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The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...
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 ...
PRAGUE, Czechia—Current European Society of Cardiology (ESC) heart failure guidelines stipulate that a urinary sodium-guided approach is best for dosing diuretics in acute congestion, but many centers ...
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