临床试验数据管理外包服务中的若干关键问题Basicconsiderations.PDF

药学学报 Acta Pharmaceutica Sinica 20 15, 50 ( 11): 1493 1497 ·1493 · 床试验数据管理外包服务中的若干关键问题 * 彤, 刘 研 (强生 ( 中国) 研发和科学事务部量化科学部, 北京 100025) 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 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 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 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。 关键词: 物临床试验; 数据管理; 合同研究组织 中图分类号: R969 文献标识码: A 文章编号: 0513-4870 (20 15) 11-1493-05 Basic considerations during outsourcing of clinical data management services * SHEN Tong , LIU Yan (QS China of China R D and Scientif ic Aff aires, Pharmaceutical Company of Johnson Johnson, Beijing 100025, China ) Abstract : With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.