FDA issues final guidance on risk-based clinical trial monitoring

The final FDA guidance entitled “Guidance for Industry Oversight of Clinical Investigations —A Risk-Based Approach to Monitoring,” issued early August is similar to the draft guidance published in 2011.  FDA encourages risk based remote monitoring, electronic tracking methods, and also defines that if a CRO is responsible for monitoring a study, the Sponsor should still review the CRO to ensure they are meeting regulatory and contract requirements. Zachary Brenna from outsourcingpharma.com notes in a recent article that this approach may be most appropriate for Phase II and IV trials, and, reviews some of the rationale as to why Sponsors may be slow to adopt this with pivotal registration trials.  To read Brenna’s article, click here and to view FDA’s final guidance, click here.   Need assistance with your clinical trial?  Contact us at contact@pearlpathways.com for assistance with IRB reviews, protocol writing, development and execution of risk based monitoring plans, CRO audits, and more.