Risk-based monitoring of clinical trials: the FDA perspective

By Dr Nicola Davies

The US Food and Drug Administration (FDA) released its final guidance on risk-based monitoring of clinical investigations in April 2023.1

This document provides recommendations for drug manufacturers, in a question-and-answer format, on planning and developing risk-based monitoring strategies for clinical trials of drugs, biologics, and medical devices. The latest guidance expands on an earlier draft guidance released in August 2013, titled ‘Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring’.2