依托于医院信息系统的临床试验管理模块建设  

Construction of clinical trials management modules based on hospital information system

作　　者：李雯[1,2] 卢守四[2,3] 刘平[2] 乔虹[1] 宋杰[2] 段云侠 杨春山 王天放 LI Wen;LU Shousi;LIU Ping;QIAO Hong;SONG Jie;DUAN Yunxia;YANG Chunshan;WANG Tianfang(Office of Clinical Trial Institution,China Rehabilitation Research Center(Beijing Boai Hospital),Beijing100068,China;Research Ward of Clinical Trial,China Rehabilitation Research Center(Beijing Boai Hospital),Beijing100068,China;Department of Science and Education,China Rehabilitation Research Center(Beijing Boai Hospital),Beijing100068,China;Chuanghui Kang Technology Co.,LTD Beijing100055,China;China Rehabilitation Science Institute,Beijing100068,China)

机构地区：[1]中国康复研究中心(北京博爱医院)临床试验管理办公室,北京100068 [2]中国康复研究中心(北京博爱医院)研究型病房,北京100068 [3]中国康复研究中心(北京博爱医院)科教处,北京100068 [4]创业慧康科技股份有限公司,北京100055 [5]中国康复科学所信息所,北京100068

出　　处：《中国医药导报》2023年第29期190-193,共4页China Medical Herald

基　　金：国家科技支撑计划二级子课题(2012BAI34B03-6)。

摘　　要：为探索基于医院信息系统(HIS)的临床试验信息化管理模式,弥补临床试验医嘱无法实时审核、相关费用需要先行垫付、人工报销出现发票遗漏等问题,提高工作效率,中国康复研究中心(北京博爱医院)基于现有HIS系统,建设临床试验管理模块,优化临床试验随访及内部转账流程,探索出独有的临床试验信息化管理途径。该临床试验模块于2021年9月至2022年11月在25个临床试验项目中实施,操作简单,使用、管理便捷,实现了临床试验过程实时监管。解决了纸质申请单信息不准确、易丢失、难溯源等各种问题,避免了临床试验检验、检查费用与医疗保险费用混淆不清的情况,有效提高了临床研究信息化管理水平。In order to explore the clinical trial information management mode based on hospital information system(HIS),make up for the problems such as the inability to review clinical trial medical orders in real time,the need to advance related expenses in advance,and the omission of invoices in manual reimbursement,and improve work efficiency,Beijing Boai Hospital built a clinical trial management module based on the existing HIS system to optimize clinical trial follow-up and internal transfer processes,explore a unique way of clinical trial information management.The clinical trial module was implemented in 25 clinical trial projects from September 2021 to November 2022,the operation is simple,convenient to use and manage,and realizes real-time supervision of the clinical trial process.It solves various problems such as inaccurate,easy to lose and difficult to trace the paper application form information,avoids the confusion between clinical trial inspection costs and medical insurance costs,and effectively improves the level of clinical research information management.

关 键 词：临床试验管理模块 医院信息系统 信息化管理 实时监管 

分 类 号：R95[医药卫生—药学]