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 ...

List of acronyms and abbreviations commonly used in clinical trials research. Clinical Trials Glossary List of terms commonly used in clinical trials research. Glossary of Medical Terms in Lay ...

Follow the step-by-step instructions below to successfully maintain and close a protocol with the IRB. Instructions below include information about continuing reviews, amendments, event reporting (new ...

The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...