE10 mnpvisfdt DATETIME232 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 sb1 F100 vr1 F100 score F100 score2 F100 rb1 F100 rb2 F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' As of by ias

163 Documentation secutrial 47 Export Formats mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-id' mnpvisno'visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' sb1 'horizontal radiobutton' vr1 'vertical radiobutton' score 'score berechnen' score2 'score function' rb1 'erste Frage' rb2 'zweite Frage' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' As of by ias

164 Documentation secutrial 47 Export Formats 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' VALUE LABEL sb1 1 'eins' 2 'zwei' 3 'drei' VALUE LABEL vr1 1 'eins' 2 'zwei' 5 'fünf' 4 'vier' VALUE LABEL rb1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL rb2 1 'rot' 3 'grün' 2 'blau' CACHE EXECUTE DATASET NAME atmnpias1score WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/mnpias1bild_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpvisid F100 mnpcvpid F100 mnpvisno F100 mnpvispdt EDATE10 mnpvisfdt DATETIME232 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 farbe F100 zahl F20 wort A60 bild1 F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-id' mnpvisno'visit sequence' As of by ias

165 Documentation secutrial 47 Export Formats mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' farbe 'Lieblingsfarbe' zahl 'Lieblingszahl' wort 'Lieblingswort' bild1 'Lieblingsbild' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' VALUE LABEL farbe As of by ias

166 Documentation secutrial 47 Export Formats 1 'rot' 3 'grün' 2 'blau' CACHE EXECUTE DATASET NAME mnpias1bild WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1bild_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnpatdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpvisid F100 mnpcvpid F100 mnpvisno F100 mnpvispdt EDATE10 mnpvisfdt DATETIME232 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 farbe F100 zahl F20 wort A60 bild1 F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-id' mnpvisno'visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' farbe 'Lieblingsfarbe' zahl 'Lieblingszahl' wort 'Lieblingswort' As of by ias

167 Documentation secutrial 47 Export Formats bild1 'Lieblingsbild' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' VALUE LABEL farbe 1 'rot' 3 'grün' 2 'blau' CACHE EXECUTE DATASET NAME atmnpias1bild WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/mnpias1bild1_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 As of by ias

168 Documentation secutrial 47 Export Formats mnplastedit DATETIME232 mnpptnid F100 mnpvisid F100 mnpcvpid F100 mnpvisno F100 mnpvispdt EDATE10 mnpvisfdt DATETIME232 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 farbe F100 zahl F20 wort A60 bild1 F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-id' mnpvisno'visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' farbe 'Lieblingsfarbe' zahl 'Lieblingszahl' wort 'Lieblingswort' bild1 'Lieblingsbild' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' As of by ias

169 Documentation secutrial 47 Export Formats VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' VALUE LABEL farbe 1 'rot' 3 'grün' 2 'blau' CACHE EXECUTE DATASET NAME mnpias1bild1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1bild1_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnpatdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpvisid F100 mnpcvpid F100 mnpvisno F100 mnpvispdt EDATE10 mnpvisfdt DATETIME232 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 As of by ias

170 Documentation secutrial 47 Export Formats sigreason A200 farbe F100 zahl F20 wort A60 bild1 F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-id' mnpvisno'visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' farbe 'Lieblingsfarbe' zahl 'Lieblingszahl' wort 'Lieblingswort' bild1 'Lieblingsbild' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' As of by ias

171 Documentation secutrial 47 Export Formats 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' VALUE LABEL farbe 1 'rot' 3 'grün' 2 'blau' CACHE EXECUTE DATASET NAME atmnpias1bild1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/mnpias1status_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 eppc1 A120 epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F100 rasse1 F100 farbe1 F100 tier2 F100 rasse2 F100 farbe2 F100 tier3 F100 rasse3 F100 farbe3 F100 hb1 F100 hb2 F100 hb3 F100 hb4 F100 hb5 F100 hb6 F100 r1s1 F20 r1s2 F20 r1s3 F20 r2s1 F20 r2s2 F20 r2s3 F20 As of by ias

172 Documentation secutrial 47 Export Formats cb1 F20 rb1 F100 rrb1 F100 cb3 F20 rrb3 F100 ugcb1 F20 ug F220 ugm F100 ugt1 A4 ugcb2 F20 ug1 F220 ugm1 F100 ugt2 A4 cb2 F20 rb2 F100 rrb2 F100 pp1 F100 score1 F100 gz1 F30 kz1 F103 score2 F100 text1 A40 text2 A120 zeit1 A6 datum1 A8 zeit2 A4 datum2 A6 random1 A5 hobbies1 F100 haustier1 F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' tier3 'a) Haustier' rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' rb1 'b) einfacher RadioButton' As of by ias

173 Documentation secutrial 47 Export Formats rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12 IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ug1 'b) Messwert' ugm1 '13 IASUnitGroup' ugt2 'c) Meßzeitpunkt' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (53)' score2 'c) Score über Zahlenfelder' text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' As of by ias

174 Documentation secutrial 47 Export Formats VALUE LABEL mnpfsct 1 'with comment' VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier2 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier3 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' As of by ias

175 Documentation secutrial 47 Export Formats 6 'Araber' 7 'Perser' VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb4 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau' VALUE LABEL r1s1 0 'no' 1 'yes' VALUE LABEL r1s2 0 'no' 1 'yes' VALUE LABEL r1s3 0 'no' 1 'yes' VALUE LABEL r2s1 0 'no' 1 'yes' VALUE LABEL r2s2 0 'no' 1 'yes' VALUE LABEL r2s3 0 'no' 1 'yes' VALUE LABEL cb1 0 'no' 1 'yes' VALUE LABEL rb1 As of by ias

176 Documentation secutrial 47 Export Formats 1 'ja' 0 'nein' VALUE LABEL rrb1 1 'ja' 0 'nein' VALUE LABEL cb3 0 'no' 1 'yes' VALUE LABEL rrb3 1 'ja' 0 'nein' VALUE LABEL ugcb1 0 'no' 1 'yes' VALUE LABEL ugm 2 'mol' 1 'g' VALUE LABEL ugcb2 0 'no' 1 'yes' VALUE LABEL ugm1 2 'mol' 1 'g' VALUE LABEL cb2 0 'no' 1 'yes' VALUE LABEL rb2 1 'ja' 0 'nein' VALUE LABEL rrb2 1 'ja' 0 'nein' VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hobbies1 1 'Sport' 2 'Faulenzen' 3 'Lesen' VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' CACHE EXECUTE DATASET NAME mnpias1status WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1status_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnpatdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpfs0 F20 mnpfs1 F20 As of by ias

177 Documentation secutrial 47 Export Formats mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 eppc1 A120 epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F100 rasse1 F100 farbe1 F100 tier2 F100 rasse2 F100 farbe2 F100 tier3 F100 rasse3 F100 farbe3 F100 hb1 F100 hb2 F100 hb3 F100 hb4 F100 hb5 F100 hb6 F100 r1s1 F20 r1s2 F20 r1s3 F20 r2s1 F20 r2s2 F20 r2s3 F20 cb1 F20 rb1 F100 rrb1 F100 cb3 F20 rrb3 F100 ugcb1 F20 ug F220 ugm F100 ugt1 A4 ugcb2 F20 ug1 F220 ugm1 F100 ugt2 A4 cb2 F20 rb2 F100 rrb2 F100 pp1 F100 score1 F100 gz1 F30 kz1 F103 score2 F100 text1 A40 text2 A120 zeit1 A6 datum1 A8 zeit2 A4 datum2 A6 random1 A5 hobbies1 F100 haustier1 F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' As of by ias

178 Documentation secutrial 47 Export Formats mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' tier3 'a) Haustier' rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' rb1 'b) einfacher RadioButton' rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12 IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ug1 'b) Messwert' ugm1 '13 IASUnitGroup' ugt2 'c) Meßzeitpunkt' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (53)' score2 'c) Score über Zahlenfelder' text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 As of by ias

179 Documentation secutrial 47 Export Formats 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier2 1 'Katze' As of by ias

180 Documentation secutrial 47 Export Formats 2 'Pferd' 3 'Hund' VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier3 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb4 1 'rot' 3 'grün' As of by ias

181 Documentation secutrial 47 Export Formats 2 'blau' VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau' VALUE LABEL r1s1 0 'no' 1 'yes' VALUE LABEL r1s2 0 'no' 1 'yes' VALUE LABEL r1s3 0 'no' 1 'yes' VALUE LABEL r2s1 0 'no' 1 'yes' VALUE LABEL r2s2 0 'no' 1 'yes' VALUE LABEL r2s3 0 'no' 1 'yes' VALUE LABEL cb1 0 'no' 1 'yes' VALUE LABEL rb1 1 'ja' 0 'nein' VALUE LABEL rrb1 1 'ja' 0 'nein' VALUE LABEL cb3 0 'no' 1 'yes' VALUE LABEL rrb3 1 'ja' 0 'nein' VALUE LABEL ugcb1 0 'no' 1 'yes' VALUE LABEL ugm 2 'mol' 1 'g' VALUE LABEL ugcb2 0 'no' 1 'yes' VALUE LABEL ugm1 2 'mol' 1 'g' VALUE LABEL cb2 0 'no' 1 'yes' VALUE LABEL rb2 1 'ja' 0 'nein' As of by ias

182 Documentation secutrial 47 Export Formats VALUE LABEL rrb2 1 'ja' 0 'nein' VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hobbies1 1 'Sport' 2 'Faulenzen' 3 'Lesen' VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' CACHE EXECUTE DATASET NAME atmnpias1status WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/mnpias1ae_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpaeid F100 mnpaedate DATETIME232 mnpaeno F100 mnpaefuid F100 mnpaefudt DATETIME232 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 eppc1 A120 epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F100 rasse1 F100 farbe1 F100 tier2 F100 rasse2 F100 farbe2 F100 tier3 F100 rasse3 F100 farbe3 F100 hb1 F100 hb2 F100 hb3 F100 hb4 F100 hb5 F100 hb6 F100 r1s1 F20 As of by ias

183 Documentation secutrial 47 Export Formats r1s2 F20 r1s3 F20 r2s1 F20 r2s2 F20 r2s3 F20 cb1 F20 rb1 F100 rrb1 F100 cb3 F20 rrb3 F100 ugcb1 F20 ug F220 ugm F100 ugt1 A4 ugcb2 F20 ug1 F220 ugm1 F100 ugt2 A4 cb2 F20 rb2 F100 rrb2 F100 pp1 F100 score1 F100 gz1 F30 kz1 F103 score2 F100 text1 A40 text2 A120 zeit1 A6 datum1 A8 zeit2 A4 datum2 A6 random1 A5 hobbies1 F100 haustier1 F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpaeid 'Adverse Event-ID' mnpaedate 'Adverse Event date' mnpaeno 'Adverse Event case number' mnpaefuid 'Adverse Event Follow-up-ID' mnpaefudt 'Adverse Event Follow-up date' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' tier3 'a) Haustier' rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' As of by ias

184 Documentation secutrial 47 Export Formats hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' rb1 'b) einfacher RadioButton' rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12 IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ug1 'b) Messwert' ugm1 '13 IASUnitGroup' ugt2 'c) Meßzeitpunkt' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (53)' score2 'c) Score über Zahlenfelder' text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' As of by ias

185 Documentation secutrial 47 Export Formats 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier2 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier3 As of by ias

186 Documentation secutrial 47 Export Formats 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb4 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau' VALUE LABEL r1s1 0 'no' 1 'yes' VALUE LABEL r1s2 0 'no' 1 'yes' VALUE LABEL r1s3 0 'no' 1 'yes' VALUE LABEL r2s1 0 'no' 1 'yes' VALUE LABEL r2s2 0 'no' 1 'yes' As of by ias

187 Documentation secutrial 47 Export Formats VALUE LABEL r2s3 0 'no' 1 'yes' VALUE LABEL cb1 0 'no' 1 'yes' VALUE LABEL rb1 1 'ja' 0 'nein' VALUE LABEL rrb1 1 'ja' 0 'nein' VALUE LABEL cb3 0 'no' 1 'yes' VALUE LABEL rrb3 1 'ja' 0 'nein' VALUE LABEL ugcb1 0 'no' 1 'yes' VALUE LABEL ugm 2 'mol' 1 'g' VALUE LABEL ugcb2 0 'no' 1 'yes' VALUE LABEL ugm1 2 'mol' 1 'g' VALUE LABEL cb2 0 'no' 1 'yes' VALUE LABEL rb2 1 'ja' 0 'nein' VALUE LABEL rrb2 1 'ja' 0 'nein' VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hobbies1 1 'Sport' 2 'Faulenzen' 3 'Lesen' VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' CACHE EXECUTE DATASET NAME mnpias1ae WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1ae_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED As of by ias

188 Documentation secutrial 47 Export Formats /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnpatdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpaeid F100 mnpaedate DATETIME232 mnpaeno F100 mnpaefuid F100 mnpaefudt DATETIME232 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 eppc1 A120 epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F100 rasse1 F100 farbe1 F100 tier2 F100 rasse2 F100 farbe2 F100 tier3 F100 rasse3 F100 farbe3 F100 hb1 F100 hb2 F100 hb3 F100 hb4 F100 hb5 F100 hb6 F100 r1s1 F20 r1s2 F20 r1s3 F20 r2s1 F20 r2s2 F20 r2s3 F20 cb1 F20 rb1 F100 rrb1 F100 cb3 F20 rrb3 F100 ugcb1 F20 ug F220 ugm F100 ugt1 A4 ugcb2 F20 ug1 F220 ugm1 F100 ugt2 A4 cb2 F20 rb2 F100 rrb2 F100 pp1 F100 score1 F100 gz1 F30 kz1 F103 score2 F100 text1 A40 text2 A120 zeit1 A6 datum1 A8 As of by ias

189 Documentation secutrial 47 Export Formats zeit2 A4 datum2 A6 random1 A5 hobbies1 F100 haustier1 F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpaeid 'Adverse Event-ID' mnpaedate 'Adverse Event date' mnpaeno 'Adverse Event case number' mnpaefuid 'Adverse Event Follow-up-ID' mnpaefudt 'Adverse Event Follow-up date' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' tier3 'a) Haustier' rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' rb1 'b) einfacher RadioButton' rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12 IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ug1 'b) Messwert' ugm1 '13 IASUnitGroup' ugt2 'c) Meßzeitpunkt' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (53)' score2 'c) Score über Zahlenfelder' As of by ias

190 Documentation secutrial 47 Export Formats text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' As of by ias

191 Documentation secutrial 47 Export Formats VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier2 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier3 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' As of by ias

192 Documentation secutrial 47 Export Formats 16 'bunt' VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb4 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau' VALUE LABEL r1s1 0 'no' 1 'yes' VALUE LABEL r1s2 0 'no' 1 'yes' VALUE LABEL r1s3 0 'no' 1 'yes' VALUE LABEL r2s1 0 'no' 1 'yes' VALUE LABEL r2s2 0 'no' 1 'yes' VALUE LABEL r2s3 0 'no' 1 'yes' VALUE LABEL cb1 0 'no' 1 'yes' VALUE LABEL rb1 1 'ja' 0 'nein' VALUE LABEL rrb1 1 'ja' 0 'nein' VALUE LABEL cb3 0 'no' 1 'yes' VALUE LABEL rrb3 1 'ja' 0 'nein' VALUE LABEL ugcb1 0 'no' 1 'yes' As of by ias

193 Documentation secutrial 47 Export Formats VALUE LABEL ugm 2 'mol' 1 'g' VALUE LABEL ugcb2 0 'no' 1 'yes' VALUE LABEL ugm1 2 'mol' 1 'g' VALUE LABEL cb2 0 'no' 1 'yes' VALUE LABEL rb2 1 'ja' 0 'nein' VALUE LABEL rrb2 1 'ja' 0 'nein' VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hobbies1 1 'Sport' 2 'Faulenzen' 3 'Lesen' VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' CACHE EXECUTE DATASET NAME atmnpias1ae WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/mnpias1sae1_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpaeid F100 mnpaedate DATETIME232 mnpaeno F100 mnpaefuid F100 mnpaefudt DATETIME232 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 eppc1 A120 As of by ias

194 Documentation secutrial 47 Export Formats epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F100 rasse1 F100 farbe1 F100 tier2 F100 rasse2 F100 farbe2 F100 tier3 F100 rasse3 F100 farbe3 F100 hb1 F100 hb2 F100 hb3 F100 hb4 F100 hb5 F100 hb6 F100 r1s1 F20 r1s2 F20 r1s3 F20 r2s1 F20 r2s2 F20 r2s3 F20 cb1 F20 rb1 F100 rrb1 F100 cb3 F20 rrb3 F100 ugcb1 F20 ug F220 ugm F100 ugt1 A4 ugcb2 F20 ug1 F220 ugm1 F100 ugt2 A4 cb2 F20 rb2 F100 rrb2 F100 pp1 F100 score1 F100 gz1 F30 kz1 F103 score2 F100 text1 A40 text2 A120 zeit1 A6 datum1 A8 zeit2 A4 datum2 A6 random1 A5 hobbies1 F100 haustier1 F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpaeid 'Adverse Event-ID' mnpaedate 'Adverse Event date' mnpaeno 'Adverse Event case number' mnpaefuid 'Adverse Event Follow-up-ID' mnpaefudt 'Adverse Event Follow-up date' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' As of by ias

195 Documentation secutrial 47 Export Formats sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' tier3 'a) Haustier' rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' rb1 'b) einfacher RadioButton' rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12 IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ug1 'b) Messwert' ugm1 '13 IASUnitGroup' ugt2 'c) Meßzeitpunkt' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (53)' score2 'c) Score über Zahlenfelder' text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' As of by ias

196 Documentation secutrial 47 Export Formats VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier2 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' As of by ias

197 Documentation secutrial 47 Export Formats VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier3 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb4 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau' As of by ias

198 Documentation secutrial 47 Export Formats VALUE LABEL r1s1 0 'no' 1 'yes' VALUE LABEL r1s2 0 'no' 1 'yes' VALUE LABEL r1s3 0 'no' 1 'yes' VALUE LABEL r2s1 0 'no' 1 'yes' VALUE LABEL r2s2 0 'no' 1 'yes' VALUE LABEL r2s3 0 'no' 1 'yes' VALUE LABEL cb1 0 'no' 1 'yes' VALUE LABEL rb1 1 'ja' 0 'nein' VALUE LABEL rrb1 1 'ja' 0 'nein' VALUE LABEL cb3 0 'no' 1 'yes' VALUE LABEL rrb3 1 'ja' 0 'nein' VALUE LABEL ugcb1 0 'no' 1 'yes' VALUE LABEL ugm 2 'mol' 1 'g' VALUE LABEL ugcb2 0 'no' 1 'yes' VALUE LABEL ugm1 2 'mol' 1 'g' VALUE LABEL cb2 0 'no' 1 'yes' VALUE LABEL rb2 1 'ja' 0 'nein' VALUE LABEL rrb2 1 'ja' 0 'nein' VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hobbies1 1 'Sport' As of by ias

199 Documentation secutrial 47 Export Formats 2 'Faulenzen' 3 'Lesen' VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' CACHE EXECUTE DATASET NAME mnpias1sae1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1sae1_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnpatdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpaeid F100 mnpaedate DATETIME232 mnpaeno F100 mnpaefuid F100 mnpaefudt DATETIME232 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 eppc1 A120 epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F100 rasse1 F100 farbe1 F100 tier2 F100 rasse2 F100 farbe2 F100 tier3 F100 rasse3 F100 farbe3 F100 hb1 F100 hb2 F100 hb3 F100 hb4 F100 hb5 F100 hb6 F100 r1s1 F20 r1s2 F20 r1s3 F20 r2s1 F20 r2s2 F20 r2s3 F20 cb1 F20 rb1 F100 rrb1 F100 cb3 F20 rrb3 F100 As of by ias

200 Documentation secutrial 47 Export Formats ugcb1 F20 ug F220 ugm F100 ugt1 A4 ugcb2 F20 ug1 F220 ugm1 F100 ugt2 A4 cb2 F20 rb2 F100 rrb2 F100 pp1 F100 score1 F100 gz1 F30 kz1 F103 score2 F100 text1 A40 text2 A120 zeit1 A6 datum1 A8 zeit2 A4 datum2 A6 random1 A5 hobbies1 F100 haustier1 F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpaeid 'Adverse Event-ID' mnpaedate 'Adverse Event date' mnpaeno 'Adverse Event case number' mnpaefuid 'Adverse Event Follow-up-ID' mnpaefudt 'Adverse Event Follow-up date' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' tier3 'a) Haustier' rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' As of by ias

201 Documentation secutrial 47 Export Formats rb1 'b) einfacher RadioButton' rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12 IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ug1 'b) Messwert' ugm1 '13 IASUnitGroup' ugt2 'c) Meßzeitpunkt' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (53)' score2 'c) Score über Zahlenfelder' text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' As of by ias

202 Documentation secutrial 47 Export Formats 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier2 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL tier3 1 'Katze' 2 'Pferd' 3 'Hund' VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' As of by ias

203 Documentation secutrial 47 Export Formats 5 'Siam' 6 'Araber' 7 'Perser' VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb4 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau' VALUE LABEL r1s1 0 'no' 1 'yes' VALUE LABEL r1s2 0 'no' 1 'yes' VALUE LABEL r1s3 0 'no' 1 'yes' VALUE LABEL r2s1 0 'no' 1 'yes' VALUE LABEL r2s2 0 'no' 1 'yes' VALUE LABEL r2s3 0 'no' 1 'yes' VALUE LABEL cb1 0 'no' 1 'yes' As of by ias

204 Documentation secutrial 47 Export Formats VALUE LABEL rb1 1 'ja' 0 'nein' VALUE LABEL rrb1 1 'ja' 0 'nein' VALUE LABEL cb3 0 'no' 1 'yes' VALUE LABEL rrb3 1 'ja' 0 'nein' VALUE LABEL ugcb1 0 'no' 1 'yes' VALUE LABEL ugm 2 'mol' 1 'g' VALUE LABEL ugcb2 0 'no' 1 'yes' VALUE LABEL ugm1 2 'mol' 1 'g' VALUE LABEL cb2 0 'no' 1 'yes' VALUE LABEL rb2 1 'ja' 0 'nein' VALUE LABEL rrb2 1 'ja' 0 'nein' VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' VALUE LABEL hobbies1 1 'Sport' 2 'Faulenzen' 3 'Lesen' VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' CACHE EXECUTE DATASET NAME atmnpias1sae1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/mnpias1bilder_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpvisid F100 mnpcvpid F100 As of by ias

205 Documentation secutrial 47 Export Formats mnpvisno F100 mnpvispdt EDATE10 mnpvisfdt DATETIME232 mnpaeid F100 mnpaedate DATETIME232 mnpaeno F100 mnpaefuid F100 mnpaefudt DATETIME232 mnpcrtdt DATETIME232 mnpcrtpt F100 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 img F100 bild2 F100 bezeichnung A60 img1 F100 bild3 F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-id' mnpvisno'visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpaeid 'Adverse Event-ID' mnpaedate 'Adverse Event date' mnpaeno 'Adverse Event case number' mnpaefuid 'Adverse Event Follow-up-ID' mnpaefudt 'Adverse Event Follow-up date' mnpcrtdt 'Document create date' mnpcrtpt 'Document creator (participant)' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' img '1) Bild a' bild2 '2) Bild b' bezeichnung 'Bezeichnung' img1 'Bild c' bild3 'Bild d' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpcrtpt 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 As of by ias

