日本临床研究协调员行业发展透视和经验借鉴  

Perspectives of Japanese Clinical Research Coordinator Industry Development and Experience Reference

作　　者：王欣[1] 汪芳[1] 

机构地区：[1]北京医院临床试验研究中心,北京100730

出　　处：《中国药房》2016年第18期2587-2589,共3页China Pharmacy

基　　金："重大新药创制"科技重大专项(No.2012ZX-09303-008-002)

摘　　要：目的:为我国临床研究协调员(CRC)行业的健康发展提供借鉴。方法:采用文献研究和实地调查研究相结合的方法,对日本CRC行业的发展现状、培训认证和工作模式进行总结,并对我国CRC行业发展提出建议。结果:日本CRC行业逐渐成熟、人员趋于稳定,已建立规范化培训和认证体系,其范围包括对医疗卫生机构、药物临床试验和临床研究等多方面的支持和服务。我国CRC行业应当完善制度建设、开展规范化培训和认证考试、加强研究机构对CRC的直接管理、拓展CRC的临床研究服务业务等。结论:日本CRC行业的制度建设、规范化培训和工作模式等方面的发展经验对我国CRC行业的健康发展有良好的借鉴意义。OBJECTIVE：To provide reference of Clinical Research Coordinator（CRC）industry development in China. METH-ODS：By using the method of literature research combining with field survey research,the development status,training certifica-tion and working mode of CRC industry in Japan were summarized,and suggestions on the development of the CRC industry in China were proposed. RESULTS：Japanese CRC industry gradually matured,and staff tended to be stable,the standardized train-ing and certification system have been established,the services include the support on medical institutions,clinical trials,clinical researches and other multiple aspects. CRC industry in China should perfect the company system construction,carry out standard-ized training and certification examination, strengthen the hospitals＇ direct management of CRC, and expand the CRC services in clinical research. CONCLUSIONS：The experience of CRC industry development in Japan,including system construction,stan-dardized training and working mode,is a good example for China CRC industry to learn.

关 键 词：临床研究协调员 日本 中国 

分 类 号：R951[医药卫生—药学]