Issue Date: December 30, 2024
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Draft
Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices
This guidance provides recommendations to assist sponsors, clinical investigators, and institutional review boards (IRBs) in defining, identifying, and reporting protocol deviations in clinical investigations. FDA regulations do not include a definition of the term protocol deviation or provide a system for classifying the various types of deviations that may occur during the conduct of a clinical investigation. A system that applies consistent classification, reporting, and documentation standards is important to assure the most interpretable and useful information emerges from the reporting of protocol deviations. To address these considerations, this guidance includes definitions for protocol deviations and important protocol deviations, recommendations on the types of protocol deviations that sponsors should report to FDA in clinical study reports for drugs and devices, recommendations on the types of protocol deviations that investigators should report to sponsors and to IRBs, and recommendations for IRBs in their evaluation of protocol deviations.
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