药物临床试验机构的管理

Management of clinical trial institution

我国药物临床试验必须在通过国家食品药品监督管理局和卫生部组织的资格认定的医疗机构中进行。药物临床试验机构与研究者在GCP中共同承担研究方的角色,两者之间是管理者与被管理者的关系。药物临床试验机构的主要职责,一是医疗机构从事药物临床试验的医疗与研究条件的系统管理,包括理化检查相关科室和实验室的质量管理、研究用药品的管理、源文件和源数据的现场管理;二是对所承担的临床试验项目的管理,包括立项评估、接受监查/稽查,并对监查的质量进行评估。

Clinical trials can only be done in the State Food and Drug Adminstration （SFDA） certified investigator sites. Clinical trial institution and investigator servers jointly as the ＂investigator/institution＂ mentioned in good clinical practice（GCP）. The relationship between institu- tion and investigator is supervisor and supervisee. The major responsibilities of a clinical trial institution are as follows： maintaining and manage- ment of system srelated to medical service and facilitating the clinical research conditions, including quality management of related physical and chemical examination department, management of clinical research medicines, site management of source files and source documents ; clinical trial project management, including feasibility assessment, receiving monitoring/audit, and quality evaluation of monitoring activities.