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

Overview

The objective of the R Consortium R submission Pilot 2 Project is to test the concept that a Shiny application created with the R-language can be bundled into a submission package and transferred successfully to FDA reviewers. The application was built using the source data sets and analyses contained in the R submission Pilot 1 Project, with materials available on the RConsortium/submissions-pilot1 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.

While the intent of the project is to enable execution of the Shiny application in a reviewer's local R environment, a deployed version of the application is available in open access through the Shinyapps.io service at rconsortium.shinyapps.io/submissions-pilot2.

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

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

The RConsortium/submissions-pilot2 repository demonstrates an approach to organize a Shiny application as 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 response letter

Run Shiny Application

To run the Pilot 2 Shiny application, you can follow the steps described in the ADRG document based on the program saved in the module 5. A web version of the ADRG is also available at http://rsubmission-draft.website-us-east-1.linodeobjects.com/.

The application is also available online at rconsortium.shinyapps.io/submissions-pilot2.

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
    └── rconsortiumpilot2
        └── 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
                    ├── r1pkg.txt         # Application R package in txt format

Other files: (Do not include in eCTD package)

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

News

Questions

Report issues in https://github.com/RConsortium/submissions-pilot2-to-fda/issues