https://github.com/RConsortium/submissions-pilot2-to-fda
eCTD package for pilot 2 submission
https://github.com/RConsortium/submissions-pilot2-to-fda
Last synced: 4 months ago
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eCTD package for pilot 2 submission
- Host: GitHub
- URL: https://github.com/RConsortium/submissions-pilot2-to-fda
- Owner: RConsortium
- Created: 2022-08-31T17:24:58.000Z (over 2 years ago)
- Default Branch: main
- Last Pushed: 2023-09-28T17:43:35.000Z (over 1 year ago)
- Last Synced: 2024-08-13T07:18:28.925Z (8 months ago)
- Language: XSLT
- Size: 4.07 MB
- Stars: 23
- Watchers: 7
- Forks: 7
- Open Issues: 1
-
Metadata Files:
- Readme: README.md
Awesome Lists containing this project
- jimsghstars - RConsortium/submissions-pilot2-to-fda - eCTD package for pilot 2 submission (XSLT)
README
> 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](https://github.com/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](https://rconsortium.shinyapps.io/submissions-pilot2/).
The [RConsortium/submissions-pilot1-to-fda](https://github.com/RConsortium/submissions-pilot1-to-fda)
repository demonstrates the eCTD submission package based on the [RConsortium/submissions-pilot1](https://github.com/RConsortium/submissions-pilot1) repo.
The [RConsortium/submissions-pilot1](https://github.com/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](https://github.com/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](https://rconsortium.github.io/submissions-wg/) and the [R consortium working group page](https://www.r-consortium.org/projects/isc-working-groups).
## FDA Response
- Initial submission
+ version: [v0.1.0](https://github.com/RConsortium/submissions-pilot2-to-fda/releases/tag/v0.1.0)
+ [Cover letter](https://github.com/RConsortium/submissions-pilot2-to-fda/blob/main/m1/us/cover-letter.pdf)
- [FDA response letter](https://github.com/RConsortium/submissions-wg/blob/0f1dc5c30985d413f75d196c2b6caa96231b26ee/_Documents/Summary_R_Pilot2_Submission%2027SEP2023.pdf)
## Run Shiny Application
To run the Pilot 2 Shiny application, you can follow the steps described in the
[ADRG document](https://github.com/RConsortium/submissions-pilot2-to-fda/blob/main/m5/datasets/rconsortiumpilot2/analysis/adam/datasets/adrg.pdf) based on the
[program saved in the module 5](https://github.com/RConsortium/submissions-pilot2-to-fda/tree/main/m5/datasets/rconsortiumpilot2/analysis/adam/programs). A web version of the ADRG is also available at .
The application is also available online at [rconsortium.shinyapps.io/submissions-pilot2](https://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
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## Questions
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