FDA Draft Guidance: A Risk-Based Approach to Monitoring of Clinical Investigations -- Questions and Answers

Today the FDA published the draft guidance for industry “A Risk-Based Approach to Monitoring of Clinical Investigations -- Questions and Answers.”   This document provides guidance to industry on a risk-based approach to monitoring of investigational studies of human drug and biological products, medical devices, and combinations thereof.  This guidance expands on FDA’s guidance for industry "Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring" (RBM guidance) by providing clarifications and additional guidance to facilitate and encourage sponsors’ implementation of risk-based monitoring.   FDA’s experiences since the RBM guidance was finalized in 2013 suggest that additional guidance would be beneficial regarding FDA’s recommendations for planning a monitoring approach, developing the content of monitoring plans, and addressing and communicating monitoring results.  The questions and answers in this guidance are intended to provide more detailed guidance to assist sponsors in planning and conducting risk-based monitoring. In 2019, FDA plans to issue a pre-recorded webinar related to this guidance. More information will be posted on the Small Business and Industry Assistance Webinars page as it becomes available. Comments on this draft guidance will be accepted via the related docket (FDA-2019-D-0362).