Using R in submissions to healthcare regulators is challenging since the quality of any packages used must be ensured and evidence of ensuring this quality must be made available on request. This working group strives to identify and prototype at least one technical framework that can support a transparent, open, dynamic, cross-industry approach of establishing and maintaining a ‘repository’ of R packages with accompanying evidence of their quality and the assessment criteria, that can be used to simplify necessary in-house validation processes as much as possible. Such a cross-industry ‘repository’ could help with burden-sharing of validation efforts, improve quality via transparent, open peer review, and de-risk the use of public R packages for regulatory submissions. We seek a pragmatic solution, ideally endorse by key regulators. Even though we strive to keep the approach as open as possible the initial focus lies on the pharmaceutical industry and their regulatory environment.

This document details the scope and initial short-term goals supporting the creation of a cross-pharma regulatory package repository.

How to get involved



In roughly the order in which tasks will be addressed, this work will include

  • Feature scoping

  • Exploration of feasibility

  • Evaluation of compute hosting and execution options

  • Evaluation of package repository hosting solutions

  • Initial prototype implementation

  • Enterprise stress testing and evaluation of technical capabilities

  • Soliciting feedback from experts in R infrastructure and automation (R-Hub, ROpenSci, CRAN)

  • Characterizing trade-offs and making a recommendation based on evaluations


  • Deciding on exact criteria required for qualification (this discussion is better had by the broader R Validation Hub)


    title Regulatory R Package Repository
    dateFormat  YYYY-MM-DD

    Team Assembling & Scoping  :m1, 2022-12-01,  90d
    Knowledge Gathering & POCs :m2, after m1, 90d
    Public Prototype Build     :m3, after m2, 180d

Milestone 1 (Est. 3 Months)

  • Assemble a team with backgrounds spanning

    • R package development (specifically testing & builds)

    • Infrastructure & administration (containers, CI/CD, repository hosting)

    • Front end & API serving

  • Itemize blocking uncertainties

  • Scope & prioritize key deliverables

    • Specify technical objectives

    • Produce budget estimate for R Consortium Board if the initiative would benefit from monetary funding (Deadline EOY 2022)

Milestone 2 (Est. 3 Months)

The next milestone will focus on immediately actionable proofs of concepts and knowledge gathering, leveraging existing experts in this space for guidance and suggestions.

  • For technical feasibility that can be assessed quickly, implement proofs-of-concept to demonstrate features.

  • For open questions that require deeper expertise, solicit feedback from experts in this area, soliciting feedback from R Consortium and ROpenSci expertise for the evaluation of packages, hosting of build services and serving of package repositories.

  • Decide on scope for a prototype

Milestone 3 (Est. 6 Months)

The third milestone will focus on prototyping a system, with the goal of using such a prototype as a public showcase of what such a solution could offer. Cosmetics, UI/UX and performance are out of scope. An ideal outcome would be that such a prototype could be used to foster more interest and endorsement of a cross-industry solution.

  • Build a service for the evaluation of packages

  • And the hosting or publishing of packages to a publicly accessible R repository

Ideation & Proposals

Initial ideation was proposed to the R Consortium Repositories WG