临床试验药物信息化管理系统的构建与应用

Construction and Application of the Information Management System for Clinical Trial Drugs

目的:规范我院临床试验药物管理,探讨信息化管理系统的构建及其在临床试验药物管理过程中的应用。方法:结合本院临床试验药物管理的模式和流程,在电子病历系统的基础上开发适合本院实际情况的临床试验药物信息化管理系统,并应用于试验项目的药物管理过程中。结果:与传统纸质表格管理模式相比,信息管理系统能够实现试验药物的建库、入库、专用处方开具、发放与回收、盘点与查询、有效期管理、退回与资料归档全过程的实时记录与在线信息流程管理。结论:信息化系统保证了临床试验药物管理的规范化,数据及时备份,可保障数据的安全性,有助于提高GCP管理水平。

Objective: To standardize the management of clinical trial drugs in our hospital and explore the construction of the information management system and its application in the process of managing clinical trial drugs. Methods: The information management system for clinical trial drugs was developed on the basis of the electronic medical record system. It was combined with the mode and process of the clinical trial drug management in our hospital and was applied to the management process of the clinical trials. Results: Compared with the traditional management mode, the information management system can realize the real-time recording and online management of the whole process of the database establishment, inputting, special prescription, distribution and recovery, inventory and inquiry, validity management, return and data archiving of the clinical trial drugs. Conclusion: The information management system ensures the standardization of management for clinical trial drugs. The timely data backup can ensure the safety of data and help to improve the management level of GCP.