Challenges and Barriers to Adverse Event Reporting in Clinical Trials: A Children's Oncology Group Report.

Objective: Adverse event (AE) reporting is crucial for determining safety of trials. Adverse events are captured manually by clinical research associates (CRAs) and research nurses (RNs), and prior studies show underreporting. It is necessary to understand AE reporting training, processes, and institution-level differences to improve AE capture.