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All written comments should be identified with this document's docket number: FDA-2023-D-5016

Docket Number:
FDA-2023-D-5016
Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

Center for Devices and Radiological Health

Oncology Center of Excellence

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.