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目的:探讨研究者发起的研究(IIT)中多中心药物临床研究存在的问题，为制定管理策略提供参考依据。方法:分析IIT中多中心药物临床研究中心招募、学术和伦理审查、协议签署、培训等各阶段存在的问题，讨论研究质量控制措施和研究进度的影响因素，提出IIT中多中心药物临床研究的管理要点及解决问题的策略。结果:开展IIT中多中心药物临床研究时，选择经验丰富、配合度高、硬件条件符合方案要求、院内流程顺畅的中心是保证研究进度和质量的基础；参与研究的医疗机构对科学性审查多无明确规定，但较多三级或以上医疗机构尚不能采用牵头单位的伦理审查结果，需对伦理进行再次审查；科研合作协议的审核流程和要求也因研究管理归属部门不同而存在差异，由药物临床试验机构负责审核的协议，对研究的经费预算和管理提出了更高要求；研究启动前与实施过程中，严格且及时的培训是保证研究质量的关键环节；研究质量和进度互相制约，受多种因素的影响，在开展过程中应制定详细的质量控制措施，加强培训和监查，项目管理与数据管理密切配合，及时发现各中心的数据质量问题并与研究者充分沟通，落实改进措施。结论:IIT中多中心药物临床研究的各个环节，对研究进度和质量存在影响，在开展研究前，应制定科学的研究方案，充分评估其可行性，准备阶段严格筛选分中心，尽量缩短立项、伦理审查和协议准备周期，同时加强研究者培训、监查、数据管理、风险管理及文档管理，还应充分利用信息化平台和手段，提高管理效率和研究进度与质量。“,”Objective:Discuss the problems of multi-center pharmaceutical clinical trial which initiated by investigator (IIT), providing references for developing study management strategies.Methods:By analyzing the site recruitment, academic and ethical review, study contract, study training, quality control, influencing factors of subject enrollment, proposed management strategies of multi-center pharmaceutical clinical study which initiated by investigator.Results:While conducting multi-center pharmaceutical clinical study initiated by investigator, the study experiences, study team, hospital equipment, and the internal process of hospitals are the factors which ensure the progress and quality of clinical study. Most of the sites have no clear statement of scientific review, but most of the high-level hospitals do not use the ethical review results of the head hospitals, the ethics must be reviewed repeatedly; Contract also has different requirements due to different management departments. During the preparation and implement of IIT, the investigators should undergo a rigorous training which is a key element to ensure the quality of the study. Research quality and progress restrict each other and are affected by many factors, detailed quality control measures should be developed, training and inspection, and the cooperation of project management and data management, also with discover the data problems of sites and communicate with investigators timely to ensure the improvement measures are implemented.Conclusions:There are many factors have impact on study progress and quality of multi-center pharmaceutical clinical trial of IIT. Before conducting research, protocols should be developed scientifically, and fully assessing its feasibility, screening study sites strictly, shorten the time of ethical review and contract preparation. Study training, inspection, data management, risk management and document management should be implement strictly, and make full use of information platforms and means, improve management efficiency and IIT progress and quality.