What is the UTHSC IRB policy regarding reporting of adverse events?
All adverse events must be reported if the event meets the definition for an unanticipated serious event and is also possibly, probably, or clearly related to the intervention. All deaths, regardless of cause or anticipation, must be reported within 24 hours of such occurrence. All other adverse events must be reported within 5 working days from the date of the occurrence. The relationship of the adverse event to the research intervention must be determined by the investigator.
