[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:
> 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.
> Some commercial vendors (SAS and Insightful) also offers tools for
> validation of the installation and operation of the software. SAS has
> 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:
>> Though it is to be superseded by a draft document here:
> 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.
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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