pilot2.qmd

---
title: "R Submission Pilot 2"
---

## Pilot 2 - shiny submission

**Goal**: Example R based submission contains a shiny app, submission through the current FDA e-submission system and process 

**Key evaluation aspects**:

- For Submitter
  - Submission of an shiny app through the eCTD portal
  - The shiny codes will be provided as a proprietary R package
- For FDA Reviewer
  - Reproduce analysis results by deploying the shiny app on a FDA laptop/server 

**Timeline**: 2022 H1

**Data and analysis scope**:
  
- a shiny app that displays the 4 TLFs submitted in [pilot 1]((https://github.com/RConsortium/submissions-pilot1-to-fda)), with basic data set filtering functionalities. 
- Simulated data from CDISC Pilot (the same data set as in pilot 1)

**Links**:

[R Submission Pilot 2 Development Repo](https://github.com/RConsortium/submissions-pilot2)


[R Submission Pilot 2 eCTD Submission Package to FDA](https://github.com/RConsortium/submissions-pilot2-to-fda)


**Key team members**: 

Developer team:     
- Ning Leng, Heng Wang (Roche)  
- Mike Stakehouse, Eli Miller (Atorus)  
- Yilong Zhang, Gregery Chen (Merck)  
- Eric Nantz (Eli Lilly)


FDA Staff:  
- Paul Schuette  
- Hye Soo Cho