Version 3.1, January Sanofi ecrf, V4.6 Quick Reference Guide for Site User

Transcription

1 Sanofi ecrf, V4.6 Quick Reference Guide for Site User

2 Sanofi ecrf, V Quick Reference Guide for Site User I- Connect/Disconnect to RDC Onsite system Login p3 Logout p6 II- RDC Onsite overview RDC Onsite Tabs: a- Home Tab p7 b- Casebooks Tab p9 c- Review tab p10 d- Report Tab p11 Search Pane p12 Icon color codes p13 ecrf page and Toolbar p15 III Completing Tasks Record patient data p17 Review pages entered p30 Review AEs p31 Approve reviewed pages p32 Find & resolve discrepancies pending to your action p33 ecrf Reports p37 2 For more information Changes from p35 p40

3 I- Connect / disconnect to ecrf (RDC Onsite) system Login 2 steps for Log in : 1- Connect to Sanofi R&D Computer Systems 2- Connect to RDC Onsite system 1- Connect to Sanofi R&D Computer systems External Portal 1- Browse the link to sanofi R&D External Website: 2- Connect to e-crf (=RDC Onsite) system (1/3) 2- Click link ecrf System 3 3

4 I- Connect / disconnect to ecrf (RDC Onsite) system Login 2- Connect to ecrf system (2/3) 3- Fill Username (FX000000) and Password (case sensitive) 4- Login You might be invited to change your password (process as explained) 4 4

5 I- Connect / disconnect to ecrf (RDC Onsite) system Login 2- Connect to ecrf system (3/3) 7- Click on the link Production ecrf environment You will be connected to the Home Tab of ecrf system 5 5

6 I- Connect / disconnect to ecrf(rdc Onsite) system Logout Click Logout to disconnect from RDC Onsite 6

7 II- RDC Onsite overview RDC Onsite Tabs: Home Tab Home Tab : first page after Login From the Home Tab, you will select Study, Site, Patient(s) and Activity (step - 2 or -3) Depending on the activity you selected, this will bring you to Casebook Tab, Review Tab or Report Tab Possibility to select another Tab 1- Select study and Site 2- Select a pre-defined activity by clicking on one link i.e. : Review Active Discrepancies You may also select patient(s) first, and then the activity (see at next slide) 7

8 II- RDC Onsite overview RDC Onsite Tabs: Home Tab (cont d) Home Tab : Review Patient Casebooks for selected patient(s) 2- Once patients are selected, select then the activity and click Go (Default activity is Open Patient Casebook, but you may select another activity with the dropdown list) 1-Patients are selected individually or all in one click ( Select All ) 8 8

9 II- RDC Onsite overview RDC Onsite Tabs: Casebooks Tabs From the Casebook Tab, you will: View patients CRF pages Perform Data Entry 1 row= 1 patient Only 1 visit displayed at a time Select a following visit ( By default, first visit is displayed) View the following patients (from those selected) It s also possible to select patient(s), then an activity from this Tab (In this example, it will bring you to the Reports Tab) Data entry functionalities View the following visit pages 9

10 II- RDC Onsite overview RDC Onsite Tabs: Review Tab =>4 sub Tabs See at following pages Inv. Comments : should not to be used The Review Tab consists of 4 sub-tabs; 3 are used: CRFs sub- tab (default sub Tab) : shows a consolidated view of RDC Onsite pages to review entered RDC Onsite pages to review a selection of pages and resolve issues on pages To approve selected pages 1 row= 1 page Several visits can be displayed at a time Discrepancies sub-tab : to review only the RDC Onsite pages with discrepancies / queries to your action Investigator comments sub-tab (should not be used ) Special Listings sub tab : to generate a patient report on coded data (i.e. AE, Medications) ; Patient may have been selected from the Home page, by indicating Review entered CRF activity Possibility to select CRF page individually or to Select All It s also possible to select patient(s) and activity from this sub-tab In this example, to approve all selected page(s) 10 CRFs tab displays pages for which data have been recorded 10

11 II- RDC Onsite overview RDC Onsite Tabs: -d- Report Tab Report Tab allows to view a Patient Data Report (PDR) or a Blank Casebook report PDR: pdf file of all the RDC Onsite pages collected for a patient, including discrepancies and audit history (site will be provided with these report at the end of the study) Blank CRF: pdf file of blank CRF for a patient New Patient Data Report or New Blank Casebook report are generated by the Data Manager/ or CRA Please do not generate a new report, but only view an existing one With the name of the report, identify: -a Patient Data report -a Blank Casebook report: job name contains BLKN View an existing report by clicking on this link 11

