Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Image Removed

Image Added







Project Scope

There is consensus across industry that software used for regulatory submission needs to be validated. However, there are few industry accepted guidelines on what is specifically required to meet the bar of validation for Open Source tools and user-contributed extensions, specifically R and R packages

.

There are two deliverables from this project: a White Paper and an R package. The White Paper will serve as a reference for industry on how to perform validation for user-contributed extensions of programming software. It will detail the elements that need to be met for the extension to be validated, and ways to document the process in a reusable, efficient, and sharable fashion. The R package will be developed to provide the tools and guidance for validating an R package. It will show how to take advantage of the tools that exist in the R language, and it will be based on the White Paper to ensure the baseline requirements are achieved

.

With these tools, there will be a standard to reference on how to approach validation of extensions to the R language. Additionally, by demonstrating how to perform validation, the framework can be more generally applied to software extensions in other languages

.


Project

Lead

Leads

Email

Eli Miller
ellishughes@live.com

Ellis Hughes

ellis.h.hughes@gsk.com 

Lauren White (PHUSE Project Coordinator)lauren@phuse.global



Objectives and DeliverablesTimelines

Develop and submit a white paper detailing the elements that would be required for any open source technologies user-contributed extensions.

Q3 2021 

Develop an R package that would provide the necessary tools and guide the user through the necessary steps to achieve a validated R package. 

Q4 2021 

Key Milestones 

ObjectiveTimelineComplete the Docker POC Project Q4 2020 Kick off the Docker pilot for a real submission Q4 2020

White Paper on best practices for interactive analyses for decision making & submissions

Q4 2020 


Status
colourBlue
titleCurrent Status

Continuing to write the White Paper, awaiting feedback from the FDA on the POC submission

Q3/42021

White Paper published on the PHUSE Website, project concluded



Project Members 

Name Organisation 

Catherine Xiao

Gilead

Douglas Warfield

Ireview

Eric Herbel

Industry

Gaoyang Li 

Bayer

Hari J Vardhan 

Chiltern

Iraj Mohebalian  

Bayer

Karl Brand 

BayerMaria Dalton GSK

Mary Nilsson 

Eli LillyMominul Islam 

Sarepta

Nagadip Rao 

Elissen

Volunteer Today

Organisation 

Aiming Yang

Merck

Chris Battiston Women’s College Hospital
Drew Foglia Veeva Systems

Hanming Tu

Frontage Laboratories

Heidi CurinckxJanssen Research & Development

Katherine Ostbye  

(SCHARP) Fred Hutchinson
Kelci MiclausVeeva
Kostas LymperisOmicron

Marie Vendettuoli

(SCHARP) Fred Hutchinson

Mike Stackhouse

Atorus Research

Paul Stutzman 

(SCHARP) Fred Hutchinson
Pavan ReddyGENINVO

Peyman Eshghi

Janssen Research & Development
Philip Bowsher

RStudio

Rafael Kuttner(SCHARP) Fred Hutchinson

Shrishaila Patil

Navitas Life Sciences
Srinivasa PilarisettyAstraZeneca 
Stella Guo Bayer
Ting Zhang

Sanofi

Yoni Sidi

Industry 

Our project always welcomes new members to collaborate in an open, transparent and non-competitive project. If you are interested in joining please contact workinggroups@phuse.eu.