Which events require expedited reporting in clinical trials?

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In clinical trials, events that are serious enough to threaten a participant’s health or require prompt treatment are handled with expedited safety reporting. A serious adverse event is defined by outcomes such as death, a life-threatening situation, hospitalization or prolongation of hospitalization, significant disability, congenital anomaly, or other medically important events that may jeopardize the patient and require medical or surgical intervention. Because these events could signal risks associated with the investigational product, they must be reported quickly to the study sponsor (and then to the regulatory authorities and ethics committees as required). This rapid reporting helps protect participants and allows regulators to assess whether the trial should continue or require changes. Non-serious adverse events or events that do not meet the seriousness criteria do not have the same expedited reporting requirements.