Adverse Events and Protocol Deviations

Abstract

An adverse event is any untoward medical occurrence in a patient or subject administered a pharmaceutical product, treated with a research device, or involved in a research procedure. A serious adverse event is one that results in death, is life-threatening, requires hospitalization, results in a persistent or significant disability or incapacity, and results in a congenital anomaly or birth defect, or other serious conditions, such as a new cancer. All adverse events and serious events must be reported to the sponsor and the IRB, although some may be reported instead as endpoints, as decided by the sponsor. A protocol deviation is any change, divergence, or departure from the approved study design or procedures of a research protocol that has not been approved by the IRB.