R Submission Pilot 3
Goals:
- Expand on the work done in Submission Pilot 1, by now utilizing R to generate ADaM datasets.
- Deliver a publicly accessible R-based Submission to the FDA
Key evaluation aspects:
- For Submitter
- Generation of a reproducible R environment with a proprietary R package from git and open source R packages using
{renv} - Preparation of R-based submission materials
- Generation of a reproducible R environment with a proprietary R package from git and open source R packages using
- For FDA Staff
- Reproduce analysis results by reproducing the R environment and retrieving both proprietary & open source packages
Timeline:
- Submitted to FDA on August 28th, 2023
- Feedback from FDA on February 2nd, 2024 (See feedback here)
- Re-submitted to FDA on April 19th, 2024
Data and analysis scope:
- ADaMs created using R (SDTM
.xptsourced from the CDISC Pilot study) - TLFs created using R (ADaMs
.xptsourced from the ADaMs generated in R by the Pilot 3 team)
Links:
R Submission Pilot 3 Development Repo
- Development area for Pilot 3 Team
- See Closed Issues discussion for how we worked
- See Wiki for Common Issues we ran into and QC Findings we encountered when comparing the ADaMs generated in the CDISC Pilot study.
- We made use of a GitHub Project Board (Kanban Style Board) to drive development.
R Submission Pilot 3 eCTD Submission Package to FDA
- Materials submitted to the FDA following eCTD standards
- Breakdown of the Github repositories and files used for analysis development, e-submission and proprietary Pilot 3 R Package
- Renderings of ADaMs, TLFs, ADRG and Cover Letter
- Discussions at Conferences and feedback from FDA
Key team members:
Developer team:
- Joel Laxamana-Roche
- Thomas Neitmann-Denali
- Phanikumar Tata-Syneos
- Robert Devine-J&J
- Steven Haesendonckx-J&J
- Lei Zhao-Roche
- Nicole Jones-Denali
- Kangjie Zhang-Bayer
- Benjamin Straub-GSK
- Declan Hodges-GSK
- Bingjun Wang - Merck
FDA Staff:
- Paul Schuette
- Hye Soo Cho