Seriousness

In Safety & pharmacovigilance

Seriousness is the regulatory classification of an adverse event based on its outcome, not on how intense it feels. An event is serious if it results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability, or is a congenital anomaly. Seriousness determines the reporting obligations that follow.

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Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.