1. WG4: Data Guide/Data Description Work Group Meeting August 29, 2012

2. Agenda Introductions Recap of Data Guide project plan Purpose and scope for this work group Summary of activities to date Initial review of proposed data description content Next steps

3. Data Guide Sub-team Sub-team Co-leads: – Scott Bahlavooni, Genentech – Joanna Koft, Biogen Idec – Gail Stoner, J&J (also CDISC liaison) – Helena Sviglin, CDER FDA – Douglas Warfield, CDER FDA – Amy Malla, CBER FDA

4. Data Description Work Group Gail Stoner – Lead Scott Bahlavooni John Brega Nancy Brucken John Franchino Susan Kenny Steve Kirby Misty Odle Madhavi Vemuri Lin Yan

5. Data Guide Project Plan (1) Project Plan: – Review existing Data Guide examples and begin discussion around content – Identify “required” and optional/recommended sections of content and develop clear descriptions – Create best practice content (review, finalize) – Repeat above process for format/structure – Create proposed template for Data Guide We are here

6. Data Guide Project Plan (2) Project Plan: – Proposal to FDA via sub-team representative – Create master Data Guide incorporating FDA feedback – Review/Finalize – Next Steps

7. Action Plan Form three work groups to further define intended content and organization of content – Study level – Data description – Data validation Sub-team leads to compile updated template Sub-team members to pilot template and bring results back to work group Obtain comment from sub-team and FDA Finalize and publish template Our work group

8. Activities completed to date Reviewed examples posted on Wiki from – Doug Warfield – Pharmastat – CDISC SDTM Metadata Submission Guideline – Several others Summary of comments – 8 people posted comments – Focus was on template provided by Doug Warfield and SDTM Suggestion: Develop SDTM Data Guide first and then go back to ADaM

9. Discussion Question Responses - General Generally positive comments on the template but many comments/concerns on details of content Majority of respondents questioned duplication of information found in SDTM documentation, define.xml, or elsewhere in submission – Suggestions to focus on information unique to the trial or clarify areas of potential confusion

10. Discussion Question Responses – Data Description aCRF – Indicate if there are multiple data sources (secondary CRFs for substudy, diary, etc) – Indicate other data sources/forms not included in SDTM (e.g., operational forms processed by other functions such as SAEs) – Explain any annotation conventions that might not be obvious to reviewers CT – Intent of section not clear – Could be used to describe sponsor extensions to CDISC CT or mapping of collected terms to standard CT – Comment on level of adherence to CDISC CT – Move after Domains section?

11. Discussion Question Responses – Data Description Domains – Focus on non-standard information; avoid duplication of define.xml Custom domains “Odd” mapping situations Derived domains (e.g., EX) Describe domains of primary importance – Whether data on screen failures submitted – Whether any domains not submitted due to no data – Explain data found in SUPP--, FA, RELREC – Assignment errors – Data cutoff

12. Aug 29 Attendees Gail Stoner – Lead√ Scott Bahlavooni John Brega √ Nancy Brucken John Franchino Susan Kenny √ Steve Kirby √ Misty Odle Madhavi Vemuri √ Lin Yan √

13. Notes from Aug 29 meeting See Data Description Sections Details.docx – Reviewed and commented on Overview and aCRF sections – Will begin with Domains section at next meeting General comments – Standard format very important for reviewers – reduces “noise” – Important to pilot proposed template in 10-12 studies and include in FDA review – ADaM data guide may be a separate team Susan has examples of ADaM data guide to post Although content may differ, try for a common look and feel

14. Next Steps Next meeting Tues., Sep. 4 at 3 PM Eastern Agenda: Continue to discuss Data Description Section Details document – Start with Domains section – CT section – Rank value to reviewers – Order/organize

15. Links phuse wiki home page FDA Working Groups home page Work Group 4: Standards Implementation Issues Work Group 4: Standards Implementation Issues Data Guide project