View Attendee List
- “Joseph Rickert - R Consortium”
- “Adrian Waddell - Roche”
- “Doug Kelkhoff - Genentech”
- “Bob Engle - Biogen”
- “Juliane Manitz - Emd Serono”
- “Lyn Taylor - Phastar”
- “Mike Stackhouse - Atorus”
- “Paul Schuette - FDA”
- “Sascha Ahrweiler - Bayer”
- “Sean Lopp - RStudio”
- “Tadeusz Lewandowski - Roche”
- “Yilong Zhang - Merck”
- “Paulo Bargo - Janssen”
- “Andy Nicholls - GSK”
- “Keaven Anderson - Merck”
- “Kevin Bolger - Procogia”
Joseph Rickert opened the meeting and provided a brief overview of R Consortium Working Group concerned with Pharma related topics:
- The R Validation Hub is working towards developing standards and tools for assessing the risk associated with working with R packages in regulatory environments
- The RTRS Working Group is working for a standard for developing R packages that will be meet the 21 CFR Part 11 standard for constructing tables for clinical trials and FDA submissions
- This new R Submissions working group will focus on IT and infrastructure issues
Paul Schuette of the FDA then gave a brief overview of FDA Submissions Infrastructure. He described:
- The Electronic Common Technical Document
- The ECTD Technical Guide
- ECTD M1 to M5 File Structure
- The Study Data Resources Document
- The Study Data Technical Conformance Guide
- CDISC - Clinical Data Interchange Standards Consortium
- STDM - Study Data Tabulation Model
- ADaM - Analysis Data Model
Adrian Waddell asked how flexible the FDA was willing to be on this infrastructure and whether it could be negotiated. Paul Schuette indicated that negotiation was possible. Thereafter, followed a robust discussion which was recorded and available on the R Consortium YouTube Channel at this link.