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

Overview

The objective of the R Consortium R submission Pilot 1 Project is to test the concept that a 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 a FDA-industry collaboration through the non-profit organization R consortium.

The RConsortium/submissions-pilot1-to-fda repo demonstrates the eCTD submission package based on the RConsortium/submissions-pilot1 repo.

The RConsortium/submissions-pilot1 repo demonstrates an approach to organize internal developed R function and table, listing, figure generation program using an R package.

To learn more about other pilots, visit the R consortium R submission working group website and the R consortium working group page.

FDA Response

• Initial submission

  • version: v0.1.0
  • Cover letter
  • FDA statistical review and evaluation response

• Updated submission

  • version: v0.1.1
  • Working group's response letter to FDA
  • Final statistical review and evaluation response from FDA

Re-run analysis

To re-run analysis, you can follow the steps described in the ADRG document based on the program saved in the module 5.

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
    └── report-tlf.pdf    # Submission TLFs 

Note: the TLF format in report-tlf.pdf is not consistent, because it reflects different table layouts in different organizations.

• m5/: module 5 of the eCTD package

m5
└── datasets
    └── rconsortiumpilot1
        └── analysis
            └── adam
                ├── datasets              # ADaM datasets in XPT format
                │   ├── adadas.xpt
                │   ├── adae.xpt
                │   ├── adcibc.xpt
                │   ├── adlbc.xpt
                │   ├── adlbcpv.xpt
                │   ├── adlbh.xpt
                │   ├── adlbhpv.xpt
                │   ├── adlbhy.xpt
                │   ├── adnpix.xpt
                │   ├── adrg.pdf          # Analysis Data Reviewer's Guide
                │   ├── adsl.xpt
                │   ├── adtte.xpt
                │   ├── advs.xpt
                │   ├── define.xml        # ADaM data define file
                │   └── define2-0-0.xsl
                └── programs
                    ├── r0pkg.txt         # Proprietary R package in txt format
                    ├── tlf-demographic.r # analysis R code for TLFs. 
                    ├── tlf-efficacy.r
                    ├── tlf-kmplot.r
                    └── tlf-primary.r

Other files: (Do not include in eCTD package)

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

News

• Successful R-based Test Package Submitted to FDA
• Update: Successful R-based Test Package Submitted to FDA

Questions

Report issues in https://github.com/RConsortium/submissions-pilot1-to-fda/issues