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Dr. Jekyll or Mr. Hyde? Which personifies the CRA? Is the CRA primarily a skilled trainer, friendly facilitator, and equal partner to the site or a stern schoolmaster, bloodhound detective sniffing fraud at every turn, and a formidable adversary? The Jekyll and Hyde personas and site response is examined in light of ICH GCP Guidelines detailing monitoring purpose, extent, and responsibilities; definitions of errors, misconduct and fraud; and the cultivation of a whistleblower.
