R Submissions Pilot 4 ECTD Package

2025-02-04T21:42:19+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 part of the R Consortium Submission Pilot 2 Project with materials available on the RConsortium/submissions-pilot2 repository, The novel technologies evaluated in Pilot 4 are the following:

• WebAssembly
• Container Technology

This repository addresses the container technology portion. 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.

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-container-adrg/.

Folder Structure

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

TODO: Revise

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
    └── rconsortiumpilot4container
        └── 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
                    ├── Dockerfile # Docker container build instructions
                    ├── entrypoint.R # Utility R script to launch Shiny application in Docker
                    ├── submissions-pilot2 # R code for Shiny application

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 2025-02-04T21:42:19+00:00 .

Questions

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