206 Documentation secutrial 47 Export Formats 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' CACHE EXECUTE DATASET NAME mnpias1bilder WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1bilder_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnpatdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpvisid F100 mnpcvpid F100 mnpvisno F100 mnpvispdt EDATE10 mnpvisfdt DATETIME232 mnpaeid F100 mnpaedate DATETIME232 mnpaeno F100 mnpaefuid F100 As of by ias

207 Documentation secutrial 47 Export Formats mnpaefudt DATETIME232 mnpcrtdt DATETIME232 mnpcrtpt F100 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 img F100 bild2 F100 bezeichnung A60 img1 F100 bild3 F100 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-id' mnpvisno'visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpaeid 'Adverse Event-ID' mnpaedate 'Adverse Event date' mnpaeno 'Adverse Event case number' mnpaefuid 'Adverse Event Follow-up-ID' mnpaefudt 'Adverse Event Follow-up date' mnpcrtdt 'Document create date' mnpcrtpt 'Document creator (participant)' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' img '1) Bild a' bild2 '2) Bild b' bezeichnung 'Bezeichnung' img1 'Bild c' bild3 'Bild d' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpcrtpt 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 As of by ias

208 Documentation secutrial 47 Export Formats 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' CACHE EXECUTE DATASET NAME atmnpias1bilder WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/mnpias1bilder1_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpvisid F100 mnpcvpid F100 mnpvisno F100 mnpvispdt EDATE10 mnpvisfdt DATETIME232 mnpaeid F100 mnpaedate DATETIME232 mnpaeno F100 mnpaefuid F100 mnpaefudt DATETIME232 mnpcrtdt DATETIME232 mnpcrtpt F100 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 As of by ias

209 Documentation secutrial 47 Export Formats mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 img F100 aufnahme A60 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-id' mnpvisno'visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpaeid 'Adverse Event-ID' mnpaedate 'Adverse Event date' mnpaeno 'Adverse Event case number' mnpaefuid 'Adverse Event Follow-up-ID' mnpaefudt 'Adverse Event Follow-up date' mnpcrtdt 'Document create date' mnpcrtpt 'Document creator (participant)' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' img '1)' aufnahme 'Aufnahme:' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpcrtpt 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' As of by ias

210 Documentation secutrial 47 Export Formats VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' CACHE EXECUTE DATASET NAME mnpias1bilder1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1bilder1_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnpatdocid F100 mnplastedit DATETIME232 mnpptnid F100 mnpvisid F100 mnpcvpid F100 mnpvisno F100 mnpvispdt EDATE10 mnpvisfdt DATETIME232 mnpaeid F100 mnpaedate DATETIME232 mnpaeno F100 mnpaefuid F100 mnpaefudt DATETIME232 mnpcrtdt DATETIME232 mnpcrtpt F100 mnpfs0 F20 mnpfs1 F20 mnpfs2 F20 mnpfs3 F20 mnpfcs0 F20 mnpfcs1 F20 mnpfcs2 F20 mnpfcs3 F20 mnpfsqa F20 mnpfsct F20 mnpfssdv F20 siguser A200 sigtext A30 sigstatus F20 sigvalid A30 sigreason A200 img F100 As of by ias

211 Documentation secutrial 47 Export Formats aufnahme A60 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-id' mnpvisno'visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpaeid 'Adverse Event-ID' mnpaedate 'Adverse Event date' mnpaeno 'Adverse Event case number' mnpaefuid 'Adverse Event Follow-up-ID' mnpaefudt 'Adverse Event Follow-up date' mnpcrtdt 'Document create date' mnpcrtpt 'Document creator (participant)' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' img '1)' aufnahme 'Aufnahme:' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpcrtpt 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' VALUE LABEL mnpfcs1 1 'with errors' VALUE LABEL mnpfcs2 1 'with warnings' VALUE LABEL mnpfcs3 1 'data entry complete' VALUE LABEL mnpfs0 1 'medical review (A)' VALUE LABEL mnpfs1 1 'data review (B)' VALUE LABEL mnpfs2 1 'manual freeze' VALUE LABEL mnpfs3 1 'rulebased freeze' As of by ias

212 Documentation secutrial 47 Export Formats VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' VALUE LABEL mnpfsqa 1 'with open query' 2 'with answered query' 4 'all queries resolved' VALUE LABEL mnpfsct 1 'with comment' CACHE EXECUTE DATASET NAME atmnpias1bilder1 WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/emnpias1medikament_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpdocid F100 mnpsubdocid F100 fgid F100 position F100 wirkstoff A40 dosis F72 einnahme A4 VARIABLE LABELS mnppid 'Patient-ID' mnpdocid'parent document-id' mnpsubdocid 'Subdocument-ID' fgid 'Question-ID of Repetition' position 'Position in Repetition' wirkstoff 'Wirkstoff' dosis 'Dosis' einnahme 'Einnahmezeit' CACHE EXECUTE DATASET NAME emnpias1medikament WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/atemnpias1medikament_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F100 mnpatdocid F100 mnpatsubdocid F100 fgid F100 position F100 wirkstoff A40 dosis F72 einnahme A4 VARIABLE LABELS mnppid 'Patient-ID' mnpatdocid'parent ATDocument-ID' As of by ias

213 Documentation secutrial 47 Export Formats mnpatsubdocid 'ATSubdocument-ID' fgid 'Question-ID of Repetition' position 'Position in Repetition' wirkstoff 'Wirkstoff' dosis 'Dosis' einnahme 'Einnahmezeit' CACHE EXECUTE DATASET NAME atemnpias1medikament WINDOW = FRONT GET DATA /TYPE = TXT /FILE = 'dat/images_ias1_ txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnpimgid F100 uploadedfilename A500 imagesize F220 contenttype A40 uploaddate DATETIME232 mnpptnid F100 originalfile A100 originalstatus A15 webfile A100 webstatus A15 thumbnailfile A100 thumbnailstatus A15 VARIABLE LABELS mnpimgid 'Image-ID' uploadedfilename 'Uploaded file' imagesize 'Image size (bytes)' contenttype 'Content type' uploaddate 'Date of upload' mnpptnid 'Participant-ID' originalfile 'Original file name' originalstatus 'Status of original file' webfile 'Web file name' webstatus 'Status of web file' thumbnailfile 'Thumbnail file name' thumbnailstatus 'Status of thumbnail file' VALUE LABEL mnpptnid 1 'Dipl biol Susanne Schneider' 151 'Dr Ulrike Jonas' CACHE EXECUTE DATASET NAME images_ias1 WINDOW = FRONT * end of file * As of by ias

214 Documentation secutrial 47 Export Formats 11 Appendix C: CDISC ODM v13 example <?xml version="10" encoding="cp1252"?> <ODM xmlns=" xmlns:ds=" xmlns:xsi=" xmlns:ias=" xsi:schemalocation=" iasxsd" Description="Patients (Valid patients) User Data(yes) AuditTrail(yes) Queries and Comments(yes) Pseudonym(yes) Images (original, web, thumbnail) Hidden Fields(yes) Esignature(yes) Validity(yes) SDV(yes)" FileType="Transactional" FileOID="secuTrialde/ST30/IAS/IAS1/5_ " CreationDateTime=" T15:59: :00" ODMVersion="13" Originator="interActive Systems" SourceSystem="secuTrial" SourceSystemVersion="&ltdev version&gt"> <Study OID="IAS1"> <!-- ***** GlobalVariables ***** --> <GlobalVariables> <StudyName>Basisregister</StudyName> <StudyDescription/> <ProtocolName>IAS1</ProtocolName> </GlobalVariables> <BasicDefinitions/> <!-- ***** MetaDataVersion ***** --> <MetaDataVersion OID="IAS10" Name="Basisregister ( :41:34 (CEST))"> <!-- ***** Protocol ***** --> <Protocol> <StudyEventRef StudyEventOID="VISIT7" OrderNumber="1" Mandatory="Yes"/> <StudyEventRef StudyEventOID="VISIT5" OrderNumber="2" Mandatory="Yes"/> <StudyEventRef StudyEventOID="VISIT3" OrderNumber="3" Mandatory="No"/> <StudyEventRef StudyEventOID="VISIT4" OrderNumber="4" Mandatory="No"/> <StudyEventRef StudyEventOID="VISIT6" OrderNumber="5" Mandatory="No"/> <StudyEventRef StudyEventOID="AE" Mandatory="No"/> <StudyEventRef StudyEventOID="CN" Mandatory="No"/> </Protocol> <!-- ***** StudyEventDef ***** --> <StudyEventDef OID="VISIT7" Name="1 Visite a" Repeating="No" Type="Scheduled" Category="fixed"> <FormRef FormOID=" FVMI" Mandatory="Yes"/> <FormRef FormOID="Fmnpias1komponenten" OrderNumber="1" Mandatory="No"/> <FormRef FormOID="Fmnpias1roentgen" OrderNumber="2" Mandatory="No"/> <FormRef FormOID="Fmnpias1score" OrderNumber="3" Mandatory="No"/> <FormRef FormOID="Fmnpias1bild" OrderNumber="4" Mandatory="No"/> <FormRef FormOID="Fmnpias1bilder" Mandatory="No"/> <FormRef FormOID="Fmnpias1bilder1" Mandatory="No"/> </StudyEventDef> <StudyEventDef OID="VISIT5" Name="2 Visite b" Repeating="No" Type="Scheduled" Category="fixed"> <FormRef FormOID=" FVMI" Mandatory="Yes"/> <FormRef FormOID="Fmnpias1komponenten" OrderNumber="1" Mandatory="No"/> <FormRef FormOID="Fmnpias1score" OrderNumber="2" Mandatory="No"/> <FormRef FormOID="Fmnpias1bild" OrderNumber="3" Mandatory="No"/> <FormRef FormOID="Fmnpias1bilder" Mandatory="No"/> <FormRef FormOID="Fmnpias1bilder1" Mandatory="No"/> </StudyEventDef> <StudyEventDef OID="VISIT3" Name="3 Visite d" Repeating="No" Type="Scheduled" Category="flexible"> <FormRef FormOID=" FVMI" Mandatory="Yes"/> <FormRef FormOID="Fmnpias1komponenten" OrderNumber="1" Mandatory="No"/> <FormRef FormOID="Fmnpias1score" OrderNumber="2" Mandatory="No"/> <FormRef FormOID="Fmnpias1bild" OrderNumber="3" Mandatory="No"/> <FormRef FormOID="Fmnpias1bilder" Mandatory="No"/> <FormRef FormOID="Fmnpias1bilder1" Mandatory="No"/> </StudyEventDef> <StudyEventDef OID="VISIT4" Name="4 Visite c" Repeating="Yes" Type="Scheduled" Category="fixed"> <FormRef FormOID=" FVMI" Mandatory="Yes"/> <FormRef FormOID="Fmnpias1komponenten" OrderNumber="1" Mandatory="No"/> <FormRef FormOID="Fmnpias1score" OrderNumber="2" Mandatory="No"/> <FormRef FormOID="Fmnpias1bild" OrderNumber="3" Mandatory="No"/> <FormRef FormOID="Fmnpias1bilder" Mandatory="No"/> <FormRef FormOID="Fmnpias1bilder1" Mandatory="No"/> </StudyEventDef> <StudyEventDef OID="VISIT6" Name="1 Visite e" Repeating="Yes" Type="Common" Category="unscheduled"> <FormRef FormOID=" FVMI" Mandatory="Yes"/> <FormRef FormOID="Fmnpias1komponenten" OrderNumber="1" Mandatory="No"/> <FormRef FormOID="Fmnpias1roentgen" OrderNumber="2" Mandatory="No"/> <FormRef FormOID="Fmnpias1score" OrderNumber="3" Mandatory="No"/> <FormRef FormOID="Fmnpias1bild" OrderNumber="4" Mandatory="No"/> <FormRef FormOID="Fmnpias1bilder" Mandatory="No"/> <FormRef FormOID="Fmnpias1bilder1" Mandatory="No"/> </StudyEventDef> <StudyEventDef OID="AE" Name="Unerwünschte Ereignisse" Repeating="Yes" Type="Common"> <FormRef FormOID="Fmnpias1ae" OrderNumber="1" Mandatory="No"/> <FormRef FormOID="Fmnpias1sae1" OrderNumber="2" Mandatory="No"/> <FormRef FormOID="Fmnpias1bilder" Mandatory="No"/> <FormRef FormOID="Fmnpias1bilder1" Mandatory="No"/> </StudyEventDef> As of by ias

215 Documentation secutrial 47 Export Formats <StudyEventDef OID="CN" Name="Patientenstatus" Repeating="No" Type="Unscheduled"> <FormRef FormOID="Fmnpias1status" OrderNumber="1" Mandatory="No"/> <FormRef FormOID="Fmnpias1bilder" Mandatory="No"/> <FormRef FormOID="Fmnpias1bilder1" Mandatory="No"/> </StudyEventDef> <!-- ***** FormDef ***** --> <FormDef OID="FVMI" Name="General visit information" Repeating="No"> <ItemGroupRef ItemGroupOID="FGSUBJID" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FGVISITDY" Mandatory="Yes"/> </FormDef> <FormDef OID="Fmnpias1komponenten" Name="Basisdaten" Repeating="No"> <Description> <TranslatedText xml:lang="en">dies ist die Formularbeschreibung in &ltfont color=&quotblue&quot&gthtml&lt/font&gt</translatedtext> </Description> <ItemGroupRef ItemGroupOID="FGSUBJID" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FGFS" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG16" OrderNumber="1" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG8" OrderNumber="3" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG110" OrderNumber="4" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG55" OrderNumber="5" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG9" OrderNumber="7" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG62" OrderNumber="8" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG94" OrderNumber="9" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG96" OrderNumber="11" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG46" OrderNumber="12" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG107" OrderNumber="13" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG54" OrderNumber="14" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG63" OrderNumber="15" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG31" OrderNumber="16" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG97" OrderNumber="17" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG80" OrderNumber="18" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG14" OrderNumber="19" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG86" OrderNumber="20" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG48" OrderNumber="21" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG453" OrderNumber="22" Mandatory="No"/> </FormDef> <FormDef OID="Fmnpias1komponenten1" Name="Komponenten 1" Repeating="No"> <Description> <TranslatedText xml:lang="en">dies ist die Formularbeschreibung in &ltfont color=&quotblue&quot&gthtml&lt/font&gt</translatedtext> </Description> <ItemGroupRef ItemGroupOID="FGSUBJID" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FGFS" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG44" OrderNumber="1" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG113" OrderNumber="3" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG58" OrderNumber="4" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG99" OrderNumber="5" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG100" OrderNumber="7" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG85" OrderNumber="8" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG13" OrderNumber="9" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG4" OrderNumber="11" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG61" OrderNumber="12" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG87" OrderNumber="13" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG116" OrderNumber="14" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG74" OrderNumber="15" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG22" OrderNumber="16" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG33" OrderNumber="17" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG93" OrderNumber="18" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG10" OrderNumber="19" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG450" OrderNumber="20" Mandatory="No"/> </FormDef> <FormDef OID="Fmnpias1roentgen" Name="Röntgenbilder" Repeating="No"> <ItemGroupRef ItemGroupOID="FGSUBJID" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FGFS" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG71" OrderNumber="1" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG73" OrderNumber="2" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG72" OrderNumber="3" Mandatory="No"/> </FormDef> <FormDef OID="Fmnpias1score" Name="Score-Test" Repeating="No"> <ItemGroupRef ItemGroupOID="FGSUBJID" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FGFS" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG38" OrderNumber="1" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG39" OrderNumber="2" Mandatory="No"/> </FormDef> <FormDef OID="Fmnpias1bild" Name="Standard-Bild" Repeating="No"> <ItemGroupRef ItemGroupOID="FGSUBJID" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FGFS" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG434" OrderNumber="1" Mandatory="No"/> As of by ias

216 Documentation secutrial 47 Export Formats <ItemGroupRef ItemGroupOID="FG435" OrderNumber="2" Mandatory="No"/> </FormDef> <FormDef OID="Fmnpias1bild1" Name="Standard-Bild-2" Repeating="No"> <ItemGroupRef ItemGroupOID="FGSUBJID" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FGFS" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG451" OrderNumber="1" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG452" OrderNumber="2" Mandatory="No"/> </FormDef> <FormDef OID="Fmnpias1status" Name="Patientenstatus" Repeating="No"> <Description> <TranslatedText xml:lang="en">dies ist die Formularbeschreibung in &ltfont color=&quotblue&quot&gthtml&lt/font&gt</translatedtext> </Description> <ItemGroupRef ItemGroupOID="FGSUBJID" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FGFS" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG24" OrderNumber="1" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG82" OrderNumber="3" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG47" OrderNumber="4" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG21" OrderNumber="5" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG112" OrderNumber="7" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG60" OrderNumber="8" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG64" OrderNumber="9" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG19" OrderNumber="11" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG5" OrderNumber="12" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG28" OrderNumber="13" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG27" OrderNumber="14" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG30" OrderNumber="15" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG7" OrderNumber="16" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG52" OrderNumber="17" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG45" OrderNumber="18" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG35" OrderNumber="19" Mandatory="No"/> </FormDef> <FormDef OID="Fmnpias1ae" Name="Adverse Event" Repeating="Yes"> <Description> <TranslatedText xml:lang="en">dies ist die Formularbeschreibung in &ltfont color=&quotblue&quot&gthtml&lt/font&gt</translatedtext> </Description> <ItemGroupRef ItemGroupOID="FGSUBJID" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FGFS" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG119" OrderNumber="1" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG98" OrderNumber="3" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG102" OrderNumber="4" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG57" OrderNumber="5" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG59" OrderNumber="7" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG79" OrderNumber="8" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG81" OrderNumber="9" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG95" OrderNumber="11" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG26" OrderNumber="12" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG65" OrderNumber="13" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG49" OrderNumber="14" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG101" OrderNumber="15" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG36" OrderNumber="16" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG105" OrderNumber="17" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG56" OrderNumber="18" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG77" OrderNumber="19" Mandatory="No"/> </FormDef> <FormDef OID="Fmnpias1sae1" Name="Serious Adverse Event" Repeating="Yes"> <Description> <TranslatedText xml:lang="en">dies ist die Formularbeschreibung in &ltfont color=&quotblue&quot&gthtml&lt/font&gt</translatedtext> </Description> <ItemGroupRef ItemGroupOID="FGSUBJID" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FGFS" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG53" OrderNumber="1" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG50" OrderNumber="3" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG6" OrderNumber="4" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG70" OrderNumber="5" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG40" OrderNumber="7" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG32" OrderNumber="8" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG114" OrderNumber="9" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG76" OrderNumber="11" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG41" OrderNumber="12" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG89" OrderNumber="13" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG3" OrderNumber="14" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG120" OrderNumber="15" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG12" OrderNumber="16" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG91" OrderNumber="17" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG66" OrderNumber="18" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG103" OrderNumber="19" Mandatory="No"/> As of by ias

217 Documentation secutrial 47 Export Formats </FormDef> <FormDef OID="Fmnpias1bilder" Name="Bilderformular mit besonders &quotlangem Namen&quot" Repeating="Yes"> <ItemGroupRef ItemGroupOID="FGSUBJID" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FGFS" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG385" OrderNumber="1" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG431" OrderNumber="2" Mandatory="No"/> </FormDef> <FormDef OID="Fmnpias1bilder1" Name="Röntgen" Repeating="Yes"> <ItemGroupRef ItemGroupOID="FGSUBJID" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FGFS" Mandatory="No"/> <ItemGroupRef ItemGroupOID="FG747" OrderNumber="1" Mandatory="No"/> </FormDef> <!-- ***** ItemGroupDef ***** --> <ItemGroupDef OID="FGSUBJID" Name="Patient identifier" Repeating="No"> <ItemRef ItemOID="FFSUBJID" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FGVISITDY" Name="Planned visit date" Repeating="No"> <ItemRef ItemOID="FFVISITDY" Mandatory="Yes"/> </ItemGroupDef> <ItemGroupDef OID="FGFS" Name="Document status information" Repeating="No"> <ItemRef ItemOID="FFFS0" Mandatory="No"/> <ItemRef ItemOID="FFFS1" Mandatory="No"/> <ItemRef ItemOID="FFFS2" Mandatory="No"/> <ItemRef ItemOID="FFFS3" Mandatory="No"/> <ItemRef ItemOID="FFFCS0" Mandatory="No"/> <ItemRef ItemOID="FFFCS1" Mandatory="No"/> <ItemRef ItemOID="FFFCS2" Mandatory="No"/> <ItemRef ItemOID="FFFCS3" Mandatory="No"/> <ItemRef ItemOID="FFFQA" Mandatory="No"/> <ItemRef ItemOID="FFFCT" Mandatory="No"/> <ItemRef ItemOID="FFFSDV" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG16" Name="IASCatalogGroup (Operationen)" Repeating="No"> <ItemRef ItemOID="FF16eppc1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF16epcc2a" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF16epcc2b" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF16epcc2c" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF16epcc2d" OrderNumber="5" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG8" Name="IASCombinedSelection" Repeating="No"> <ItemRef ItemOID="FF8tier1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF8rasse1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF8farbe1" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG110" Name="IASHorizCombinedSelection" Repeating="No"> <ItemRef ItemOID="FF110tier2" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF110rasse2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF110farbe2" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG55" Name="IASMultipleSelection" Repeating="No"> <ItemRef ItemOID="FF55tier3" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF55rasse3" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF55farbe3" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG9" Name="IASHorizRBMatrix" Repeating="No"> <ItemRef ItemOID="FF9hb1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF9hb2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF9hb3" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG62" Name="IASVertRBMatrix" Repeating="No"> <ItemRef ItemOID="FF62hb4" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF62hb5" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF62hb6" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG94" Name="IASCheckboxMatrix" Repeating="No"> <ItemRef ItemOID="FF94r1s1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF94r1s2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF94r1s3" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF94r2s1" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF94r2s2" OrderNumber="5" Mandatory="No"/> <ItemRef ItemOID="FF94r2s3" OrderNumber="6" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG96" Name="IASHorizontalGroup" Repeating="No"> <ItemRef ItemOID="FF96cb1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF96rb1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF96rrb1" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG46" Name="IASHorizontalGroup" Repeating="No"> <ItemRef ItemOID="FF46cb3" OrderNumber="1" Mandatory="No"/> As of by ias

