[R] 21 CFR Part 11 Compliance and R

From: Richard Haney <richard.haney_at_duke.edu>
Date: Tue 24 May 2005 - 04:48:13 EST

I have used S-PLUS, R, MATLAB and SAS for many years, and I am actually quite happy to use any of these four languages. The reason may in part involve my using the various languages for the purposes to which they seem most suited. Hence there are many things for which I would not use SAS or MATLAB, but for which I would greatly prefer to use R instead.

On the other hand ( to take one of a couple of examples), in the past I have not even been permitted to use "R" whatsoever in clinical trials applications, which also typically involve a need for CFR Part 11 compliance. In this context, though, may I ask if there are people who have recently been able to use R for clinical trials work that is done within an FDA-approved 21 CFR Part 11-compliant framework?

Thanks very much.

Rich Haney

Duke Comprehensive Cancer Center

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