A Serious Adverse Event (SAE) is an adverse event that results in outcomes such as death, life-threatening risk, hospitalization or prolonged hospitalization, significant disability, congenital anomaly, or other medically important conditions.
SAEs require rapid evaluation and reporting to the sponsor and, when applicable, to regulators and ethics oversight bodies according to defined timelines. Investigators assess seriousness, expectedness, and relationship to the investigational product to support appropriate safety actions. SAE reporting enables timely risk mitigation, such as protocol changes, consent updates, or enhanced monitoring. Strong SAE processes are central to participant protection and regulatory compliance throughout trial conduct.