临床监查员在临床试验中的作用  

The Role of Clinical Arbitrator in Clinical Trials

作　　者：田利华[1] 赵离钟[1] 顾佳[1] 赵勤[1] 陈佳[1] 贾慧敏[1] 蔡军[1] 

机构地区：[1]首都医科大学附属北京朝阳医院科研处,北京市100020

出　　处：《中国病案》2014年第11期17-19,共3页Chinese Medical Record

摘　　要：本文通过从申办者、受试者、研究者三个不同角度对研究工作贡献的考量指标等内容分析临床监查员在临床试验中的工作职责,总结出临床监查员在临床研究试验中主要承担试验机构筛选、研究者会议组织、协助制定试验文件、知情同意书和病例报告表核查、不良事件上报、研究资料存档等重要工作。同时分析了影响临床监查员职能发挥的因素,提示临床监查员对于临床试验意义重大,应该给予足够的重视和关注。建设高质量的临床监查员队伍,可以提供优质高效的服务,促进国内临床试验和医疗水平的发展。This paper analyzed clinical arbitrator responsibility in clinical trials from three different angles of the sponsor,the subjects,the researchers.clinical examiner mainly undertake important tasks such as the screening test institutions,researchers conference organization and assist in developing test case files,informed consent,and report verification,adverse event reporting, research data archive and so on.At the same time analyzed the factors influencing clinical arbitrator function display,prompted clinical arbitrator is of great significance for clinical trials,should give enough attention and concern.Construction of high quality clinical examiner team can provide quality and efficient services,promote the development of domestic clinical trials and health level.

关 键 词：临床试验 临床监查员 作用 

分 类 号：R197.323[医药卫生—卫生事业管理]