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Outline

Defining & Managing Data Elements and Permissible Values or CDISC Terminology - A Use Case BACUN 2010-01-08 Barrie Nelson. Outline. Controlled Terminology Driving Principles CDISC SDTM Controlled Terminology Amgen’s Controlled Terminology Solution SDF-CT Solution SDF-CT Architecture

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Outline

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  1. Defining & Managing Data Elements and Permissible Values or CDISCTerminology - A Use CaseBACUN 2010-01-08Barrie Nelson

  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. 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. CDISC SDTM Controlled Terminology

  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. SDF–CT Application Architecture

  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. Data Elements

  9. Permissible Values

  10. Subsets of Permissible Values

  11. Subsets [contd.]

  12. Subscription

  13. Sentinel Alerts

  14. Sentinel Alerts [contd.]

  15. Extract and Report

  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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