医院临床研究管理委员会及其管理文件体系构建

摘要

在深入阐释临床研究项目定义及特征的基础上,运用理论研究、对比研究和实践相结合的方法,从临床研究管理委员会的运行流程及管理文件体系两个方面深入研究,构建较为系统、全面、可行的临床研究管理委员会管理体系,为医疗机构临床研究管理委员会建设提供借鉴和参考.%This paper deeply studied the definition and characteristics of clinical research programs. On such basis, the researchers utilized theoretical and comparative studies in combination of practical studies, to probe deeply into both the operating procedures and management documents of the clinical research management council.These efforts contributed to constructing a systematic, overall and feasible management system,for reference of building such a council by medical institutions.