The objectives of the R Consortium R Submission Pilot 3 Project are:
- Deliver a publicly accessible R-based Submission through the eTCD portal
- Expand on the work done in Submission Pilot 1, by now utilizing R to generate ADaM datasets.
NOTE: This is a FDA-industry collaboration through the non-profit organization R Consortium.
This website encapsulates the hard-work of some intrepid statistical programmers from across the Pharma Industry to demonstrate a R-based Submission to the FDA.
The website is divide into 4 sections that will walk you through our efforts:
- Project Background/Setup - Scope of work, what we used and how we used it.
- Deliverables - What was sent to the FDA - Cover Letter, TLFs, Datasets, ADRG.
- Conferences - Proceedings from different conferences on Pilot Submissions
- FDA Feedback - Specific feedback from FDA on this Submission
Don’t be shy! We like to chat about R and Submissions. Find us on pharmaverse slack