218 Documentation secutrial 47 Export Formats <ItemRef ItemOID="FF46rrb3" OrderNumber="2" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG107" Name="IASHorizontalUnitGroup" Repeating="No"> <ItemRef ItemOID="FF107ugcb1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF107ug" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF107ugm" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF107ugt1" OrderNumber="4" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG54" Name="IASUnitGroup" Repeating="No"> <ItemRef ItemOID="FF54ugcb2" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF54ugt2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF54ug1" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF54ugm1" OrderNumber="4" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG63" Name="IASStandardGroup" Repeating="No"> <ItemRef ItemOID="FF63cb2" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF63rb2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF63rrb2" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF63pp1" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF63score1" OrderNumber="5" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG31" Name="IASStandardGroup Zahlenfelder - Textfelder" Repeating="No"> <ItemRef ItemOID="FF31gz1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF31kz1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF31score2" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF31text1" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF31text2" OrderNumber="5" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG97" Name="IASStandardGroup Zeitfelder" Repeating="No"> <ItemRef ItemOID="FF97zeit1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF97datum1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF97zeit2" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF97datum2" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF97ddd" OrderNumber="5" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG80" Name="IASStandardGroup - Sonstiges" Repeating="No"> <ItemRef ItemOID="FF80random1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF80hobbies1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF80haustier1" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF80abcdefghijabcdefghij" OrderNumber="4" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG14" Name="Bitte geben Sie alle weiteren Medikationen an:" Repeating="Yes"> <ItemRef ItemOID="FF14wirkstoff" OrderNumber="1" Mandatory="Yes"/> <ItemRef ItemOID="FF14dosis" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF14einnahme" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG86" Name="IASStandardGroup" Repeating="No"> <ItemRef ItemOID="FF86cb4" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF86rb3" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF86rrb4" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF86pp2" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF86score3" OrderNumber="5" Mandatory="No"/> <ItemRef ItemOID="FF86farbe" OrderNumber="6" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG48" Name="IASHorizRBMatrix 2" Repeating="No"> <ItemRef ItemOID="FF48hb7" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF48hb9" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF48hb8" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG453" Name="Und hier ein paar Bilder" Repeating="No"> <ItemRef ItemOID="FF453bild1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF453bild2" OrderNumber="2" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG44" Name="IASCatalogGroup (Operationen)" Repeating="No"> <ItemRef ItemOID="FF44eppc1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF44epcc2a" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF44epcc2b" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF44epcc2c" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF44epcc2d" OrderNumber="5" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG113" Name="IASCombinedSelection" Repeating="No"> <ItemRef ItemOID="FF113tier1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF113rasse1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF113farbe1" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG58" Name="IASHorizCombinedSelection" Repeating="No"> <ItemRef ItemOID="FF58tier2" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF58rasse2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF58farbe2" OrderNumber="3" Mandatory="No"/> As of by ias

219 Documentation secutrial 47 Export Formats </ItemGroupDef> <ItemGroupDef OID="FG99" Name="IASMultipleSelection" Repeating="No"> <ItemRef ItemOID="FF99tier3" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF99rasse3" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF99farbe3" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG100" Name="IASHorizRBMatrix" Repeating="No"> <ItemRef ItemOID="FF100hb1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF100hb2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF100hb3" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG85" Name="IASVertRBMatrix" Repeating="No"> <ItemRef ItemOID="FF85hb4" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF85hb5" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF85hb6" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG13" Name="IASCheckboxMatrix" Repeating="No"> <ItemRef ItemOID="FF13r1s1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF13r1s2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF13r1s3" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF13r2s1" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF13r2s2" OrderNumber="5" Mandatory="No"/> <ItemRef ItemOID="FF13r2s3" OrderNumber="6" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG4" Name="IASHorizontalGroup" Repeating="No"> <ItemRef ItemOID="FF4cb1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF4rb1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF4rrb1" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG61" Name="IASHorizontalGroup" Repeating="No"> <ItemRef ItemOID="FF61cb3" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF61rrb3" OrderNumber="2" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG87" Name="IASHorizontalUnitGroup" Repeating="No"> <ItemRef ItemOID="FF87ugcb1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF87ug" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF87ugm" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF87ugt1" OrderNumber="4" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG116" Name="IASUnitGroup" Repeating="No"> <ItemRef ItemOID="FF116ugcb2" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF116ug1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF116ugm1" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF116ugt2" OrderNumber="4" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG74" Name="IASStandardGroup: Codelists" Repeating="No"> <ItemRef ItemOID="FF74cb2" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF74rb2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF74rrb2" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF74pp1" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF74score1" OrderNumber="5" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG22" Name="IASStandardGroup Zahlenfelder - Textfelder" Repeating="No"> <ItemRef ItemOID="FF22gz1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF22kz1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF22score2" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF22text1" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF22text2" OrderNumber="5" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG33" Name="IASStandardGroup Zeitfelder" Repeating="No"> <ItemRef ItemOID="FF33zeit1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF33datum1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF33zeit2" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF33datum2" OrderNumber="4" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG93" Name="IASStandardGroup - Sonstiges" Repeating="No"> <ItemRef ItemOID="FF93random1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF93hobbies1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF93haustier1" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG10" Name="Bitte geben Sie alle weiteren Medikationen an:" Repeating="Yes"> <ItemRef ItemOID="FF10wirkstoff" OrderNumber="1" Mandatory="Yes"/> <ItemRef ItemOID="FF10dosis" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF10einnahme" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG450" Name="IASImageGroup" Repeating="No"> <ItemRef ItemOID="FF450bild1" OrderNumber="1" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG73" Name="Bildinformationen" Repeating="No"> As of by ias

220 Documentation secutrial 47 Export Formats <ItemRef ItemOID="FF73titel" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF73aufnahme" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF73beschreibung" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG72" Name="Klinisch auffällig?" Repeating="No"> <ItemRef ItemOID="FF72klinisch" OrderNumber="1" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG38" Name="einfache fragen" Repeating="No"> <ItemRef ItemOID="FF38sb1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF38vr1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF38score" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF38score2" OrderNumber="4" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG39" Name="rb-matrix" Repeating="No"> <ItemRef ItemOID="FF39rb1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF39rb2" OrderNumber="2" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG434" Name="Ein paar ganz normale Fragen" Repeating="No"> <ItemRef ItemOID="FF434farbe" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF434zahl" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF434wort" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG435" Name="Und hier ein paar Bilder" Repeating="No"> <ItemRef ItemOID="FF435bild1" OrderNumber="1" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG451" Name="Ein paar ganz normale Fragen" Repeating="No"> <ItemRef ItemOID="FF451farbe" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF451zahl" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF451wort" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG452" Name="Und hier ein paar Bilder" Repeating="No"> <ItemRef ItemOID="FF452bild1" OrderNumber="1" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG24" Name="IASCatalogGroup (Operationen)" Repeating="No"> <ItemRef ItemOID="FF24eppc1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF24epcc2a" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF24epcc2b" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF24epcc2c" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF24epcc2d" OrderNumber="5" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG82" Name="IASCombinedSelection" Repeating="No"> <ItemRef ItemOID="FF82tier1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF82rasse1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF82farbe1" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG47" Name="IASHorizCombinedSelection" Repeating="No"> <ItemRef ItemOID="FF47tier2" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF47rasse2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF47farbe2" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG21" Name="IASMultipleSelection" Repeating="No"> <ItemRef ItemOID="FF21tier3" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF21rasse3" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF21farbe3" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG112" Name="IASHorizRBMatrix" Repeating="No"> <ItemRef ItemOID="FF112hb1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF112hb2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF112hb3" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG60" Name="IASVertRBMatrix" Repeating="No"> <ItemRef ItemOID="FF60hb4" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF60hb5" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF60hb6" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG64" Name="IASCheckboxMatrix" Repeating="No"> <ItemRef ItemOID="FF64r1s1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF64r1s2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF64r1s3" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF64r2s1" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF64r2s2" OrderNumber="5" Mandatory="No"/> <ItemRef ItemOID="FF64r2s3" OrderNumber="6" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG19" Name="IASHorizontalGroup" Repeating="No"> <ItemRef ItemOID="FF19cb1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF19rb1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF19rrb1" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG5" Name="IASHorizontalGroup" Repeating="No"> As of by ias

221 Documentation secutrial 47 Export Formats <ItemRef ItemOID="FF5cb3" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF5rrb3" OrderNumber="2" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG28" Name="IASHorizontalUnitGroup" Repeating="No"> <ItemRef ItemOID="FF28ugcb1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF28ug" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF28ugm" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF28ugt1" OrderNumber="4" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG27" Name="IASUnitGroup" Repeating="No"> <ItemRef ItemOID="FF27ugcb2" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF27ug1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF27ugm1" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF27ugt2" OrderNumber="4" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG30" Name="IASStandardGroup" Repeating="No"> <ItemRef ItemOID="FF30cb2" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF30rb2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF30rrb2" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF30pp1" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF30score1" OrderNumber="5" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG7" Name="IASStandardGroup Zahlenfelder - Textfelder" Repeating="No"> <ItemRef ItemOID="FF7gz1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF7kz1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF7score2" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF7text1" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF7text2" OrderNumber="5" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG52" Name="IASStandardGroup Zeitfelder" Repeating="No"> <ItemRef ItemOID="FF52zeit1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF52datum1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF52zeit2" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF52datum2" OrderNumber="4" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG45" Name="IASStandardGroup - Sonstiges" Repeating="No"> <ItemRef ItemOID="FF45random1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF45hobbies1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF45haustier1" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG35" Name="IASRepetitionGroup" Repeating="Yes"> <ItemRef ItemOID="FF35wirkstoff" OrderNumber="1" Mandatory="Yes"/> <ItemRef ItemOID="FF35dosis" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF35einnahme" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG119" Name="IASCatalogGroup (Operationen)" Repeating="No"> <ItemRef ItemOID="FF119eppc1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF119epcc2a" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF119epcc2b" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF119epcc2c" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF119epcc2d" OrderNumber="5" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG98" Name="IASCombinedSelection" Repeating="No"> <ItemRef ItemOID="FF98tier1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF98rasse1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF98farbe1" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG102" Name="IASHorizCombinedSelection" Repeating="No"> <ItemRef ItemOID="FF102tier2" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF102rasse2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF102farbe2" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG57" Name="IASMultipleSelection" Repeating="No"> <ItemRef ItemOID="FF57tier3" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF57rasse3" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF57farbe3" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG59" Name="IASHorizRBMatrix" Repeating="No"> <ItemRef ItemOID="FF59hb1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF59hb2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF59hb3" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG79" Name="IASVertRBMatrix" Repeating="No"> <ItemRef ItemOID="FF79hb4" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF79hb5" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF79hb6" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG81" Name="IASCheckboxMatrix" Repeating="No"> <ItemRef ItemOID="FF81r1s1" OrderNumber="1" Mandatory="No"/> As of by ias

222 Documentation secutrial 47 Export Formats <ItemRef ItemOID="FF81r1s2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF81r1s3" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF81r2s1" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF81r2s2" OrderNumber="5" Mandatory="No"/> <ItemRef ItemOID="FF81r2s3" OrderNumber="6" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG95" Name="IASHorizontalGroup" Repeating="No"> <ItemRef ItemOID="FF95cb1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF95rb1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF95rrb1" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG26" Name="IASHorizontalGroup" Repeating="No"> <ItemRef ItemOID="FF26cb3" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF26rrb3" OrderNumber="2" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG65" Name="IASHorizontalUnitGroup" Repeating="No"> <ItemRef ItemOID="FF65ugcb1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF65ug" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF65ugm" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF65ugt1" OrderNumber="4" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG49" Name="IASUnitGroup" Repeating="No"> <ItemRef ItemOID="FF49ugcb2" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF49ug1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF49ugm1" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF49ugt2" OrderNumber="4" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG101" Name="IASStandardGroup" Repeating="No"> <ItemRef ItemOID="FF101cb2" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF101rb2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF101rrb2" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF101pp1" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF101score1" OrderNumber="5" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG36" Name="IASStandardGroup Zahlenfelder - Textfelder" Repeating="No"> <ItemRef ItemOID="FF36gz1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF36kz1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF36score2" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF36text1" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF36text2" OrderNumber="5" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG105" Name="IASStandardGroup Zeitfelder" Repeating="No"> <ItemRef ItemOID="FF105zeit1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF105datum1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF105zeit2" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF105datum2" OrderNumber="4" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG56" Name="IASStandardGroup - Sonstiges" Repeating="No"> <ItemRef ItemOID="FF56random1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF56hobbies1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF56haustier1" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG77" Name="IASRepetitionGroup" Repeating="Yes"> <ItemRef ItemOID="FF77wirkstoff" OrderNumber="1" Mandatory="Yes"/> <ItemRef ItemOID="FF77dosis" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF77einnahme" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG53" Name="IASCatalogGroup (Operationen)" Repeating="No"> <ItemRef ItemOID="FF53eppc1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF53epcc2a" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF53epcc2b" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF53epcc2c" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF53epcc2d" OrderNumber="5" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG50" Name="IASCombinedSelection" Repeating="No"> <ItemRef ItemOID="FF50tier1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF50rasse1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF50farbe1" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG6" Name="IASHorizCombinedSelection" Repeating="No"> <ItemRef ItemOID="FF6tier2" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF6rasse2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF6farbe2" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG70" Name="IASMultipleSelection" Repeating="No"> <ItemRef ItemOID="FF70tier3" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF70rasse3" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF70farbe3" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> As of by ias

223 Documentation secutrial 47 Export Formats <ItemGroupDef OID="FG40" Name="IASHorizRBMatrix" Repeating="No"> <ItemRef ItemOID="FF40hb1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF40hb2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF40hb3" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG32" Name="IASVertRBMatrix" Repeating="No"> <ItemRef ItemOID="FF32hb4" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF32hb5" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF32hb6" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG114" Name="IASCheckboxMatrix" Repeating="No"> <ItemRef ItemOID="FF114r1s1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF114r1s2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF114r1s3" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF114r2s1" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF114r2s2" OrderNumber="5" Mandatory="No"/> <ItemRef ItemOID="FF114r2s3" OrderNumber="6" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG76" Name="IASHorizontalGroup" Repeating="No"> <ItemRef ItemOID="FF76cb1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF76rb1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF76rrb1" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG41" Name="IASHorizontalGroup" Repeating="No"> <ItemRef ItemOID="FF41cb3" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF41rrb3" OrderNumber="2" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG89" Name="IASHorizontalUnitGroup" Repeating="No"> <ItemRef ItemOID="FF89ugcb1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF89ug" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF89ugm" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF89ugt1" OrderNumber="4" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG3" Name="IASUnitGroup" Repeating="No"> <ItemRef ItemOID="FF3ugcb2" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF3ug1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF3ugm1" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF3ugt2" OrderNumber="4" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG120" Name="IASStandardGroup" Repeating="No"> <ItemRef ItemOID="FF120cb2" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF120rb2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF120rrb2" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF120pp1" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF120score1" OrderNumber="5" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG12" Name="IASStandardGroup Zahlenfelder - Textfelder" Repeating="No"> <ItemRef ItemOID="FF12gz1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF12kz1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF12score2" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF12text1" OrderNumber="4" Mandatory="No"/> <ItemRef ItemOID="FF12text2" OrderNumber="5" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG91" Name="IASStandardGroup Zeitfelder" Repeating="No"> <ItemRef ItemOID="FF91zeit1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF91datum1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF91zeit2" OrderNumber="3" Mandatory="No"/> <ItemRef ItemOID="FF91datum2" OrderNumber="4" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG66" Name="IASStandardGroup - Sonstiges" Repeating="No"> <ItemRef ItemOID="FF66random1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF66hobbies1" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF66haustier1" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG103" Name="IASRepetitionGroup" Repeating="Yes"> <ItemRef ItemOID="FF103wirkstoff" OrderNumber="1" Mandatory="Yes"/> <ItemRef ItemOID="FF103dosis" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF103einnahme" OrderNumber="3" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG385" Name="erstes Bild" Repeating="No"> <ItemRef ItemOID="FF385img" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF385bild2" OrderNumber="2" Mandatory="No"/> <ItemRef ItemOID="FF385bezeichnung" OrderNumber="3" Mandatory="Yes"/> </ItemGroupDef> <ItemGroupDef OID="FG431" Name="zweites Bild" Repeating="No" ias:hidden="true"> <ItemRef ItemOID="FF431img1" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF431bild3" OrderNumber="2" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="FG747" Name="erstes Bild" Repeating="No"> As of by ias

224 Documentation secutrial 47 Export Formats <ItemRef ItemOID="FF747img" OrderNumber="1" Mandatory="No"/> <ItemRef ItemOID="FF747aufnahme" OrderNumber="2" Mandatory="No"/> </ItemGroupDef> <!-- ***** ItemDef ***** --> <ItemDef OID="FFSUBJID" Name="Patient identifier" DataType="string" Length="20" SDSVarName="SUBJID"/> <ItemDef OID="FFFS0" Name="medical review (A)" DataType="integer" Length="2"/> <ItemDef OID="FFFS1" Name="data review (B)" DataType="integer" Length="2"/> <ItemDef OID="FFFS2" Name="manual freeze" DataType="integer" Length="2"/> <ItemDef OID="FFFS3" Name="rulebased freeze" DataType="integer" Length="2"/> <ItemDef OID="FFFCS0" Name="Completion status" DataType="integer" Length="2"> <CodeListRef CodeListOID="CLclfcs_0"/> <ItemDef OID="FFFCS1" Name="Validation status (error)" DataType="integer" Length="2"/> <ItemDef OID="FFFCS2" Name="Validation status (warning)" DataType="integer" Length="2"/> <ItemDef OID="FFFCS3" Name="data entry complete" DataType="integer" Length="2"/> <ItemDef OID="FFFQA" Name="Query status" DataType="integer" Length="2"> <CodeListRef CodeListOID="CLclfqa"/> <ItemDef OID="FFFCT" Name="Comment status" DataType="integer" Length="2"/> <ItemDef OID="FFFSDV" Name="Source Data Verification" DataType="integer" Length="2"> <CodeListRef CodeListOID="CLclfssdv"/> <ItemDef OID="FFVISITDY" Name="Planned visit date" DataType="date" SDSVarName="VISITDY"/> <ItemDef OID="FF16eppc1" Name="eppc1" DataType="string" Length="120"> <TranslatedText xml:lang="en">a) Operationsgruppe</TranslatedText> <ItemDef OID="FF16epcc2a" Name="epcc2a" DataType="string" Length="120"> <TranslatedText xml:lang="en">b) Operation</TranslatedText> <ItemDef OID="FF16epcc2b" Name="epcc2b" DataType="string" Length="8"> <TranslatedText xml:lang="en">c) EPCC</TranslatedText> <ItemDef OID="FF16epcc2c" Name="epcc2c" DataType="string" Length="5"> <TranslatedText xml:lang="en">d) ICD-10</TranslatedText> <ItemDef OID="FF16epcc2d" Name="epcc2d" DataType="string" Length="5"> <TranslatedText xml:lang="en">e) ICD-10 additional</translatedtext> <ItemDef OID="FF8tier1" Name="tier1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">a) Haustier</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF8rasse1" Name="rasse1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Tier-Rasse</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1rasse"/> <ItemDef OID="FF8farbe1" Name="farbe1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">c) Tier-Farbe</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1farbe"/> <ItemDef OID="FF110tier2" Name="tier2" DataType="integer" Length="10"> <TranslatedText xml:lang="en">a) Haustier</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF110rasse2" Name="rasse2" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Tier-Rasse</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1rasse"/> <ItemDef OID="FF110farbe2" Name="farbe2" DataType="integer" Length="10"> As of by ias

225 Documentation secutrial 47 Export Formats <TranslatedText xml:lang="en">c) Tier-Farbe</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1farbe"/> <ItemDef OID="FF55tier3" Name="tier3" DataType="integer" Length="10"> <TranslatedText xml:lang="en">a) Haustier</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF55rasse3" Name="rasse3" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Tier-Rasse</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1rasse"/> <ItemDef OID="FF55farbe3" Name="farbe3" DataType="integer" Length="10"> <TranslatedText xml:lang="en">c) Tier-Farbe</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1farbe"/> <ItemDef OID="FF9hb1" Name="hb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Erste Reihe</TranslatedText> <CodeListRef CodeListOID="CL9hb1"/> <ItemDef OID="FF9hb2" Name="hb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Zweite Reihe</TranslatedText> <CodeListRef CodeListOID="CL9hb2"/> <ItemDef OID="FF9hb3" Name="hb3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Dritte Reihe</TranslatedText> <CodeListRef CodeListOID="CL9hb3"/> <ItemDef OID="FF62hb4" Name="hb4" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Erste Reihe</TranslatedText> <CodeListRef CodeListOID="CL62hb4"/> <ItemDef OID="FF62hb5" Name="hb5" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Zweite Reihe</TranslatedText> <CodeListRef CodeListOID="CL62hb5"/> <ItemDef OID="FF62hb6" Name="hb6" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Dritte Reihe</TranslatedText> <CodeListRef CodeListOID="CL62hb6"/> <ItemDef OID="FF94r1s1" Name="r1s1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Reihe eins - rot</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF94r1s2" Name="r1s2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Reihe eins - blau</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF94r1s3" Name="r1s3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Reihe eins - grün</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF94r2s1" Name="r2s1" DataType="integer" Length="3"> As of by ias

226 Documentation secutrial 47 Export Formats <TranslatedText xml:lang="en">b) Reihe zwei - rot</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF94r2s2" Name="r2s2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Reihe zwei - blau</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF94r2s3" Name="r2s3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Reihe zwei - grün</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF96cb1" Name="cb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) einfache Checkbox</TranslatedText> <CodeListRef CodeListOID="CL96cb1"/> <ItemDef OID="FF96rb1" Name="rb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) einfacher RadioButton</TranslatedText> <CodeListRef CodeListOID="CL96rb1"/> <ItemDef OID="FF96rrb1" Name="rrb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Reset-Radiobutton</TranslatedText> <CodeListRef CodeListOID="CL96rrb1"/> <ItemDef OID="FF46cb3" Name="cb3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) einfache Checkbox</TranslatedText> <CodeListRef CodeListOID="CL46cb3"/> <ItemDef OID="FF46rrb3" Name="rrb3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Reset-Radiobutton</TranslatedText> <CodeListRef CodeListOID="CL46rrb3"/> <ItemDef OID="FF107ugcb1" Name="ugcb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Messung durchgeführt?</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF107ug" Name="ug" DataType="float" Length="44" SignificantDigits="22"> <TranslatedText xml:lang="en">b) Messwert</TranslatedText> <ItemDef OID="FF107ugm" Name="ugm" DataType="integer" Length="3"> <TranslatedText xml:lang="en">12 IASHorizontalUnitGroup</TranslatedText> <CodeListRef CodeListOID="CL107ugm"/> <ItemDef OID="FF107ugt1" Name="ugt1" DataType="partialTime"> <TranslatedText xml:lang="en">c) Meßzeitpunkt</TranslatedText> <ItemDef OID="FF54ugcb2" Name="ugcb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Messung durchgeführt?</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF54ugt2" Name="ugt2" DataType="partialTime"> <TranslatedText xml:lang="en">c) Meßzeitpunkt</TranslatedText> As of by ias

227 Documentation secutrial 47 Export Formats <ItemDef OID="FF54ug1" Name="ug1" DataType="float" Length="44" SignificantDigits="22"> <TranslatedText xml:lang="en">b) Messwert</TranslatedText> <ItemDef OID="FF54ugm1" Name="ugm1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">13 IASUnitGroup</TranslatedText> <CodeListRef CodeListOID="CL54ugm1"/> <ItemDef OID="FF63cb2" Name="cb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) einfache Checkbox</TranslatedText> <CodeListRef CodeListOID="CL63cb2"/> <ItemDef OID="FF63rb2" Name="rb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) einfacher RadioButton</TranslatedText> <CodeListRef CodeListOID="CL63rb2"/> <ItemDef OID="FF63rrb2" Name="rrb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Reset-Radiobutton</TranslatedText> <CodeListRef CodeListOID="CL63rrb2"/> <ItemDef OID="FF63pp1" Name="pp1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">e) Popup</TranslatedText> <CodeListRef CodeListOID="CL63pp1"/> <ItemDef OID="FF63score1" Name="score1" DataType="float" Length="20" SignificantDigits="10"> <TranslatedText xml:lang="en">f) Score über Auswahl-Optionen (Ganzzahlen)</TranslatedText> <ItemDef OID="FF31gz1" Name="gz1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Ganzzahl (3)</TranslatedText> <ItemDef OID="FF31kz1" Name="kz1" DataType="float" Length="8" SignificantDigits="3"> <TranslatedText xml:lang="en">b) Kommazahl (53)</TranslatedText> <ItemDef OID="FF31score2" Name="score2" DataType="float" Length="20" SignificantDigits="10"> <TranslatedText xml:lang="en">c) Score über Zahlenfelder</TranslatedText> <ItemDef OID="FF31text1" Name="text1" DataType="string" Length="40"> <TranslatedText xml:lang="en">d) Kurzes Textfeld (40)</TranslatedText> <ItemDef OID="FF31text2" Name="text2" DataType="string" Length="120"> <TranslatedText xml:lang="en">e) Langes Textfeld (Area, 3x40)</TranslatedText> <ItemDef OID="FF97zeit1" Name="zeit1" DataType="partialTime"> <TranslatedText xml:lang="en">a) Zeitstempel</TranslatedText> <ItemDef OID="FF97datum1" Name="datum1" DataType="partialDate"> <TranslatedText xml:lang="en">b) Datum</TranslatedText> <ItemDef OID="FF97zeit2" Name="zeit2" DataType="incompleteDatetime"> <TranslatedText xml:lang="en">c) geprüfte Zeit</TranslatedText> As of by ias

