submissions-wg
R Submissions Working Group
Welcome to the R Consortium "R Submission" Working Group
The R submission working group is a cross industry pharma working group focusing on improving practices of R-based clinical trial regulatory submission.
Submission Pilots
- Pilot 1: R based CDER submission of static outputs (completed)
- Pilot 2: R based CDER submission with a shiny component (under review)
- Pilot 3: R based CDER submission of ADaM dataset (under development)
- Pilot 4: R based CDER submission with a container component (under development)
Related repositories:
Development repo for R submission pilot 1
R submission pilot 1 - Final eCTD submission package to FDA
Development repo for R submission pilot 2
R submission pilot 2 - Final eCTD submission package to FDA
Development repo for R submission pilot 3
News
2022/12/07 Successful R-Based Package Submission with Shiny Component to FDA
2022/03/16 UPDATE: Successful R-based Test Package Submitted to FDA