Risk Assessment

Status Update: MSA Framework by TransCelerate

TransCelerate has published “Modernization of statistical analytics (MSA) Framework”. With goals similar to the R Validation Hub, the TransCelerate MSA framework seeks to demonstrate software reliability by establishing principles of accuracy, traceability, and reproducibility for a modern analytical software environment. The MSA framework is centered around risk-assessment and mitigation practices to demonstrate reliability of software. This framework suggests assessing the accuracy of a software library via a confidence measure built on risk metrics such as published source code, issue management, usage, maturity, etc.

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Status Update: CRAN Release of `riskmetric`

We have reached a major milestone. The R package riskmetric has been released and is now available on CRAN. What is riskmetric? riskmetric is a collection of risk metrics to evaluate the quality of R packages following the framework suggested by the R validation hub (see our white paper for details). Various quality metrics are provided which evaluate best practices of software development, code documentation, community engagement and development sustainability.

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Status Update: Conferences 2021

The new year is starting with some good news for the R validation hub. We will be able to present our work at a number of different meetings in 2021: National Institute of Statistical Sciences (NISS; April 21, 2021): NISS-Merck Meet-Up on Open Source Software in Pharma Annual Meeting of Statisticians in the Pharmaceutical Industry (PSI; June 21-23, 2021): Contributed session accepted Joint Statistical Meetings (JSM; August 7-12, 2021): Topic-contributed session accepted

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Status Update: A summary of 2020

2020 was a busy year for the R Validation Hub. We released our white paper describing our current thinking on a risk based approach to using R for regulatory work. We started to support the implementation of the white paper with tools such as riskmetric and our risk assessment application. And we started a new sub-team with the aim of producing a follow-up white paper on testing. Throughout, we have continued to share and gain feedback on our proposed approach, presenting at User!

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