228 Documentation secutrial 47 Export Formats <ItemDef OID="FF97datum2" Name="datum2" DataType="partialDate"> <TranslatedText xml:lang="en">d) geprüftes Datum</TranslatedText> <ItemDef OID="FF97ddd" Name="ddd" DataType="durationDatetime"> <TranslatedText xml:lang="en">16 IASStandardGroup Zeitfelder</TranslatedText> <ItemDef OID="FF80random1" Name="random1" DataType="string" Length="5"> <TranslatedText xml:lang="en">a) Randomization-Button</TranslatedText> <ItemDef OID="FF80hobbies1" Name="hobbies1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Erweiterbare Lookuptabelle</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1hobby"/> <ItemDef OID="FF80haustier1" Name="haustier1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">c) einfache Lookuptabelle (Haustier)</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF80abcdefghijabcdefghij" Name="abcdefghijabcdefghij" DataType="integer" Length="3"> <TranslatedText xml:lang="en">namenstest mit Regel</TranslatedText> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF14wirkstoff" Name="wirkstoff" DataType="string" Length="40"> <TranslatedText xml:lang="en">wirkstoff</translatedtext> <ItemDef OID="FF14dosis" Name="dosis" DataType="float" Length="5" SignificantDigits="2"> <TranslatedText xml:lang="en">dosis</translatedtext> <ItemDef OID="FF14einnahme" Name="einnahme" DataType="partialTime"> <TranslatedText xml:lang="en">einnahmezeit</translatedtext> <ItemDef OID="FF86cb4" Name="cb4" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) einfache Checkbox</TranslatedText> <CodeListRef CodeListOID="CL86cb4"/> <ItemDef OID="FF86rb3" Name="rb3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) einfacher RadioButton</TranslatedText> <CodeListRef CodeListOID="CL86rb3"/> <ItemDef OID="FF86rrb4" Name="rrb4" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Reset-Radiobutton</TranslatedText> <CodeListRef CodeListOID="CL86rrb4"/> <ItemDef OID="FF86pp2" Name="pp2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">e) Popup</TranslatedText> <CodeListRef CodeListOID="CL86pp2"/> <ItemDef OID="FF86score3" Name="score3" DataType="float" Length="20" SignificantDigits="10"> <TranslatedText xml:lang="en">f) Score über Auswahl-Optionen (Ganzzahlen)</TranslatedText> <ItemDef OID="FF86farbe" Name="farbe" DataType="integer" Length="3"> As of by ias

229 Documentation secutrial 47 Export Formats <TranslatedText xml:lang="en">lieblingsfarbe</translatedtext> <CodeListRef CodeListOID="CL86farbe"/> <ItemDef OID="FF48hb7" Name="hb7" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Erste Reihe</TranslatedText> <CodeListRef CodeListOID="CL48hb7"/> <ItemDef OID="FF48hb9" Name="hb9" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Zweite Reihe</TranslatedText> <CodeListRef CodeListOID="CL48hb9"/> <ItemDef OID="FF48hb8" Name="hb8" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Dritte Reihe</TranslatedText> <CodeListRef CodeListOID="CL48hb8"/> <ItemDef OID="FF453bild1" Name="bild1" DataType="string" Length="100" ias:hidden="true"> <TranslatedText xml:lang="en">a) Lieblingsbild</TranslatedText> <ItemDef OID="FF453bild2" Name="bild2" DataType="string" Length="100"> <TranslatedText xml:lang="en">b) und noch ein Bild</TranslatedText> <ItemDef OID="FF44eppc1" Name="eppc1" DataType="string" Length="120"> <TranslatedText xml:lang="en">a) Operationsgruppe</TranslatedText> <ItemDef OID="FF44epcc2a" Name="epcc2a" DataType="string" Length="120"> <TranslatedText xml:lang="en">b) Operation</TranslatedText> <ItemDef OID="FF44epcc2b" Name="epcc2b" DataType="string" Length="8"> <TranslatedText xml:lang="en">c) EPCC</TranslatedText> <ItemDef OID="FF44epcc2c" Name="epcc2c" DataType="string" Length="5"> <TranslatedText xml:lang="en">d) ICD-10</TranslatedText> <ItemDef OID="FF44epcc2d" Name="epcc2d" DataType="string" Length="5"> <TranslatedText xml:lang="en">e) ICD-10 additional</translatedtext> <ItemDef OID="FF113tier1" Name="tier1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">a) Haustier</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF113rasse1" Name="rasse1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Tier-Rasse</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1rasse"/> <ItemDef OID="FF113farbe1" Name="farbe1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">c) Tier-Farbe</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1farbe"/> <ItemDef OID="FF58tier2" Name="tier2" DataType="integer" Length="10"> <TranslatedText xml:lang="en">a) Haustier</TranslatedText> As of by ias

230 Documentation secutrial 47 Export Formats <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF58rasse2" Name="rasse2" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Tier-Rasse</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1rasse"/> <ItemDef OID="FF58farbe2" Name="farbe2" DataType="integer" Length="10"> <TranslatedText xml:lang="en">c) Tier-Farbe</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1farbe"/> <ItemDef OID="FF99tier3" Name="tier3" DataType="integer" Length="10"> <TranslatedText xml:lang="en">a) Haustier</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF99rasse3" Name="rasse3" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Tier-Rasse</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1rasse"/> <ItemDef OID="FF99farbe3" Name="farbe3" DataType="integer" Length="10"> <TranslatedText xml:lang="en">c) Tier-Farbe</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1farbe"/> <ItemDef OID="FF100hb1" Name="hb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Erste Reihe</TranslatedText> <CodeListRef CodeListOID="CL100hb1"/> <ItemDef OID="FF100hb2" Name="hb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Zweite Reihe</TranslatedText> <CodeListRef CodeListOID="CL100hb2"/> <ItemDef OID="FF100hb3" Name="hb3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Dritte Reihe</TranslatedText> <CodeListRef CodeListOID="CL100hb3"/> <ItemDef OID="FF85hb4" Name="hb4" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Erste Reihe</TranslatedText> <CodeListRef CodeListOID="CL85hb4"/> <ItemDef OID="FF85hb5" Name="hb5" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Zweite Reihe</TranslatedText> <CodeListRef CodeListOID="CL85hb5"/> <ItemDef OID="FF85hb6" Name="hb6" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Dritte Reihe</TranslatedText> <CodeListRef CodeListOID="CL85hb6"/> <ItemDef OID="FF13r1s1" Name="r1s1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Reihe eins - rot</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF13r1s2" Name="r1s2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Reihe eins - blau</translatedtext> As of by ias

231 Documentation secutrial 47 Export Formats <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF13r1s3" Name="r1s3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Reihe eins - grün</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF13r2s1" Name="r2s1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Reihe zwei - rot</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF13r2s2" Name="r2s2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Reihe zwei - blau</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF13r2s3" Name="r2s3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Reihe zwei - grün</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF4cb1" Name="cb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) einfache Checkbox</TranslatedText> <CodeListRef CodeListOID="CL4cb1"/> <ItemDef OID="FF4rb1" Name="rb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) einfacher RadioButton</TranslatedText> <CodeListRef CodeListOID="CL4rb1"/> <ItemDef OID="FF4rrb1" Name="rrb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Reset-Radiobutton</TranslatedText> <CodeListRef CodeListOID="CL4rrb1"/> <ItemDef OID="FF61cb3" Name="cb3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) einfache Checkbox</TranslatedText> <CodeListRef CodeListOID="CL61cb3"/> <ItemDef OID="FF61rrb3" Name="rrb3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Reset-Radiobutton</TranslatedText> <CodeListRef CodeListOID="CL61rrb3"/> <ItemDef OID="FF87ugcb1" Name="ugcb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Messung durchgeführt?</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF87ug" Name="ug" DataType="float" Length="44" SignificantDigits="22"> <TranslatedText xml:lang="en">b) Messwert</TranslatedText> <ItemDef OID="FF87ugm" Name="ugm" DataType="integer" Length="3"> <TranslatedText xml:lang="en">12 IASHorizontalUnitGroup</TranslatedText> <CodeListRef CodeListOID="CL87ugm"/> <ItemDef OID="FF87ugt1" Name="ugt1" DataType="partialTime"> <TranslatedText xml:lang="en">c) Meßzeitpunkt</TranslatedText> <ItemDef OID="FF116ugcb2" Name="ugcb2" DataType="integer" Length="3"> As of by ias

232 Documentation secutrial 47 Export Formats <TranslatedText xml:lang="en">a) Messung durchgeführt?</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF116ug1" Name="ug1" DataType="float" Length="44" SignificantDigits="22"> <TranslatedText xml:lang="en">b) Messwert</TranslatedText> <ItemDef OID="FF116ugm1" Name="ugm1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">13 IASUnitGroup</TranslatedText> <CodeListRef CodeListOID="CL116ugm1"/> <ItemDef OID="FF116ugt2" Name="ugt2" DataType="partialTime"> <TranslatedText xml:lang="en">c) Meßzeitpunkt</TranslatedText> <ItemDef OID="FF74cb2" Name="cb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) einfache Checkbox</TranslatedText> <CodeListRef CodeListOID="CL74cb2"/> <ItemDef OID="FF74rb2" Name="rb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) einfacher RadioButton</TranslatedText> <CodeListRef CodeListOID="CL74rb2"/> <ItemDef OID="FF74rrb2" Name="rrb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Reset-Radiobutton</TranslatedText> <CodeListRef CodeListOID="CL74rrb2"/> <ItemDef OID="FF74pp1" Name="pp1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">e) Popup</TranslatedText> <CodeListRef CodeListOID="CL74pp1"/> <ItemDef OID="FF74score1" Name="score1" DataType="float" Length="20" SignificantDigits="10"> <TranslatedText xml:lang="en">f) Score über Auswahl-Optionen (Ganzzahlen)</TranslatedText> <ItemDef OID="FF22gz1" Name="gz1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Ganzzahl (3)</TranslatedText> <ItemDef OID="FF22kz1" Name="kz1" DataType="float" Length="8" SignificantDigits="3"> <TranslatedText xml:lang="en">b) Kommazahl (53)</TranslatedText> <ItemDef OID="FF22score2" Name="score2" DataType="float" Length="20" SignificantDigits="10"> <TranslatedText xml:lang="en">c) Score über Zahlenfelder</TranslatedText> <ItemDef OID="FF22text1" Name="text1" DataType="string" Length="40"> <TranslatedText xml:lang="en">d) Kurzes Textfeld (40)</TranslatedText> <ItemDef OID="FF22text2" Name="text2" DataType="string" Length="120"> <TranslatedText xml:lang="en">e) Langes Textfeld (Area, 3x40)</TranslatedText> <ItemDef OID="FF33zeit1" Name="zeit1" DataType="partialTime"> <TranslatedText xml:lang="en">a) Zeitstempel</TranslatedText> As of by ias

233 Documentation secutrial 47 Export Formats <ItemDef OID="FF33datum1" Name="datum1" DataType="partialDate"> <TranslatedText xml:lang="en">b) Datum</TranslatedText> <ItemDef OID="FF33zeit2" Name="zeit2" DataType="incompleteDatetime"> <TranslatedText xml:lang="en">c) geprüfte Zeit</TranslatedText> <ItemDef OID="FF33datum2" Name="datum2" DataType="partialDate"> <TranslatedText xml:lang="en">d) geprüftes Datum</TranslatedText> <ItemDef OID="FF93random1" Name="random1" DataType="string" Length="5"> <TranslatedText xml:lang="en">a) Randomization-Button</TranslatedText> <ItemDef OID="FF93hobbies1" Name="hobbies1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Erweiterbare Lookuptabelle</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1hobby"/> <ItemDef OID="FF93haustier1" Name="haustier1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">c) einfache Lookuptabelle (Haustier)</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF10wirkstoff" Name="wirkstoff" DataType="string" Length="40"> <TranslatedText xml:lang="en">wirkstoff</translatedtext> <ItemDef OID="FF10dosis" Name="dosis" DataType="float" Length="5" SignificantDigits="2"> <TranslatedText xml:lang="en">dosis</translatedtext> <ItemDef OID="FF10einnahme" Name="einnahme" DataType="partialTime"> <TranslatedText xml:lang="en">einnahmezeit</translatedtext> <ItemDef OID="FF450bild1" Name="bild1" DataType="string" Length="100"> <TranslatedText xml:lang="en">bild-1</translatedtext> <ItemDef OID="FF73titel" Name="titel" DataType="string" Length="60"> <TranslatedText xml:lang="en">titel</translatedtext> <ItemDef OID="FF73aufnahme" Name="aufnahme" DataType="partialDate"> <TranslatedText xml:lang="en">aufnahmedatum</translatedtext> <ItemDef OID="FF73beschreibung" Name="beschreibung" DataType="string" Length="120"> <TranslatedText xml:lang="en">beschreibung</translatedtext> <ItemDef OID="FF72klinisch" Name="klinisch" DataType="integer" Length="3"> <TranslatedText xml:lang="en">klinisch auffällig?</translatedtext> <CodeListRef CodeListOID="CL72klinisch"/> <ItemDef OID="FF38sb1" Name="sb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">horizontal radiobutton</translatedtext> <CodeListRef CodeListOID="CL38sb1"/> As of by ias

234 Documentation secutrial 47 Export Formats <ItemDef OID="FF38vr1" Name="vr1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">vertical radiobutton</translatedtext> <CodeListRef CodeListOID="CL38vr1"/> <ItemDef OID="FF38score" Name="score" DataType="float" Length="20" SignificantDigits="10"> <TranslatedText xml:lang="en">score berechnen</translatedtext> <ItemDef OID="FF38score2" Name="score2" DataType="float" Length="20" SignificantDigits="10"> <TranslatedText xml:lang="en">score function</translatedtext> <ItemDef OID="FF39rb1" Name="rb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">erste Frage</TranslatedText> <CodeListRef CodeListOID="CL39rb1"/> <ItemDef OID="FF39rb2" Name="rb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">zweite Frage</TranslatedText> <CodeListRef CodeListOID="CL39rb2"/> <ItemDef OID="FF434farbe" Name="farbe" DataType="integer" Length="3"> <TranslatedText xml:lang="en">lieblingsfarbe</translatedtext> <CodeListRef CodeListOID="CL434farbe"/> <ItemDef OID="FF434zahl" Name="zahl" DataType="integer" Length="2"> <TranslatedText xml:lang="en">lieblingszahl</translatedtext> <ItemDef OID="FF434wort" Name="wort" DataType="string" Length="60"> <TranslatedText xml:lang="en">lieblingswort</translatedtext> <ItemDef OID="FF435bild1" Name="bild1" DataType="string" Length="100"> <TranslatedText xml:lang="en">lieblingsbild</translatedtext> <ItemDef OID="FF451farbe" Name="farbe" DataType="integer" Length="3"> <TranslatedText xml:lang="en">lieblingsfarbe</translatedtext> <CodeListRef CodeListOID="CL451farbe"/> <ItemDef OID="FF451zahl" Name="zahl" DataType="integer" Length="2"> <TranslatedText xml:lang="en">lieblingszahl</translatedtext> <ItemDef OID="FF451wort" Name="wort" DataType="string" Length="60"> <TranslatedText xml:lang="en">lieblingswort</translatedtext> <ItemDef OID="FF452bild1" Name="bild1" DataType="string" Length="100"> <TranslatedText xml:lang="en">lieblingsbild</translatedtext> <ItemDef OID="FF24eppc1" Name="eppc1" DataType="string" Length="120"> <TranslatedText xml:lang="en">a) Operationsgruppe</TranslatedText> <ItemDef OID="FF24epcc2a" Name="epcc2a" DataType="string" Length="120"> <TranslatedText xml:lang="en">b) Operation</TranslatedText> As of by ias

235 Documentation secutrial 47 Export Formats <ItemDef OID="FF24epcc2b" Name="epcc2b" DataType="string" Length="8"> <TranslatedText xml:lang="en">c) EPCC</TranslatedText> <ItemDef OID="FF24epcc2c" Name="epcc2c" DataType="string" Length="5"> <TranslatedText xml:lang="en">d) ICD-10</TranslatedText> <ItemDef OID="FF24epcc2d" Name="epcc2d" DataType="string" Length="5"> <TranslatedText xml:lang="en">e) ICD-10 additional</translatedtext> <ItemDef OID="FF82tier1" Name="tier1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">a) Haustier</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF82rasse1" Name="rasse1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Tier-Rasse</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1rasse"/> <ItemDef OID="FF82farbe1" Name="farbe1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">c) Tier-Farbe</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1farbe"/> <ItemDef OID="FF47tier2" Name="tier2" DataType="integer" Length="10"> <TranslatedText xml:lang="en">a) Haustier</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF47rasse2" Name="rasse2" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Tier-Rasse</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1rasse"/> <ItemDef OID="FF47farbe2" Name="farbe2" DataType="integer" Length="10"> <TranslatedText xml:lang="en">c) Tier-Farbe</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1farbe"/> <ItemDef OID="FF21tier3" Name="tier3" DataType="integer" Length="10"> <TranslatedText xml:lang="en">a) Haustier</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF21rasse3" Name="rasse3" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Tier-Rasse</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1rasse"/> <ItemDef OID="FF21farbe3" Name="farbe3" DataType="integer" Length="10"> <TranslatedText xml:lang="en">c) Tier-Farbe</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1farbe"/> <ItemDef OID="FF112hb1" Name="hb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Erste Reihe</TranslatedText> <CodeListRef CodeListOID="CL112hb1"/> <ItemDef OID="FF112hb2" Name="hb2" DataType="integer" Length="3"> As of by ias

236 Documentation secutrial 47 Export Formats <TranslatedText xml:lang="en">b) Zweite Reihe</TranslatedText> <CodeListRef CodeListOID="CL112hb2"/> <ItemDef OID="FF112hb3" Name="hb3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Dritte Reihe</TranslatedText> <CodeListRef CodeListOID="CL112hb3"/> <ItemDef OID="FF60hb4" Name="hb4" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Erste Reihe</TranslatedText> <CodeListRef CodeListOID="CL60hb4"/> <ItemDef OID="FF60hb5" Name="hb5" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Zweite Reihe</TranslatedText> <CodeListRef CodeListOID="CL60hb5"/> <ItemDef OID="FF60hb6" Name="hb6" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Dritte Reihe</TranslatedText> <CodeListRef CodeListOID="CL60hb6"/> <ItemDef OID="FF64r1s1" Name="r1s1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Reihe eins - rot</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF64r1s2" Name="r1s2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Reihe eins - blau</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF64r1s3" Name="r1s3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Reihe eins - grün</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF64r2s1" Name="r2s1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Reihe zwei - rot</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF64r2s2" Name="r2s2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Reihe zwei - blau</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF64r2s3" Name="r2s3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Reihe zwei - grün</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF19cb1" Name="cb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) einfache Checkbox</TranslatedText> <CodeListRef CodeListOID="CL19cb1"/> <ItemDef OID="FF19rb1" Name="rb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) einfacher RadioButton</TranslatedText> <CodeListRef CodeListOID="CL19rb1"/> <ItemDef OID="FF19rrb1" Name="rrb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Reset-Radiobutton</TranslatedText> As of by ias

237 Documentation secutrial 47 Export Formats <CodeListRef CodeListOID="CL19rrb1"/> <ItemDef OID="FF5cb3" Name="cb3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) einfache Checkbox</TranslatedText> <CodeListRef CodeListOID="CL5cb3"/> <ItemDef OID="FF5rrb3" Name="rrb3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Reset-Radiobutton</TranslatedText> <CodeListRef CodeListOID="CL5rrb3"/> <ItemDef OID="FF28ugcb1" Name="ugcb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Messung durchgeführt?</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF28ug" Name="ug" DataType="float" Length="44" SignificantDigits="22"> <TranslatedText xml:lang="en">b) Messwert</TranslatedText> <ItemDef OID="FF28ugm" Name="ugm" DataType="integer" Length="3"> <TranslatedText xml:lang="en">12 IASHorizontalUnitGroup</TranslatedText> <CodeListRef CodeListOID="CL28ugm"/> <ItemDef OID="FF28ugt1" Name="ugt1" DataType="partialTime"> <TranslatedText xml:lang="en">c) Meßzeitpunkt</TranslatedText> <ItemDef OID="FF27ugcb2" Name="ugcb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Messung durchgeführt?</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF27ug1" Name="ug1" DataType="float" Length="44" SignificantDigits="22"> <TranslatedText xml:lang="en">b) Messwert</TranslatedText> <ItemDef OID="FF27ugm1" Name="ugm1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">13 IASUnitGroup</TranslatedText> <CodeListRef CodeListOID="CL27ugm1"/> <ItemDef OID="FF27ugt2" Name="ugt2" DataType="partialTime"> <TranslatedText xml:lang="en">c) Meßzeitpunkt</TranslatedText> <ItemDef OID="FF30cb2" Name="cb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) einfache Checkbox</TranslatedText> <CodeListRef CodeListOID="CL30cb2"/> <ItemDef OID="FF30rb2" Name="rb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) einfacher RadioButton</TranslatedText> <CodeListRef CodeListOID="CL30rb2"/> <ItemDef OID="FF30rrb2" Name="rrb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Reset-Radiobutton</TranslatedText> <CodeListRef CodeListOID="CL30rrb2"/> <ItemDef OID="FF30pp1" Name="pp1" DataType="integer" Length="3"> As of by ias

238 Documentation secutrial 47 Export Formats <TranslatedText xml:lang="en">e) Popup</TranslatedText> <CodeListRef CodeListOID="CL30pp1"/> <ItemDef OID="FF30score1" Name="score1" DataType="float" Length="20" SignificantDigits="10"> <TranslatedText xml:lang="en">f) Score über Auswahl-Optionen (Ganzzahlen)</TranslatedText> <ItemDef OID="FF7gz1" Name="gz1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Ganzzahl (3)</TranslatedText> <ItemDef OID="FF7kz1" Name="kz1" DataType="float" Length="8" SignificantDigits="3"> <TranslatedText xml:lang="en">b) Kommazahl (53)</TranslatedText> <ItemDef OID="FF7score2" Name="score2" DataType="float" Length="20" SignificantDigits="10"> <TranslatedText xml:lang="en">c) Score über Zahlenfelder</TranslatedText> <ItemDef OID="FF7text1" Name="text1" DataType="string" Length="40"> <TranslatedText xml:lang="en">d) Kurzes Textfeld (40)</TranslatedText> <ItemDef OID="FF7text2" Name="text2" DataType="string" Length="120"> <TranslatedText xml:lang="en">e) Langes Textfeld (Area, 3x40)</TranslatedText> <ItemDef OID="FF52zeit1" Name="zeit1" DataType="partialTime"> <TranslatedText xml:lang="en">a) Zeitstempel</TranslatedText> <ItemDef OID="FF52datum1" Name="datum1" DataType="partialDate"> <TranslatedText xml:lang="en">b) Datum</TranslatedText> <ItemDef OID="FF52zeit2" Name="zeit2" DataType="incompleteDatetime"> <TranslatedText xml:lang="en">c) geprüfte Zeit</TranslatedText> <ItemDef OID="FF52datum2" Name="datum2" DataType="partialDate"> <TranslatedText xml:lang="en">d) geprüftes Datum</TranslatedText> <ItemDef OID="FF45random1" Name="random1" DataType="string" Length="5"> <TranslatedText xml:lang="en">a) Randomization-Button</TranslatedText> <ItemDef OID="FF45hobbies1" Name="hobbies1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Erweiterbare Lookuptabelle</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1hobby"/> <ItemDef OID="FF45haustier1" Name="haustier1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">c) einfache Lookuptabelle (Haustier)</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF35wirkstoff" Name="wirkstoff" DataType="string" Length="40"> <TranslatedText xml:lang="en">wirkstoff</translatedtext> <ItemDef OID="FF35dosis" Name="dosis" DataType="float" Length="5" SignificantDigits="2"> <TranslatedText xml:lang="en">dosis</translatedtext> As of by ias

