The non-prescriptive approach adopted by the newly revised global good clinical practice guidance, E6(R3), has raised concern among industry on how to satisfy GCP inspectors.
E6(R3) Introduces Flexibility And Challenges To Clinical Trial Documentation
The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
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