药物临床试验质量管理案例分析及建议  

Cases Analysis and Suggestions about Quality Management of Pharmaceutical Clinical Trials

作　　者：王一[1] 张庆瑜[1] 郭丽敏[1] WANG Yi;ZHANG Qingyu;GUO limin(General Hospital of Tianjin Medical University,Tianjin,300052,China)

机构地区：[1]天津医科大学总医院,天津300052

出　　处：《中国卫生质量管理》2018年第4期88-90,共3页Chinese Health Quality Management

摘　　要：药物临床试验中,受试者损害事件不可避免。对药物临床试验中受试者损害案例进行分析,从药物临床试验立项与执行和损害事件后的发生与处理两方面,针对药物临床试验赔偿管理提出若干建议。In pharmaceutical clinical trials,the injury events of subjects are unavoidable.The subjects injury cases in pharmaceutical clinical trials were analyzed.From two aspects of the project and executing of pharmaceutical clinical trial,including the occurrence and processing of the damage incidents,then suggestions were put forward on compensation management in pharmaceutical clinical trials.

关 键 词：药物临床试验 受试者损害事件 损害保险 试验赔偿 

分 类 号：R95[医药卫生—药学]