基于研究型医院的临床研究中心平台建设与管理模式实践探索——上海某三级甲等综合性医院案例探讨  

Practical exploration of clinical research unit platform construction and management mode based on research-oriented hospitals: The case study of a tertiary hospital in Shanghai

作　　者：罗榕 张熙 王耀晟[1] 陈光榆[1] 吴伟洁 李学海 周欣[1] Luo Rong;Zhang Xi;Wang Yaosheng;Chen Guangyu;Wu Weijie;Li Xuehai;Zhou Xin(Clinical Research Unit, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China)

机构地区：[1]上海交通大学医学院附属新华医院临床研究中心,200092

出　　处：《中华医学科研管理杂志》2019年第2期81-85,共5页Chinese Journal of Medical Science Research Management

基　　金：上海申康医院发展中心临床科技创新项目(SHDC12017614).

摘　　要：目的总结上海交通大学医学院附属新华医院临床研究中心(Clinical Research Unit,CRU)平台成立以来的实践经验,为国内已经及正筹备建立临床研究中心平台的机构提供借鉴。方法该平台以医院需求为导向,搭建六大特色功能模块:项目管理、方法学支撑、数据管理、质量风险管理、项目转化、以及培训及对外交流模块,建立并完善相应模块制度、质控、技术支撑及信息化数据平台体系等。结果在该平台支撑下,各临床专业、科室开展临床研究积极性不断增强,学科临床研究人才储备逐渐扩大;临床研究合作意识逐步提高,国际合作领域进一步拓展;临床研究项目数及获资助经费额度迅速增长。结论上海交通大学医学院附属新华医院临床研究中心平台为临床研究项目提供全方位技术支持和全过程信息化管理,提高临床研究项目质量和效率。借鉴国际先进理念的同时,仍需不断摸索完善符合我国大型综合性研究型医院特色的平台建设和管理模式,提升医院学术科研的国际竞争力。Objective To summarize the practical experiences of Clinical Research Unit (CRU) platform established by Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine, provide reference for domestic institutions that have prepared or to prepare to establish CRU platform. Methods Oriented by demand, this platform has set up six modules including project management module, methodology support module, data management module, quality risk management module, project transformation module and training and international exchange module. Besides, it also establishes and improves the corresponding module system, quality assurance, technical support and information data platform system. Results With this platform, the enthusiasm of departments to carry out clinical research has been continuously enhanced, the talent pool of clinical research has been expanded;the awareness of clinical research cooperation has been improved and the international cooperation fields have been further extended;the number of clinical research projects and funding have increased rapidly. Conclusions CRU Platform in Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine provides all-dimensional technical support and whole-process informatization management to improve clinical research quality and efficiency. While learning from the advanced international concepts, we still need to explore and improve the platform construction and management mode in line with general research-oriented hospitals in China, further to enhance the academic research internationally.

关 键 词：临床研究中心 平台建设 管理模式 

分 类 号：R197.3[医药卫生—卫生事业管理]