临床试验数据管理国际法规的概述  

Overview of global clinical data management regulations and standards

作　　者：刘川 

机构地区：[1]北京科林利康医学研究有限公司,北京100123

出　　处：《药学学报》2015年第11期1443-1451,共9页Acta Pharmaceutica Sinica

摘　　要：临床试验研究质量和数据真实完整性是对试验药物有效性和安全性进行科学和公正评价的基础。临床试验过程的规范化和标准化,可以保证临床试验及其数据的质量,而规范化和标准化的实践反过来又可推动和提高实际工作的效率和可靠性。目前,国际上针对临床试验及其数据管理的标准规范较为完备,欧美国家对试验数据管理规程指南或条例,以及执行力度都较为成熟。我国在临床试验及其数据管理方面的经验和监管规范尚有待完善。本文从良好临床数据管理的角度,对全球临床试验数据管理的法规和标准作出介绍,期待能对完善我国临床试验数据监管体系有所借鉴。Quality and integrity of clinical trials and associated data management is a basis on the scientificand rightly assessments of drug safety and efficacy. While both normalization and standardization of clinicaltrial procedures assure quality of clinical trials and the relevant data processes, they will drive and improvethe efficiency and reliability of real-world deliverables in clinical trials in turn. Currently, the comprehensivestandards and practices of clinical trials and associated data management are globally established better, and USand EMA have enacted and implemented adequate guidances and regulations well. China is in the initial stageof development of relevant regulations regarding clinical trials and associated data management. This reviewwill focus on the above-mentioned global regulations and standards of clinical data management in the views ofgood clinical data management standpoints, making references to improve the Chinese regulative system ofclinical data management.

关 键 词：临床试验 数据管理 临床数据 数据标准 良好临床数据管理规范 

分 类 号：R969[医药卫生—药理学]