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
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