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# Clinical Investigation Protocol Deviations
- URL: https://www.fdaweb.com/clinical-investigation-protocol-deviations/
- Published: 2025-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:49:27.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5158382

FDA has published a draft guidance, *Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices*, to assist sponsors, clinical investigators, and institutional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](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/protocol-deviations-clinical-investigations-drugs-biological-products-and-devices?ref=fdaweb.com) 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.