摘要
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。CRC作为临床试验过程中的一员,发挥着协调和管理项目的重要作用。本文结合作者的工作体会,对我国CRC的来源、认证、培训和管理等方面进行分析,为建立适合我国国情的CRC管理体系提供参考。
The effects of clinical research coordinator （CRC） in clinical trials of high quality have received quite a lot of attention from clinical drug trial institutions and applicants. CRC, as a member of the clinical trial process, plays an important role in the coordination and management of the project. This paper analyzed the origination, certification, training and management, and other aspects of CRC in China combined with our own work experience, to provide reference for establishment of CRC management system in our country.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2015年第12期918-920,共3页
Chinese Journal of New Drugs and Clinical Remedies
关键词
临床试验
临床研究协调员
组织和管理
研究人员
personnel clinical trails
clinical research coordinator
organization and administration
research
