Understanding the FDA’s Draft Guidance on Protocol Deviations in Clinical Investigations

The U.S. Food and Drug Administration (FDA) has released a draft guidance document titled Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices. This guidance aims to clarify defining, identifying, and reporting protocol deviations in clinical research. Since FDA regulations do not currently provide a standardized system for classifying protocol deviations, this guidance seeks to establish a consistent framework for sponsors, investigators, and Institutional Review Boards (IRBs) to follow.