Do not includ
.gitignorefiles into the final submission.
The objective of the R Consortium R submission Pilot 1 Project is to test the concept that a R-language based submission package can meet the needs and the expectations of the FDA reviewers, including assessing code review and analyses reproducibility. 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.
The RConsortium/submissions-pilot1 repo demonstrates an approach to organize internal developed R function and table, listing, figure generation program using 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.
The folder is organized as a demo eCTD package following ICH guidance.
m1/: module 1 of the eCTD package
m1 └── us ├── cover-letter.pdf # Submission cover letter └── report-tlf.pdf # Submission TLFs
Note: the TLF format in
report-tlf.pdfis not consistent, because it reflects different table layouts in different organizations.
m5/: module 5 of the eCTD package
m5 └── datasets └── rconsortiumpilot1 └── analysis └── adam ├── datasets # ADaM datasets in XPT format │ ├── adadas.xpt │ ├── adae.xpt │ ├── adcibc.xpt │ ├── adlbc.xpt │ ├── adlbcpv.xpt │ ├── adlbh.xpt │ ├── adlbhpv.xpt │ ├── adlbhy.xpt │ ├── adnpix.xpt │ ├── adrg.pdf # Analysis Data Reviewer's Guide │ ├── adsl.xpt │ ├── adtte.xpt │ ├── advs.xpt │ ├── define.xml # ADaM data define file │ └── define2-0-0.xsl └── programs ├── r0pkg.txt # Proprietary R package in txt format ├── tlf-demographic.r # analysis R code for TLFs. ├── tlf-efficacy.r ├── tlf-kmplot.r └── tlf-primary.r
Other files: (Do not include in eCTD package)
.gitignore: git ignore file
README.md: readme file for github repo
- Successful R-based Test Package Submitted to FDA
- Update: Successful R-based Test Package Submitted to FDA
Report issues in https://github.com/RConsortium/submissions-pilot1-to-fda/issues