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.
- Pilot 1: R based CDER submission of static outputs (completed)
- Pilot 2: R based CDER submission with a shiny component (completed)
- Pilot 3: R based CDER submission of ADaM dataset (completed)
- Pilot 4: R based CDER submission with a container component (under development)
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
R submission pilot 3 - Final eCTD submission package to FDA
Development repo for R submission pilot 4
[2024/08/08] Pilot 3 (ADaM) FDA response letter received! link
[2023/09/28] Pilot 2 (shiny) FDA response letter received! link
[2023/09/11] Pilot 3 (ADaM) has been successfully submitted to FDA
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