药物临床试验机构的平台建设

Platform Construction of Drug Clinical Trial Institution

阐述了我国药物临床试验及《药品临床试验质量管理规范》,介绍了山西医科大学第一医院药物临床试验机构的发展史、组织结构及其建设进展,简述了伦理委员会的工作情况。

This paper expounds China＇s drug clinical trial and GCP （Good Clinical Practice）, introduces the development history, organizational structure and construction progress of the drug clinical trial institution in the First Hospital of Shanxi Medical University, and briefly sketches the work of ethics committee.