Overview

The objectives of the R Consortium R Submission Pilot 5 Project are:

1. Deliver a publicly accessible R-based Submission through the eCTD portal using datasetjson.
2. Expand on the work done in Submission Pilot 1 and Pilot 3, by now utilizing R to generate ADaM datasets.

NOTE: This is a FDA-industry collaboration through the non-profit organization R Consortium.