基于医疗机构视角的临床研究协调员现状分析及管理优化探讨

Analysis of status of clinical research coordinators and discussion on management optimization from perspective of medical institution

随着临床试验研究工作的发展,临床研究协调员(CRC)逐渐成为临床试验项目团队中不可或缺的部分。本研究通过分析受聘于本院的152名CRC的基本概况,对临床试验CRC管理中存在的业务水平参差不齐,项目分配依据有待优化,人员流动快,职责分工不明确、定位不清晰等问题进行梳理,提出创建CRC档案库和面试题库、规范服务项目分配标准、完善SMO纳入标准、加强CRC培训与管理,优化医疗机构对CRC的监管。

With the development of clinical trial research, the clinical research coordinator(CRC) has gradually become an integral part of the clinical trial team. This study analyzed the basic profiles of 152 CRCs employed in the hospital. The problems in CRC management, such as uneven business level, project allocation basis to be optimized, fast personnel flow, and unclear division of responsibilities were sorted out. The supervision of CRC can be optimized by creating CRC archives and interview question banks, standardizing service item allocation standards, improving SMO inclusion standards, and strengthening CRC training and supervision.