Optimizing the Use of Data Standards Project: SDTM Exceptions

Industry Co-Lead: Joanna Koft FDA Co-Lead: Jingyee Khou, Ph.D. SDTM Exceptions Industry Co-Lead: Joanna Koft FDA Co-Lead: Jingyee Khou, Ph.D. - Speak to need for additional industry co-lead

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

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.

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

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

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

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

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?

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

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

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