R Submission Pilot 2

Pilot 2 - shiny submission

Goal: Example R based submission contains a shiny app, submission through the current FDA e-submission system and process

Key evaluation aspects:

  • For Submitter
    • Submission of an shiny app through the eCTD portal
    • The shiny codes will be provided as a proprietary R package
  • For FDA Reviewer
    • Reproduce analysis results by deploying the shiny app on a FDA laptop/server

Timeline: 2022 H1

Data and analysis scope:

  • a shiny app that displays the 4 TLFs submitted in pilot 1, with basic data set filtering functionalities.
  • Simulated data from CDISC Pilot (the same data set as in pilot 1)


R Submission Pilot 2 Development Repo

R Submission Pilot 2 eCTD Submission Package to FDA

Key team members:

Developer team:
- Ning Leng, Heng Wang (Roche)
- Mike Stakehouse, Eli Miller (Atorus)
- Yilong Zhang, Gregery Chen (Merck)
- Eric Nantz (Eli Lilly)

FDA Staff:
- Paul Schuette
- Hye Soo Cho