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submissions-wg

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R Submissions Working Group

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# 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](https://rconsortium.github.io/submissions-wg/)
  
# 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](https://github.com/RConsortium/submissions-pilot1)

[R submission pilot 1 - Final eCTD submission package to FDA](https://github.com/RConsortium/submissions-pilot1-to-fda)

[Development repo for R submission pilot 2](https://github.com/RConsortium/submissions-pilot2)

[R submission pilot 2 - Final eCTD submission package to FDA](https://github.com/RConsortium/submissions-pilot2-to-fda)

[Development repo for R submission pilot 3](https://github.com/RConsortium/submissions-pilot3-adam)

[R submission pilot 3 - Final eCTD submission package to FDA](https://github.com/RConsortium/submissions-pilot3-adam-to-fda)

[Development repo for R submission pilot 4](https://github.com/RConsortium/submissions-pilot4-webR)

# News

[2024/08/08] Pilot 3 (ADaM) FDA response letter received! [link](https://github.com/RConsortium/submissions-wg/blob/main/_Documents/Summary_R_Pilot3_Submission.pdf)

[2023/09/28] Pilot 2 (shiny) FDA response letter received! [link](https://github.com/RConsortium/submissions-wg/blob/0f1dc5c30985d413f75d196c2b6caa96231b26ee/_Documents/Summary_R_Pilot2_Submission%2027SEP2023.pdf)

[2023/09/11] [Pilot 3 (ADaM) has been successfully submitted to FDA](https://www.r-consortium.org/announcement/2023/09/11/first-publicly-available-r-based-submission-package-submitted-to-fda-pilot-3)

[2022/12/07 Successful R-Based Package Submission with Shiny Component to FDA](https://www.r-consortium.org/blog/2022/12/07/update-successful-r-based-package-submission-with-shiny-component-to-fda)

[2022/03/16 UPDATE: Successful R-based Test Package Submitted to FDA](https://www.r-consortium.org/blog/2022/03/16/update-successful-r-based-test-package-submitted-to-fda)

[2021/12/08 Successful R-based Test Package Submitted to FDA](https://www.r-consortium.org/blog/2021/12/08/successful-r-based-test-package-submitted-to-fda)

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