The R Consortium is pleased to announce that on August 28, 2023, the R Submissions Working Group successfully submitted an R-based test submission pilot 3 package through the FDA eCTD gateway! The FDA CDER staff are now able to begin their evaluation process. All submission materials can be found at: https://github.com/RConsortium/submissions-pilot3-adam-to-fda
The pilot 3 test submission is an example of an all R submission package following eCTD specifications. These include the installation and loading of the proprietary {pilot3} R package and other open-source R packages, R scripts for the analysis data model (ADaM) datasets from pilot 3 and tables, listings, figures (TLFs) from pilot 1, analysis data reviewer’s guide (adrg), and other required eCTD components. To our knowledge, this is the first publicly available R-based FDA submission package, which includes R scripts to generate ADaM datasets and TLFs. We hope this submission package and our learnings can serve as a good reference for future R-based regulatory submissions from different sponsors. Additional agency feedback will be shared in future communications. For any future questions, you may contact the pilot 3 team here: https://rconsortium.github.io/submissions-pilot3-adam/main/index.html.
See here for more information about pilot 1, 2, 3 and the future plans for pilot 4.