临床研究协调员在临床试验工作中重要性的调查研究  

Investigation of the clinical research coordinators' importance in clinical trials

作　　者：赵海娟[1] 张可欣 刘伟[2] 王娟 郝金娟 王欣[1] ZHAO Hai-juan;ZHANG Ke-xin;LIU Wei;WANG Juan;HAO Jin-juan;WANG Xin(Clinical Trials Research Center;Department of Research;Hospital Administration Office,Bering Hospital,National Center of Gerontology,Being Hospital,Beijing 100730,China)

机构地区：[1]北京医院国家老年医学中心临床试验研究中心,北京100730 [2]北京医院国家老年医学中心科研处,北京100730 [3]北京医院国家老年医学中心院长办公室,北京100730

出　　处：《中国临床药理学杂志》2018年第15期1923-1925,共3页The Chinese Journal of Clinical Pharmacology

基　　金：临床试验研究支撑平台建设课题资助项目(2017ZX09304026001)

摘　　要：探讨临床研究协调员(CRC)在临床试验工作中的重要性。方法本文采用调查问卷形式对CRC在临床试验中工作内容进行调查。同时,通过调查研究者和临床监查员(CRA)对CRC在临床试验工作在协助研究者进行材料收集与递交、物资交接与保管、受试者筛选、病例报告表(CRF)填写等重要性问题展开调查。最终,根据调查问卷结果通过EXCEL2 0 0 3和模糊综合分析法对调查问卷中进行统计分析。结果 CRC的工作已经参与临床试验工作大部分工作中,包括资料申报、协助研究者筛选入选、CRF填写、协助药物管理等。最终,研究者和监查员综合认为CRC在临床试验中重要性结果评定为重要和很重要。结论 CRC在临床试验中起着至关重要的角色,制定管理制度、建立培训体系和完善晋升体制在CRC行业发展中至关重要。Objective To explore the importance of clinical research coordinator（ CRC） in clinical trials. Methods The questionnaire was used to investigate the contents of CRC in clinical trials. At the same time,the importance of CRC in Clinical trials such as helping researchers to collect submitted materials, transfer and storage, the participants screening,case report form（ CRF） filling were investigated by the investigators and clinical research associate（ CRA） importance problem such as fill in the investigation. Finally,the questionnaire was analyzed by EXCEL2003 and fuzzy comprehensive analysis. Results CRC has been involved in most of the work of clinical trials,including data declaration,assistance in screening of candidates,CRF filling,and drug administration. In the end,the researchers and the inspectors concluded that CRC was important and very important in the evaluation of the importance of CRC in clinical trials. Conclusion CRC plays an important role in clinical trials,and it is very important to develop management system,establish training system and improve the promotion system in CRC industry.

关 键 词：临床研究协调员 药物临床试验 重要性 

分 类 号：R97[医药卫生—药品]