基于HIS系统的临床试验医院信息化整合系统(CTHMS)的创建及应用  

Construction and Application of Clinical Trial Hospital Management System (CTHMS) Based on HIS system

作　　者：朱瑞芳 黄立峰 Zhu Rui-fang;Huang Li-feng(Department of Pharmacy,Suzhou Science&Technology Town Hospital,Suzhou 215153,Jiangsu Province,China)

机构地区：[1]苏州科技城医院药学部,江苏苏州215153

出　　处：《科学与信息化》2022年第16期152-156,共5页Technology and Information

基　　金：院内新冠课题专项,项目名称:抗新型病毒感染药物临床评价IIT信息化平台创建,项目编号:yjxm2020002。

摘　　要：为提高临床试验的质量,加强研究者发起的临床研究(IIT)及制药企业(IST)发起的试验项目全周期的管理,适应新版药物临床试验质量管理规范实施背景下对于药物临床试验质量管理以及数据溯源的要求,本机构依托院内信息系统研发了整合临床试验运行及管理全过程的CTHMS系统,通过该阐述系统的构建过程、实践难点以及存在的优势和不足,并结合国内外研究进展及本机构的信息化建设经验为系统进一步的开发完善提供支持。To improve the quality of clinical trials,strengthens the full-cycle management of clinical investigator initiated clinical trial(IIT)and industry-sponsored clinical trial(IST),and adapt to the requirements of drug clinical trial quality management and source data traceability under the implementation of the new issued Good Clinical Practice(GCP),this institution has developed a clinical trial hospital management system(CTHMS)platform that integrates the entire process of clinical trial operation and management based on the hospital information system.Through the explanation of the construction process,practical difficulties,and existing advantages and disadvantages of this system,combined with the research progress in China and abroad and the information construction experience of this institution,it will provide support for the further development and improvement of the system.

关 键 词：临床试验 信息系统 IIT IST 临床试验管理 

分 类 号：F27[经济管理—企业管理]