药物临床试验机构专业科室建设与规范管理的探索

Discussion on the development and standardized management of professional department in drug clinical trial institutions

机构专业科室的建设与规范管理是国家药物临床试验机构建设与质控的核心,本文结合委署大型综合性三甲医院药物临床试验机构在长期以来的机构及专业建设过程中的实践与探索,分别从基本硬件配备、药物临床试验团队的组建、专业制度建设及培训等方面详细阐述了机构专业规范管理的主要内容和基本思路。

The development and standardized management of professional department is the core of the national drug clinical trial institution development and quality control. Combined with the practice and exploration of the development of drug clinical trial institution in large comprehensive hospitals,this paper states main elements and basic ideas of standardized management of professional department in detailed from the following several aspects： the basic hardware,the formation of good clinical practice（ GCP） team,the system construction of professional department and the training of investigator.