The FDA released its final guidance governing clinical trial oversight and urges a risk-based approach to monitoring. The Agency builds on the main tenets described in the original 2011 draft guidance, urging drug and medical-device sponsors to utilize more remote and targeted risk-based monitoring rather than relying solely on on-site methods.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 while the Sponsor can transfer monitoring responsibilities to contract research organizations (CROs), the CROs should be regularly monitored for their compliance to regulations.
