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：

藥物臨床試驗協調員; 組織與管理; 職責與經驗

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目前臨床研究協調員（CRC）在完成高質量的臨床試驗中所扮演的角色越來越受到國內藥物臨床試驗機構及藥物申辦者的廣泛關注。作為臨床試驗過程中重要的一員，CRC承擔著協調及管理臨床試驗項目的任務，具有“項目管理助手、后勤保障支持”的特點。四川大學華西醫院國家藥物臨床試驗機構在中醫專業新藥臨床試驗過程中，嘗試配備CRC并在實際工作中取得了一定成效，同時也積累了實踐經驗。現就該機構中醫專業新藥臨床試驗過程中，CRC的運行機制和具體工作職責進行簡要介紹，為各藥物臨床試驗機構的建設和管理、藥物臨床試驗的質量和整體水平的提高提供參考。

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

1.	李發慶, 邵蓉. 臨床研究協調員在中國的職業定位[J]. 上海醫藥, 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.	國家食品藥品監督管理局.藥物臨床試驗質量管理規范[EB/OL]. (2003-08-06) [2012-02-28]. http://www.sda.gov.cn/WS01/CL0053/24473.html.
6.	盧家秀, 董瑜, 鄧蓉等. 護士在抗感染藥物臨床研究中的作用[J]. 寄生蟲病與感染性疾病, 2006, 4(4): 208-209.
7.	顧瓊華. 研究護士在國內新藥臨床試驗中的現狀與進展[J]. 上海護理, 2011, 11(1): 64-66.
8.	卜擎燕, 熊寧寧, 鄒建東, 等. 臨床試驗的重要角色: 臨床研究協調員[J]. 中國臨床藥理學與治療學, 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, 楊方英, 劉麗華, 等. 藥物臨床試驗研究護士的培養與實踐[J]. 護理學報, 2010, 17(3A): 38-40.

1. 　李發慶, 邵蓉. 臨床研究協調員在中國的職業定位[J]. 上海醫藥, 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. 　國家食品藥品監督管理局.藥物臨床試驗質量管理規范[EB/OL]. (2003-08-06) [2012-02-28]. http://www.sda.gov.cn/WS01/CL0053/24473.html.
6. 　盧家秀, 董瑜, 鄧蓉等. 護士在抗感染藥物臨床研究中的作用[J]. 寄生蟲病與感染性疾病, 2006, 4(4): 208-209.
7. 　顧瓊華. 研究護士在國內新藥臨床試驗中的現狀與進展[J]. 上海護理, 2011, 11(1): 64-66.
8. 　卜擎燕, 熊寧寧, 鄒建東, 等. 臨床試驗的重要角色: 臨床研究協調員[J]. 中國臨床藥理學與治療學, 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, 楊方英, 劉麗華, 等. 藥物臨床試驗研究護士的培養與實踐[J]. 護理學報, 2010, 17(3A): 38-40.

West China Medical Journal

Obligation and Experience of Clinical Research Coordinator in Good Clinical Practice

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