Lexology January 10, 2025
The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for sponsors, investigators, and institutional review boards (IRBs) in defining, identifying, and reporting protocol deviations in clinical trials. It spotlights concern over “important” deviations, such as incorrectly enrolled, monitored, or assessed study participants; improperly obtained, missing, or inaccurately recorded data; frequent protocol deviations for safety reporting; missing collection of protocol-specified safety laboratory values; and incorrectly performed efficacy endpoint assessment procedures. We have summarized the guidance below, for which FDA invites comments through February 28.
FDA defines a protocol deviation as a “generally unintentional” departure from IRB-approved protocol, noting they are commonly not discovered until after...
Today's Sponsors
Today's Sponsor