A protocol deviation or violation is any departure from the study procedures or treatment plans as specified in the IRB-approved protocol. Protocol deviations occur when an investigator does not ...

The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...

UConn Health has acknowledged that it had a lapse in an approved research protocol involving use of animals in the research process and that it was reported to federal regulators. A spokeswoman for ...

For more information, contact Janet Cline, Director of Research Integrity and Compliance, at 606-783-2541. NOTE: All researchers/investigators who submit a research ...