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WG4: Standards Implementation Issues with CDISC Data Models
Team Update: June 18, 2012
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Meeting Purpose and Outcomes
PurposeProvide 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
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Agenda
• Introductions• Re-cap of Conference outcomes• Wiki Overview• Data Guide Sub-team Kickoff• Next Steps: Co-Leads and Volunteers• Q&A
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WG4 Leadership
Helena Sviglin, CDERSteve Wilson, CDERJohn Brega, PharmaStatJoanna Koft, Biogen IdecLiz Leahy, RocheScott Bahlavooni, Genentech
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WG4 Conference Outcomes
Identified 3 workstreams:1.Data Guide2.SDTM submission exceptions3.Challenges Industry facing with
implementing standards
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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
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Wiki Overview
Main source of content!– General Information– Meeting Minutes and Presentations– Current Projects• Discussion Threads
– Issues List: The parking lot is open!
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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
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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
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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
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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
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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
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Data Guide Sub-team Kickoff
FDA perspective Douglas WarfieldCDER/FDA
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Meeting Purpose and Outcomes
PurposeProvide 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
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Questions