239 Documentation secutrial 47 Export Formats <ItemDef OID="FF35einnahme" Name="einnahme" DataType="partialTime"> <TranslatedText xml:lang="en">einnahmezeit</translatedtext> <ItemDef OID="FF119eppc1" Name="eppc1" DataType="string" Length="120"> <TranslatedText xml:lang="en">a) Operationsgruppe</TranslatedText> <ItemDef OID="FF119epcc2a" Name="epcc2a" DataType="string" Length="120"> <TranslatedText xml:lang="en">b) Operation</TranslatedText> <ItemDef OID="FF119epcc2b" Name="epcc2b" DataType="string" Length="8"> <TranslatedText xml:lang="en">c) EPCC</TranslatedText> <ItemDef OID="FF119epcc2c" Name="epcc2c" DataType="string" Length="5"> <TranslatedText xml:lang="en">d) ICD-10</TranslatedText> <ItemDef OID="FF119epcc2d" Name="epcc2d" DataType="string" Length="5"> <TranslatedText xml:lang="en">e) ICD-10 additional</translatedtext> <ItemDef OID="FF98tier1" Name="tier1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">a) Haustier</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF98rasse1" Name="rasse1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Tier-Rasse</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1rasse"/> <ItemDef OID="FF98farbe1" Name="farbe1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">c) Tier-Farbe</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1farbe"/> <ItemDef OID="FF102tier2" Name="tier2" DataType="integer" Length="10"> <TranslatedText xml:lang="en">a) Haustier</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF102rasse2" Name="rasse2" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Tier-Rasse</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1rasse"/> <ItemDef OID="FF102farbe2" Name="farbe2" DataType="integer" Length="10"> <TranslatedText xml:lang="en">c) Tier-Farbe</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1farbe"/> <ItemDef OID="FF57tier3" Name="tier3" DataType="integer" Length="10"> <TranslatedText xml:lang="en">a) Haustier</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF57rasse3" Name="rasse3" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Tier-Rasse</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1rasse"/> As of by ias

240 Documentation secutrial 47 Export Formats <ItemDef OID="FF57farbe3" Name="farbe3" DataType="integer" Length="10"> <TranslatedText xml:lang="en">c) Tier-Farbe</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1farbe"/> <ItemDef OID="FF59hb1" Name="hb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Erste Reihe</TranslatedText> <CodeListRef CodeListOID="CL59hb1"/> <ItemDef OID="FF59hb2" Name="hb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Zweite Reihe</TranslatedText> <CodeListRef CodeListOID="CL59hb2"/> <ItemDef OID="FF59hb3" Name="hb3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Dritte Reihe</TranslatedText> <CodeListRef CodeListOID="CL59hb3"/> <ItemDef OID="FF79hb4" Name="hb4" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Erste Reihe</TranslatedText> <CodeListRef CodeListOID="CL79hb4"/> <ItemDef OID="FF79hb5" Name="hb5" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Zweite Reihe</TranslatedText> <CodeListRef CodeListOID="CL79hb5"/> <ItemDef OID="FF79hb6" Name="hb6" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Dritte Reihe</TranslatedText> <CodeListRef CodeListOID="CL79hb6"/> <ItemDef OID="FF81r1s1" Name="r1s1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Reihe eins - rot</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF81r1s2" Name="r1s2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Reihe eins - blau</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF81r1s3" Name="r1s3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Reihe eins - grün</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF81r2s1" Name="r2s1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Reihe zwei - rot</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF81r2s2" Name="r2s2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Reihe zwei - blau</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF81r2s3" Name="r2s3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Reihe zwei - grün</translatedtext> <CodeListRef CodeListOID="CLclcb"/> As of by ias

241 Documentation secutrial 47 Export Formats <ItemDef OID="FF95cb1" Name="cb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) einfache Checkbox</TranslatedText> <CodeListRef CodeListOID="CL95cb1"/> <ItemDef OID="FF95rb1" Name="rb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) einfacher RadioButton</TranslatedText> <CodeListRef CodeListOID="CL95rb1"/> <ItemDef OID="FF95rrb1" Name="rrb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Reset-Radiobutton</TranslatedText> <CodeListRef CodeListOID="CL95rrb1"/> <ItemDef OID="FF26cb3" Name="cb3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) einfache Checkbox</TranslatedText> <CodeListRef CodeListOID="CL26cb3"/> <ItemDef OID="FF26rrb3" Name="rrb3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Reset-Radiobutton</TranslatedText> <CodeListRef CodeListOID="CL26rrb3"/> <ItemDef OID="FF65ugcb1" Name="ugcb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Messung durchgeführt?</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF65ug" Name="ug" DataType="float" Length="44" SignificantDigits="22"> <TranslatedText xml:lang="en">b) Messwert</TranslatedText> <ItemDef OID="FF65ugm" Name="ugm" DataType="integer" Length="3"> <TranslatedText xml:lang="en">12 IASHorizontalUnitGroup</TranslatedText> <CodeListRef CodeListOID="CL65ugm"/> <ItemDef OID="FF65ugt1" Name="ugt1" DataType="partialTime"> <TranslatedText xml:lang="en">c) Meßzeitpunkt</TranslatedText> <ItemDef OID="FF49ugcb2" Name="ugcb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Messung durchgeführt?</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF49ug1" Name="ug1" DataType="float" Length="44" SignificantDigits="22"> <TranslatedText xml:lang="en">b) Messwert</TranslatedText> <ItemDef OID="FF49ugm1" Name="ugm1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">13 IASUnitGroup</TranslatedText> <CodeListRef CodeListOID="CL49ugm1"/> <ItemDef OID="FF49ugt2" Name="ugt2" DataType="partialTime"> <TranslatedText xml:lang="en">c) Meßzeitpunkt</TranslatedText> <ItemDef OID="FF101cb2" Name="cb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) einfache Checkbox</TranslatedText> <CodeListRef CodeListOID="CL101cb2"/> As of by ias

242 Documentation secutrial 47 Export Formats <ItemDef OID="FF101rb2" Name="rb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) einfacher RadioButton</TranslatedText> <CodeListRef CodeListOID="CL101rb2"/> <ItemDef OID="FF101rrb2" Name="rrb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Reset-Radiobutton</TranslatedText> <CodeListRef CodeListOID="CL101rrb2"/> <ItemDef OID="FF101pp1" Name="pp1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">e) Popup</TranslatedText> <CodeListRef CodeListOID="CL101pp1"/> <ItemDef OID="FF101score1" Name="score1" DataType="float" Length="20" SignificantDigits="10"> <TranslatedText xml:lang="en">f) Score über Auswahl-Optionen (Ganzzahlen)</TranslatedText> <ItemDef OID="FF36gz1" Name="gz1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Ganzzahl (3)</TranslatedText> <ItemDef OID="FF36kz1" Name="kz1" DataType="float" Length="8" SignificantDigits="3"> <TranslatedText xml:lang="en">b) Kommazahl (53)</TranslatedText> <ItemDef OID="FF36score2" Name="score2" DataType="float" Length="20" SignificantDigits="10"> <TranslatedText xml:lang="en">c) Score über Zahlenfelder</TranslatedText> <ItemDef OID="FF36text1" Name="text1" DataType="string" Length="40"> <TranslatedText xml:lang="en">d) Kurzes Textfeld (40)</TranslatedText> <ItemDef OID="FF36text2" Name="text2" DataType="string" Length="120"> <TranslatedText xml:lang="en">e) Langes Textfeld (Area, 3x40)</TranslatedText> <ItemDef OID="FF105zeit1" Name="zeit1" DataType="partialTime"> <TranslatedText xml:lang="en">a) Zeitstempel</TranslatedText> <ItemDef OID="FF105datum1" Name="datum1" DataType="partialDate"> <TranslatedText xml:lang="en">b) Datum</TranslatedText> <ItemDef OID="FF105zeit2" Name="zeit2" DataType="incompleteDatetime"> <TranslatedText xml:lang="en">c) geprüfte Zeit</TranslatedText> <ItemDef OID="FF105datum2" Name="datum2" DataType="partialDate"> <TranslatedText xml:lang="en">d) geprüftes Datum</TranslatedText> <ItemDef OID="FF56random1" Name="random1" DataType="string" Length="5"> <TranslatedText xml:lang="en">a) Randomization-Button</TranslatedText> <ItemDef OID="FF56hobbies1" Name="hobbies1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Erweiterbare Lookuptabelle</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1hobby"/> As of by ias

243 Documentation secutrial 47 Export Formats <ItemDef OID="FF56haustier1" Name="haustier1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">c) einfache Lookuptabelle (Haustier)</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF77wirkstoff" Name="wirkstoff" DataType="string" Length="40"> <TranslatedText xml:lang="en">wirkstoff</translatedtext> <ItemDef OID="FF77dosis" Name="dosis" DataType="float" Length="5" SignificantDigits="2"> <TranslatedText xml:lang="en">dosis</translatedtext> <ItemDef OID="FF77einnahme" Name="einnahme" DataType="partialTime"> <TranslatedText xml:lang="en">einnahmezeit</translatedtext> <ItemDef OID="FF53eppc1" Name="eppc1" DataType="string" Length="120"> <TranslatedText xml:lang="en">a) Operationsgruppe</TranslatedText> <ItemDef OID="FF53epcc2a" Name="epcc2a" DataType="string" Length="120"> <TranslatedText xml:lang="en">b) Operation</TranslatedText> <ItemDef OID="FF53epcc2b" Name="epcc2b" DataType="string" Length="8"> <TranslatedText xml:lang="en">c) EPCC</TranslatedText> <ItemDef OID="FF53epcc2c" Name="epcc2c" DataType="string" Length="5"> <TranslatedText xml:lang="en">d) ICD-10</TranslatedText> <ItemDef OID="FF53epcc2d" Name="epcc2d" DataType="string" Length="5"> <TranslatedText xml:lang="en">e) ICD-10 additional</translatedtext> <ItemDef OID="FF50tier1" Name="tier1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">a) Haustier</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF50rasse1" Name="rasse1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Tier-Rasse</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1rasse"/> <ItemDef OID="FF50farbe1" Name="farbe1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">c) Tier-Farbe</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1farbe"/> <ItemDef OID="FF6tier2" Name="tier2" DataType="integer" Length="10"> <TranslatedText xml:lang="en">a) Haustier</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF6rasse2" Name="rasse2" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Tier-Rasse</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1rasse"/> <ItemDef OID="FF6farbe2" Name="farbe2" DataType="integer" Length="10"> As of by ias

244 Documentation secutrial 47 Export Formats <TranslatedText xml:lang="en">c) Tier-Farbe</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1farbe"/> <ItemDef OID="FF70tier3" Name="tier3" DataType="integer" Length="10"> <TranslatedText xml:lang="en">a) Haustier</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF70rasse3" Name="rasse3" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Tier-Rasse</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1rasse"/> <ItemDef OID="FF70farbe3" Name="farbe3" DataType="integer" Length="10"> <TranslatedText xml:lang="en">c) Tier-Farbe</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1farbe"/> <ItemDef OID="FF40hb1" Name="hb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Erste Reihe</TranslatedText> <CodeListRef CodeListOID="CL40hb1"/> <ItemDef OID="FF40hb2" Name="hb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Zweite Reihe</TranslatedText> <CodeListRef CodeListOID="CL40hb2"/> <ItemDef OID="FF40hb3" Name="hb3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Dritte Reihe</TranslatedText> <CodeListRef CodeListOID="CL40hb3"/> <ItemDef OID="FF32hb4" Name="hb4" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Erste Reihe</TranslatedText> <CodeListRef CodeListOID="CL32hb4"/> <ItemDef OID="FF32hb5" Name="hb5" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Zweite Reihe</TranslatedText> <CodeListRef CodeListOID="CL32hb5"/> <ItemDef OID="FF32hb6" Name="hb6" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Dritte Reihe</TranslatedText> <CodeListRef CodeListOID="CL32hb6"/> <ItemDef OID="FF114r1s1" Name="r1s1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Reihe eins - rot</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF114r1s2" Name="r1s2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Reihe eins - blau</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF114r1s3" Name="r1s3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Reihe eins - grün</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF114r2s1" Name="r2s1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Reihe zwei - rot</translatedtext> As of by ias

245 Documentation secutrial 47 Export Formats <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF114r2s2" Name="r2s2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Reihe zwei - blau</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF114r2s3" Name="r2s3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) Reihe zwei - grün</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF76cb1" Name="cb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) einfache Checkbox</TranslatedText> <CodeListRef CodeListOID="CL76cb1"/> <ItemDef OID="FF76rb1" Name="rb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) einfacher RadioButton</TranslatedText> <CodeListRef CodeListOID="CL76rb1"/> <ItemDef OID="FF76rrb1" Name="rrb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Reset-Radiobutton</TranslatedText> <CodeListRef CodeListOID="CL76rrb1"/> <ItemDef OID="FF41cb3" Name="cb3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) einfache Checkbox</TranslatedText> <CodeListRef CodeListOID="CL41cb3"/> <ItemDef OID="FF41rrb3" Name="rrb3" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Reset-Radiobutton</TranslatedText> <CodeListRef CodeListOID="CL41rrb3"/> <ItemDef OID="FF89ugcb1" Name="ugcb1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Messung durchgeführt?</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF89ug" Name="ug" DataType="float" Length="44" SignificantDigits="22"> <TranslatedText xml:lang="en">b) Messwert</TranslatedText> <ItemDef OID="FF89ugm" Name="ugm" DataType="integer" Length="3"> <TranslatedText xml:lang="en">12 IASHorizontalUnitGroup</TranslatedText> <CodeListRef CodeListOID="CL89ugm"/> <ItemDef OID="FF89ugt1" Name="ugt1" DataType="partialTime"> <TranslatedText xml:lang="en">c) Meßzeitpunkt</TranslatedText> <ItemDef OID="FF3ugcb2" Name="ugcb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Messung durchgeführt?</translatedtext> <CodeListRef CodeListOID="CLclcb"/> <ItemDef OID="FF3ug1" Name="ug1" DataType="float" Length="44" SignificantDigits="22"> <TranslatedText xml:lang="en">b) Messwert</TranslatedText> <ItemDef OID="FF3ugm1" Name="ugm1" DataType="integer" Length="3"> As of by ias

246 Documentation secutrial 47 Export Formats <TranslatedText xml:lang="en">13 IASUnitGroup</TranslatedText> <CodeListRef CodeListOID="CL3ugm1"/> <ItemDef OID="FF3ugt2" Name="ugt2" DataType="partialTime"> <TranslatedText xml:lang="en">c) Meßzeitpunkt</TranslatedText> <ItemDef OID="FF120cb2" Name="cb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) einfache Checkbox</TranslatedText> <CodeListRef CodeListOID="CL120cb2"/> <ItemDef OID="FF120rb2" Name="rb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">b) einfacher RadioButton</TranslatedText> <CodeListRef CodeListOID="CL120rb2"/> <ItemDef OID="FF120rrb2" Name="rrb2" DataType="integer" Length="3"> <TranslatedText xml:lang="en">c) Reset-Radiobutton</TranslatedText> <CodeListRef CodeListOID="CL120rrb2"/> <ItemDef OID="FF120pp1" Name="pp1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">e) Popup</TranslatedText> <CodeListRef CodeListOID="CL120pp1"/> <ItemDef OID="FF120score1" Name="score1" DataType="float" Length="20" SignificantDigits="10"> <TranslatedText xml:lang="en">f) Score über Auswahl-Optionen (Ganzzahlen)</TranslatedText> <ItemDef OID="FF12gz1" Name="gz1" DataType="integer" Length="3"> <TranslatedText xml:lang="en">a) Ganzzahl (3)</TranslatedText> <ItemDef OID="FF12kz1" Name="kz1" DataType="float" Length="8" SignificantDigits="3"> <TranslatedText xml:lang="en">b) Kommazahl (53)</TranslatedText> <ItemDef OID="FF12score2" Name="score2" DataType="float" Length="20" SignificantDigits="10"> <TranslatedText xml:lang="en">c) Score über Zahlenfelder</TranslatedText> <ItemDef OID="FF12text1" Name="text1" DataType="string" Length="40"> <TranslatedText xml:lang="en">d) Kurzes Textfeld (40)</TranslatedText> <ItemDef OID="FF12text2" Name="text2" DataType="string" Length="120"> <TranslatedText xml:lang="en">e) Langes Textfeld (Area, 3x40)</TranslatedText> <ItemDef OID="FF91zeit1" Name="zeit1" DataType="partialTime"> <TranslatedText xml:lang="en">a) Zeitstempel</TranslatedText> <ItemDef OID="FF91datum1" Name="datum1" DataType="partialDate"> <TranslatedText xml:lang="en">b) Datum</TranslatedText> <ItemDef OID="FF91zeit2" Name="zeit2" DataType="incompleteDatetime"> <TranslatedText xml:lang="en">c) geprüfte Zeit</TranslatedText> As of by ias

247 Documentation secutrial 47 Export Formats <ItemDef OID="FF91datum2" Name="datum2" DataType="partialDate"> <TranslatedText xml:lang="en">d) geprüftes Datum</TranslatedText> <ItemDef OID="FF66random1" Name="random1" DataType="string" Length="5"> <TranslatedText xml:lang="en">a) Randomization-Button</TranslatedText> <ItemDef OID="FF66hobbies1" Name="hobbies1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">b) Erweiterbare Lookuptabelle</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1hobby"/> <ItemDef OID="FF66haustier1" Name="haustier1" DataType="integer" Length="10"> <TranslatedText xml:lang="en">c) einfache Lookuptabelle (Haustier)</TranslatedText> <CodeListRef CodeListOID="CLlmnpias1tier"/> <ItemDef OID="FF103wirkstoff" Name="wirkstoff" DataType="string" Length="40"> <TranslatedText xml:lang="en">wirkstoff</translatedtext> <ItemDef OID="FF103dosis" Name="dosis" DataType="float" Length="5" SignificantDigits="2"> <TranslatedText xml:lang="en">dosis</translatedtext> <ItemDef OID="FF103einnahme" Name="einnahme" DataType="partialTime"> <TranslatedText xml:lang="en">einnahmezeit</translatedtext> <ItemDef OID="FF385img" Name="img" DataType="string" Length="100"> <TranslatedText xml:lang="en">1) Bild a</translatedtext> <ItemDef OID="FF385bild2" Name="bild2" DataType="string" Length="100" ias:hidden="true"> <TranslatedText xml:lang="en">2) Bild b</translatedtext> <ItemDef OID="FF385bezeichnung" Name="bezeichnung" DataType="string" Length="60"> <TranslatedText xml:lang="en">bezeichnung</translatedtext> <ItemDef OID="FF431img1" Name="img1" DataType="string" Length="100" ias:hidden="true"> <TranslatedText xml:lang="en">bild c</translatedtext> <ItemDef OID="FF431bild3" Name="bild3" DataType="string" Length="100" ias:hidden="true"> <TranslatedText xml:lang="en">bild d</translatedtext> <ItemDef OID="FF747img" Name="img" DataType="string" Length="100"> <TranslatedText xml:lang="en">1)</translatedtext> <ItemDef OID="FF747aufnahme" Name="aufnahme" DataType="string" Length="60"> <TranslatedText xml:lang="en">aufnahme:</translatedtext> <!-- ***** CodeList ***** --> <CodeList DataType="integer" OID="CL100hb1" Name="hb1"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> As of by ias

248 Documentation secutrial 47 Export Formats <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL100hb2" Name="hb2"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL100hb3" Name="hb3"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL101cb2" Name="cb2"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">no einheit</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">yes einheit</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL101pp1" Name="pp1"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL101rb2" Name="rb2"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> As of by ias

249 Documentation secutrial 47 Export Formats <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL101rrb2" Name="rrb2"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL107ugm" Name="ugm"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">g</translatedtext> <CodeListItem CodedValue="2" Rank="2"> <TranslatedText xml:lang="en">mol</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL112hb1" Name="hb1"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL112hb2" Name="hb2"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL112hb3" Name="hb3"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> As of by ias

250 Documentation secutrial 47 Export Formats </CodeList> <CodeList DataType="integer" OID="CL116ugm1" Name="ugm1"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">g</translatedtext> <CodeListItem CodedValue="2" Rank="2"> <TranslatedText xml:lang="en">mol</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL120cb2" Name="cb2"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">no einheit</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">yes einheit</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL120pp1" Name="pp1"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL120rb2" Name="rb2"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL120rrb2" Name="rrb2"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL19cb1" Name="cb1"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">no einheit</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">yes einheit</translatedtext> As of by ias

251 Documentation secutrial 47 Export Formats </CodeList> <CodeList DataType="integer" OID="CL19rb1" Name="rb1"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL19rrb1" Name="rrb1"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL26cb3" Name="cb3"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">no einheit</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">yes einheit</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL26rrb3" Name="rrb3"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL27ugm1" Name="ugm1"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">g</translatedtext> <CodeListItem CodedValue="2" Rank="2"> <TranslatedText xml:lang="en">mol</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL28ugm" Name="ugm"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">g</translatedtext> <CodeListItem CodedValue="2" Rank="2"> <TranslatedText xml:lang="en">mol</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL3ugm1" Name="ugm1"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">g</translatedtext> As of by ias

252 Documentation secutrial 47 Export Formats <CodeListItem CodedValue="2" Rank="2"> <TranslatedText xml:lang="en">mol</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL30cb2" Name="cb2"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">no einheit</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">yes einheit</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL30pp1" Name="pp1"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL30rb2" Name="rb2"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL30rrb2" Name="rrb2"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL32hb4" Name="hb4"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL32hb5" Name="hb5"> <CodeListItem CodedValue="2" Rank="1"> As of by ias

253 Documentation secutrial 47 Export Formats <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL32hb6" Name="hb6"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL38sb1" Name="sb1"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">eins</translatedtext> <CodeListItem CodedValue="2" Rank="2"> <TranslatedText xml:lang="en">zwei</translatedtext> <CodeListItem CodedValue="3" Rank="3"> <TranslatedText xml:lang="en">drei</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL38vr1" Name="vr1"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">eins</translatedtext> <CodeListItem CodedValue="2" Rank="2"> <TranslatedText xml:lang="en">zwei</translatedtext> <CodeListItem CodedValue="4" Rank="3"> <TranslatedText xml:lang="en">vier</translatedtext> <CodeListItem CodedValue="5" Rank="4"> <TranslatedText xml:lang="en">fünf</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL39rb1" Name="rb1"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> As of by ias

