R Submissions Pilot 5 ECTD Package

2025-10-03T17:31:39+00:00

Do not include README.md and .gitignore files into the final submission.

Overview

The objective of the R Consortium R Submission Pilot 5 Project is to test the concept that an R-language based submission package can meet the needs and the expectations of the FDA reviewers, including assessing code review and analyses reproducibility. All submission materials and communications from this pilot are publicly available, with the aim of providing a working example for future R-language based FDA submissions. This is an FDA-industry collaboration through the non-profit organization R Consortium.

The RConsortium.submissions-pilot5-datasetjson-to-fda repository demonstrates the eCTD submission package based on the RConsortium.submissions-pilot5-datasetjson repository.

The RConsortium.submissions-pilot5-datasetjson repository demonstrates an approach to organized an R-language based submission, including JSON data files as ADaM/SDTM data sets, tables, and figures.

To learn more about other pilots, visit the R Consortium R Submission Working Group website and the R Consortium Working Groups webpage.

FDA Response

• Initial submission
  • version: [v0.1.0] (link TBC)
  • Cover letter (Draft version)

Folder Structure

The folder is organized as a demo eCTD package following ICH guidance.

eCTD package:

• m1/: module 1 of the eCTD package

m1
└── us
    ├── cover-letter.pdf  # Submission cover letter

• m5/: module 5 of the eCTD package

m5
└── datasets
    └── rconsortiumpilot5
        ├── analysis
        │   └── adam
        │       ├── datasets
        │       │   ├── adadas.json
        │       │   ├── adae.json
        │       │   ├── adlbc.json
        │       │   ├── adrg.pdf
        │       │   ├── adsl.json
        │       │   └── adtte.json
        │       └── programs
        │           ├── adadas.r
        │           ├── adae.r
        │           ├── adlbc.r
        │           ├── adsl.r
        │           ├── adtte.r
        │           ├── pilot5-helper-fcns.r
        │           ├── renv-lock.txt
        │           ├── tlf-demographic.r
        │           ├── tlf-efficacy.r
        │           ├── tlf-kmplot.r
        │           └── tlf-primary.r
        └── tabulations
            └── sdtm
                ├── ae.json
                ├── cm.json
                ├── dm.json
                ├── ds.json
                ├── ex.json
                ├── lb.json
                ├── mh.json
                ├── qs.json
                ├── relrec.json
                ├── sc.json
                ├── se.json
                ├── suppae.json
                ├── suppdm.json
                ├── suppds.json
                ├── supplb.json
                ├── sv.json
                ├── ta.json
                ├── te.json
                ├── ti.json
                ├── tv.json
                └── vs.json

Other files: (Do not include in eCTD package)

• .gitignore: git ignore file
• README.md: readme file for github repo

News

The ECTD bundle and associated compiled application archive were last rendered on 2025-10-03T17:31:39+00:00 .

Questions

Report issues in https://github.com/RConsortium/submissions-pilot5-datasetjson/issues