药物临床试验管理系统设计与应用

Design and Application of Drug Clinical Trial Management System

介绍药物临床试验管理系统设计原则、建设目标、总体架构及业务流程,从申办方、机构办公室、专业组、药物管理、系统管理等方面详细阐述系统功能,指出该系统的应用能够提高药物临床试验工作效率,质控更及时,试验各环节可溯源,流程管理更规范。

The paper introduces the design principle,building goal,overall architecture and business process of the drug clinical trial management system,elaborates the system functions in detail from the aspects of applicant,office,professional group,drug management,system management,etc.,points out that the application of this system can improve the working efficiency of drug clinical trials,and also provide more timely quality control,traceability of each testing link,more standardized process management.