Project Scope

The initial scope of the project is guidance on the use of open-source projects, as well as collaboration on and creation of open-source projects. The primary aim is to provide guidance and link out to more information. If gaps are found, they will be noted for later follow-up and potential follow-on working groups:

Using open source
- Relevance of different licence types
- Watchouts on governance models and assessing risk
- Landscape of tools available for vulnerability detection, validation/qualification/risk and enforcing licence policies, with particular reference to R-specific tools
Building open source
- A summary and recommendation of licence types, with particular focus on permissive vs copyleft licences and the ramifications on code built on top of your project
- Relevance of licences present in dependencies, direct vs transitive dependencies, and the issues around compiling with dependencies that could occur in something like a public shiny app
- Landscape of places to place open-source projects and build collaborative communities
- Pros/benefits and cons/risks for companies to open source clinical reporting codebases
- Governance models for open-source projects with reference to their use today across clinical reporting collaborations
- Survey and summary of contract types present where intellectual property and copyright is shared between companies
- Tools available to understand the general health of projects (e.g. LFX tools), with specific reference to R extensions (e.g. metacran, riskmetric, openpharma)
- Examples of release models, particularly where projects have inter-project dependencies (e.g. tidyverse de-coupled release model vs bioconductor cohort release model)
- Tools for releasing and maintaining projects, with particular reference to tools for R packages

Project Leads	Email
Mike Stackhouse, Atorus Research	mike.stackhouse@atorusresearch.com
James Black, Roche	James.black.jb2@roche.com
Nicola Newton, PHUSE Project Assistant	nicky@phuse.global

CURRENT STATUS Q3 2023
Project to close after their talk at the EU Connect.

Objectives & Deliverables	Timelines
Create a living guidance document (using a tool like MkDocs or GitBook) that provides a reference document for open-source collaboration for pharma companies	Q1 – Q2 2022
Release white paper as static snapshot of v1.0 of the guidance	Q2 2023