医疗机构干细胞临床研究质量受权人制度的现状及管理实践  

Current situation and management practice of qualified person system for stem cell clinical research in medical institutions

作　　者：张吉刚 张铭健 曹佩 赫慧琛 张岩 祝延红[1] 郑兴东 丁雪鹰 Zhang Jigang;Zhang Mingjian;Cao Pei;He Huichen;Zhang Yan;Zhu Yanhong;Zheng Xingdong;Ding xueying(Shanghai General Hospital,Shanghai Jiaotong University School of Medicine,Shanghai 200080,China)

机构地区：[1]上海交通大学医学院附属第一人民医院,200080

出　　处：《中华医学科研管理杂志》2022年第6期401-405,共5页Chinese Journal of Medical Science Research Management

基　　金：上海申康医院发展中心促进市级医院临床技能与临床创新三年行动计划(20CR4001A);上海市科学技术委员会软科学研究计划(21692112600)。

摘　　要：目的分析与研究干细胞临床研究质量受权人制度实施中的难点与对策,并分享医院管理实践中的经验,推动并完善医疗机构质量受权人管理体系建设。方法对医疗机构质量受权人制度中的人才匮乏、资质不明、职责不清、缺乏考核标准等进行总结分析。结果针对目前质量受权人制度实施中难点,建议从完善法律法规体系,加强干细胞研究机构顶层设计、明晰资质门槛、细化职责、继续培训考核制度、建立支撑体系等方面综合考虑。结论医疗机构作为干细胞临床研究的责任主体,质量受权人制度的完善对我国细胞产业的发展具有促进作用。Objective To analyze and study the difficulties and countermeasures in the implementation of the Qualified Person(QP)system for stem cell clinical research,and share the experience of QP management practice in our hospital in order to promote and improve the construction of the QP management system in medical institutions.Methods Comprehensive investigations were conducted to summarize and analyze the shortage of talents,unclear qualifications,unclear responsibilities,and lack of assessment standards in the QP system of medical institutions.Results In view of the difficulties in the implementation of the current QP system,it is suggested to consider a combination of improving the system of laws and regulations,strengthening the top-level design of stem cell research institutions,clarifying the qualification threshold,refining QP responsibilities,continuing training and assessment system,establishing QP support system,etc.Conclusions Medical institutions are responsible for stem cell clinical research,and the improvement of the QP system can promote the development of the cell industry in China.

关 键 词：干细胞 质量受权人 临床研究 管理 规范 

分 类 号：R329.2[医药卫生—人体解剖和组织胚胎学]