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Subject:
Re: Drug Trial Retention?
From:
Barbara Wyton <[log in to unmask]>
Reply To:
Records Management Program <[log in to unmask]>
Date:
Mon, 7 May 2012 15:24:51 +0000
Content-Type:
text/plain
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text/plain (28 lines) 
Hi Rikki,

The only "global standard" that I'm aware of is the guideline issued by the ICH.    This is the minimum requirement.  Each country then creates their own law/regulation/guideline based on this document.

REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
ICH HARMONISED TRIPARTITE GUIDELINE
GUIDELINE FOR GOOD CLINICAL PRACTICE
E6(R1)
 
I'm not familiar with the FDA's requirements but I can tell you that in Canada, we are required to keep Clinical Trial data a minimum of 25 years.
 

Barb


Barbara Wyton
Records Management Specialist
GLAXOSMITHKLINE
7333 Mississauga Rd
Mississauga, Ontario  L5N 6L4
(direct) 905-819-7050
(fax) 905-819-3099

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