| Date: | Tue, 26 Jan 1999 08:55:46 -0500 |
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| Reply-To: | "Hudson, Spencer" <shudson@VIROPHARMA.COM> |
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| Sender: | "SAS(r) Discussion" <SAS-L@UGA.CC.UGA.EDU> |
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| From: | "Hudson, Spencer" <shudson@VIROPHARMA.COM> |
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| Subject: | Information on Computer System Validation in Clinical Research |
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| Content-Type: | text/plain; charset="iso-8859-1" |
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In my ongoing quest for information regarding the FDA requirements for
validating the installation and use of SAS I have found that The
Association for Clinical Data Management (ACDM) and Statisticians in the
Pharmaceutical Industry (PSI) Working Party has recently published
"Computer Systems Validation in Clinical Research: A Practical Guide". A
copy is available at their web site: http://www.acdm.org.uk
<http://www.acdm.org.uk> . It includes some useful information
applicable to SAS users in the pharmaceutical industry.
Spencer Hudson
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