新药临床试验安全性通报及监测  

Monitoring and Notification of Adverse Events in New Drug Clinical Trial

作　　者：范大超[1] 

机构地区：[1]ICON控股临床研究国际有限公司亚太区

出　　处：《中国处方药》2010年第5期70-71,共2页Journal of China Prescription Drug

摘　　要：以人体为试验对象的新药临床试验,受试者的安全不容忽视,对于研究者来说,正确地做好安全报告是极其重要的任务。本期专栏重点关注临床试验过程中面对各种不良反应事件发生时的处理及通报工作,确保受试者的安全以及临床试验的顺利进行。The safety of subjects cannot be ignored in clinical trials of new drugs with human body as the test subjects, for the researchers, right preparation of safety report is an extremely important task.The focus of the column in this issue is management and notification if adverse events occur during clinical trials, to ensure the safety of subjects and clinical trials being carried out smoothly.

关 键 词：新药临床试验 安全性 通报 不良事件 监测 终点指标 药政法规 SAE 

分 类 号：R96[医药卫生—药理学]