高质量发展视角下对研究者发起的临床研究全过程管理的问题探讨
Discussion on whole process management of IIT clinical research from perspective of high quality development
尹妍1
作者信息
- 1. 首都医科大学宣武医院科研处,北京 100053
- 折叠
摘要
研究者发起的临床研究(IIT)是临床研究的重要组成部分.本文结合北京某三甲医院IIT管理的工作实践,从临床研究组织管理架构设计、科学性审查和伦理审查要点、系统备案、IIT合同审核重点和项目质量控制等方面与国家卫生健康委员会出台的IIT管理办法逐一比照分析,并针对上述方面提出相应的优化对策,旨在为建立健全医疗机构内部组织管理体系,促进临床研究高质量发展.
Abstract
Investigator-initiated-trial(IIT)is the most important part of clinical researches.Based on the IIT management practice of one 3 A grade hospital in Beijing,this paper analyzed the organizational structure of clinical research,the key points of scientific review and ethical review,recordation filling,contract verification and quality control,which were compared with the IIT management measures issued by the NHC one by one.According to the above,this paper puts forward some corresponding countermeasures,aiming at improving the management level and promoting high-quality development of clinical research.
关键词
临床研究/质量控制/全面质量管理/组织和管理Key words
clinical study/quality control/total quality management/organization and administration引用本文复制引用
出版年
2024
NETL
NSTL
万方数据