1. SDTM and ADaM Implementation FAQ
WG: Optimizing the Use of Data Standards
Project Team Wrap Up from CSS
21th March, 2017
Presented by Co-Leads
Bhavin Busa
Mathew Bryant

2. Sub-team Outcomes, Day 1 Over 75 attendees
Robust Discussion on general operating rules of collecting, rejecting, response development, and publishing
Agreed to not interpret regulatory or standards guidance

3. Sub-team Outcomes, Day 2
SDTM/ADaM IG Nuances, Mike Hamadi, Lead Team completed review and drafted responses to questions submitted to date Validation/Conformance Rules, Veena Nataraj, Lead Data Submissions (SDTM and ADaM), Bhavin Busa, Nate Freimark, Co-Leads Team completed review of drafted responses Agreed to request a white paper that captures case studies of submission that contained both legacy and CDISC data Trial Design Domains, Diane Wold, Lead Therapeutic Area Specific – Recruiting Lead Legacy SDTM Mapping – Recruiting Lead

4. Collaboration Tools PhUSE Wiki (Open to PhUSE Membership)
Project Teamwork site (Open to Team Members Only)