254 Documentation secutrial 47 Export Formats <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL39rb2" Name="rb2"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL4cb1" Name="cb1"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">no einheit</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">yes einheit</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL4rb1" Name="rb1"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL4rrb1" Name="rrb1"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL40hb1" Name="hb1"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL40hb2" Name="hb2"> As of by ias

255 Documentation secutrial 47 Export Formats <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL40hb3" Name="hb3"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL41cb3" Name="cb3"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">no einheit</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">yes einheit</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL41rrb3" Name="rrb3"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL434farbe" Name="farbe"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL451farbe" Name="farbe"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> As of by ias

256 Documentation secutrial 47 Export Formats <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL46cb3" Name="cb3"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">no einheit</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">yes einheit</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL46rrb3" Name="rrb3"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL48hb7" Name="hb7"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL48hb8" Name="hb8"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL48hb9" Name="hb9"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> As of by ias

257 Documentation secutrial 47 Export Formats <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL49ugm1" Name="ugm1"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">g</translatedtext> <CodeListItem CodedValue="2" Rank="2"> <TranslatedText xml:lang="en">mol</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL5cb3" Name="cb3"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">no einheit</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">yes einheit</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL5rrb3" Name="rrb3"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL54ugm1" Name="ugm1"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">g</translatedtext> <CodeListItem CodedValue="2" Rank="2"> <TranslatedText xml:lang="en">mol</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL59hb1" Name="hb1"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL59hb2" Name="hb2"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> As of by ias

258 Documentation secutrial 47 Export Formats <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL59hb3" Name="hb3"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL60hb4" Name="hb4"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL60hb5" Name="hb5"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL60hb6" Name="hb6"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> As of by ias

259 Documentation secutrial 47 Export Formats <CodeList DataType="integer" OID="CL61cb3" Name="cb3"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">no einheit</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">yes einheit</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL61rrb3" Name="rrb3"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL62hb4" Name="hb4"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL62hb5" Name="hb5"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL62hb6" Name="hb6"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL63cb2" Name="cb2"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">no einheit</translatedtext> As of by ias

260 Documentation secutrial 47 Export Formats <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">yes einheit</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL63pp1" Name="pp1"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL63rb2" Name="rb2"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> <CodeListItem CodedValue="3" Rank="3"> <TranslatedText xml:lang="en">grün</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL63rrb2" Name="rrb2"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL65ugm" Name="ugm"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">g</translatedtext> <CodeListItem CodedValue="2" Rank="2"> <TranslatedText xml:lang="en">mol</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL72klinisch" Name="klinisch"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> <CodeListItem CodedValue="3" Rank="3"> As of by ias

261 Documentation secutrial 47 Export Formats <TranslatedText xml:lang="en">unklar</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL74cb2" Name="cb2"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">no einheit</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">yes einheit</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL74pp1" Name="pp1"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL74rb2" Name="rb2"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL74rrb2" Name="rrb2"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL76cb1" Name="cb1"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">no einheit</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">yes einheit</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL76rb1" Name="rb1"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> As of by ias

262 Documentation secutrial 47 Export Formats </CodeList> <CodeList DataType="integer" OID="CL76rrb1" Name="rrb1"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL79hb4" Name="hb4"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL79hb5" Name="hb5"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL79hb6" Name="hb6"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL85hb4" Name="hb4"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> As of by ias

263 Documentation secutrial 47 Export Formats </CodeList> <CodeList DataType="integer" OID="CL85hb5" Name="hb5"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL85hb6" Name="hb6"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL86cb4" Name="cb4"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">no einheit</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">yes einheit</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL86farbe" Name="farbe"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL86pp2" Name="pp2"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> As of by ias

264 Documentation secutrial 47 Export Formats <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL86rb3" Name="rb3"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> <CodeListItem CodedValue="3" Rank="3"> <TranslatedText xml:lang="en">grün</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL86rrb4" Name="rrb4"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL87ugm" Name="ugm"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">g</translatedtext> <CodeListItem CodedValue="2" Rank="2"> <TranslatedText xml:lang="en">mol</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL89ugm" Name="ugm"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">g</translatedtext> <CodeListItem CodedValue="2" Rank="2"> <TranslatedText xml:lang="en">mol</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL9hb1" Name="hb1"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL9hb2" Name="hb2"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> As of by ias

265 Documentation secutrial 47 Export Formats <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL9hb3" Name="hb3"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">grün</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">rot</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL95cb1" Name="cb1"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">no einheit</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">yes einheit</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL95rb1" Name="rb1"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL95rrb1" Name="rrb1"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL96cb1" Name="cb1"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">no einheit</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">yes einheit</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL96rb1" Name="rb1"> <CodeListItem CodedValue="1" Rank="1"> As of by ias

266 Documentation secutrial 47 Export Formats <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CL96rrb1" Name="rrb1"> <CodeListItem CodedValue="1" Rank="1"> <TranslatedText xml:lang="en">ja</translatedtext> <CodeListItem CodedValue="0" Rank="2"> <TranslatedText xml:lang="en">nein</translatedtext> </CodeList> <CodeList DataType="integer" OID="CLSubjectIdentifier" Name="Subject identification"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">pseudonym</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">aid</translatedtext> </CodeList> <CodeList DataType="integer" OID="CLSubjectStatus" Name="Subject status"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">active</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">not shown</translatedtext> <CodeListItem CodedValue="3"> <TranslatedText xml:lang="en">delete pseudonym</translatedtext> <CodeListItem CodedValue="8"> <TranslatedText xml:lang="en">frozen</translatedtext> <CodeListItem CodedValue="16"> <TranslatedText xml:lang="en">deceased</translatedtext> <CodeListItem CodedValue="33"> <TranslatedText xml:lang="en">to be deleted</translatedtext> <CodeListItem CodedValue="128"> <TranslatedText xml:lang="en">visit plan closed</translatedtext> </CodeList> <CodeList DataType="integer" OID="CLSubjectStatusType" Name="Subject type"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">subject</translatedtext> <CodeListItem CodedValue="1"> As of by ias

267 Documentation secutrial 47 Export Formats <TranslatedText xml:lang="en">subject in study</translatedtext> </CodeList> <CodeList DataType="integer" OID="CLclcb" Name="CheckBox"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">no</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">yes</translatedtext> </CodeList> <CodeList DataType="integer" OID="CLclfcs_0" Name="Completion status"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">empty</translatedtext> <CodeListItem CodedValue="2"> <TranslatedText xml:lang="en">partly filled</translatedtext> <CodeListItem CodedValue="4"> <TranslatedText xml:lang="en">completely filled</translatedtext> </CodeList> <CodeList DataType="integer" OID="CLclfqa" Name="Query status"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">without query</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">with open query</translatedtext> <CodeListItem CodedValue="2"> <TranslatedText xml:lang="en">with answered query</translatedtext> <CodeListItem CodedValue="4"> <TranslatedText xml:lang="en">all queries resolved</translatedtext> <CodeListItem CodedValue="8"> <TranslatedText xml:lang="en">all queries resolved</translatedtext> </CodeList> <CodeList DataType="integer" OID="CLclfssdv" Name="Source Data Verification"> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">not done</translatedtext> <CodeListItem CodedValue="2"> <TranslatedText xml:lang="en">not necessary</translatedtext> <CodeListItem CodedValue="4"> <TranslatedText xml:lang="en">not possible</translatedtext> <CodeListItem CodedValue="8"> <TranslatedText xml:lang="en">deferred</translatedtext> As of by ias

268 Documentation secutrial 47 Export Formats Text> <CodeListItem CodedValue="16"> <TranslatedText xml:lang="en">in progress</translatedtext> <CodeListItem CodedValue="32"> <TranslatedText xml:lang="en">verified</translatedtext> <CodeListItem CodedValue="64"> <TranslatedText xml:lang="en">verified with errors</translatedtext> </CodeList> <CodeList DataType="integer" OID="CLclqa" Name="type of query entry"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en"/> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">open</translatedtext> <CodeListItem CodedValue="2"> <TranslatedText xml:lang="en">answered</translatedtext> <CodeListItem CodedValue="4"> <TranslatedText xml:lang="en">resolved</translatedtext> <CodeListItem CodedValue="8"> <TranslatedText xml:lang="en">check again</translatedtext> </CodeList> <CodeList DataType="string" OID="CLclqtype" Name="Query type"> <CodeListItem CodedValue="M"> <TranslatedText xml:lang="en">query generated because of a manual check</translatedtext> <CodeListItem CodedValue="A"> <TranslatedText xml:lang="en">query generated because of an automatical check (discrepancy)</translated- </CodeList> <CodeList DataType="integer" OID="CLlmnpias1farbe" Name="Haustier-Farbe"> <CodeListItem CodedValue="5" Rank="1"> <TranslatedText xml:lang="en">blau</translatedtext> <CodeListItem CodedValue="2" Rank="2"> <TranslatedText xml:lang="en">braun</translatedtext> <CodeListItem CodedValue="13" Rank="3"> <TranslatedText xml:lang="en">braun</translatedtext> <CodeListItem CodedValue="6" Rank="4"> <TranslatedText xml:lang="en">braun</translatedtext> As of by ias

269 Documentation secutrial 47 Export Formats <CodeListItem CodedValue="15" Rank="5"> <TranslatedText xml:lang="en">braun-schwarz</translatedtext> <CodeListItem CodedValue="16" Rank="6"> <TranslatedText xml:lang="en">bunt</translatedtext> <CodeListItem CodedValue="1" Rank="7"> <TranslatedText xml:lang="en">getigert</translatedtext> <CodeListItem CodedValue="11" Rank="8"> <TranslatedText xml:lang="en">palomino</translatedtext> <CodeListItem CodedValue="9" Rank="9"> <TranslatedText xml:lang="en">rappe</translatedtext> <CodeListItem CodedValue="12" Rank="10"> <TranslatedText xml:lang="en">rot</translatedtext> <CodeListItem CodedValue="8" Rank="11"> <TranslatedText xml:lang="en">rot</translatedtext> <CodeListItem CodedValue="14" Rank="12"> <TranslatedText xml:lang="en">schimmel</translatedtext> <CodeListItem CodedValue="10" Rank="13"> <TranslatedText xml:lang="en">schwarz</translatedtext> <CodeListItem CodedValue="4" Rank="14"> <TranslatedText xml:lang="en">schwarz-weiß</translatedtext> <CodeListItem CodedValue="3" Rank="15"> <TranslatedText xml:lang="en">tabby</translatedtext> <CodeListItem CodedValue="7" Rank="16"> <TranslatedText xml:lang="en">weiß</translatedtext> </CodeList> <CodeList DataType="integer" OID="CLlmnpias1hobby" Name="Hobbies"> <CodeListItem CodedValue="2" Rank="1"> <TranslatedText xml:lang="en">faulenzen</translatedtext> <CodeListItem CodedValue="3" Rank="2"> <TranslatedText xml:lang="en">lesen</translatedtext> <CodeListItem CodedValue="1" Rank="3"> <TranslatedText xml:lang="en">sport</translatedtext> </CodeList> <CodeList DataType="integer" OID="CLlmnpias1rasse" Name="Haustier-Rasse"> As of by ias

270 Documentation secutrial 47 Export Formats <CodeListItem CodedValue="6" Rank="1"> <TranslatedText xml:lang="en">araber</translatedtext> <CodeListItem CodedValue="2" Rank="2"> <TranslatedText xml:lang="en">dackel</translatedtext> <CodeListItem CodedValue="4" Rank="3"> <TranslatedText xml:lang="en">hannoveraner</translatedtext> <CodeListItem CodedValue="3" Rank="4"> <TranslatedText xml:lang="en">kurzhaar</translatedtext> <CodeListItem CodedValue="7" Rank="5"> <TranslatedText xml:lang="en">perser</translatedtext> <CodeListItem CodedValue="1" Rank="6"> <TranslatedText xml:lang="en">schäferhund</translatedtext> <CodeListItem CodedValue="5" Rank="7"> <TranslatedText xml:lang="en">siam</translatedtext> </CodeList> <CodeList DataType="integer" OID="CLlmnpias1tier" Name="Haustiere"> <CodeListItem CodedValue="3" Rank="1"> <TranslatedText xml:lang="en">hund</translatedtext> <CodeListItem CodedValue="1" Rank="2"> <TranslatedText xml:lang="en">katze</translatedtext> <CodeListItem CodedValue="2" Rank="3"> <TranslatedText xml:lang="en">pferd</translatedtext> </CodeList> <CodeList DataType="integer" OID="CLqact" Name="Query or comment"> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">query entry</translatedtext> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">comment</translatedtext> </CodeList> <CodeList DataType="integer" OID="CLsig" Name="reason for storage"> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">data edited</translatedtext> <CodeListItem CodedValue="2"> <TranslatedText xml:lang="en">review A performed</translatedtext> <CodeListItem CodedValue="3"> <TranslatedText xml:lang="en">review B performed</translatedtext> As of by ias

271 Documentation secutrial 47 Export Formats <CodeListItem CodedValue="4"> <TranslatedText xml:lang="en">comment added</translatedtext> <CodeListItem CodedValue="5"> <TranslatedText xml:lang="en">query added</translatedtext> <CodeListItem CodedValue="6"> <TranslatedText xml:lang="en">query answered</translatedtext> <CodeListItem CodedValue="7"> <TranslatedText xml:lang="en">form manually frozen</translatedtext> <CodeListItem CodedValue="8"> <TranslatedText xml:lang="en">form unfrozen</translatedtext> <CodeListItem CodedValue="9"> <TranslatedText xml:lang="en">source data verified</translatedtext> <CodeListItem CodedValue="10"> <TranslatedText xml:lang="en">review A revoked</translatedtext> <CodeListItem CodedValue="11"> <TranslatedText xml:lang="en">query resolved</translatedtext> <CodeListItem CodedValue="12"> <TranslatedText xml:lang="en">data entry completed</translatedtext> <CodeListItem CodedValue="13"> <TranslatedText xml:lang="en">data modified</translatedtext> <CodeListItem CodedValue="14"> <TranslatedText xml:lang="en">form frozen</translatedtext> </CodeList> <CodeList DataType="integer" OID="CLsigvalid" Name="signature check"> <CodeListItem CodedValue="0"> <TranslatedText xml:lang="en">not signed</translatedtext> <CodeListItem CodedValue="1"> <TranslatedText xml:lang="en">valid</translatedtext> <CodeListItem CodedValue="2"> <TranslatedText xml:lang="en">invalid</translatedtext> </CodeList> </MetaDataVersion> </Study> <!-- ***** AdminData ***** --> <AdminData> As of by ias

272 Documentation secutrial 47 Export Formats <!-- ***** User ***** --> <User OID="USER1"> <LoginName>susanne</LoginName> <FullName>Dipl biol Susanne Schneider</FullName> <FirstName>Susanne</FirstName> <LastName>Schneider</LastName> <LocationRef LocationOID="LOCATION1"/> <LocationRef LocationOID="LOCATION151"/> </User> <User OID="USER151"> <LoginName>ulrike</LoginName> <FullName>Dr Ulrike Jonas</FullName> <FirstName>Ulrike</FirstName> <LastName>Jonas</LastName> <LocationRef LocationOID="LOCATION1"/> <LocationRef LocationOID="LOCATION151"/> </User> <Location OID="LOCATION1" Name="Berlin" LocationType="Site"> <MetaDataVersionRef StudyOID="IAS1" MetaDataVersionOID="IAS10" EffectiveDate=" "/> </Location> <Location OID="LOCATION151" Name="Hamburg" LocationType="Site"> <MetaDataVersionRef StudyOID="IAS1" MetaDataVersionOID="IAS10" EffectiveDate=" "/> </Location> <Location OID="LOCATION172" Name="Zürich" LocationType="Site"> <MetaDataVersionRef StudyOID="IAS1" MetaDataVersionOID="IAS10" EffectiveDate=" "/> </Location> <!-- ***** Signature ***** --> <SignatureDef OID="SIG0" Methodology="Electronic"> <Meaning>Data edited</meaning> <LegalReason>Daten eingegeben</legalreason> </SignatureDef> </AdminData> <!-- ***** ClinicalData ***** --> <ClinicalData StudyOID="IAS1" MetaDataVersionOID="IAS10"> <!-- ***** SubjectData edq296 ***** --> <SubjectData SubjectKey="SUBJECT136" TransactionType="Insert"> <InvestigatorRef UserOID="USER151"/> <SiteRef LocationOID="LOCATION1"/> <Annotation SeqNum="1"> <Comment>active</Comment> <Flag> <FlagValue CodeListOID="CLSubjectStatus">0</FlagValue> <FlagType CodeListOID="CLSubjectStatusType">0</FlagType> </Flag> </Annotation> <Annotation SeqNum="2"> <Comment>active</Comment> <Flag> <FlagValue CodeListOID="CLSubjectStatus">0</FlagValue> <FlagType CodeListOID="CLSubjectStatusType">1</FlagType> </Flag> </Annotation> <Annotation SeqNum="3"> <Comment>edq296</Comment> <Flag> <FlagValue CodeListOID="CLSubjectIdentifier">0</FlagValue> </Flag> </Annotation> <StudyEventData StudyEventOID="VISIT7" TransactionType="Insert"> <!-- ***** FormData mnpias1bilder1 ***** --> <FormData FormOID="Fmnpias1bilder1" FormRepeatKey="mnpdid199" TransactionType="Insert"> <AuditRecord> <UserRef UserOID="USER1"/> <LocationRef LocationOID="LOCATION1"/> <DateTimeStamp> T16:18: :00</DateTimeStamp> <ReasonForChange>Daten eingegeben</reasonforchange> <SourceID>mnpdid199</SourceID> </AuditRecord> <Annotation SeqNum="1"> <Comment>Document-No 199-1</Comment> </Annotation> <Annotation SeqNum="2"> <Comment>Daten eingegeben</comment> <Flag> <FlagValue CodeListOID="CLsig">1</FlagValue> </Flag> </Annotation> <Annotation SeqNum="4"> <Comment>not signed</comment> As of by ias

273 Documentation secutrial 47 Export Formats <Flag> <FlagValue CodeListOID="CLsigvalid">0</FlagValue> </Flag> </Annotation> <ItemGroupData ItemGroupOID="FGSUBJID"> <ItemDataString ItemOID="FFSUBJID">edq296</ItemDataString> </ItemGroupData> <ItemGroupData ItemGroupOID="FGFS"> <ItemDataInteger ItemOID="FFFS0">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS0">4</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFQA">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCT">0</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG747"> <ItemDataString ItemOID="FF747img" ias:imagedataid="mnpimgid147">patientimages/6/36/136/ jpg</itemdatastring> <ItemDataString ItemOID="FF747aufnahme">Ruhepause</ItemDataString> </ItemGroupData> </FormData> <!-- ***** FormData mnpias1bilder1 ***** --> <FormData FormOID="Fmnpias1bilder1" FormRepeatKey="mnpdid200" TransactionType="Insert"> <AuditRecord> <UserRef UserOID="USER1"/> <LocationRef LocationOID="LOCATION1"/> <DateTimeStamp> T16:18: :00</DateTimeStamp> <ReasonForChange>Daten eingegeben</reasonforchange> <SourceID>mnpdid200mnpatdid175</SourceID> </AuditRecord> <Annotation SeqNum="1"> <Comment>Document-No 200-1</Comment> </Annotation> <Annotation SeqNum="2"> <Comment>Daten eingegeben</comment> <Flag> <FlagValue CodeListOID="CLsig">1</FlagValue> </Flag> </Annotation> <Annotation SeqNum="4"> <Comment>not signed</comment> <Flag> <FlagValue CodeListOID="CLsigvalid">0</FlagValue> </Flag> </Annotation> <ItemGroupData ItemGroupOID="FGSUBJID"> <ItemDataString ItemOID="FFSUBJID">edq296</ItemDataString> </ItemGroupData> <ItemGroupData ItemGroupOID="FGFS"> <ItemDataInteger ItemOID="FFFS0">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS0">2</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFQA">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCT">0</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG747"> <ItemDataString ItemOID="FF747img" ias:imagedataid="mnpimgid148">patientimages/6/36/136/ jpg</itemdatastring> <ItemDataAny ItemOID="FF747aufnahme" IsNull="Yes"/> </ItemGroupData> </FormData> <!-- ***** FormData mnpias1bilder1 ***** --> <FormData FormOID="Fmnpias1bilder1" FormRepeatKey="mnpdid200" TransactionType="Update"> <AuditRecord> <UserRef UserOID="USER1"/> <LocationRef LocationOID="LOCATION1"/> <DateTimeStamp> T16:42: :00</DateTimeStamp> <ReasonForChange>Daten eingegeben</reasonforchange> <SourceID>mnpdid200</SourceID> </AuditRecord> As of by ias

274 Documentation secutrial 47 Export Formats <Annotation SeqNum="1"> <Comment>Document-No 200-2</Comment> </Annotation> <Annotation SeqNum="2"> <Comment>Daten eingegeben</comment> <Flag> <FlagValue CodeListOID="CLsig">1</FlagValue> </Flag> </Annotation> <Annotation SeqNum="4"> <Comment>not signed</comment> <Flag> <FlagValue CodeListOID="CLsigvalid">0</FlagValue> </Flag> </Annotation> <ItemGroupData ItemGroupOID="FGFS"> <ItemDataInteger ItemOID="FFFS0">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS0">4</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFQA">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCT">0</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG747"> <ItemDataString ItemOID="FF747img" ias:imagedataid="mnpimgid148">patientimages/6/36/136/ jpg</itemdatastring> <ItemDataString ItemOID="FF747aufnahme">Idylle am Wasser</ItemDataString> </ItemGroupData> </FormData> <!-- ***** FormData mnpias1komponenten ***** --> <FormData FormOID="Fmnpias1komponenten" TransactionType="Insert"> <AuditRecord> <UserRef UserOID="USER1"/> <LocationRef LocationOID="LOCATION1"/> <DateTimeStamp> T14:45: :00</DateTimeStamp> <ReasonForChange>Daten eingegeben</reasonforchange> <SourceID>mnpdid214</SourceID> </AuditRecord> <Signature> <UserRef UserOID="USER1"/> <LocationRef LocationOID="LOCATION1"/> <SignatureRef SignatureOID="SIG0"/> <DateTimeStamp> T14:45: :00</DateTimeStamp> <ias:validity>valid</ias:validity> <ias:version>0</ias:version> </Signature> <Annotation SeqNum="1"> <Comment>Document-No 214-1</Comment> </Annotation> <Annotation SeqNum="2"> <Comment>Daten eingegeben</comment> <Flag> <FlagValue CodeListOID="CLsig">1</FlagValue> </Flag> </Annotation> <Annotation SeqNum="4"> <Comment>valid</Comment> <Flag> <FlagValue CodeListOID="CLsigvalid">1</FlagValue> </Flag> </Annotation> <ItemGroupData ItemGroupOID="FGSUBJID"> <ItemDataString ItemOID="FFSUBJID">edq296</ItemDataString> </ItemGroupData> <ItemGroupData ItemGroupOID="FGFS"> <ItemDataInteger ItemOID="FFFS0">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS0">2</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS2">1</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFQA">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCT">0</ItemDataInteger> As of by ias

