[R] 21 CFR Part 11 Compliance and R

Frank E Harrell Jr f.harrell at vanderbilt.edu
Mon May 23 21:37:23 CEST 2005

Richard Haney wrote:
> 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?


Whoever told you that is not well-informed.  CFR Part 11 has to do with 
critical software that runs medical devices and about certain primary 
data management software.  It does not apply to statistical analysis 
software.  We use R all the time in industry-sponsored and NIH sponsored 
clinical trials.  You do not need to seek FDA's approval.  FDA accepts 
all comers and does not dictate software policy for analysis.  They even 
accept Excel and Minitab for NDAs.  There are many messages related to 
this in the r-help archive; please look at them.


> Thanks very much.
> Rich Haney
> Richard.Haney at duke.edu
> Duke Comprehensive Cancer Center

Frank E Harrell Jr   Professor and Chair           School of Medicine
                      Department of Biostatistics   Vanderbilt University

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