WHITE PAPER. CONVERTING SDTM DATA TO ADaM DATA AND CREATING SUBMISSION READY SAFETY TABLES AND LISTINGS. SUCCESSFUL TRIALS THROUGH PROVEN SOLUTIONS

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1 WHITE PAPER CONVERTING SDTM DATA TO ADaM DATA AND CREATING SUBMISSION READY SAFETY TABLES AND LISTINGS. An innovative approach to deliver statistical analysis and data in a CDISC ADaM complient manner using the power of ClinPlus Report. SUCCESSFUL TRIALS THROUGH PROVEN SOLUTIONS

2 Introduction The challenges facing our industry to effectively meet the clinical data study standards set out by the Clinical Data Interchange Standards Consortium (CDISC) specifically with regards to the Study Data Tabulation Module (SDTM) and the Analysis Data Model (ADaM) can be daunting. Our ADaM Data Conversion and Reporting Toolkit may be the solution you are looking for to generate all of your safety tables and listings and provide supporting documentation in a validated, standardized CDISC ADaM compliant manner. Background Adhering to CDISC standards has been proven to facilitate efficient data integration and transport as well as access and review. Ideally FDA Reviewers will want to perform analytic review using ADaM standards. Converting your SDTM data to ADaM data, then to submission ready tables and accurately documenting the process can present numerous challenges. One of the primary challenges is providing complete documentation of the creation of the tables and listings and the underlying ADaM data sets, the process by which each variable in the ADaM is traced back to its original source. CDISC specifications indicate that any variables copied or derived from an SDTM domain into an ADaM data set must retain the integrity of the data in the SDTM domain. Another challenge is to produce and present in-text tables and data listings in a highly readable manner with consistent formatting table to table and study to study. 2

3 Solution DZS Software has developed the ClinPlus ADaM Data Conversion and Reporting Toolkit, an elegant solution for both metadata driven conversion of SDTM data to ADaM data and the production of metadata driven flexible safety tables and listings from the ADaM data. The metadata, defined in Microsoft Excel spreadsheets becomes the ADaM documentation, therefore eliminating any chance that documentation is not corresponding to the actual process. Below is an example of an Excel Worksheet containing the metadata for the conversion of demographic data from SDTM to ADaM format. A separate worksheet is used for each data domain. 3

4 Table and Listing Production The second step is to produce the submission ready safety tables and listings using the ClinPlus ADaM Report Generator with the newly converted ADaM data as input. Several templates/domain are provided as root templates from which many variations of the default report layout may be generated by altering the parameter values in the report metadata. For instance, an Adverse Events table may display PLACEBO as the first column or last column or the same Adverse Event table can display AEs across Treatment Group or across Severity by manipulating the metadata parameters. In addition to the flexibility in content, sorting and orientation of each table, all display attributes such as fonts, margins, lines, page number style, etc. can be adjusted using ClinPlus Report. The following table describes the three root templates for the Adverse Event tables that can spawn 18 (or more) variations. A library of table and listing templates is provided to facilitate submission quality safety tables and listings for the following domains: Demographics Subject Status Adverse Events Concomitant Medication Medical History ECG Physical Measurements Physical Exams Vital Signs Lab 4

5 Table and Listing Production (cont.) Below is an example for Adverse Event tables. The first Excel worksheet contains the metadata parameters for the root template and the next worksheet is metadata parameters for the same template where the Treatment Group variable ACROSS is replaced by SEVERITY. Both controlling metadata are shown with the reports. Adverse Event Table Excel worksheet metadata for the root table and the derived Adverse Event table when the ACROSS variable is Severity (AESEV). Table names are aet021 and aet022 consecutively. 5

6 Table and Listing Production (cont.) Adverse Event Tables created from the metadata above: Table aet021: Table aet022: 6

7 How to use the ClinPlus Report Engine (continued) Below is an example for Adverse Event Listing. Adverse Event Table EXCEL worksheet metadata for the root listing Adverse Event List AEL01 created from the metadata above: The ClinPlus Report Engine delivers highly flexible data presentations. Extending the ClinPlus ADaM conversion and reporting by adding general or study specific templates to produce efficacy tables or graphics is accomplished using ClinPlus Report authoring capabilities and/or SAS programming. Any number of new templates can be defined using these same tools and techniques. 7

8 Conclusion The challenge of effectively having metadata driven conversion of SDTM data to ADaM data and then producing in-text safety tables and data listings in a highly readable and consistent manner can easily be done using the new ClinPlus ADam Data Converter and Reporting Toolkit. Using this new Toolkit will allow you to lay aside all the concerns of completely documenting the conversion from SDTM to ADaM. The Toolkit also provides you with root templates for many domains. By altering the parameter values in the root templates metadata you can produce numerous other report variations. The new ClinPlus ADaM Data Converter and Reporting Toolkit is the CDISC compliant solution to creating submission ready safety tables and listings using ADaM data. 8

9 About DZS Software Solutions, Inc. DZS Software Solutions, Inc. has been providing clinical trials software for data management & analysis to the pharmaceutical industry since Our ClinPlus suite of products provides the premium quality tools necessary for pharmaceutical companies, contract research organizations (CROs), biotechs, and medical device manufacturers to expedite clinical trials and meet the strict requirements of the FDA. From data collection, coding, analysis, and submission, ClinPlus provides the edge you need to get products to market faster. Averaging 15 years each in the pharmaceutical industry, DZS software engineers bring several decades of experience in areas such as statistical analysis, clinical data management, and ADE/Drug coding. Our real world experience is incorporated in each system s design and is evident in the many features not found elsewhere. DZS Software Solutions, Inc For more information please visit ClinPlus is a registered trademark of DZS Software Solutions, Inc. SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. Microsoft is a registered trademark of Microsoft Corp. in the U.S. and other countries. Excel is a registered trademark of Microsoft Corp. in the U.S. and other countries. indicates USA registration.