药物临床试验综合信息管理系统功能设计

目的介绍由广东省计算机集成制造重点实验室主研的药物临床试验综合信息管理系统（GCPMS）的主要功能。方法介绍系统的主要功能模块,包括：《药物临床试验质量管理规范》（GCP）系统管理、GCP项目管理、受试者管理、GCP药品管理等。结果与结论 GCP MS成功开发后,已经在广东省的几家国家药物临床试验机构运用。系统的运用解决了传统药物临床实验缺乏即时动态的缺陷,缩短了研究者与药物临床试验机构的时空差距,使各科室与相关部门的衔接更加紧密,也促使药物临床试验向全面无纸化迈出了重要的一步。

Function Design of Drug Clinical Trial Integrated Information Management System

Objective To share and introduce the main functions of the drug clinical trial integrated information management system developed by Guangdong Computer Integrated Manufacturing Key Laboratory（National computer software registration certificate：No.2012SR032897）. Methods Themain function modules of the system,including GCP（Good Clinical Practice）System management,GCP Project management,subjects management and GCP drug management were introduced.Results After the successful development of GCPMS,it was applied in several national drug clinical trial institutions in Guangdong.Conclusion The use of the system solves the traditional defect of lack of real-time dynamic and shortens the gap of time between the researchers and Drug Clinical Trial Institution Office,establishes a closer connection between clinical departments and relevant departments,and at the same time promotes the comprehensive paperless drug clinical trial.