WG4: Standards Implementation Issues with CDISC Data Models

1. WG4: Standards Implementation Issues with CDISC Data Models Team Update: June 18, 2012

2. Meeting Purpose and Outcomes Purpose Provide WG4 volunteers with an update of WG4’s activities since the conference , help guide them through the Wiki, Kickoff for Data Guide Outcomes • Volunteers are able to review WG4 content on wiki and post discussion comments • Next steps for Data Guide Sub-team • Volunteers will understand their action items and WG4’s next steps

3. Agenda • Introductions • Re-cap of Conference outcomes • Wiki Overview • Data Guide Sub-team Kickoff • Next Steps: Co-Leads and Volunteers • Q&A

4. WG4 Leadership Helena Sviglin, CDER Steve Wilson, CDER John Brega, PharmaStat Joanna Koft, Biogen Idec Liz Leahy, Roche Scott Bahlavooni, Genentech

5. WG4 Conference Outcomes Identified 3 workstreams: • Data Guide • SDTM submission exceptions • Challenges Industry facing with implementing standards

6. Since the conference…. • Weekly Teleconference • Developed content on the wiki • Creating project-specific pages • Gathering Data Guide Examples/Analysis • Testing Wiki Functionality • Update to Steering Committee

7. Wiki Overview Main source of content! • General Information • Meeting Minutes and Presentations • Current Projects • Discussion Threads • Issues List: The parking lot is open!

8. Data Guide Sub-team Kickoff 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

9. Data Guide Sub-team Kickoff 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

10. Data Guide Sub-team Kickoff Project Plan: • Proposal to FDA via sub-team representative • Create master Data Guide incorporating FDA feedback • Review/Finalize • Next Steps

11. Data Guide Sub-team Kickoff Next Steps: Co-Leads • Co-leads to post project plan with timeline to wiki • Begin to consolidate comments • Set up next teleconference update

12. Data Guide Sub-team Kickoff Next Steps: Volunteers • Create Phuse wiki account • Add a reply to the “Getting Familiar with the Wiki” discussion • Review Data Guide Analysis and Examples • Provide feedback on Doug Warfield’s example • Contribute to the “Data Guide Content” discussion • Add additional discussion topics as needed

13. Data Guide Sub-team Kickoff FDA perspective Douglas Warfield CDER/FDA

14. Meeting Purpose and Outcomes Purpose Provide WG4 volunteers with an update of WG4’s activities since the conference , help guide them through the Wiki, Kickoff for Data Guide Outcomes • Volunteers are able to review WG4 content on wiki and post discussion comments • Next steps for Data Guide Sub-team • Volunteers will understand their action items and WG4’s next steps

15. Questions