FDA issues final guidance on oversight of clinical studies

08/12/2013 | OutSourcing-Pharma.com

The FDA has released its final guidance governing clinical trial oversight, urging drug and medical-device sponsors to utilize more remote and targeted risk-based monitoring rather than relying solely on on-site methods. The guidance provides various risk-based monitoring strategies, and clarifies that the sponsor can transfer monitoring responsibilities to contract research organizations, but it "should evaluate CRO compliance with regulatory requirements and contractual obligations in an ongoing manner."

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