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 ...
GlobalData on MSN
FDA protocol deviation guidance could go further
Protocol deviations can be extremely costly to clinical trials - both financially and with patient safety. In some cases, ...
The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...
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