R Submissions Pilot 4 ECTD Package

2024-09-19T19:10:29+00:00

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

Overview

The objective of the R Consortium R submission Pilot 4 Project is to test the concept that a Shiny application created with the R-language can be bundled with novel technologies and transferred successfully to FDA reviewers. The application was built as a modified version of the application contained R submission Pilot 2 Project, with materials available on the RConsortium/submissions-pilot2 repository, 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.

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

Instructions for Electronic Gateway Transfer

Due to a limitation on file size imposed by GitHub, this repostitory does not include the pilot 4 pre-compiled application file r4app.zip. Please use the following procedure to prepare the local clone of this repository for the electronic gateway transfer:

1. Clone this repository to your local machine or download the ZIP archive of the repostory using https://github.com/RConsortium/submissions-pilot4-webR-to-fda/archive/refs/heads/main.zip and extract to your local machine.
2. Create a new directory called programs in the m5/datasets/rconsortiumpilot4/analysis/adam/ directory.
3. Download the r4app.zip archive from this link and save it to the m5/datasets/rconsortiumpilot4/analysis/adam/programs/ directory.

FDA Response

• Initial submission

TBD

Run Shiny Application

To run the Pilot 4 Shiny application using web-assembly, you can follow the steps described in the ADRG document. A web (HTML) version of the ADRG is also available at https://rpodcast.quarto.pub/pilot4-webassembly-adrg/.

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
    └── rconsortiumpilot4webR
        └── analysis
            └── adam
                ├── datasets              # ADaM datasets in XPT format
                │   ├── adadas.xpt
                │   ├── adlbc.xpt
                │   ├── adrg.pdf          # Analysis Data Reviewer's Guide
                │   ├── adsl.xpt
                │   ├── adtte.xpt
                │   ├── define.xml        # ADaM data define file
                │   └── define2-0-0.xsl
                └── programs
                    ├── r4app.zip         # Pre-compiled application in zip archive

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 2024-09-19T19:10:29+00:00 .

Questions

Report issues in https://github.com/RConsortium/submissions-pilot4-to-fda/issues