生物等效性试验数据管理系统的构建与应用研究

Construction and application of the bioequivalence test data management system

目的:满足日益增长的生物等效性试验的需求,提高试验效率与质量。方法:结合医院生物等效性试验的流程,通过WebService、XML等数据电子化技术构建生物等效性试验数据管理系统,并将其应用于生物等效性试验的实施。结果:生物等效性试验数据管理系统涵盖受试者联网查重管理、试验设计、实施、电子数据采集、质控管理、数据查看与管理等各环节,可对试验执行的全过程进行综合管理。结论:该系统具备规范现场操作、规范数据录入的功能,能够实现试验数据全生命周期管理,减少差错和误操作,提高生物等效性临床试验数据采集的效率和质量。

Objective To meet the increasing demands of bioequivalence tests and improve the efficiency and quality of the tests.Methods Combined with the process of bioequivalence test in the hospital,the bioequivalence test data management system was built through WebService,XML and other data electronization technologies,and applied to the implementation of the bioequivalence tests.Results The bioequivalence test data management system covers the online duplicate checking management of subjects,test design and implementation,electronic data collection,quality control management,data viewing and management,etc.,and can comprehensively manage the whole process of test execution.Conclusion The system has the functions of standardizing field operation and data entry,and realize the whole life cycle management of test data,reduce errors and misoperations,and improve the efficiency and quality of bioequivalence clinical trial data collection.