临床研究协调员在药物临床试验过程中的工作职责与经验.pdfVIP

812 West China Medical Journal Vol.27 No.6 Jun. 2012 2012 27 , , 华西医学 , （6） 药物临床试验与研究 临床研究协调员在药物临床试验过程中的 工作职责与经验 1 1 2 佘彬，陈雁，张瑞明 【摘要】　目前临床研究协调员（CRC ）在完成高质量的临床试验中所扮演的角色越来越受到国内药物临床试验 机构及药物申办者的广泛关注。作为临床试验过程中重要的一员，CRC 承担着协调及管理临床试验项目的任务，具 有“项目管理助手、后勤保障支持”的特点。四川大学华西医院国家药物临床试验机构在中医专业新药临床试验过程 中，尝试配备 CRC 并在实际工作中取得了一定成效，同时也积累了实践经验。现就该机构中医专业新药临床试验过 程中，CRC 的运行机制和具体工作职责进行简要介绍，为各药物临床试验机构的建设和管理、药物临床试验的质量 和整体水平的提高提供参考。 【关键词】　药物临床试验协调员；组织与管理；职责与经验 【文献标识码】　A　　　 Obligation and Experience of Clinical Research Coordinator in Good Clinical Practice　SHE Bin 1 1 , CHEN Yan , ZHANG Rui-ming2. 1. Department of Integrated Traditional Chinese and Western Medicine; 2. Institute of Drug Clinical Trial ·GCP Center; West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China Corresponding author: ZHANG Rui-ming, E-mail: zhruim-001@163.com 【Abstract】 At present, the function of clinical researcher coordinator (CRC) in good clinical practice (GCP) has drawn quite a lot of attention from clinical drug trial institutions and drug-production qualification applicants. CRC is characterized with “an assistant for managing project” and “logistics supporter” in GCP. Greater achievements have been attained in GCP after CRC was introduced in traditional Chinese medicine at West China Hospital. At the same time, we have also got much experience. Therefore we introduced the operation mechanism of CRC in traditional Chinese medicine at West China Hospital, which could be beneficial to improve the quality of GCP i