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在新药临床试验中开展临床研究协调员工作 被引量:11

Work experience of clinical research coordinator in clinical trials of new drugs
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摘要 临床研究协调员(CRC)作为临床试验的参与者和一种职业在国外已有多年历史,而我国的CRC工作刚刚起步。青岛市市立医院国家药物临床试验机构在新药临床试验中设置了CRC,并在实际工作中取得一定成效。本文就我院CRC的运行机制和具体工作进行介绍和总结。 Clinical research coordinator (CRC), as an important member and a special vocation in clinical trial conduction, has been in existence for many years in abroad, but it is still a new thing for researchers and administrators in China. We have practiced CRC in clinical trial quality control in recent years and improved the quantity and quality of the clinical trials in our hospital. This article mainly deals with the operating mechanism and experiences of CRC in our hospital.
出处 《中国新药与临床杂志》 CAS CSCD 北大核心 2009年第8期635-637,共3页 Chinese Journal of New Drugs and Clinical Remedies
关键词 临床试验 组织与管理 研究人员 临床研究协调员 coordinator clinical trials organization and administration research personnel clinical research
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参考文献2

  • 1DAVIS 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.
  • 2RICO-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, 4: 6.

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