In serious adverse evens happened during the clinical research, researchers should adapt suitable protective measure for the patients immediately, and report to the ethics committee and drug clinical research base, and signature in the report and indicate the exact date. 在临床研究中如出现严重不良事件,研究者应立即对受试者采用适当的保护措施,并报告伦理委员会和药品临床研究基地,研究者要在报告上签名并注明日期。