传染病专科医院药物临床试验机构管理特点及对策  

Management characteristics and solutions of drug clinical trial institution in communicable diseases hospitals

作　　者：顾俊[1] 张琴[1] 张志勇[1] 

机构地区：[1]上海市公共卫生临床中心,上海201508

出　　处：《中国新药与临床杂志》2010年第2期151-154,共4页Chinese Journal of New Drugs and Clinical Remedies

基　　金：重大新药创制科技重大专项(2008ZX09312-007)

摘　　要：药物临床试验机构是研究者安全、有效实施药物临床试验的重要保障。加强对药物临床试验机构的管理,对提高新药临床试验水平具有重大的意义。《药物临床试验机构资格认定办法(试行)》强调了药物临床试验机构的重要性和必要性。本文以我中心药物临床试验机构管理为例,结合传染病专科医院特点,从组织结构、人力资源、财务、资产和关键环节管理等方面探讨管理对策。Drug clinical trial institution is an important guarantee for researchers to conduct drug clinical trials safely and effectively. It is important to enhance the management of drug clinical trial institutions for improving the performance ability of new drug clinical trial. The importance and necessity of drug clinical trial institutions was stressed in ＂Accreditation Measures for Drug Clinical Trial Institution （Trial） ＂. Based on the management model of our center＇s drug clinical trial institution, combined with the features of communicable disease specialized hospitals, this article discussed the management solutions from all aspects like organizational structure, human resources, finance, assets, and key process management.

关 键 词：临床试验 组织机构 组织和管理 传染病 

分 类 号：R969.4[医药卫生—药理学]