北京某儿科医院临床研究一体化管理体系建设探索与实践  

Exploration and practice on construction of clinical research integrated management system of a pediatric hospital in Beijing

作　　者：梁宇光 王谦 丁倩 郭春彦 张萌 张怡 王晓玲 郭鹏 Liang Yuguang;Wang Qian;Ding Qian;Guo Chunyan;Zhang Meng;Zhang Yi;Wang Xiaoling;Guo Peng(National Center for Children’s Health/Clinical Research Center,Beijing Children’s Hospital,Capital Medical University,Beijing 100045,China)

机构地区：[1]国家儿童医学中心,首都医科大学附属北京儿童医院临床研究中心,北京100045

出　　处：《中华医学科研管理杂志》2025年第1期69-74,共6页Chinese Journal of Medical Science Research Management

基　　金：北京市研究型病房示范建设项目(BCRW202101);首都医科大学附属北京儿童医院管理类课题"临床研究一体化管理平台建设及多中心合作模式探索"(YGLY2022001);北京市卫生健康科技成果和适宜技术推广项目"儿童专科医疗机构个性化/普适化科技管理工作探索研究"(BHTPP2024069)。

摘　　要：目的从现阶段我国儿科临床研究发展中存在的主要问题出发,聚焦临床研究管理体系建设,创新平台管理模式,提升人员技能水平,为临床研究平台完善和未来可持续发展提供支持和保障。方法建立"申办者发起的临床试验(IST)与研究者发起的临床研究(IIT)一体化管理平台",实施IST和IIT项目一体化管理,同时针对质量管理的薄弱环节,实施管理人才和研究人才同步培养,实现项目全流程管理质量和平台服务效率双提升。结果通过建章立制,优化了临床研究组织架构、完善了管理制度并强化了IIT项目质量监管,实现了临床研究项目管理提质增效。结论在分析国内现状和参考国际经验的基础上,搭建符合医院发展的临床研究管理平台,实现了IST和IIT项目全流程中心化管理,并强化了项目过程质控,有望为同行提供参考和借鉴。ObjectiveThis study starts from the main problems existing in the current stage of the development of pediatric clinical research in China and focuses on the construction of a clinical research management system.By innovating the platform management model and enhancing personnel skills,we can provide support and assurance for improving the clinical research platform and its sustainable development in the future.MethodsThis study established an integrated management platform for Industry-Sponsored Initiated Clinical Research Trial(IST)and Investigator Initiated Clinical Research(IIT)and implement integrated management of IST and IIT projects.At the same time,in response to the weak links in quality management,synchronous training of management and research talents should be implemented to achieve dual improvement in project management quality and platform service efficiency throughout the process.ResultsWe had optimized the clinical research organization structure,improved the management system,and strengthened the quality supervision of IIT projects by establishing rules and systems to improve the quality and efficiency of project management.ConclusionsBased on analyzing the current situation in China and referring to international experience,we have built a clinical research management platform in line with the development of the hospital,and implemented centralized management of the entire process of IST and IIT projects,strengthened project process quality control,which is expected to provide a reference for peers.

关 键 词：临床研究 一体化管理 提质增效 

分 类 号：F42[经济管理—产业经济]