Glossary Term

Adverse Event (AE)

Data & Safety

Also known as: AE, adverse events, untoward event

Any untoward medical occurrence in a research participant, whether or not considered related to the study intervention.

An adverse event is any unfavorable medical occurrence in a subject. AEs do not need to have a causal relationship to the study to be reported.

Key categories

**Serious adverse event (SAE)**: death, life-threatening, hospitalization, persistent disability, congenital anomaly, or important medical event
**Unanticipated problem (UP)**: unexpected, related or possibly related, and suggests greater risk than previously known

Reporting timelines depend on seriousness, expectedness, and relatedness, and are defined by the IRB, sponsor, and FDA/OHRP.

Elemental IRB provides fast, transparent ethical oversight for commercial and academic research.