A Risk-Based Approach To Monitoring of Clinical Investigations-Questions and Answers; Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "A Risk- Based Approach to Monitoring of Clinical Investigations--Questions and Answers." This guidance provides information on risk-based approaches to monitoring investigational studies of human drug and biological products, medical devices, and combination products. The guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results. This guidance expands on the guidance for industry entitled "Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring" (August 2013) by providing additional information to facilitate sponsors' implementation of risk-based monitoring. This guidance finalizes the draft guidance entitled "A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers," issued on March 15, 2019.