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Optimizing the Use of Data Standards

Optimizing the Use of Data Standards. Project: SDTM Exceptions. SDTM Exceptions. Industry Co-Lead: Joanna Koft FDA Co-Lead: Jingyee Khou , Ph.D. SDTM Exceptions. Background WG4 identified issues Issues were categorized and prioritized 2012 PhUSE/CSS meeting: SDTM Data Guide

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Optimizing the Use of Data Standards

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  1. Optimizing the Use of Data Standards Project: SDTM Exceptions

  2. SDTM Exceptions Industry Co-Lead: Joanna Koft FDA Co-Lead: Jingyee Khou, Ph.D.

  3. SDTM Exceptions • Background • WG4 identified issues • Issues were categorized and prioritized • 2012 PhUSE/CSS meeting: • SDTM Data Guide • SDTM exceptions for submission • Brainstorming session • Proposed short list of data elements

  4. SDTM Exceptions • REV-030: • Sponsors often include unnecessary operational content that should not be submitted (e.g. subject initials) in sponsor-defined domains, core domain variables, supplemental qualifiers or FA.

  5. SDTM Exceptions • Project Objective: Develop a proposal document: • Project Rationale • Project Scope • Proposed List (examples/rationales) • Recommendations for use

  6. SDTM Exceptions • Project Tasks: • Further define project rationale • Identify issues • Why would this help

  7. SDTM Exceptions • Project Tasks: 2. Define project scope • What will include • Limited utility to FDA reviewers? • Limited utility to data analysis? • Define what is out of scope for project

  8. SDTM Exceptions • Project Tasks: 3. Review and modify existing proposed list of data elements of limited utility from PhUSE/FDA CSS 2012 meeting • Examples of data elements • Rationale for each data element

  9. SDTM Exceptions • Project Tasks: 4. Recommendations for next steps • What does the working group recommend as next steps to take with this document? • Facilitation of FDA/Sponsors working together?

  10. SDTM Exceptions • Project Tasks: 5. Internal review of proposal document by: • Optimizing Data Standards workgroup • Steering Committee • Any others?

  11. SDTM Exceptions • Project Tasks: 6. Revision and release of proposal document • FDA • Others?

  12. SDTM Exceptions • Project Breakout Sessions: • Session 1: Intro/Project Rationale/Scope • Session 2: Discuss data elements • Session 3: Examples/Rationales of data elements (subgroups) • Session 4: Present Examples/Discuss recommendations for use/Next Steps

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