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An adverse event that is related to the use of the study drug, device or intervention is one for which there is a reasonable possibility that the adverse event may have been caused by the drug, device or intervention. A related event has a temporal relationship to the drug, device or intervention, and an alternative etiology is unlikely. Our local policies require that PIs further define the adverse event by stating whether the event is “possibly related”, “probably related”, or “definitely related” to the study intervention or treatment.
Publication Source: Committees on Human Research
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