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目的:拟解决我国多中心药物临床试验传统纸质管理方式落后、缺乏信息共享及协同管理等问题。方法:研究开发了一套基于J2EE跨平台技术体系的多中心药物临床试验管理信息系统,并介绍了其系统功能、技术架构及实现示例。结果与结论:该系统分为标准规范体系和信息安全两大体系,由基础层、数据层、支撑层、应用层和表现层五层结构组成;实现了药物临床试验项目信息、受试者信息、药品管理、质量控制等主要环节的信息化管理,对确保药物临床试验管理的时效性、规范性和提高管理效率有重要意义,适用于广域网络环境下多中心药物临床试验的信息化管理。
Objective: To solve the traditional paper-based management of multi-center drug clinical trials in our country lagging behind, the lack of information sharing and collaborative management issues. Methods: A multi-center clinical trial management information system based on J2EE cross-platform technology was researched and developed, and its system function, technical architecture and implementation examples were introduced. RESULTS AND CONCLUSION: This system is divided into two systems: standard system and information security. It consists of five layers: basic layer, data layer, support layer, application layer and presentation layer. It realizes the information of drug clinical trial, information of subjects , Information management of major aspects such as drug management and quality control is of great significance to ensure the timeliness and standardization of drug clinical trial management and the improvement of management efficiency and is applicable to the information management of multi-center drug clinical trial in the wide area network environment.