Abstract: Objective To explore and analyze the adverse event record problems in quality control of drug clinical trial institutions. Methods The records, treatment and reports of adverse events in the quality control reports of 19 clinical trial projects conducted in the institution from 2017 to 2018 were collected and analyzed. Results Problems include omission of adverse events, unclear determination of causality between adverse events and trial drugs, incomplete records of adverse events, and delayed SAE learning time. The reasons for the above problems include the researchers' weak awareness of GCP, insufficient understanding and attention to adverse events, and insufficient training and subject education. Conclusion The records of adverse events are easy to cause quality problems, researchers should attach great importance to them. All parties involved in clinical trials should strengthen the supervision of adverse events and jointly improve the quality and level of the project.

Key words: drug clinical trials, quality control, adverse events