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

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

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

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

WG4 Conference Outcomes Identified 3 workstreams: 1.Data Guide 2.SDTM submission exceptions 3.Challenges Industry facing with implementing standards

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

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

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

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

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

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

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

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

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

Questions