Search results with tag "Trial of an investigational medicinal product"

Protocol Deviations and Serious Breaches of GCP in a ...

Protocol Deviations and Serious Breaches of GCP in a Clinical Trial of an Investigational Medicinal Product (CTIMP) 1) What is a Protocol Deviation? A protocol deviation can be described as any departure from the approved trial protocol. Deviations from trial protocols and GCP are a frequent occurrence in clinical trials and are usually minor

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