Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices." This draft guidance provides recommendations to assist sponsors, clinical investigators, and institutional review boards (IRBs) in defining, identifying, and reporting protocol deviations. The guidance provides definitions for protocol deviations and important protocol deviations. In addition, the guidance provides a recommended classification system for sponsors to report protocol deviations to FDA in clinical study reports for drugs, biological products, and devices; for investigators to report protocol deviations to sponsors and to IRBs; and for IRBs to evaluate protocol deviations.
Abstract as published in the Federal Register.
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