tidyverse, tidymodels, r-lib, and gt R packages: Regulatory Compliance and Validation Issues A Guidance Document for the use of affiliated R packages in Regulated Clinical Trial Environments September 2020 RStudio PBC 250 Northern Ave Boston, MA USA 02210 Tel: (+1) 844 448 1212 Email:
[email protected] 1.Purpose and Introduction The purpose of this document is to demonstrate that certain R packages affiliated with the tidyverse[15], tidymodels[14], and r-lib[8] GitHub organizations, along with the gt package[2], when used in a qualified fashion, can support the appropriate regulatory requirements for validated systems, thus ensuring that resulting electronic records are “trustworthy, reliable and generally equivalent to paper records.” For R, please see the document below: R: Regulatory Compliance and Validation Issues A Guidance Document for the Use of R in Regulated Clinical Trial Environments[10] What qualifies as a record? Validation guidance is a result of regulation, most notably the US Food and Drug Administration’s 21 CFR Part 11[5]. This regulation was originally written to apply to health records. The definition of a record has subsequently been clarified and extended. A key consideration for companies subject to this regulation is determining the extent to which analytic software systems such as R, and the outputs they produce (plots, tables, models, predicted values, etc.) constitute records or derived records subject to Part 11 compliance[5]. RStudio, following the work of the R core foundation and the R Validation Hub, does not consider the outputs created, in whole or in part, by R and R packages as records directly subject to compliance regulations[10].