pilot1.qmd

---
title: "R Submission Pilot 1"
comments:
  giscus:
    repo: RConsortium/submissions-wg
    repo-id: "MDEwOlJlcG9zaXRvcnkzMTk1MjUxNTI="
---

## Pilot 1 - Common Analyses

**Goal**: Example R based submission contains common analyses, submission through the current FDA e-submission system and process.

**Key evaluation aspects**: 
  
- For Submitter  
  - Submission of proprietary R packages
  - Preparation of R-based submission materials
- For FDA Staff
  - Reproduce analysis results by reconstructing submitted proprietary packages / retrieving open source packages

**Data and analysis scope**:
  
- 4 TLFs 
- Simulated data from CDISC Pilot


**Success Criteria**:
  
- Submitter:
  - Successfully submit via eCTD portal
- FDA Reviewer:
  - Reproduce analysis results


**Timeline**: 

- 2021.11   Initial submission to FDA. 
- 2022.12   Received FDA response 
- 2022.02   Revised submission to FDA
- 2022.03   Received final FDA response. 


**Links**:

[R Submission Pilot 1 Development Repo](https://github.com/RConsortium/submissions-pilot1)


[R Submission Pilot 1 eCTD Submission Package to FDA](https://github.com/RConsortium/submissions-pilot1-to-fda)

**Additional Activities**
- explore pilot submissions to other HAs (Japan, China)
 
**Key team members**:  

Developer team:     
- Ning Leng, Heng Wang (Roche)  
- Mike Stakehouse, Eli Miller (Atorus)  
- Yilong Zhang, Peikun Wu (Merck)  

Esub team:  
- Beverly Chin (Roche)  
- Tim Powell (Biogen)  

FDA Staff:  
- Paul Schuette  
- Hye Soo Cho