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

2. 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

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