275 Documentation secutrial 47 Export Formats String> <ItemDataInteger ItemOID="FFFSDV">1</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG16"> <ItemDataString ItemOID="FF16eppc1">Art der Operation</ItemDataString> <ItemDataString ItemOID="FF16epcc2a">Operation mit Zugang über den rechten Ventrikel</ItemData- <ItemDataString ItemOID="FF16epcc2b">120812</ItemDataString> <ItemDataAny ItemOID="FF16epcc2c" IsNull="Yes"/> <ItemDataAny ItemOID="FF16epcc2d" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG8"> <ItemDataInteger ItemOID="FF8tier1">2</ItemDataInteger> <ItemDataInteger ItemOID="FF8rasse1">6</ItemDataInteger> <ItemDataInteger ItemOID="FF8farbe1">6</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG110"> <ItemDataInteger ItemOID="FF110tier2">1</ItemDataInteger> <ItemDataInteger ItemOID="FF110rasse2">7</ItemDataInteger> <ItemDataInteger ItemOID="FF110farbe2">12</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG55"> <ItemDataInteger ItemOID="FF55tier3">1</ItemDataInteger> <ItemDataInteger ItemOID="FF55rasse3">5</ItemDataInteger> <ItemDataInteger ItemOID="FF55farbe3">3</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG9"> <ItemDataInteger ItemOID="FF9hb1">1</ItemDataInteger> <ItemDataInteger ItemOID="FF9hb2">3</ItemDataInteger> <ItemDataInteger ItemOID="FF9hb3">2</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG62"> <ItemDataInteger ItemOID="FF62hb4">2</ItemDataInteger> <ItemDataInteger ItemOID="FF62hb5">3</ItemDataInteger> <ItemDataInteger ItemOID="FF62hb6">1</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG94"> <ItemDataInteger ItemOID="FF94r1s1">0</ItemDataInteger> <ItemDataInteger ItemOID="FF94r1s2">1</ItemDataInteger> <ItemDataInteger ItemOID="FF94r1s3">0</ItemDataInteger> <ItemDataInteger ItemOID="FF94r2s1">1</ItemDataInteger> <ItemDataInteger ItemOID="FF94r2s2">0</ItemDataInteger> <ItemDataInteger ItemOID="FF94r2s3">1</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG96"> <ItemDataInteger ItemOID="FF96cb1">1</ItemDataInteger> <ItemDataInteger ItemOID="FF96rb1">0</ItemDataInteger> <ItemDataInteger ItemOID="FF96rrb1">0</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG46"> <ItemDataInteger ItemOID="FF46cb3">1</ItemDataInteger> <ItemDataInteger ItemOID="FF46rrb3">1</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG107"> <ItemDataInteger ItemOID="FF107ugcb1">0</ItemDataInteger> <ItemDataAny ItemOID="FF107ug" IsNull="Yes"/> <ItemDataAny ItemOID="FF107ugm" IsNull="Yes"/> <ItemDataAny ItemOID="FF107ugt1" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG54"> <ItemDataInteger ItemOID="FF54ugcb2">1</ItemDataInteger> <ItemDataPartialTime ItemOID="FF54ugt2">14:43</ItemDataPartialTime> <ItemDataFloat ItemOID="FF54ug1"> </ItemDataFloat> <ItemDataInteger ItemOID="FF54ugm1">2</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG63"> <ItemDataInteger ItemOID="FF63cb2">1</ItemDataInteger> <ItemDataInteger ItemOID="FF63rb2">1</ItemDataInteger> <ItemDataInteger ItemOID="FF63rrb2">1</ItemDataInteger> <ItemDataInteger ItemOID="FF63pp1">2</ItemDataInteger> <ItemDataFloat ItemOID="FF63score1">4002</ItemDataFloat> </ItemGroupData> <ItemGroupData ItemGroupOID="FG31"> <ItemDataInteger ItemOID="FF31gz1">4</ItemDataInteger> <ItemDataFloat ItemOID="FF31kz1">454</ItemDataFloat> <ItemDataFloat ItemOID="FF31score2">494</ItemDataFloat> <ItemDataString ItemOID="FF31text1">kurz</ItemDataString> <ItemDataString ItemOID="FF31text2">lange</ItemDataString> </ItemGroupData> <ItemGroupData ItemGroupOID="FG97"> As of by ias

276 Documentation secutrial 47 Export Formats <ItemDataAny ItemOID="FF97zeit1" IsNull="Yes"/> <ItemDataAny ItemOID="FF97datum1" IsNull="Yes"/> <ItemDataAny ItemOID="FF97zeit2" IsNull="Yes"/> <ItemDataAny ItemOID="FF97datum2" IsNull="Yes"/> <ItemDataAny ItemOID="FF97ddd" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG80"> <ItemDataAny ItemOID="FF80random1" IsNull="Yes"/> <ItemDataAny ItemOID="FF80hobbies1" IsNull="Yes"/> <ItemDataAny ItemOID="FF80haustier1" IsNull="Yes"/> <ItemDataInteger ItemOID="FF80abcdefghijabcdefghij">0</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG14" ItemGroupRepeatKey="0"> <ItemDataString ItemOID="FF14wirkstoff">wirkstoff 1</ItemDataString> <ItemDataFloat ItemOID="FF14dosis">10</ItemDataFloat> <ItemDataPartialTime ItemOID="FF14einnahme">11:10</ItemDataPartialTime> </ItemGroupData> <ItemGroupData ItemGroupOID="FG86"> <ItemDataInteger ItemOID="FF86cb4">0</ItemDataInteger> <ItemDataAny ItemOID="FF86rb3" IsNull="Yes"/> <ItemDataAny ItemOID="FF86rrb4" IsNull="Yes"/> <ItemDataAny ItemOID="FF86pp2" IsNull="Yes"/> <ItemDataFloat ItemOID="FF86score3">00</ItemDataFloat> <ItemDataAny ItemOID="FF86farbe" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG48"> <ItemDataInteger ItemOID="FF48hb7">1</ItemDataInteger> <ItemDataInteger ItemOID="FF48hb9">3</ItemDataInteger> <ItemDataInteger ItemOID="FF48hb8">2</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG453"> <ItemDataAny ItemOID="FF453bild1" IsNull="Yes"/> <ItemDataString ItemOID="FF453bild2" ias:imagedataid="mnpimgid164">patientimages/6/36/136/ jpg</itemdatastring> </ItemGroupData> </FormData> </StudyEventData> <StudyEventData StudyEventOID="VISIT5" TransactionType="Insert"> </StudyEventData> <StudyEventData StudyEventOID="AE" StudyEventRepeatKey="AE11" TransactionType="Insert"> <!-- ***** FormData mnpias1ae ***** --> <FormData FormOID="Fmnpias1ae" FormRepeatKey="AE11FU1" TransactionType="Insert"> <AuditRecord> <UserRef UserOID="USER1"/> <LocationRef LocationOID="LOCATION1"/> <DateTimeStamp> T18:27: :00</DateTimeStamp> <ReasonForChange>Daten eingegeben</reasonforchange> <SourceID>mnpdid176</SourceID> </AuditRecord> <Annotation SeqNum="1"> <Comment>Document-No 176-1</Comment> </Annotation> <Annotation SeqNum="2"> <Comment>Daten eingegeben</comment> <Flag> <FlagValue CodeListOID="CLsig">1</FlagValue> </Flag> </Annotation> <Annotation SeqNum="4"> <Comment>not signed</comment> <Flag> <FlagValue CodeListOID="CLsigvalid">0</FlagValue> </Flag> </Annotation> <ItemGroupData ItemGroupOID="FGSUBJID"> <ItemDataString ItemOID="FFSUBJID">edq296</ItemDataString> </ItemGroupData> <ItemGroupData ItemGroupOID="FGFS"> <ItemDataInteger ItemOID="FFFS0">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS0">2</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS1">1</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFQA">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCT">0</ItemDataInteger> </ItemGroupData> As of by ias

277 Documentation secutrial 47 Export Formats <ItemGroupData ItemGroupOID="FG119"> <ItemDataAny ItemOID="FF119eppc1" IsNull="Yes"/> <ItemDataAny ItemOID="FF119epcc2a" IsNull="Yes"/> <ItemDataAny ItemOID="FF119epcc2b" IsNull="Yes"/> <ItemDataAny ItemOID="FF119epcc2c" IsNull="Yes"/> <ItemDataAny ItemOID="FF119epcc2d" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG98"> <ItemDataAny ItemOID="FF98tier1" IsNull="Yes"/> <ItemDataAny ItemOID="FF98rasse1" IsNull="Yes"/> <ItemDataAny ItemOID="FF98farbe1" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG102"> <ItemDataAny ItemOID="FF102tier2" IsNull="Yes"/> <ItemDataAny ItemOID="FF102rasse2" IsNull="Yes"/> <ItemDataAny ItemOID="FF102farbe2" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG57"> <ItemDataAny ItemOID="FF57tier3" IsNull="Yes"/> <ItemDataAny ItemOID="FF57rasse3" IsNull="Yes"/> <ItemDataAny ItemOID="FF57farbe3" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG59"> <ItemDataAny ItemOID="FF59hb1" IsNull="Yes"/> <ItemDataAny ItemOID="FF59hb2" IsNull="Yes"/> <ItemDataAny ItemOID="FF59hb3" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG79"> <ItemDataAny ItemOID="FF79hb4" IsNull="Yes"/> <ItemDataAny ItemOID="FF79hb5" IsNull="Yes"/> <ItemDataAny ItemOID="FF79hb6" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG81"> <ItemDataInteger ItemOID="FF81r1s1">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r1s2">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r1s3">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r2s1">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r2s2">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r2s3">0</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG95"> <ItemDataInteger ItemOID="FF95cb1">0</ItemDataInteger> <ItemDataAny ItemOID="FF95rb1" IsNull="Yes"/> <ItemDataAny ItemOID="FF95rrb1" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG26"> <ItemDataInteger ItemOID="FF26cb3">0</ItemDataInteger> <ItemDataAny ItemOID="FF26rrb3" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG65"> <ItemDataInteger ItemOID="FF65ugcb1">0</ItemDataInteger> <ItemDataAny ItemOID="FF65ug" IsNull="Yes"/> <ItemDataAny ItemOID="FF65ugm" IsNull="Yes"/> <ItemDataAny ItemOID="FF65ugt1" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG49"> <ItemDataInteger ItemOID="FF49ugcb2">0</ItemDataInteger> <ItemDataAny ItemOID="FF49ug1" IsNull="Yes"/> <ItemDataAny ItemOID="FF49ugm1" IsNull="Yes"/> <ItemDataAny ItemOID="FF49ugt2" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG101"> <ItemDataInteger ItemOID="FF101cb2">0</ItemDataInteger> <ItemDataAny ItemOID="FF101rb2" IsNull="Yes"/> <ItemDataAny ItemOID="FF101rrb2" IsNull="Yes"/> <ItemDataAny ItemOID="FF101pp1" IsNull="Yes"/> <ItemDataFloat ItemOID="FF101score1">00</ItemDataFloat> </ItemGroupData> <ItemGroupData ItemGroupOID="FG36"> <ItemDataAny ItemOID="FF36gz1" IsNull="Yes"/> <ItemDataAny ItemOID="FF36kz1" IsNull="Yes"/> <ItemDataAny ItemOID="FF36score2" IsNull="Yes"/> <ItemDataAny ItemOID="FF36text1" IsNull="Yes"/> <ItemDataAny ItemOID="FF36text2" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG105"> <ItemDataAny ItemOID="FF105zeit1" IsNull="Yes"/> <ItemDataAny ItemOID="FF105datum1" IsNull="Yes"/> <ItemDataAny ItemOID="FF105zeit2" IsNull="Yes"/> As of by ias

278 Documentation secutrial 47 Export Formats <ItemDataAny ItemOID="FF105datum2" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG56"> <ItemDataAny ItemOID="FF56random1" IsNull="Yes"/> <ItemDataAny ItemOID="FF56hobbies1" IsNull="Yes"/> <ItemDataAny ItemOID="FF56haustier1" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG77" ItemGroupRepeatKey="0"> <ItemDataAny ItemOID="FF77wirkstoff" IsNull="Yes"/> <ItemDataAny ItemOID="FF77dosis" IsNull="Yes"/> <ItemDataAny ItemOID="FF77einnahme" IsNull="Yes"/> </ItemGroupData> </FormData> <!-- ***** FormData mnpias1bilder1 ***** --> <FormData FormOID="Fmnpias1bilder1" FormRepeatKey="AE11FU1mnpdid192" TransactionType="Insert"> <AuditRecord> <UserRef UserOID="USER1"/> <LocationRef LocationOID="LOCATION1"/> <DateTimeStamp> T15:49: :00</DateTimeStamp> <ReasonForChange>Daten eingegeben</reasonforchange> <SourceID>mnpdid192</SourceID> </AuditRecord> <Annotation SeqNum="1"> <Comment>Document-No 192-1</Comment> </Annotation> <Annotation SeqNum="2"> <Comment>Daten eingegeben</comment> <Flag> <FlagValue CodeListOID="CLsig">1</FlagValue> </Flag> </Annotation> <Annotation SeqNum="4"> <Comment>not signed</comment> <Flag> <FlagValue CodeListOID="CLsigvalid">0</FlagValue> </Flag> </Annotation> <ItemGroupData ItemGroupOID="FGSUBJID"> <ItemDataString ItemOID="FFSUBJID">edq296</ItemDataString> </ItemGroupData> <ItemGroupData ItemGroupOID="FGFS"> <ItemDataInteger ItemOID="FFFS0">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS0">4</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFQA">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCT">0</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG747"> <ItemDataString ItemOID="FF747img" ias:imagedataid="mnpimgid144">patientimages/6/36/136/ jpg</itemdatastring> <ItemDataString ItemOID="FF747aufnahme">Büffet</ItemDataString> </ItemGroupData> </FormData> <!-- ***** FormData mnpias1bilder1 ***** --> <FormData FormOID="Fmnpias1bilder1" FormRepeatKey="AE11FU1mnpdid193" TransactionType="Insert"> <AuditRecord> <UserRef UserOID="USER1"/> <LocationRef LocationOID="LOCATION1"/> <DateTimeStamp> T15:50: :00</DateTimeStamp> <ReasonForChange>Daten eingegeben</reasonforchange> <SourceID>mnpdid193</SourceID> </AuditRecord> <Annotation SeqNum="1"> <Comment>Document-No 193-1</Comment> </Annotation> <Annotation SeqNum="2"> <Comment>Daten eingegeben</comment> <Flag> <FlagValue CodeListOID="CLsig">1</FlagValue> </Flag> </Annotation> <Annotation SeqNum="4"> <Comment>not signed</comment> <Flag> As of by ias

279 Documentation secutrial 47 Export Formats <FlagValue CodeListOID="CLsigvalid">0</FlagValue> </Flag> </Annotation> <ItemGroupData ItemGroupOID="FGSUBJID"> <ItemDataString ItemOID="FFSUBJID">edq296</ItemDataString> </ItemGroupData> <ItemGroupData ItemGroupOID="FGFS"> <ItemDataInteger ItemOID="FFFS0">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS0">4</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFQA">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCT">0</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG747"> <ItemDataString ItemOID="FF747img" ias:imagedataid="mnpimgid145">patientimages/6/36/136/ jpg</itemdatastring> <ItemDataString ItemOID="FF747aufnahme">Tannenbaum</ItemDataString> </ItemGroupData> </FormData> </StudyEventData> <StudyEventData StudyEventOID="AE" StudyEventRepeatKey="AE22" TransactionType="Insert"> <!-- ***** FormData mnpias1ae ***** --> <FormData FormOID="Fmnpias1ae" FormRepeatKey="AE22FU1" TransactionType="Insert"> <AuditRecord> <UserRef UserOID="USER1"/> <LocationRef LocationOID="LOCATION1"/> <DateTimeStamp> T15:51: :00</DateTimeStamp> <ReasonForChange>Daten eingegeben</reasonforchange> <SourceID>mnpdid195mnpatdid178</SourceID> </AuditRecord> <Annotation SeqNum="1"> <Comment>Document-No 195-1</Comment> </Annotation> <Annotation SeqNum="2"> <Comment>Daten eingegeben</comment> <Flag> <FlagValue CodeListOID="CLsig">1</FlagValue> </Flag> </Annotation> <Annotation SeqNum="4"> <Comment>not signed</comment> <Flag> <FlagValue CodeListOID="CLsigvalid">0</FlagValue> </Flag> </Annotation> <ItemGroupData ItemGroupOID="FGSUBJID"> <ItemDataString ItemOID="FFSUBJID">edq296</ItemDataString> </ItemGroupData> <ItemGroupData ItemGroupOID="FGFS"> <ItemDataInteger ItemOID="FFFS0">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS0">2</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS1">1</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFQA">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCT">0</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG119"> <ItemDataAny ItemOID="FF119eppc1" IsNull="Yes"/> <ItemDataAny ItemOID="FF119epcc2a" IsNull="Yes"/> <ItemDataAny ItemOID="FF119epcc2b" IsNull="Yes"/> <ItemDataAny ItemOID="FF119epcc2c" IsNull="Yes"/> <ItemDataAny ItemOID="FF119epcc2d" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG98"> <ItemDataAny ItemOID="FF98tier1" IsNull="Yes"/> <ItemDataAny ItemOID="FF98rasse1" IsNull="Yes"/> <ItemDataAny ItemOID="FF98farbe1" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG102"> <ItemDataAny ItemOID="FF102tier2" IsNull="Yes"/> As of by ias

280 Documentation secutrial 47 Export Formats <ItemDataAny ItemOID="FF102rasse2" IsNull="Yes"/> <ItemDataAny ItemOID="FF102farbe2" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG57"> <ItemDataAny ItemOID="FF57tier3" IsNull="Yes"/> <ItemDataAny ItemOID="FF57rasse3" IsNull="Yes"/> <ItemDataAny ItemOID="FF57farbe3" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG59"> <ItemDataAny ItemOID="FF59hb1" IsNull="Yes"/> <ItemDataAny ItemOID="FF59hb2" IsNull="Yes"/> <ItemDataAny ItemOID="FF59hb3" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG79"> <ItemDataAny ItemOID="FF79hb4" IsNull="Yes"/> <ItemDataAny ItemOID="FF79hb5" IsNull="Yes"/> <ItemDataAny ItemOID="FF79hb6" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG81"> <ItemDataInteger ItemOID="FF81r1s1">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r1s2">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r1s3">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r2s1">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r2s2">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r2s3">0</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG95"> <ItemDataInteger ItemOID="FF95cb1">0</ItemDataInteger> <ItemDataAny ItemOID="FF95rb1" IsNull="Yes"/> <ItemDataAny ItemOID="FF95rrb1" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG26"> <ItemDataInteger ItemOID="FF26cb3">0</ItemDataInteger> <ItemDataAny ItemOID="FF26rrb3" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG65"> <ItemDataInteger ItemOID="FF65ugcb1">0</ItemDataInteger> <ItemDataAny ItemOID="FF65ug" IsNull="Yes"/> <ItemDataAny ItemOID="FF65ugm" IsNull="Yes"/> <ItemDataAny ItemOID="FF65ugt1" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG49"> <ItemDataInteger ItemOID="FF49ugcb2">0</ItemDataInteger> <ItemDataAny ItemOID="FF49ug1" IsNull="Yes"/> <ItemDataAny ItemOID="FF49ugm1" IsNull="Yes"/> <ItemDataAny ItemOID="FF49ugt2" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG101"> <ItemDataInteger ItemOID="FF101cb2">0</ItemDataInteger> <ItemDataAny ItemOID="FF101rb2" IsNull="Yes"/> <ItemDataAny ItemOID="FF101rrb2" IsNull="Yes"/> <ItemDataAny ItemOID="FF101pp1" IsNull="Yes"/> <ItemDataFloat ItemOID="FF101score1">00</ItemDataFloat> </ItemGroupData> <ItemGroupData ItemGroupOID="FG36"> <ItemDataAny ItemOID="FF36gz1" IsNull="Yes"/> <ItemDataAny ItemOID="FF36kz1" IsNull="Yes"/> <ItemDataAny ItemOID="FF36score2" IsNull="Yes"/> <ItemDataAny ItemOID="FF36text1" IsNull="Yes"/> <ItemDataAny ItemOID="FF36text2" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG105"> <ItemDataAny ItemOID="FF105zeit1" IsNull="Yes"/> <ItemDataAny ItemOID="FF105datum1" IsNull="Yes"/> <ItemDataAny ItemOID="FF105zeit2" IsNull="Yes"/> <ItemDataAny ItemOID="FF105datum2" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG56"> <ItemDataAny ItemOID="FF56random1" IsNull="Yes"/> <ItemDataAny ItemOID="FF56hobbies1" IsNull="Yes"/> <ItemDataAny ItemOID="FF56haustier1" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG77" ItemGroupRepeatKey="0"> <ItemDataAny ItemOID="FF77wirkstoff" IsNull="Yes"/> <ItemDataAny ItemOID="FF77dosis" IsNull="Yes"/> <ItemDataAny ItemOID="FF77einnahme" IsNull="Yes"/> </ItemGroupData> </FormData> <!-- ***** FormData mnpias1ae ***** --> As of by ias

281 Documentation secutrial 47 Export Formats <FormData FormOID="Fmnpias1ae" FormRepeatKey="AE22FU1" TransactionType="Update"> <AuditRecord> <UserRef UserOID="USER1"/> <LocationRef LocationOID="LOCATION1"/> <DateTimeStamp> T17:32: :00</DateTimeStamp> <ReasonForChange>Daten eingegeben</reasonforchange> <SourceID>mnpdid195</SourceID> </AuditRecord> <Annotation SeqNum="1"> <Comment>Document-No 195-2</Comment> </Annotation> <Annotation SeqNum="2"> <Comment>Daten eingegeben</comment> <Flag> <FlagValue CodeListOID="CLsig">1</FlagValue> </Flag> </Annotation> <Annotation SeqNum="4"> <Comment>not signed</comment> <Flag> <FlagValue CodeListOID="CLsigvalid">0</FlagValue> </Flag> </Annotation> <ItemGroupData ItemGroupOID="FGFS"> <ItemDataInteger ItemOID="FFFS0">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS0">2</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS1">1</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFQA">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCT">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFSDV">1</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG119"> <ItemDataAny ItemOID="FF119eppc1" IsNull="Yes"/> <ItemDataAny ItemOID="FF119epcc2a" IsNull="Yes"/> <ItemDataAny ItemOID="FF119epcc2b" IsNull="Yes"/> <ItemDataAny ItemOID="FF119epcc2c" IsNull="Yes"/> <ItemDataAny ItemOID="FF119epcc2d" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG98"> <ItemDataAny ItemOID="FF98tier1" IsNull="Yes"/> <ItemDataAny ItemOID="FF98rasse1" IsNull="Yes"/> <ItemDataAny ItemOID="FF98farbe1" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG102"> <ItemDataAny ItemOID="FF102tier2" IsNull="Yes"/> <ItemDataAny ItemOID="FF102rasse2" IsNull="Yes"/> <ItemDataAny ItemOID="FF102farbe2" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG57"> <ItemDataAny ItemOID="FF57tier3" IsNull="Yes"/> <ItemDataAny ItemOID="FF57rasse3" IsNull="Yes"/> <ItemDataAny ItemOID="FF57farbe3" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG59"> <ItemDataAny ItemOID="FF59hb1" IsNull="Yes"/> <ItemDataAny ItemOID="FF59hb2" IsNull="Yes"/> <ItemDataAny ItemOID="FF59hb3" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG79"> <ItemDataAny ItemOID="FF79hb4" IsNull="Yes"/> <ItemDataAny ItemOID="FF79hb5" IsNull="Yes"/> <ItemDataAny ItemOID="FF79hb6" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG81"> <ItemDataInteger ItemOID="FF81r1s1">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r1s2">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r1s3">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r2s1">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r2s2">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r2s3">0</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG95"> <ItemDataInteger ItemOID="FF95cb1">0</ItemDataInteger> <ItemDataAny ItemOID="FF95rb1" IsNull="Yes"/> As of by ias

