1. Defining & Managing Data Elements and Permissible Values or CDISC Terminology - A Use Case BACUN 2010-01-08 Barrie Nelson

2. 2 Outline  Controlled Terminology Driving Principles  CDISC SDTM Controlled Terminology  Amgen’s Controlled Terminology Solution –SDF-CT Solution –SDF-CT Architecture –SDF-CT Glossary  Discussion of SDF-CT Concepts  Conclusion  Q&A

3. 3 Driving Principles  Content & Semantics as important as structure  Consistent use of terminology facilitates: –Meta-analysis / data mining –Standardization  Adoption at the point of collection minimizes downstream data transformation –End-to-End Philosophy

4. 4 CDISC SDTM Controlled Terminology

5. 5 SDF-CT  Design Considerations: –NCI Terminology Repository (EVS & caDSR) –Internal Use Case (based on spreadsheets)  Integration with SDTM ETL tool –Develop as an integral tool within Amgen’s SDF System? –Develop as a standalone application?  Global Librarian –Successful adoption requires dedicated management  Harmonization across multiple CDM Systems –E.g. OC, EDC

6. 6 SDF–CT Application Architecture

7. 7 SDF-CT Glossary  Data Element: –Codelist Name (SAS Format name) –Data Element Version  Permissible Value: –Codelist item (SAS Format item)  Subset: –A distinct set of permissible values used in a defined application (e.g. domain/column)  Hierarchy –Key Group: A logical grouping of Data Elements (SAS Format Catalog) –Key Group Referrer: A hierarchical ordering of Key Groups (SAS FMTSEARCH)

8. 8 Data Elements

9. 9 Permissible Values

10. 10 Subsets of Permissible Values

11. 11 Subsets [contd.]

12. 12 Subscription

13. 13 Sentinel Alerts

14. 14 Sentinel Alerts [contd.]

15. 15 Extract and Report

16. 16 Conclusion  Clearly defined business rules for adopting CDISC Terminology are required  Terminology should be adopted at: –Point of Collection –Within an in-stream data flow  Integration with SDTM creation software/process –Apply integrity constraints against variables within domains –Facilitate creation of Define.xml  Standalone Tool –Share Terminology across Functions/Enterprise

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