Note: this README.md is not part of the submission package: delete after read.
This repo contains a demo eCTD submission package (not R package) as a companion of the book R for Clinical Study Reports and Submission.
The folder structure only focuses on the primary components where R is involved:
- Module 1: administrative information and prescribing information
- Module 5: clinical study reports
thus is greatly simplified compared to a full submission package.
The example ADaM dataset is from the PHUSE CDISC Pilot replication ADaMs following ADaM IG v1.0, publicly available at the PHUSE Github Repository.
For a demo R package, check esubdemo.