Do not includ
README.md
and.gitignore
files into the final submission.
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.
- Initial submission
TBD
TODO: Add reference to ADRG
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 # Application R package in zip archive
Other files: (Do not include in eCTD package)
.gitignore
: git ignore fileREADME.md
: readme file for github repo
Report issues in https://github.com/RConsortium/submissions-pilot4-to-fda/issues