282 Documentation secutrial 47 Export Formats <ItemDataAny ItemOID="FF95rrb1" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG26"> <ItemDataInteger ItemOID="FF26cb3">0</ItemDataInteger> <ItemDataAny ItemOID="FF26rrb3" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG65"> <ItemDataInteger ItemOID="FF65ugcb1">0</ItemDataInteger> <ItemDataAny ItemOID="FF65ug" IsNull="Yes"/> <ItemDataAny ItemOID="FF65ugm" IsNull="Yes"/> <ItemDataAny ItemOID="FF65ugt1" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG49"> <ItemDataInteger ItemOID="FF49ugcb2">0</ItemDataInteger> <ItemDataAny ItemOID="FF49ug1" IsNull="Yes"/> <ItemDataAny ItemOID="FF49ugm1" IsNull="Yes"/> <ItemDataAny ItemOID="FF49ugt2" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG101"> <ItemDataInteger ItemOID="FF101cb2">0</ItemDataInteger> <ItemDataAny ItemOID="FF101rb2" IsNull="Yes"/> <ItemDataAny ItemOID="FF101rrb2" IsNull="Yes"/> <ItemDataAny ItemOID="FF101pp1" IsNull="Yes"/> <ItemDataFloat ItemOID="FF101score1">00</ItemDataFloat> </ItemGroupData> <ItemGroupData ItemGroupOID="FG36"> <ItemDataAny ItemOID="FF36gz1" IsNull="Yes"/> <ItemDataAny ItemOID="FF36kz1" IsNull="Yes"/> <ItemDataAny ItemOID="FF36score2" IsNull="Yes"/> <ItemDataString ItemOID="FF36text1">Beinbruch</ItemDataString> <ItemDataAny ItemOID="FF36text2" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG105"> <ItemDataAny ItemOID="FF105zeit1" IsNull="Yes"/> <ItemDataAny ItemOID="FF105datum1" IsNull="Yes"/> <ItemDataAny ItemOID="FF105zeit2" IsNull="Yes"/> <ItemDataAny ItemOID="FF105datum2" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG56"> <ItemDataAny ItemOID="FF56random1" IsNull="Yes"/> <ItemDataAny ItemOID="FF56hobbies1" IsNull="Yes"/> <ItemDataAny ItemOID="FF56haustier1" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG77" ItemGroupRepeatKey="0"> <ItemDataAny ItemOID="FF77wirkstoff" IsNull="Yes"/> <ItemDataAny ItemOID="FF77dosis" IsNull="Yes"/> <ItemDataAny ItemOID="FF77einnahme" IsNull="Yes"/> </ItemGroupData> </FormData> <!-- ***** FormData mnpias1ae ***** --> <FormData FormOID="Fmnpias1ae" FormRepeatKey="AE22FU2" TransactionType="Insert"> <AuditRecord> <UserRef UserOID="USER1"/> <LocationRef LocationOID="LOCATION1"/> <DateTimeStamp> T15:51: :00</DateTimeStamp> <ReasonForChange>Daten eingegeben</reasonforchange> <SourceID>mnpdid196</SourceID> </AuditRecord> <Annotation SeqNum="1"> <Comment>Document-No 196-1</Comment> </Annotation> <Annotation SeqNum="2"> <Comment>Daten eingegeben</comment> <Flag> <FlagValue CodeListOID="CLsig">1</FlagValue> </Flag> </Annotation> <Annotation SeqNum="4"> <Comment>not signed</comment> <Flag> <FlagValue CodeListOID="CLsigvalid">0</FlagValue> </Flag> </Annotation> <ItemGroupData ItemGroupOID="FGSUBJID"> <ItemDataString ItemOID="FFSUBJID">edq296</ItemDataString> </ItemGroupData> <ItemGroupData ItemGroupOID="FGFS"> <ItemDataInteger ItemOID="FFFS0">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS1">0</ItemDataInteger> As of by ias

283 Documentation secutrial 47 Export Formats <ItemDataInteger ItemOID="FFFS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS0">2</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS1">1</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFQA">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCT">0</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG119"> <ItemDataAny ItemOID="FF119eppc1" IsNull="Yes"/> <ItemDataAny ItemOID="FF119epcc2a" IsNull="Yes"/> <ItemDataAny ItemOID="FF119epcc2b" IsNull="Yes"/> <ItemDataAny ItemOID="FF119epcc2c" IsNull="Yes"/> <ItemDataAny ItemOID="FF119epcc2d" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG98"> <ItemDataAny ItemOID="FF98tier1" IsNull="Yes"/> <ItemDataAny ItemOID="FF98rasse1" IsNull="Yes"/> <ItemDataAny ItemOID="FF98farbe1" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG102"> <ItemDataAny ItemOID="FF102tier2" IsNull="Yes"/> <ItemDataAny ItemOID="FF102rasse2" IsNull="Yes"/> <ItemDataAny ItemOID="FF102farbe2" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG57"> <ItemDataAny ItemOID="FF57tier3" IsNull="Yes"/> <ItemDataAny ItemOID="FF57rasse3" IsNull="Yes"/> <ItemDataAny ItemOID="FF57farbe3" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG59"> <ItemDataAny ItemOID="FF59hb1" IsNull="Yes"/> <ItemDataAny ItemOID="FF59hb2" IsNull="Yes"/> <ItemDataAny ItemOID="FF59hb3" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG79"> <ItemDataAny ItemOID="FF79hb4" IsNull="Yes"/> <ItemDataAny ItemOID="FF79hb5" IsNull="Yes"/> <ItemDataAny ItemOID="FF79hb6" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG81"> <ItemDataInteger ItemOID="FF81r1s1">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r1s2">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r1s3">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r2s1">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r2s2">0</ItemDataInteger> <ItemDataInteger ItemOID="FF81r2s3">0</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG95"> <ItemDataInteger ItemOID="FF95cb1">0</ItemDataInteger> <ItemDataAny ItemOID="FF95rb1" IsNull="Yes"/> <ItemDataAny ItemOID="FF95rrb1" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG26"> <ItemDataInteger ItemOID="FF26cb3">0</ItemDataInteger> <ItemDataAny ItemOID="FF26rrb3" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG65"> <ItemDataInteger ItemOID="FF65ugcb1">0</ItemDataInteger> <ItemDataAny ItemOID="FF65ug" IsNull="Yes"/> <ItemDataAny ItemOID="FF65ugm" IsNull="Yes"/> <ItemDataAny ItemOID="FF65ugt1" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG49"> <ItemDataInteger ItemOID="FF49ugcb2">0</ItemDataInteger> <ItemDataAny ItemOID="FF49ug1" IsNull="Yes"/> <ItemDataAny ItemOID="FF49ugm1" IsNull="Yes"/> <ItemDataAny ItemOID="FF49ugt2" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG101"> <ItemDataInteger ItemOID="FF101cb2">0</ItemDataInteger> <ItemDataAny ItemOID="FF101rb2" IsNull="Yes"/> <ItemDataAny ItemOID="FF101rrb2" IsNull="Yes"/> <ItemDataAny ItemOID="FF101pp1" IsNull="Yes"/> <ItemDataFloat ItemOID="FF101score1">00</ItemDataFloat> </ItemGroupData> <ItemGroupData ItemGroupOID="FG36"> <ItemDataAny ItemOID="FF36gz1" IsNull="Yes"/> As of by ias

284 Documentation secutrial 47 Export Formats <ItemDataAny ItemOID="FF36kz1" IsNull="Yes"/> <ItemDataAny ItemOID="FF36score2" IsNull="Yes"/> <ItemDataAny ItemOID="FF36text1" IsNull="Yes"/> <ItemDataAny ItemOID="FF36text2" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG105"> <ItemDataAny ItemOID="FF105zeit1" IsNull="Yes"/> <ItemDataAny ItemOID="FF105datum1" IsNull="Yes"/> <ItemDataAny ItemOID="FF105zeit2" IsNull="Yes"/> <ItemDataAny ItemOID="FF105datum2" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG56"> <ItemDataAny ItemOID="FF56random1" IsNull="Yes"/> <ItemDataAny ItemOID="FF56hobbies1" IsNull="Yes"/> <ItemDataAny ItemOID="FF56haustier1" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG77" ItemGroupRepeatKey="0"> <ItemDataAny ItemOID="FF77wirkstoff" IsNull="Yes"/> <ItemDataAny ItemOID="FF77dosis" IsNull="Yes"/> <ItemDataAny ItemOID="FF77einnahme" IsNull="Yes"/> </ItemGroupData> </FormData> <!-- ***** FormData mnpias1bilder1 ***** --> <FormData FormOID="Fmnpias1bilder1" FormRepeatKey="AE22FU2mnpdid198" TransactionType="Insert"> <AuditRecord> <UserRef UserOID="USER1"/> <LocationRef LocationOID="LOCATION1"/> <DateTimeStamp> T16:17: :00</DateTimeStamp> <ReasonForChange>Daten eingegeben</reasonforchange> <SourceID>mnpdid198</SourceID> </AuditRecord> <Annotation SeqNum="1"> <Comment>Document-No 198-1</Comment> </Annotation> <Annotation SeqNum="2"> <Comment>Daten eingegeben</comment> <Flag> <FlagValue CodeListOID="CLsig">1</FlagValue> </Flag> </Annotation> <Annotation SeqNum="4"> <Comment>not signed</comment> <Flag> <FlagValue CodeListOID="CLsigvalid">0</FlagValue> </Flag> </Annotation> <ItemGroupData ItemGroupOID="FGSUBJID"> <ItemDataString ItemOID="FFSUBJID">edq296</ItemDataString> </ItemGroupData> <ItemGroupData ItemGroupOID="FGFS"> <ItemDataInteger ItemOID="FFFS0">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS0">2</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFQA">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCT">0</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG747"> <ItemDataString ItemOID="FF747img" ias:imagedataid="mnpimgid146">patientimages/6/36/136/ jpg</itemdatastring> <ItemDataAny ItemOID="FF747aufnahme" IsNull="Yes"/> </ItemGroupData> </FormData> </StudyEventData> <StudyEventData StudyEventOID="CN" TransactionType="Insert"> <!-- ***** FormData mnpias1bilder1 ***** --> <FormData FormOID="Fmnpias1bilder1" FormRepeatKey="mnpdid174" TransactionType="Insert"> <AuditRecord> <UserRef UserOID="USER151"/> <LocationRef LocationOID="LOCATION1"/> <DateTimeStamp> T16:22: :00</DateTimeStamp> <ReasonForChange>Daten eingegeben</reasonforchange> <SourceID>mnpdid174</SourceID> </AuditRecord> <Annotation SeqNum="1"> As of by ias

285 Documentation secutrial 47 Export Formats <Comment>Document-No 174-1</Comment> </Annotation> <Annotation SeqNum="2"> <Comment>Daten eingegeben</comment> <Flag> <FlagValue CodeListOID="CLsig">1</FlagValue> </Flag> </Annotation> <Annotation SeqNum="4"> <Comment>not signed</comment> <Flag> <FlagValue CodeListOID="CLsigvalid">0</FlagValue> </Flag> </Annotation> <ItemGroupData ItemGroupOID="FGSUBJID"> <ItemDataString ItemOID="FFSUBJID">edq296</ItemDataString> </ItemGroupData> <ItemGroupData ItemGroupOID="FGFS"> <ItemDataInteger ItemOID="FFFS0">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS0">4</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFQA">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCT">0</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG747"> <ItemDataString ItemOID="FF747img" ias:imagedataid="mnpimgid126">patientimages/6/36/136/ jpg</itemdatastring> <ItemDataString ItemOID="FF747aufnahme">Familienbild</ItemDataString> </ItemGroupData> </FormData> <!-- ***** FormData mnpias1status ***** --> <FormData FormOID="Fmnpias1status" TransactionType="Insert"> <AuditRecord> <UserRef UserOID="USER1"/> <LocationRef LocationOID="LOCATION1"/> <DateTimeStamp> T14:40: :00</DateTimeStamp> <ReasonForChange>Daten eingegeben</reasonforchange> <SourceID>mnpdid212</SourceID> </AuditRecord> <Signature> <UserRef UserOID="USER1"/> <LocationRef LocationOID="LOCATION1"/> <SignatureRef SignatureOID="SIG0"/> <DateTimeStamp> T14:40: :00</DateTimeStamp> <ias:validity>valid</ias:validity> <ias:version>0</ias:version> </Signature> <Annotation SeqNum="1"> <Comment>Document-No 212-1</Comment> </Annotation> <Annotation SeqNum="2"> <Comment>Daten eingegeben</comment> <Flag> <FlagValue CodeListOID="CLsig">1</FlagValue> </Flag> </Annotation> <Annotation SeqNum="4"> <Comment>valid</Comment> <Flag> <FlagValue CodeListOID="CLsigvalid">1</FlagValue> </Flag> </Annotation> <ItemGroupData ItemGroupOID="FGSUBJID"> <ItemDataString ItemOID="FFSUBJID">edq296</ItemDataString> </ItemGroupData> <ItemGroupData ItemGroupOID="FGFS"> <ItemDataInteger ItemOID="FFFS0">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFS3">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS0">2</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS1">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS2">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCS3">0</ItemDataInteger> As of by ias

286 Documentation secutrial 47 Export Formats String> <ItemDataInteger ItemOID="FFFQA">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFCT">0</ItemDataInteger> <ItemDataInteger ItemOID="FFFSDV">1</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG24"> <ItemDataString ItemOID="FF24eppc1">Operationen an den Ventrikeln und am Ventrikelseptum</ItemData- <ItemDataString ItemOID="FF24epcc2a">LV, Operation am linken Ventrikel</ItemDataString> <ItemDataString ItemOID="FF24epcc2b">120726</ItemDataString> <ItemDataAny ItemOID="FF24epcc2c" IsNull="Yes"/> <ItemDataAny ItemOID="FF24epcc2d" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG82"> <ItemDataInteger ItemOID="FF82tier1">3</ItemDataInteger> <ItemDataInteger ItemOID="FF82rasse1">2</ItemDataInteger> <ItemDataInteger ItemOID="FF82farbe1">2</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG47"> <ItemDataInteger ItemOID="FF47tier2">1</ItemDataInteger> <ItemDataInteger ItemOID="FF47rasse2">3</ItemDataInteger> <ItemDataInteger ItemOID="FF47farbe2">16</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG21"> <ItemDataInteger ItemOID="FF21tier3">2</ItemDataInteger> <ItemDataInteger ItemOID="FF21rasse3">6</ItemDataInteger> <ItemDataInteger ItemOID="FF21farbe3">14</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG112"> <ItemDataInteger ItemOID="FF112hb1">2</ItemDataInteger> <ItemDataInteger ItemOID="FF112hb2">3</ItemDataInteger> <ItemDataInteger ItemOID="FF112hb3">1</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG60"> <ItemDataInteger ItemOID="FF60hb4">1</ItemDataInteger> <ItemDataInteger ItemOID="FF60hb5">3</ItemDataInteger> <ItemDataInteger ItemOID="FF60hb6">2</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG64"> <ItemDataInteger ItemOID="FF64r1s1">1</ItemDataInteger> <ItemDataInteger ItemOID="FF64r1s2">0</ItemDataInteger> <ItemDataInteger ItemOID="FF64r1s3">1</ItemDataInteger> <ItemDataInteger ItemOID="FF64r2s1">0</ItemDataInteger> <ItemDataInteger ItemOID="FF64r2s2">1</ItemDataInteger> <ItemDataInteger ItemOID="FF64r2s3">0</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG19"> <ItemDataInteger ItemOID="FF19cb1">1</ItemDataInteger> <ItemDataInteger ItemOID="FF19rb1">0</ItemDataInteger> <ItemDataInteger ItemOID="FF19rrb1">1</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG5"> <ItemDataInteger ItemOID="FF5cb3">1</ItemDataInteger> <ItemDataInteger ItemOID="FF5rrb3">1</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG28"> <ItemDataInteger ItemOID="FF28ugcb1">1</ItemDataInteger> <ItemDataFloat ItemOID="FF28ug">20</ItemDataFloat> <ItemDataInteger ItemOID="FF28ugm">1</ItemDataInteger> <ItemDataPartialTime ItemOID="FF28ugt1">12:12</ItemDataPartialTime> </ItemGroupData> <ItemGroupData ItemGroupOID="FG27"> <ItemDataInteger ItemOID="FF27ugcb2">0</ItemDataInteger> <ItemDataAny ItemOID="FF27ug1" IsNull="Yes"/> <ItemDataAny ItemOID="FF27ugm1" IsNull="Yes"/> <ItemDataAny ItemOID="FF27ugt2" IsNull="Yes"/> </ItemGroupData> <ItemGroupData ItemGroupOID="FG30"> <ItemDataInteger ItemOID="FF30cb2">1</ItemDataInteger> <ItemDataInteger ItemOID="FF30rb2">0</ItemDataInteger> <ItemDataInteger ItemOID="FF30rrb2">0</ItemDataInteger> <ItemDataInteger ItemOID="FF30pp1">3</ItemDataInteger> <ItemDataFloat ItemOID="FF30score1">23</ItemDataFloat> </ItemGroupData> <ItemGroupData ItemGroupOID="FG7"> <ItemDataInteger ItemOID="FF7gz1">4</ItemDataInteger> <ItemDataFloat ItemOID="FF7kz1">45</ItemDataFloat> <ItemDataFloat ItemOID="FF7score2">85</ItemDataFloat> <ItemDataString ItemOID="FF7text1">kurz</ItemDataString> <ItemDataString ItemOID="FF7text2">lang</ItemDataString> As of by ias

287 Documentation secutrial 47 Export Formats </ItemGroupData> <ItemGroupData ItemGroupOID="FG52"> <ItemDataPartialTime ItemOID="FF52zeit1">12:23:45</ItemDataPartialTime> <ItemDataPartialDate ItemOID="FF52datum1"> </ItemDataPartialDate> <ItemDataIncompleteDatetime ItemOID="FF52zeit2">-----T-:39:51</ItemDataIncompleteDatetime> <ItemDataPartialDate ItemOID="FF52datum2"> </ItemDataPartialDate> </ItemGroupData> <ItemGroupData ItemGroupOID="FG45"> <ItemDataAny ItemOID="FF45random1" IsNull="Yes"/> <ItemDataInteger ItemOID="FF45hobbies1">2</ItemDataInteger> <ItemDataInteger ItemOID="FF45haustier1">3</ItemDataInteger> </ItemGroupData> <ItemGroupData ItemGroupOID="FG35" ItemGroupRepeatKey="0"> <ItemDataString ItemOID="FF35wirkstoff">acetylsäure</ItemDataString> <ItemDataFloat ItemOID="FF35dosis">124</ItemDataFloat> <ItemDataPartialTime ItemOID="FF35einnahme">14:40</ItemDataPartialTime> </ItemGroupData> </FormData> </StudyEventData> <ias:imagedata ID="mnpimgid148" uploadedfilename="badespaß kleinjpg" contenttype="image/jpeg" imagesize="69274"> <ias:userentry> <UserRef UserOID="USER1"/> <DateTimeStamp> T16:18: :00</DateTimeStamp> </ias:userentry> <ias:imagefiledata type="original" filename="img/6/36/136/ jpg" filestatus="valid"/> <ias:imagefiledata type="web" filename="img/6/36/136/ _webjpg" filestatus="valid"/> <ias:imagefiledata type="thumbnail" filename="img/6/36/136/ _tnjpg" filestatus="valid"/> </ias:imagedata> <ias:imagedata ID="mnpimgid126" uploadedfilename="dsc_0298jpg" contenttype="image/jpeg" imagesize="99544"> <ias:userentry> <UserRef UserOID="USER151"/> <DateTimeStamp> T16:22: :00</DateTimeStamp> </ias:userentry> <ias:imagefiledata type="original" filename="patientimages/6/36/136/ jpg" filestatus="valid"/> <ias:imagefiledata type="web" filename="patientimages/6/36/136/ _webjpg" filestatus="valid"/> <ias:imagefiledata type="thumbnail" filename="patientimages/6/36/136/ _tnjpg" filestatus="valid"/> </ias:imagedata> <ias:imagedata ID="mnpimgid146" uploadedfilename="p jpg" contenttype="image/jpeg" imagesize="60361"> <ias:userentry> <UserRef UserOID="USER1"/> <DateTimeStamp> T16:17: :00</DateTimeStamp> </ias:userentry> <ias:imagefiledata type="original" filename="patientimages/6/36/136/ jpg" filestatus="valid"/> <ias:imagefiledata type="web" filename="patientimages/6/36/136/ _webjpg" filestatus="valid"/> <ias:imagefiledata type="thumbnail" filename="patientimages/6/36/136/ _tnjpg" filestatus="valid"/> </ias:imagedata> <ias:imagedata ID="mnpimgid147" uploadedfilename="baden macht hungrig kleinjpg" contenttype="image/jpeg" imagesize="46542"> <ias:userentry> <UserRef UserOID="USER1"/> <DateTimeStamp> T16:18: :00</DateTimeStamp> </ias:userentry> <ias:imagefiledata type="original" filename="patientimages/6/36/136/ jpg" filestatus="valid"/> <ias:imagefiledata type="web" filename="patientimages/6/36/136/ _webjpg" filestatus="valid"/> <ias:imagefiledata type="thumbnail" filename="patientimages/6/36/136/ _tnjpg" filestatus="valid"/> </ias:imagedata> <ias:imagedata ID="mnpimgid164" uploadedfilename="berliner Dom blau-rotjpg" contenttype="image/jpeg" imagesize="45338"> <ias:userentry> <UserRef UserOID="USER1"/> <DateTimeStamp> T14:44: :00</DateTimeStamp> </ias:userentry> <ias:imagefiledata type="original" filename="patientimages/6/36/136/ jpg" filestatus="valid"/> <ias:imagefiledata type="web" filename="patientimages/6/36/136/ _webjpg" filestatus="valid"/> As of by ias

288 Documentation secutrial 47 Export Formats <ias:imagefiledata type="thumbnail" filename="patientimages/6/36/136/ _tnjpg" filestatus="valid"/> </ias:imagedata> <ias:imagedata ID="mnpimgid145" uploadedfilename="p jpg" contenttype="image/jpeg" imagesize="51551"> <ias:userentry> <UserRef UserOID="USER1"/> <DateTimeStamp> T15:50: :00</DateTimeStamp> </ias:userentry> <ias:imagefiledata type="original" filename="patientimages/6/36/136/ jpg" filestatus="valid"/> <ias:imagefiledata type="web" filename="patientimages/6/36/136/ _webjpg" filestatus="valid"/> <ias:imagefiledata type="thumbnail" filename="patientimages/6/36/136/ _tnjpg" filestatus="valid"/> </ias:imagedata> <ias:imagedata ID="mnpimgid144" uploadedfilename="p jpg" contenttype="image/jpeg" imagesize="90624"> <ias:userentry> <UserRef UserOID="USER1"/> <DateTimeStamp> T15:49: :00</DateTimeStamp> </ias:userentry> <ias:imagefiledata type="original" filename="patientimages/6/36/136/ jpg" filestatus="valid"/> <ias:imagefiledata type="web" filename="patientimages/6/36/136/ _webjpg" filestatus="valid"/> <ias:imagefiledata type="thumbnail" filename="patientimages/6/36/136/ _tnjpg" filestatus="valid"/> </ias:imagedata> </SubjectData> </ClinicalData> </ODM> As of by ias