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药物临床试验管理是医院管理中非常重要的组成部分。药物临床试验机构是对医院药物临床试验相关活动进行管理的独立职能部门。本文根据医院药物临床试验机构10余年的发展，结合我国各医院药物临床试验机构的整体运行情况，从组织架构和质量保障体系、归档整理管理体系、试验药物管理体系等方面分析推出“三线式”管理方法，旨在推动药物临床试验工作的进步。“,”Drug clinical trials management is a very important component of hospital management. Drug clinical trial institution is an independent depart-ment managing the drug clinical trials related activities in hospital. Based on more than ten years of development,combined with the overall Running conditions of drug clinical trials institution in china,in this paper,discusses on the drug clinical triala institution arganizational structure and quality as-surance system,file dala management system,drugs management system,and introduce the three lines way in order to promote the drug clinical trials.