Objective To analyze problems in the management of adverse events during quality control in drug clinical trial institutions, and to improve the quality of clinical trials.Methods Quality control reports from 48 Phase I–IV drug clinical trial projects involving non-healthy subjects (i.e., patients) conducted at our institution from January to December 2023 were collected. Based on the Good Clinical Practice (GCP) and the Points for Drug Registration Verification and Determination Principles (Drug Clinical Trials) (Trial), statistical analysis was performed on issues related to adverse event management.Results A total of 267 issues related to adverse event management were identified. Among these, problems in adverse event determination were the most frequent (197 items, 73.78%), including unassessed abnormal values (130 items, 48.69%), insufficient basis for determination (46 items, 17.23%), inconsistent determination criteria (21 items, 7.87%), non-standard documentation (33 items, 12.36%), missed reports (22 items, 8.24%), lack of follow-up (12 items, 4.49%), and unreasonable causality assessment (3 items, 1.12%).Conclusion This study systematically analyzes the main causes of problems in adverse event management and proposes measures that institutions should adopt, providing a basis for optimizing quality management in clinical trials.