SDTM and ADaM Implementation FAQ

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Presentation transcript:

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

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

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

Collaboration Tools PhUSE Wiki (Open to PhUSE Membership) http://www.phusewiki.org/wiki/index.php?title=SDTM_ADaM_Implementation_FAQ Project Teamwork site (Open to Team Members Only) https://phuse.teamworkpm.net/projects/157138/overview