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Date:         Wed, 12 Dec 2001 16:44:17 +0100
Reply-To:     Ace <b.rogers@VIRGIN.NET>
Sender:       "SAS(r) Discussion" <SAS-L@LISTSERV.UGA.EDU>
From:         Ace <b.rogers@VIRGIN.NET>
Subject:      Re: Clinical trials NOT using SAS?
Content-Type: text/plain; charset=us-ascii

On Wed, 12 Dec 2001 08:45:37 -0500, Ken Milstead <krmilstead@hotmail.com> wrote:

>Ace wrote: > >> It doesn't need to be rerunnable _by_ the FDA. As long as normal >> systems standards are applied, the original system would either still >> be in place or have been replaced by something else, in either cases >> ensuring that backward-compatibility is maintained. > >Well, actually, according to the FDA Guidance "Computerized Systems in Clinical >Trials", backward-compatibility is not necessarily sufficient. This guidance >calls for companies to maintain indefinitely the actual hardware and software >versions used to create a submission so that a submission can be duplicated >exactly as created (using the audit trail of data changes, etc.) if requested by >FDA.

But it doesn't happen. I've been working on systems for the last year to enable a client to reproduce submission reports on a different hardware/software platform then that originally used...

The thing with 'guidance' is that it's just that - not a hard-and-fast rule.

-- Ace in Alsace


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