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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 successfully 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 working group website.

The RConsortium/submissions-pilot2 demonstrates an approach to organize a Shiny application as an R package.

The RConsortium/submissions-pilot2-to-fda repo demonstrates the eCTD submission package based on the RConsortium/submissions-pilot2 repo.

Meeting Minutes

Repo wiki

FDA response

[2023/09/28] Pilot 2 (shiny) FDA response letter received! link

Installing teal :

Follow the link here

Running application

• Clone this repository to your local machine
• Open the project within RStudio, and run renv::restore() if prompted to restore the {renv} package library
• Open the app.R script and run the application within RStudio by clicking the Run App button