12 II- RDC Onsite overview Search pane Search functionality is available from any Tab, but search criteria are different from one tab to another When no patient have been selected from the Home Tab, you will need to use the Search function To select patients: click here to select the first patient of the range ; this opens a second search window (see below) To select patient: click here to select the last patient of the range ; if no last patient is selected, only the first patient of the range is displayed (see below) Clear to remove selected criteria 1 row= 1 patient ID Click on this icon to quick select one patient Id To select any other criteria: use the drop-down box Click Go to view all the pages for all patients that have been selected By default, all the criteria are selected; If you click on Go with no specific criteria defined, you will get all pages for all patients 12

13 II- RDC Onsite overview Patient icon Patient icon colors indicate patient data entry status or patient data validation status There is at least one discrepancy to your action for this patient There is at least one other discrepancy (not to your action) for this patient Data entry not yet started for this patient Data entry started No discrepancies for this patient 13

14 II- RDC Onsite overview Page icons Page icon colors and signs indicate page data entry, data validation, verification, and approval status ; They may cumulate on the same page 4- Checkmark at the left top of the page: Monitor has flagged the page as verified 5- Checkmark at the left top of the page + red arrow: page has been changed since last verification; needs to be reverified by the Monitor 6- Signature at the bottom of the page : Investigator has approved the page 7- Red page: at least one discrepancy for your action on this page 10- Loaded data (i.e Laboratory data) 1- Blank page, with green arrow: Page never entered; data are expected for this page 2- Page with writing signs: data entry done for this page and no discrepancies 3- Blank page, no writing signs: page has been intentionally marked as blank 8- Signature at the bottom of the page + red arrow: page has been changed since last approval; needs to be re-approved 9- Yellow page: at least one other discrepancy (not for your action) on this page Note: on the example page is also flagged as verified by the Monitor 14

15 II- RDC Onsite overview ecrf page 1- Open the ecrf page by clicking on the page icon ecrf page Tool bar (see explanations at next page) To move to the next /previous CRF page Indicates fields highlighted on the page; by default, Active Discrepancies is selected, then all page red fields are highlighted Discrepancy pane To close the page To open audit history pane To open discrepancy/query pane Audit history pane 15

16 II- RDC Onsite overview Page tool bar Page tool bar is displayed at the top of RDC Onsite page Verification history Investigator comments (should not be used) Delete Row Delete page Save data Add a discrepancy (for CRA or Data Manager - Should not be used by site users ) Blank- Unblank page Single page Approval (Investigator) Print page 16 16

17 III- Completing Tasks Record Patient Data Steps to enter patient data From the Home Tab, select one patient, and move to the Casebooks Tab 2- Select Open Patient Casebooks (default choice) 1- Select patient 3- Click Go On the Casebooks Tab, select the appropriate visit 4-Select visit 17 17

18 III- Completing Tasks Record Patient Data Steps to enter patient data (Cont d ) 5- Click on page icon to open the page 8 a- Move directly to the next page if you want to perform data entry for the next page 6- Record data in fields 7-Save your page when data entry is finished 8b- Or close the page if you do not want to enter data on the next page 18

19 III- Completing Tasks Record Patient Data Data Entry Formats Below the default field formats in RDC Onsite In addition to this, user may refer to Study Data Entry Convention Field Acceptable data format Date Time Checkbox Must be DD-MMM-YYYY or DD-MM-YYYY or DD-MM-YY or use the calendar Partial date accepted for medication and surgery Shortcuts: Enter T for Today, Y for Yesterday, L for last date entered in the system Use the 24 hour clock 22: Click on the box to select it Acceptable List of values When a magnifying glass icon is close to the field, this indicates that a list is attached Free text Numeric Use. and not, Compute Age is automatically calculated 19

20 2- Select patient III- Completing Tasks Record Patient Data Add an unplanned page to a visit 3- Click Add visit page Add visit page = add a new page to a visit from the list of the pages setup for this visit (this list is defined by Data Manager ) e.g. : Add an AE page to the AE/SAE visit 1- Select appropriate visit 4- Select the type of page to be added (for AE/SAE visit, only an AE page can be selected) 5- Click Continue This number in the box indicates that this is the first added page; automatically selected, no need to change 7- Click on the new page added to open the page and start data entry 6- Click Apply 20

