临床试验数据管理外包服务中的若干关键问题  

Basic considerations during outsourcing of clinical data management services

作　　者：沈彤 刘研 

机构地区：[1]强生(中国)研发和科学事务部量化科学部,北京100025

出　　处：《药学学报》2015年第11期1493-1497,共5页Acta Pharmaceutica Sinica

摘　　要：随着国际、国内药物临床试验相关法规的日趋完善,药物临床试验的质量也越来越受到广泛关注,为了既能实施更高质量的临床试验又能有效配置和利用资源,很多制药企业采用外包形式的临床试验管理。临床试验的数据管理作为药物临床试验的一个重要组成部分,也可以采取外包的形式,其实施的基础是选择优质的合同研究组织、采取适宜的外包形式、并能进行有效的质量控制以确保临床试验数据的真实性、完整性和准确性。With worldwide improvements in the regulations of international and domestic clinical trialconductions, the quality of clinical trials and trial data management are receiving a great deal of attention. Toensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and externalresources, the outsourcing model is used in the management of clinical data in operation of pharmaceuticalcompanies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualifiedcontract research organizations （CRO）; establishment of appropriate outsourcing model, and generation ofeffective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.

关 键 词：药物临床试验 数据管理 合同研究组织 

分 类 号：R969[医药卫生—药理学]