A Risk-based Approach to R Validation

Workshop - R/Pharma 2020

October 6th, 2020


Andy Nicholls
Andy Nicholls
Marly Gotti
Marly Gotti


Thank you for enrolling in this workshop!

In this site you can find information about the workshop as well as the steps you need to follow to prepare for it.


The workshop will last three hours, starting at 12pm EST on October 6th, 2020.

In the workshop we will walk through an implementation of the R Validation Hub’s white paper: A Risk-based Approach for Assessing R Package Accuracy within a Validated Infrastructure. The workshop will explore two core themes:

  1. R Packages Risk Assessment
  2. Testing

In part 1, we will use a set of pre-selected R packages to see how the R Validation Hub’s Risk Assessment Application and the riskmetric R package can be used to create risk assessment reports for an R package.

In part 2, we will discuss how testing can be used to reduce the risk for those packages with high risk. In particular, we will discuss the testing philosophy with respect to software validation and demonstrate how the testthat package can be used to perform the necessary steps to follow traceability requirements. Prior knowledge of the basic structure of R packages is required for the second part of this workshop.

Workshop Outline
  • Introduction - 15 mins
  • Overview of the white paper - 20 mins
  • BREAK - 10 mins
  • Risk Assessment Tools - 30 mins
  • Exercise - 30 mins
  • BREAK - 10 mins
  • Responding to Risk - 30 mins
  • Exercise - 30 mins

Prepare for the workshop

Before the workshop, please join the RStudio Cloud space here.

After clicking the link you will be prompted to log in or create an account if you do not have one. Afterwards, you can click the button Join Space. On the Projects tab, you will see the project Test framework, which we will use in class.

Optional: If you have time to spare, you can get familiar with the white paper A Risk-based Approach for Assessing R Package Accuracy within a Validated Infrastructure



We would like to thank

  • the R Validation Hub (PSI, EFR Consortium)
  • the wonderful TA’s that were instrumental in facilitating the discussion during the exercises:
    • Keaven Anderson (MSD)
    • Yilong Zhang (MSD)
    • Paulo Bargo (Janssen)
    • Magda Zwierzyna (GSK)
    • Juliane Manitz (EMD Serono)
    • Eli Miller (Atorus Research)
  • the team working on riskmetric
  • the team working on the Risk Assessment App

Thanks to all those involved in pulling together the R/Pharma conference!

About the R Validation Hub

R Validation Hub is a cross-industry initiative whose mission is to enable the use of R by the Bio-Pharmaceutical Industry in a regulatory setting, where the output may be used in submissions to regulatory agencies.

To learn more about the work we do, please go to pharmar.org.