严重不良事件报告对于体现注册类药物临床试验数据和结果的科学、真实、可靠以及保护受试者权益和安全具有一定价值。国家相关法规要求对严重不良事件报告做出了规定，但伦理委员会在严重不良事件的受理和审查工作中仍面临着许多困惑和亟待解决的难题。对国内20家医院伦理委员会注册类药物临床试验严重不良事件报告要求进行调研和分析，为伦理委员会做好安全性事件的风险把控，规范、完善安全性信息报告流程提供参考。

Serious adverse event reports have certain value in reflecting the scientific, truthful, and reliable nature of clinical trial data and results of registered drugs, as well as protecting the rights and safety of subjects. The relevant national regulations require regulations on serious adverse event reports, but the ethics committee still faces many confusions and urgent problems in the acceptance and review of serious adverse events. This article conducts research and analysis on the reporting requirements for serious adverse events in clinical trials of registered drugs in 20 domestic hospitals’ ethics committees, providing reference for ethics committees to control the risks of safety events, standardize and improve the safety information reporting process.

R925.4