Date: Thu, 13 Dec 2001 22:21:57 -0500
Reply-To: Ken Milstead <krmilstead@HOTMAIL.COM>
Sender: "SAS(r) Discussion" <SAS-L@LISTSERV.UGA.EDU>
From: Ken Milstead <krmilstead@HOTMAIL.COM>
Organization: Bell Sympatico
Subject: Re: Clinical trials NOT using SAS?
Content-Type: text/plain; charset=us-ascii
> 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
Actually, the safest way to treat a guidance is as a single-edged sword. If you DON'T
follow the FDA guidances, this can (and likely WILL) be used against you if you are
audited. If you DO follow the FDA guidances, it is not necessarily going to keep you
OUT of trouble.