药品上市后临床试验远程数据管理模式的架构  

Remote mode of data management for a certain medicine in clinical trial after appearing on the market

作　　者：曹红波[1,2] 刘智[2] 李楠[1] 翟静波[1] 王辉[1] 刘春香[1] 商洪才[1,2] 

机构地区：[1]天津中医药大学中医药研究院,天津300193 [2]天津中医药临床评价研究所,天津300193

出　　处：《天津中医药》2014年第12期730-734,共5页Tianjin Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金青年科学基金项目(81202849);天津市高等学校创新团队资助(TD12-5032);天津市高等学校科技发展基金计划(20110202)

摘　　要：药品上市后临床试验是生产药品临床证据的重要手段,而临床试验的质量控制是证据可靠性的关键。数据管理是药品上市后临床试验质量控制的重要内容,随着计算机技术的发展和应用,临床试验的远程数据管理模式逐渐成为趋势,文章对药品上市后临床试验当中传统数据管理与远程管理的区别和远程管理模式的架构作一介绍。Clinical trial is an important measure in providing some clinical evidences for production of a certain medicine. While the quality control of the clinical trial is the key for the evidence reliability. Data management is an important content in quality control of clinical trial after its appearing on the market and the remote data management mode of clinical trial has gradually become a trend along with the development and application of computer technology. In this paper, we will discuss the difference between the classical data management and remote data management. Meanwhile and the framework of remote data management will be introduced.

关 键 词：临床试验 远程数据管理 药品 

分 类 号：R954[医药卫生—药学]