药物临床试验信息管理系统的设计及应用

Design and Application of the Research of Drug Clinical Trial Information Management System

目的:解决药物临床试验纸质化管理中存在的问题,探讨信息化管理在药物临床试验过程中的应用。方法:结合药物临床试验项目的管理流程,采用C/S架构,设计开发了药物临床试验信息管理系统,并在多个临床科室进行了应用。结果:与传统模式相比,实现了对药物临床试验项目的全过程实时监控管理,方便研究者开立用药、检验、检查医嘱,并与HIS、LIS做了接口,实现了数据传输,解决了检验报告不能溯源的问题。结论:提高了药物临床试验的管理水平和工作效率,保证了药物临床试验实施过程的规范化,减少了医疗差错的发生。

Objective： This paper intends to solve problems in the paper management of drug clinical trials. It investigates the application of information management in the process of drug clinical trials. Methods： Combined with the management process of the drug clinical trial project and based on the C/S architecture, the information management system of drug clinical trial is designed and developed, and carried out in a number of clinical departments. P,.esults： Compared with the traditional model, the system realizes the real-time monitoring and management of the whole process of the drug clinical trial project. It is convenient for researchers to open the doctor＇s order of medication, inspection and examination. The system achieved data transmission with Hospital Information System and Laboratory Information System. The inspection report could be traced to the source. Conclusion： It has improved the management level and working efficiency of the drug clinical trial, and it guaranteed the standardization of drug clinical trial implementation process and reduced the occurrence of medical errors.