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.

Website

Submission Pilots

• 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)

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

R submission pilot 3 - Final eCTD submission package to FDA

Development repo for R submission pilot 4

News

[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

2021/12/08 Successful R-based Test Package Submitted to FDA