WG4: Standards Implementation Issues with CDISC Data Models

Team Update: June 18, 2012

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

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, CDERSteve Wilson, CDERJohn Brega, PharmaStatJoanna Koft, Biogen IdecLiz Leahy, RocheScott Bahlavooni, Genentech

WG4 Conference Outcomes

Identified 3 workstreams:1.Data Guide2.SDTM submission exceptions3.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 WarfieldCDER/FDA

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

Questions