Re: [R] 21 CFR Part 11 Compliance and R

From: Frank E Harrell Jr <f.harrell_at_vanderbilt.edu>
Date: Tue 24 May 2005 - 05:37:23 EST

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?

Rich,

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.

Frank

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

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

______________________________________________
R-help@stat.math.ethz.ch mailing list
https://stat.ethz.ch/mailman/listinfo/r-help
PLEASE do read the posting guide! http://www.R-project.org/posting-guide.html
Received on Tue May 24 05:37:47 2005

This archive was generated by hypermail 2.1.8 : Fri 03 Mar 2006 - 03:32:00 EST