Clinical Investigation Protocol Deviations

FDA has published a draft guidance, Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices, to assist sponsors, clinical investigators, and institutional review boards (IRBs) in defining, identifying, and reporting protocol deviations in clinical investigations. The document says agency 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.

The draft 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 medical devices;
• recommendations on the types of protocol deviations that investigators should report to sponsors; and
• recommendations for IRBs in their evaluation of protocol deviations.