试验用药品智能信息系统的设计与开发

Design and Development of an Intelligent Information System for Investigational Products

我国试验用药品管理仍以“手工+纸质”的传统方式为主,具有采集效率低、过程繁琐和易损毁等缺点。为提升管理质量,探索构建试验用药品信息管理系统逐渐成为行业共识。本文综述了当前试验用药品信息管理系统设计模式分类,明确了系统设计原则和要求,并基于本院试验用药品智能信息系统(ISIP)开发经验,阐述了系统设计的关键要素,包括架构设计、信息安全与权限管理、关键功能实现等,还详细介绍了全周期管理、监控预警与智能提醒、数据可视化、多层级台账、特殊双盲试验盲态保持、报表导出和编码设计、外部系统对接、身份核对与签名和一键溯源等重要功能模块。结果表明ISIP系统的应用能实现药房数据的可视化,量化工作量指标,显著提升试验用药品管理效率效能,可为试验用药品信息管理系统的开发提供参考。

The management of investigational products in China still relies primarily on traditional"manual and paper"methods,which has the disadvantages of low collection efficiency,tedious process,and vulnerability to damage.In order to improve the quality of management,there is a growing consensus in the industry to explore the construction of an investigational product information management system.This paper summarizes the current classification of design patterns for intelligent information systems related to investigational products,clarifies the principles and requirements for system design.Based on the development experience of our hospital's intelligent information system for investigational products(ISIP),this paper elaborates on key elements of system design,such as architecture,information security,authority management,and key function realization.It also details the design of important functional modules such as drug lifecycle management,monitoring and warning,data visualization,multi-level ledger,special double-blind trial functionality,report export,unique coding design,external system integration,identity verification and signature,and traceability query.The results demonstrate that the application of the ISIP system achieves the visualization of pharmacy data,quantifies workload indices,and significantly improves the efficiency of investigational product management.ISIP serves as a valuable reference for the development of investigational product information management systems.