Any untoward medical occurrence in a clinical trial participant administered an investigational drug, regardless of suspected causality.
Investigators record adverse events in the Electronic Data Capture (EDC) system, where they are encoded using MedDRA Preferred Terms (PTs) to determine frequency and safety signals.
A serious adverse event (SAE) — resulting in death, hospitalization, disability, or life-threatening conditions — requires expedited regulatory reporting to the FDA under IND safety rules.