Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of whether it is related to treatment.
AEs are collected systematically throughout study participation and categorized by severity, seriousness, and expectedness. Comprehensive AE documentation supports safety signal detection and ongoing oversight. Regulatory reporting obligations depend on the seriousness and relatedness of the event. Effective AE management strengthens participant protection and data credibility.