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Date: | Mon, 7 May 2012 13:49:30 +0000 |
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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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