药物临床试验免费检查信息系统的设计与应用  

Design and application of free examination information system for drug clinical trial

作　　者：周焕[1,2] 谢蕴秋[1] 周叶[2] 夏广敏[1] 张茜[1] 李彬[1] 

机构地区：[1]蚌埠医学院第一附属医院,安徽蚌埠233004 [2]蚌埠医学院卫生管理教研室,安徽蚌埠233004

出　　处：《中国新药与临床杂志》2017年第6期337-339,共3页Chinese Journal of New Drugs and Clinical Remedies

基　　金：蚌埠市科技发展指导性项目(20150339);国家大学生创新创业项目(201610367003)

摘　　要：药物临床试验中如何做好受试者免费检查的监管及溯源是机构管理面临的难题。本研究在医院信息管理系统基础上设计了一套临床试验电子免费检查系统,通过信息化手段减少因纸质免费申请单发生的错误,解决了临床试验检查数据溯源难题。该系统成本低,性价比高,便于临床使用,有效提升了药物临床试验中免费检查效率,优化了受试者体验,有利于经费的核算,实现了药物临床试验免费检查的全流程动态监管,值得今后进一步推广应用。How to achieve supervision in the free-examination of clinical trial subjects is a problem faced by many clinical trial institutions. Based on the hospital information management system, this study designed a free-examination system to reduce the error frequency in paper free- examination by means of information. The electronic free-examination system can solve the problem of difficulties in clinical trial examination data source. It＇s convenient and has high cost efficiency. The system can optimize the participants＂ experience and is conducive to financial accounting. The whole process of dynamic monitoring in free-examination of clinical trial can be realized by this system. It＇s worth promotion and application in other hospitals in the future.

关 键 词：临床试验 药物临床试验质量管理规范 信息系统 设计 

分 类 号：R954[医药卫生—药学]