pilot3.qmd

---
title: "R Submission Pilot 3"
---

**Goals**:

-   Expand on the work done in [Submission Pilot 1](pilot1.qmd), by now utilizing R to generate ADaM datasets.
-   Deliver a publicly accessible R-based Submission to the FDA

**Key evaluation aspects**:

-   For Submitter
    -   Generation of a reproducible R environment with a proprietary R package from git and open source R packages using `{renv}`
    -   Preparation of R-based submission materials
-   For FDA Staff
    -   Reproduce analysis results by reproducing the R environment and retrieving both proprietary & open source packages

**Timeline**:

-   Submitted to FDA on August 28th, 2023
-   Feedback from FDA on February 2nd, 2024 (See feedback [here](https://rconsortium.github.io/submissions-wg/minutes/2024-02-02/))
-   Re-submitted to FDA on April 19th, 2024

**Data and analysis scope**:

-   ADaMs created using R (SDTM `.xpt` sourced from the CDISC Pilot study)
-   TLFs created using R (ADaMs `.xpt` sourced from the ADaMs generated in R by the Pilot 3 team)

**Links**:

[R Submission Pilot 3 Development Repo](https://github.com/RConsortium/submissions-pilot3-adam)

-   Development area for Pilot 3 Team
-   See Closed Issues discussion for how we worked
-   See [Wiki](https://github.com/RConsortium/submissions-pilot3-adam/wiki) for Common Issues we ran into and QC Findings we encountered when comparing the ADaMs generated in the CDISC Pilot study.
-   We made use of a [GitHub Project Board](https://docs.github.com/en/issues/planning-and-tracking-with-projects/learning-about-projects/about-projects) (Kanban Style Board) to drive development.

[R Submission Pilot 3 eCTD Submission Package to FDA](https://github.com/RConsortium/submissions-pilot3-adam-to-fda)

-   Materials submitted to the FDA following eCTD standards

[R Submission Pilot 3 Website](https://rconsortium.github.io/submissions-pilot3-adam/main/)

-   Breakdown of the Github repositories and files used for analysis development, e-submission and proprietary Pilot 3 R Package
-   Renderings of ADaMs, TLFs, ADRG and Cover Letter
-   Discussions at Conferences and feedback from FDA

**Key team members**:

Developer team:

-   Joel Laxamana-Roche
-   Thomas Neitmann-Denali
-   Phanikumar Tata-Syneos
-   Robert Devine-J&J
-   Steven Haesendonckx-J&J
-   Lei Zhao-Roche
-   Nicole Jones-Denali
-   Kangjie Zhang-Bayer
-   Benjamin Straub-GSK
-   Declan Hodges-GSK
-   Bingjun Wang - Merck

FDA Staff:

-   Paul Schuette\
-   Hye Soo Cho