There is the OECD, (Organisation for Economic Cooperation and Development) but they pretty much repeat the GLP guidelines which states trial information should be retained:
As applicable, the longer of:
Last product registration + 7 years or
Project termination + 7 years or
As long as company holds the research or marketing permit + 7 years, unless otherwise justified
This could add up to be a very long time! Having been in pharmaceuticals for over 20 years, I have yet to dispose of any original trial information. :)
Happy Monday back!
Cherise
-----Original Message-----
From: Records Management Program [mailto:[log in to unmask]] On Behalf Of Chesley, Rikki
Sent: Monday, May 07, 2012 9:50 AM
To: [log in to unmask]
Subject: [RM] Drug Trial Retention?
Hello list.
I wonder if anyone out there is willing to help me?
I have the FDA rules on drug trials, and I know this is going to shock and amaze you all, but one of my researchers doesn't feel that this is quite long enough and is certain that there is an international standard out there that trumps and exceeds the FDA standards on the retention of drug trail information. I have not found it. I will be honest I only gave a modest effort knowing I could come to you and some of you must work in Pharma and know the regs inside and out.
So, my question, is there some ISO standard or standards governing retention of drug trial data and if so, will you please point me to it?
Thanks and have a smashing Monday morning.
Rikki Chesley, CRM
University Records Manager
Manuscript, Archives, and Rare Book Library Emory University Robert W. Woodruff Library
540 Asbury Circle
Atlanta, Georgia 30322
404-727-8816
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