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14th Feb 2020, 10:49 AM
#6
Documenting Oversight is usually a function of your Risk Assessment to determine. The EMA IWG gives some slight guidance in their Q & A :- " The sponsor/CRO should determine the extent of monitoring of each party, within the context of GCP, under particular circumstances. This should be justifiable, and ensure GCP compliance, in the context of the clinical site organisation and the nature of the product and protocol being studied. "
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