21 III- Completing Tasks Record Patient Data Delete a page 1st case : Delete a planned page If deleting a normal page (page planned for the visit, data entry requested for this page)=> page status will turn to Data entry not done (blank page with green arrow) If deleting an unplanned page ( page that has been added to a visit )=>page will disappear 1- Select patient 2- Open the page you want to delete 3- Click on the Trashcan button 2nd case: Delete a unplanned page 4- Click Delete When a page that was added to the visit is deleted, page icon disappears Page status turns to Data entry not done 21

22 III- Completing Tasks Record Patient Data Blank & Unblank page To re-open the fields for data entry: A page is marked Intentionally blank by clicking the box at the top of the page; all the fields into the page turn to grey and are not enterable 1- Click on Blank-Un blank tool 2- Uncheck the first box on top 4- Uncheck now this box for the page section 6- Save the changes on the page 3- Click OK 5- Confirm Fields are now reopened for data entry Specific case: AE/SAE page contains 2 page sections: ADVERSE EVENT (AE1) and SAFETY COMPLEMENTARY FORM (SAEC2) Uncheck the second box to un blank the section for the Safety Complementary Form 22 22

23 III- Completing Tasks Record Patient Data Delete a row 2- Click on the tool Delete row 3- Click Save 1- Click on the row to be deleted Row is deleted Note: Do not clear each of the fields of one row one by one :the row remains in the system and there will be a discrepancy generated for each of missing fields 23

24 III- Completing Tasks Record Patient Data Answer to a validation message during data entry Data Manager sets up validation rules on standard modules to detect values out of range, erroneous data format, time consistency between dates, or missing mandatory fields. Those rules are activated on field data entry, or when page is saved Example #1 : value recorded is out of the normal bounds set up in the system 2 options: 1st option : Value is not the right one; a new value must be recorded 2nd option: Value is the correct one and is confirmed Validation Error window pops up Value out off normal bounds is entered in the system : when moving to the next field 24

25 III- Completing Tasks Record Patient Data Answer to a validation message during data entry- Ex #1 1st option : Value is not the right one and a new value must be recorded 1- Click Cancel Field is cleared for new data entry : Perform new data entry

26 III- Completing Tasks Record Patient Data Answer to a validation message during data entry - Ex # 1 2nd option : Value entered is the correct one and is confirmed: a discrepancy message is sent to CRA to maintain the value in the system Send to CRA for Review 1- Indicate in comment section that value is confirmed 2- Send message to CRA Send to CRA for Review Under Investigator Review 3- Click OK The discrepancy is sent to the CRA 4- To view the new status of the discrepancy, select on the highlight box Active and Other Discrepancies Field will be displayed in yellow: this indicates that a the discrepancy is no more to your action, but is sent in that case to the CRA 5- Finish data entry -Save page and close CRA will review the discrepancy and then will close it 26

27 III- Completing Tasks Record Patient Data Answer to a validation message during data entry - Ex #2 Example # 2: one mandatory field has not been recorded =>system discrepancy is generated as page is saved 4- Save page after correction and close 1- Open discrepancy pane Field turns red on page save, indicating a discrepancy for your action on this field 3- Record missing data 2- Check the message of the discrepancy System discrepancy will close automatically upon data correction ; field color will turn to white 27

28 III- Completing Tasks Record Patient Data Perform data correction after page has been saved Each time a data, which has been saved, is modified, a popup window opens, requesting a Reason for change 3- Click save and close page 1-Open page and record a new value on data field Data correction is the default reason; no need to change it 2- Just click OK to make the change effective 28

29 III- Completing Tasks Record Patient Data View Page Audit History Data changed (after page save) are tracked in the Page Audit History 1- On the highlight box, select Audit History Field changed appears colored blue 3- Open Audit History pane 2- Click on blue field 4- View changes performed to the field, who did the change, when, comments & details 29 29

30 III- Completing Tasks Review page(s) entered 1- Select Review Tab: by default CRFs sub-tab is selected 2- Open the Search pane to select the pages you want to review 3- If necessary, sort pages by any of these columns (click on the column header) Indicates when the last modification was done to the page It s possible to open 3 ecrf pages at the same time (from the same Tab or from another Tab) Click on page icon to open page and perform correction if needed

