adverse event
Also written as: AE — adverse event
Any unfavorable medical occurrence in psychiatric research participants, regardless of suspected relationship to study treatment, requiring documentation and reporting.
Full Definition
An adverse event (AE) is any untoward medical occurrence, sign, symptom, or disease that develops or worsens during a psychiatric research study, regardless of whether it is considered related to the study intervention. Adverse events must be systematically collected, documented, and reported according to regulatory requirements and institutional protocols. In psychiatric research, this includes monitoring for both medical side effects and potential worsening of mental health symptoms.
Usage
Usage note: Distinguish from 'serious adverse event' which has specific regulatory definitions.
In Context
- "All adverse events were recorded from the time of informed consent through 30 days post-treatment." — Safety monitoring protocol
- "The most common adverse event was mild headache, occurring in 15% of participants." — Safety results