Validating clinical trial data reporting with sas
To verify that R works as designed and documented, a suite of validation tests compares the output of R against known data and known results.
Of course, the fact that R itself is maintained with a compliant development process doesn't complete the whole validation process, since R is always part of a larger process to collect, analyze, and report clinical trial data.
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To that end, the R Foundation has created the document R: Regulatory Compliance and Validation Issues.
Described as "a guidance document for the use of R in regulated clinical trial environments", the purpose of this document is to demonstrate that R, when used in a qualified fashion, can support the various regulatory requirements for validated systems, most notably 21 CFR Part 11 and the relevant "good practice" documents (Gx P) and industry guidance documents.
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This enables our clients in the pharmaceutical sector validate their installation of REvolution R, and if required any associated scripts and in-house or third-party packages being used, within the clinical analysis process.
OQ refers to Operational Qualification: is the software operating correctly?