摘要
随着我国加入国际人用药品注册技术协调会(ICH),提高机构管理质量显得尤为重要,手工记录方式已不能满足当前大数据时代信息化管理需求。鉴于此,软件公司已基于信息化技术相继开发出医院机构管理系统并将其运用于机构管理。介绍当前医院机构管理系统在临床试验中的运用,讨论机构管理系统普及后可能出现的问题,并提出应对措施,以供其他临床试验机构参考。
With China joining the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH),it is particularly important to improve the quality of institution management,and the manual recording method has been unable to meet the current informatization management needs in the big data era.In view of this,software companies have successively developed hospital institution management systems based on information technology and applied them to institution management.This paper introduces application of hospital institution management system in clinical trials,and discusses the problems that may arise after the popularization of institution management system,and propose countermeasures for the reference of other clinical trial institutions.
作者
易红红
易锐
焦志海
YI Hong-hong;YI Rui;JIAO Zhi-hai(National Drug Clinical Trial Institution,The First Affiliated Hospital of Hunan Medical University,Huaihua 418000,China)
出处
《现代药物与临床》
CAS
2022年第2期420-424,共5页
Drugs & Clinic
基金
湖南省自然科学基金科药联合基金资助项目(2020JJ9049)。
关键词
机构管理系统
临床试验
运用
挑战
institution management system
clinical trial
application
challenge
作者简介
易红红(1991—),女,江西南昌人,硕士研究生,研究方向为临床试验机构管理。E-mail:az3306630@163.com;通信作者:焦志海(1965—),男,副主任药师,研究方向为临床试验机构管理,BE、PK研究。E-mail:2488984422@qq.com。
