基于全过程管理的Ⅰ期临床试验管理系统设计与实现  

Implementation and Design of Phase Ⅰ Clinical Trial Management System Based on the Whole Process Management

作　　者：张帧[1] 李汉民[1] 肖辉[1] ZHANG Zhen;LI Hanmin;XIAO Hui(Zhongnan Hospital of Wuhan University,Information Center,Wuhan,Hubei,430071)

机构地区：[1]武汉大学中南医院信息中心,湖北省武汉市430071

出　　处：《中国卫生信息管理杂志》2022年第1期100-104,120,共6页Chinese Journal of Health Informatics and Management

基　　金：湖北省卫生健康委员会医学科技创新平台支撑项目《医院信息系统临床试验检查检验闭环管理功能研发》(项目编号:PTXM2019039)。

摘　　要：目的实现Ⅰ期临床试验全过程管理,畅通研究各方的沟通交流,提高项目管理规范性,形成唯一、留痕、可溯源的数据记录。方法从不同环节对Ⅰ期临床试验管理业务进行梳理,运用全过程管理理念进行多角色的流程优化和管理闭环。结果设计了包含项目配置、项目计划执行、受试者管理、生物样本管理、药品管理、质量控制等功能的Ⅰ期临床试验系统。结论Ⅰ期临床试验全过程信息化管理,符合法规要求,保证了临床研究数据的真实性、规范性及完整性,促进了Ⅰ期临床试验管理的标准化、全流程化、同质化,提升了临床试验质量和管理效率。Objective Realize the whole process management of phase Ⅰ clinical trials, smooth communication between all parties in the research, improve the standardization of project management,and form a unique, marked and traceable data record. Methods Based on the concept of whole process management, sort out the business process of phase Ⅰ clinical trial management. Results Design a phase Ⅰ clinical trial system, which enables functions including project configuration, project plan execution,subject management, biological sample management, drug management, quality control and other functions. Conclusion The information management of the whole process of phase Ⅰ clinical trials meets the requirements of laws and regulations, ensures the authenticity, standardization and completeness of clinical research data, realizes the double improvement of clinical trial quality and clinical trial management efficiency.

关 键 词：Ⅰ期临床试验 信息系统 全过程管理 分析与设计 

分 类 号：R-058[医药卫生] R197.3