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

ICON CD04 - Ensuring Compliant and Consistent Data Mappings for SDTM-based Studies – an ICON Approach Jennie Mc Guirk 11 th October 2011. Setting the Scene. Study 1 – PI/II. Study 2 – PIII. Study 3- CRO. Study 1. Study 2. Integrated. Custom Domains??. Value Level??.

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

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

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

  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 Define File Study1 SDTM Datasets Data Warehouse SDTM specification Annotated CRF Metadata

  5. Data Warehouse Build – multiple studies Study 1 Study 2 Study 3 Data Warehouse SDTM spec SDTM spec SDTM Spec aCRF aCRF aCRF 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 QNAM QLABEL 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 1 Study 2 Study 3 Integrated Supplemental Values Value Level Custom Domains 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 ?

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