Obligation and Experience of Clinical Research Coordinator in Good Clinical Practice_West China Medical Journal

Authors：

SHE Bin ¹ , CHEN Yan ¹ ,  ZHANG Ruiming ²

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 Ruiming, Email: she-bin@163.com

Keywords：

药物临床试验协调员; 组织与管理; 职责与经验

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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。

Citation： SHE Bin,CHEN Yan,ZHANG Ruiming. Obligation and Experience of Clinical Research Coordinator in Good Clinical Practice. West China Medical Journal, 2012, 27(6): 812-814. doi: Copy

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11.	The DCCT Research Group. The impact of the trail coordinator in the Diabetes Control and Complications Trial (DCCT)[J]. Diabetes Educ, 1993, 19(6): 509-512.
12.	江子芳, 杨方英, 刘丽华, 等. 药物临床试验研究护士的培养与实践[J]. 护理学报, 2010, 17(3A): 38-40.

1. 　李发庆, 邵蓉. 临床研究协调员在中国的职业定位[J]. 上海医药, 2010, 31(11): 504-506.
2. 　Poston RD, Buescher CR. The essential role of the clinical research nurse (CRN)[J]. Urol Nurs, 2010, 30(1): 55-63.
3. 　Hill G, Macarthur J. Professional issues associated with the role of the research nurse[J]. Nurs Stand, 2006, 20(39): 41-47.
4. 　Rico-Villademoros F, Hernando T, Sanz JL, et al. The role of the clinical research coordinator - data manager - in oncology clinical trials[J]. BMC Med Res Methodol, 2004, 3(25): 4-6.
5. 　国家食品药品监督管理局.药物临床试验质量管理规范[EB/OL]. (2003-08-06) [2012-02-28]. http://www.sda.gov.cn/WS01/CL0053/24473.html.
6. 　卢家秀, 董瑜, 邓蓉等. 护士在抗感染药物临床研究中的作用[J]. 寄生虫病与感染性疾病, 2006, 4(4): 208-209.
7. 　顾琼华. 研究护士在国内新药临床试验中的现状与进展[J]. 上海护理, 2011, 11(1): 64-66.
8. 　卜擎燕, 熊宁宁, 邹建东, 等. 临床试验的重要角色: 临床研究协调员[J]. 中国临床药理学与治疗学, 2006, 11(10): 1190-1193.
9. 　Davis AM, Hull SC, Grady C, et al. The invisible hand in clinical research: the study coordinator’s critical role in human subjects protection[J]. J Law Med Ethics, 2002, 30(3): 411-419.
10. 　Ocker BM, Plank DM. The research nurse role in a clinic-based oncology research setting[J]. Cancer Nurs, 2000, 23(4): 286-294.
11. 　The DCCT Research Group. The impact of the trail coordinator in the Diabetes Control and Complications Trial (DCCT)[J]. Diabetes Educ, 1993, 19(6): 509-512.
12. 　江子芳, 杨方英, 刘丽华, 等. 药物临床试验研究护士的培养与实践[J]. 护理学报, 2010, 17(3A): 38-40.

West China Medical Journal

Obligation and Experience of Clinical Research Coordinator in Good Clinical Practice

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