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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

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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

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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

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Project

Lead

Leads

Email

Ellis Hughes

ellishughes@liveellis.h.hughes@gsk.com 

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



Objectives and DeliverablesTimelines

Key Milestones 

ObjectiveTimeline

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 


Status
colourBlue
titleCurrent Status
 Q42020 Q3/42021

White Paper published on the PHUSE Website, project concluded. 

  • Assembling team and level-setting expectations
  • Assigning responsibilities of white paper sections to team members
  • Created repository for {valtools}, the home of the R package for helping with validation



    Project Members 

    Organisation 

    Aiming Yang

    Merck

    Chris Battiston Women’s College Hospital
    Drew Foglia Veeva Systems

    Hanming Tu

    Frontage Laboratories

    Heidi CurinckxJanssen Research & Development

    Katherine Katherine  Ostbye  

    (SCHARP) Fred Hutchinson
    Kelci MiclausVeeva
    Kostas LymperisOmicron

    Marie Vendettuoli

    (SCHARP) Fred Hutchinson

    Mike Stackhouse

    Atorus Research

    Paul  Paul Stutzman 

    (SCHARP) Fred Hutchinson
    Pavan ReddyGENINVO

    Peyman Eshghi

    GSK
    Janssen Research & Development
    Philip Bowsher

    RStudio

    Rafael Kuttner(SCHARP) Fred Hutchinson

    Shrishaila Patil

    Navitas Life Sciences
    Srinivasa PilarisettyAstraZeneca 
    Stella Guo Bayer
    Ting Zhang

    Sanofi

    Vincent AlliboneYPrime

    Yoni Sidi

    Industry