1. ICON CD04 - Ensuring Compliant and Consistent Data Mappings for SDTM-based Studies – an ICON Approach Jennie Mc Guirk 11 th October 2011

2. Setting the Scene Study 1 – PI/II Study 1 Study 2 Integrated Study 2 – PIII Study 3- CRO Value Level?? Custom Domains?? Supplemental Values?? Controlled Terminology??

3. An ICON Approach Compliancy – single study –Independent Review / Interpretation of IG –Validation methodologies (e.g. Double programming) –Integrity Checks –WebSDM –OpenCDISC –Define Checker Consistency – multiple studies –Data Warehouse Tool

4. Data Warehouse Build – single study Study1 SDTM Datasets Annotated CRF SDTM specification Data Warehouse Define File Metadata

5. Data Warehouse Build – multiple studies aCRFSDTM Spec Data Warehouse Study 1 aCRFSDTM spec Study 2 aCRFSDTM spec Study 3 Metadata

6. Data Warehouse Reports 7 Reports –Report 1: Summary of Domain Distribution by Study. –Report 2: Summary of Variable Distribution by Study. –Report 3: Summary of Variable Values by Study. –Report 4: SDTM Pairing of Test Code and Test Name. –Report 5: SDTM Extended Paired Variables. –Report 6: SDTM Nested Variable Values. –Report 7: CRF Page Number Comparisons.

7. Data Warehouse - Report 1 Summary of Domain Distribution by Study Consistency of Custom Domain Names

8. Data Warehouse - Report 2 Summary of Variable Distribution by Study QNAMQLABEL Consistency of Supplemental Variable Values

9. Data Warehouse - Report 3 Summary of Variable Values by Study VALUE Consistency of Value Level

10. Data Warehouse - Report 4 SDTM Pairing of Test Code and Test Name --TESTCD--TEST Consistency of Extensible Controlled Terminology

11. Data Warehouse - Report 5 SDTM Extended Paired Variables --TESTCD --TEST --STRESU --CAT Consistency of Paired Variables

12. Data Warehouse - Report 6 SDTM Nested Variables --TESTCD --TEST --CAT--SPEC Consistency of Nested Variables

13. Data Warehouse - Report 7 CRF Page Number Comparisons Consistency of aCRF and Define File

14. Conclusion Study 1 Study 2 Study 3 Study 2Study 3 Value Level Integrated Custom Domains Supplemental Values Controlled Terminology

15. Conclusion Effective Tool for individual / large scale projects Benefits –Efficient Data Integration –Report runs on individual study data -> no need for integration –ICON developed SAS tool ->Low cost to create & maintain –Harmonisation as new studies introduced to drug program –Harmonisation as company standards or IG evolves –Code reuse - SDTM, ADaM and TLGs –Aid Heath Authority Review Current Enhancement –Adding filtering to just highlight inconsistencies Future Enhancement –Add further reports / checks as required

16. Acknowledgements Co-author: Steven Thacker Tool Developer: Annie Gou

17. Ensuring Compliant and Consistent Data Mappings for SDTM-based Studies – an ICON Approach