R Submission Pilot 1

Pilot 1 - Common Analyses

Goal: Example R based submission contains common analyses, submission through the current FDA e-submission system and process.

Key evaluation aspects:

  • For Submitter
    • Submission of proprietary R packages
    • Preparation of R-based submission materials
  • For FDA Staff
    • Reproduce analysis results by reconstructing submitted proprietary packages / retrieving open source packages

Data and analysis scope:

  • 4 TLFs
  • Simulated data from CDISC Pilot

Success Criteria:

  • Submitter:
    • Successfully submit via eCTD portal
  • FDA Reviewer:
    • Reproduce analysis results

Timeline: - Submitted 2021 Nov (v0.1.0) - FDA first response 2021 Nov - Resubmission 2022 Feb (v0.1.0)


R Submission Pilot 1 Development Repo

R Submission Pilot 1 eCTD Submission Package to FDA

Additional Activities - explore pilot submissions to other HAs (Japan, China)

Key team members:

Developer team:
- Ning Leng, Heng Wang (Roche)
- Mike Stakehouse, Eli Miller (Atorus)
- Yilong Zhang, Peikun Wu (Merck)

Esub team:
- Beverly Chin (Roche)
- Tim Powell (Biogen)

FDA Staff:
- Paul Schuette
- Hye Soo Cho