The FDA has published a draft guidance for “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices.”
This draft guidance adopts the ICH E3(R1) definitions for protocol deviation and important protocol deviation, providing more standardized terminology, which is a great thing. Avoiding the term “protocol violation”, it primarily uses “protocol deviation” and “important protocol deviation.”
The FDA guidance provides detailed sections on the roles and responsibilities of investigators, sponsors, and IRBs in monitoring, mitigating, and reporting protocol deviations. It as specific recommendations for reporting protocol deviations to sponsors, IRBs, and FDA, including timelines and methods.
It mostly seems a good application of a quality-by-design approach, focusing on critical-to-quality factors and risk-based monitoring for clinical studies. Hopefully it will help clear up confusion in this area.
Investigations of a Dog 