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多中心临床试验协调中心(CC)项目管理者在本文定义为协调中心对试验进行管理的人,他在制定和实施多中心临床试验计划中扮演着越来越重要的角色.在一项“无症状颈动脉斑(ACAPS)”的早期预防试验中,项目管理者为协调中心主要调查者(CCPI)充当代理人和发言人,并在试验协调中心和所有试验点之间担任联络.其一般责任包括:阐明试验中出现的各种问题和争论、调整试验人员的工作、传递新信息以及对尚未解决的问题作进一步研究,其具体内容包括:制定调查表和执行手册、组织和(或)参与资料收集、资料处理的训练班、到现场调查、筹划指导委员会议、起草试验进程汇报,参加质量控制的监测工作等.在ACAPS试验中,项目管理者的责任涉及试验的各个阶段,如制定计划、
The Multi-Center Clinical Trials Coordination Center (CC) project manager, defined in this paper as the person managing the trial in the focal point, plays an increasingly important role in developing and implementing a multicenter clinical trial program. In the Early Prevention Trial of Symptomatic Carotid Plaque (ACAPS), project managers acted as agents and spokespersons for the CCPI, and acted as liaison between the Test Coordination Center and all test sites. Including clarifying the various issues and controversies that occurred during the trial, adjusting the work of the experimenters, transmitting new information and conducting further research on unresolved issues, including the development of questionnaires and handbooks, the organization and / or participation Data collection and data processing training, on-site investigation, planning steering committee meeting, drafting test process report, attending quality control monitoring work, etc. In the ACAPS test, project manager’s responsibility involves all stages of the trial, such as making plans ,