药物临床试验伦理审查的跟踪审查研究  

Continuing Review in Ethical Review of Drug Clinical Trials

作　　者：徐蕾 吕德成[1] 夏云龙[1] 刘俊[1] 黄伟[1] 王一楠[1] 赵娜[1] 刘汉英[1] XU Lei;LV Deng-cheng;XIA Yun-long(Ethics Committee,The First Affiliated Hospital of Dalian Medical University,Dalian 116011,China)

机构地区：[1]大连医科大学附属第一医院伦理委员会,辽宁大连116011

出　　处：《医学与哲学（A）》2018年第7期26-28,共3页Medicine & Philosophy:Humanistic & Social Medicine Edition

摘　　要：伦理委员会对药物临床试验的跟踪审查是保障药物临床试验质量,保护受试者权益的核心手段。通过对伦理审查中跟踪审查的含义、类别、内容和形式的阐述,以及对跟踪审查意义的探讨和研究,结合我国近年来伦理委员会跟踪审查的难点进行分析。在建立伦理委员会的监管机制,完善跟踪审查操作规程,加强对伦理委员会委员及研究者的继续教育和培训,完善伦理审查信息管理几方面提出切实可行的建议。Continuing review in ethical review of drug clinical trials by ethics committee is a key procedure to ensure the quality of drug clinical trials and protect the subjects.By illustrating the definition,classification,content and form of continuing review,and discussing its significance,the authors analyzed the practical difficulties of continuing review and proposed the solutions,including setting up the oversight mechanism of ethics committee,improving the standard of procedures of continuing review,strengthening the continuing education and training for ethics committee members and investigators,and improving the information management of ethical review.

关 键 词：药物临床试验 伦理审查 跟踪审查 

分 类 号：R-052[医药卫生]