基于JCI标准规范的临床试验不良事件管理  

Management of adverse events in clinical trial based on JCI standard

作　　者：程毅[1] 鲁瑞萍[1] 布格拉.米吉提 张翌韦 袁明奎[1] 杨建华[1] 

机构地区：[1]新疆医科大学第一附属医院药物临床试验机构,新疆乌鲁木齐830011

出　　处：《中国新药与临床杂志》2015年第11期827-830,共4页Chinese Journal of New Drugs and Clinical Remedies

基　　金：新疆医科大学2014年度"人文社会科学基金项目-改革与发展专项"(2014XYFG48)

摘　　要：按照JCI标准,通过建立不良事件管理小组和健全不良事件的管理机制,从不良事件的记录、处理、上报分析、追踪随访管理等环节对不良事件进行规范的管理,促进持续的质量改进,最大限度的保障受试者的安全和权益。并结合作者工作经历,对本院在JCI评审中对临床试验中不良事件的管理具体做法进行探讨和总结。To set up the adverse events management groups and improve adverse events regulations in the hospital based on JCI standards. Using effective process to implement and improve the adverse events process in such aspects as recording, processing, reporting analysis, followed up management. For the safety of the tested subjects and promotion of the clinical trial, the controlling mechanism must be strengthened through the correlative organizations. This article introduces the experiences and good suggestions of ours during recent years.

关 键 词：JCI标准 临床试验 药物毒性 不良事件 

分 类 号：R969[医药卫生—药理学]