pilot4.qmd

---
title: "R Submission Pilot 4"
---

**Goal**: Utilize alternative methods of distributing a self-contained submission bundle of the Pilot 2 Shiny application with container and web-assembly technologies.

**Key evaluation aspects**:

- For Submitter
  - Generation of a reproducible execution environment containing both the system and R-specific dependencies using [Podman](https://podman.io/) as the container runtime.
  - Generation of a web-assembly version of the Pilot 2 Shiny application (with small modifications) that can be executed in an existing R process running a web server using the `{httpuv}` R package
  - Preparation of submission materials with detailed instructions on setting up the execution environments
- For FDA Staff
  - Reproduce the ability to use the Shiny application by building the specific Podman container and viewing the web-assembly version of the application using the Edge internet browser.

**Timeline**: Targeting a first submission in Q2 2024

**Data and analysis scope**:

- A shiny app that replicates most of the functionality from the [pilot 2]((https://github.com/RConsortium/submissions-pilot2-to-fda)), with small modifications to account for the web-assembly constraints.
- Simulated data from CDISC Pilot (the same data set as in pilot 1)

**Links**:

[R Submission Pilot 4 Container Development Repository](https://github.com/Appsilon/experimental-fda-submission-4-podman)

[R Submission Pilot 4 Web-Assembly App Repository](https://github.com/RConsortium/submissions-pilot4-webR)

**Key team members**

Developer team:

- Eric Nantz (Eli Lilly)
- Sam Parmar (Pfizer)
- Pedro Silva (Appsilon)
- Ismael Rodgriguez (Appsilon)
- Andre Verissimo (Appsilon)
- Robert Devine (J&J)
- Nate Mockler (Biogen)
- Andrew Borgman (Bristol Myers Squibb)
- Ben Straub (GSK)

FDA Staff:

- Paul Schutte
- Hye Soo Cho