Risk-Based Approach To Monitoring Of Clinical Investigations – Halloran's Review Of FDA's Guidance

By Lyn Agostinelli And John Sikora

In April of 2023, the U.S. Food and Drug Administration (FDA) issued the "A Risk-Based Approach to Monitoring of Clinical Investigations, Questions and Answers, Guidance for Industry." This guidance builds upon the earlier "Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring," released in August 2013, and aims to provide clarification on the recommendations within it.

Delve into four key themes found within the guidance as reviewed by the authors, including addressing risk-related questions, shaping your monitoring strategy, viewing risk assessment as an ongoing process, and emphasizing the significance of root cause analysis.