摘要
目的:探讨在新版《药物临床试验质量管理规范》要求下,临床研究协调员(clinical research coordinator, CRC)在公立医院的培养及管理模式。方法:分析国内公立医院不同的CRC管理模式,并以我院为例探讨CRC管理模式和考核体系的优化改进。结果:针对目前国内CRC管理模式的问题,应采取的措施包括规范化培训和认证考试、建立院内职业等级评估、完善现场管理组织制度建设和协助CRC优化管理流程的对策。结论:CRC给临床试验带来质量提升的同时也伴随着挑战,可针对存在的问题采取相应措施加以解决,以期促进CRC在我国临床试验中发挥更多的作用。
Objective: To explore the training and management mode for the clinical research coordinator(CRC)in public hospitals according to the requirements of new Standard for Quality Management of Drug Clinical Trials. Methods: This paper analyzed the different CRC management modes in domestic public hospitals, and took our hospital as an example to discuss the CRC management mode and assessment system.Results: Aiming at the current domestic CRC management mode, measures, including standardized training and certification examination, establishment of vocational grade assessment in hospitals, improvement of the construction of on-site management organization system and assisting CRC in optimizing the management process, etc, should be taken. Conclusion: CRC brings both quality improvement and challenges to clinical trials. Corresponding measures can be taken to solve the existing problems in order to promote CRC to play its due role in clinical trials in China.
作者
雷凯
胡梦薇
吴建元
陈博
孙道琴
黄建英
Lei Kai;Hu Mengwei;Wu Jianyuan;Chen Bo;Sun Daoqin;Huang Jianying(Clinical Trial Center of Zhongnan Hospital,Wuhan University,Wuhan 430071,China)
出处
《中国药师》
CAS
2022年第6期1056-1059,共4页
China Pharmacist
基金
2020年湖北省重点研发计划项目(编号:2020BCB016)。
关键词
临床试验
临床研究协调员
管理模式
质量控制
Clinical trials
Clinical research coordinator
Management mode
Quality control