31 III- Completing Tasks Review Adverse Events Special Listings allow the review of coded data, and more especially, the review of Adverse Events for one selected patient 1- Select Review Tab / Special Listings 2- Select one patient 3- Select MEDDRA /AE 4- Click Go 8- Click Refresh to view new page status after correction 5- Possibility to sort by verbatim (click on the header of the column) 6- Review here all the information about the AE 7- When needed, open page to perform correction 31

32 III- Completing Tasks Approve page(s) Only Investigator can approve pages Serious AE pages must be approved just after data entry Page can be approved individually, by clicking on the Approval tool bar icon, at the top of one opened ecrf page, or pages can be approved by group (see below) 1- Select Review Tab: by default CRFs sub-tab is displayed - Open the earch pane to elect the pages ou want to eview On this example, only Adverse Events pages are selected 3- Click go to execute the Search -Select ages for pproval 5- Click Go (Approve is the default choice) 6- Enter Username and Password (required as well for group pages approval or for single page approval 7- Uncheck these tow boxes to include all pages 8- Click Continue 32 32

33 III- Completing Tasks Find & Resolve discrepancies pending to your action Active Discrepancies (discrepancies where your action is needed) can be accessed either via the Review Tab, or by clicking on the Quick link Review Active Discrepancies from the Home Tab 1-From the Home Tab, click on the link Review Active Discrepancies Or select Discrepancies sub Tab from the Review Tab Possibility to open Search and select review criteria (i.e. only Medication pages, ) When needed, click here to get more information on the discrepancy (Date, history, review status, ) it s possible to sort any Tab by the column header (i.e Patient Number,, Description) Only the red pages- (pages where there is at least a discrepancy to your action)- are selected 2- Open page to resolve page discrepancies 33 33

34 III- Completing Tasks Find & Resolve discrepancies pending to your action 2- Open the discrepancy pane to view discrepancy description 1- Click on the red field to highlight the corresponding discrepancy on the discrepancy list (useful when several discrepancies)

35 III- Completing Tasks Find & Resolve discrepancies pending to your action A manual discrepancy should be returned to the author of the discrepancy : DM, CRA or PV (Please check the author at the Discrepancy Reason ) All discrepancies system generated ( where TYPE is NOT Manual Discrepancy from ) should be returned to CRA Note : Site User should not create manual discrepancy 3- Click here to display discrepancy details 4- Check at the discrepancy text 5- Check the author of the discrepancy (CRA, DM, PV or system) 6- With the Action, select the appropriate reviewer (CRA, DM or PV ) 8- Provide a comment Click Go : this will open the discrepancy answer box 9- Click OK

36 III- Completing Tasks Find & Resolve discrepancies pending to your action 10- Select Highlight= Active and other discrepancies to check the new status of the discrepancy 11- Save and close the page Field with other discrepancy (not to your action) is now highlighted in yellow Discrepancy turns yellow Discrepancy status is now Under CRA review Do not forget to correct data (i.e correct date of birth) if this is part of the resolution No more action for you on this page ; proceed similarly with the following red pages

37 III- Completing Tasks ecrf reports From the Home Page, you can generate study status reports 1-Click on one selected report Corresponding report is automatically generated 37 37

38 Should you need more information RDC Onsite Overview elearning module, as well just on time task-based module are available on the Sanofi R&D External Portal 1-On R&D computer systems portal, select TRAINING 2- Select ecrf Training for Site User 38 38

39 Should you need more information Required training to get user access Additional training or refresh training 39 39

40 Changes from OC/RDC to OC/RDC 4.6 The changes from OC/RDC to OC/RDC 4.6 are minor and intuitive Therefore elearning modules have not been updated for 4.6. From OC/RDC to 4.6 : ecrf Login simplified Security Procedure Anti-spam is removed from login page Two action buttons are removed (These 2 actions are now system- automatic) (See details on next slide) Please keep this information for your next visit of the elearning modules 40 40

41 Changes from OC/RDC to OC/RDC End ecrf Login procedure simplified Two action buttons are removed : Go button from Home Tab, and Refresh button from Casebooks Tab These 2 actions are now system-automatic 41 41