论药物临床试验网络化质控的标准化建设  

Construction of the standardization for drug clinical trials of quality based on network

作　　者：曹红波[1,2] 张俊华[1,2] 翟静波[1,2] 刘智[1,2] CAO Hong-bo ZHANG Jun-hua ZHAI Jing-bo LIU Zhi(Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China Tianjin Institute of Traditional Chinese Medicine Clinical Evaluation, Tianjin 300193, China)

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》2017年第6期392-395,共4页Tianjin Journal of Traditional Chinese Medicine

基　　金：天津市131人才第二层次项目(ZX160123);国家自然科学基金项目(81202849)

摘　　要：质量控制是临床试验的关键环节和重要内容,临床试验质量的高低关乎到试验结果的可靠性。因此,临床研究人员长期致力于如何加强药物临床试验的质量控制研究。随着近年来电子数据和远程模式在临床试验数据管理中的应用和发展,建立新型临床试验质量控制体系迫在眉睫。基于前期研究经验,提出中心化质量控制的概念,即基于网络技术,实现药物临床试验主要环节和人员的线上互动,通过角色分配和责任划分,实现动态质量监管。药物临床试验中心化质量控制实施的根本在于标准化,其中网络监管与临床设计的无缝衔接是关键。Quality control is a key link in the process of clinical trials and important content, the quality of clinical trials about the reliability of test results. Therefore, clinical researchers devoted to study how to strengthen the quality control of drug clinical trials. As the electronic data and remote mode in recent years in the application and development of clinical trial data management, establishing the new clinical trials quality control system is imminent. Based on previous research experience, this paper puts forward the concept of quality of centralized control, which is based on network technology, the realization of drug clinical trials main links and personnel online interaction, through the role assignment and responsibility, realize the dynamic quality control. Centralized drug clinical trial the fundamental lies in the standardization for the implementation of quality control, including the seamless network supervision and clinical design is the key. In this paper, regarding the centralized modern drug clinical trials quality control paper introduced standardized specifications and requirements of the construction of the peer to reference.

关 键 词：药物临床试验 中心化质量控制 标准化建设 

分 类 号：R969.4[医药卫生—药理学]