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.