新药临床试验的原理与操作(6)——统计学处理的标准操作规程指南(续完)  

Principle and manipulation of clinical trials(6) ——Guidelines for standard operating procedure (continued 2)

作　　者：薛禾生[1] 曹彩 汤旦林[3] 

机构地区：[1]中国预防医学科学院,北京100050 [2]国家药品监督管理局药品认证管理中心,北京100061 [3]中日友好医院,北京100029

出　　处：《中国新药杂志》2001年第7期500-504,共5页Chinese Journal of New Drugs

摘　　要：本文介绍制药业统计学家协会标准操作规程指南的第 9～ 12部分。这里强调临床试验的归档文件应包含足以让人根据原始数据库重新进行统计分析和写出报告的材料、通过统计学家自始至终的参与以及培训来建立质量保证体系 ,总合分析必须事先计划 ,并给出了总合分析应包含的主要内容 ,同时详细论述了申办公司与CRO(合同研究组织 )Parts 9～12 of guidelines for standard operating procedures produced by the Statisticians in the Pharmaceutical Industry (SPI) are introduced.The archiving clinical trial data should provide sufficient information to permit the reconstruction of a statistical analysis and to write report based on the original data.Quality assurance and quality control systems are built up via the continuous participation of statisticians and training programs.Data overviews should be planned beforehand and its main contents should be contained.Interaction between a sponsor company and a CRO(Contract Research Organization) are also discussed in detail. [

关 键 词：文件归档 质量控制 总合分析 新药 临床试验 

分 类 号：R969.4[医药卫生—药理学]