[R] SAS or R software

Frank E Harrell Jr f.harrell at vanderbilt.edu
Sat Dec 18 15:03:12 CET 2004

Henric Nilsson wrote:
> Marc Schwartz said the following on 2004-12-18 01:19:
>> As you are likely aware, other statistically relevant issues are
>> contained in various ICH guidance documents regarding GCP considerations
>> and principles for clinical trials:
>> http://www.ich.org/UrlGrpServer.jser?@_ID=475&@_TEMPLATE=272
> ICH E9 states that (p. 27):
> "The computer software used for data management and statistical analysis 
> should be reliable, and documentation of appropriate software testing 
> procedures should be available."
> Some commercial software vendors (SAS, Insightful, and StatSoft) offer 
> white papers stating that their software can work within an 21 CFR Part 
> 11 compliant system.
> http://www.sas.com/industry/pharma/develop/papers.html
> http://www.insightful.com/industry/pharm/21cfr_part11_Final.pdf
> http://www.statsoft.com/support/whitepapers/pdf/STATISTICA_CFR.pdf
> Some commercial vendors (SAS and Insightful) also offers tools for 
> validation of the installation and operation of the software. SAS has
> http://support.sas.com/documentation/installcenter/common/91/ts1m3/qualification_tools_guide.pdf 
> and S-PLUS has validate().
> As a statistical consultant working within the pharamceutical industry, 
> I think that our clients find the white papers being some kind of 
> quality seal. It signals that someone has actually thought about the 
> issues involved, written a document about it, and even stated that it 
> can be done. Of course, there's a lot of FUD going on here. But if our 
> lives can be made simpler by producing similar white papers and QA 
> tools, why not?
> (But for some people, only SAS will do:
> Last week we were audited on behalf of a client. One of the specific 
> issues discussed were validation and the Part 11 compliance of S-PLUS. 
> In this specific trial, data are to be transferred from Oracle Clinical 
> -> SAS -> SPLUS, and they auditors were really worried about the first 
> and last link of that chain. Finally, they suggested using only SAS... 
> And in this particular case, Part 11 is really a non-issue since 
> physical records exists (i.e. case report forms) and all final S-PLUS 
> output and code will also be stored physically (i.e. print-outs) -- no 
> need for electronic signatures here!)
>> There is also a general guidance document for computer systems used in
>> clinical trials here:
>> http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm
>> Though it is to be superseded by a draft document here:
>> http://www.fda.gov/cder/guidance/6032dft.htm 
>  From the introduction (p. 2):
> "This document provides guidance about computerized systems that are 
> used to create, modify, maintain, archive, retrieve, or transmit 
> clinical data required to be maintained and/or submitted to the Food and 
> Drug Administration (FDA)"
> The `retrieve' part is certainly applicable. 
> Henric

That is not clear.  And since FDA allows submissions using Excel, with 
not even an audit trail, and with known major statistical computing 
errors in Excel, I am fairly certain that it is not applicable or at the 
least is not enforced  in any meaningful way.

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

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