This edition of the Clinical Research Support Office (CRSO)'s QA Compliance Corner discusses adverse events.
An adverse event (AE) is defined as: “Any untoward medical occurrence (or worsening of an existing condition) in a clinical trial participant, which may or may not have a causal relationship with the study treatment.” The timeframe and scope of collection of AEs is generally defined by the study protocol. The study team may become aware of AEs through a variety of methods, including: direct participant report, follow-up surveys or assessments, subject diaries or patient reported outcome (PRO) measures, or changes in concomitant medications.