药物临床试验管理系统的设计与应用

Design and Application of Drug Clinical Trial Management System

目的:探讨信息化管理在药物临床试验管理中的应用。方法:结合我院药物临床试验运行特点、流程及临床试验过程中易出现的药物、医嘱、检验检查管理方面的问题,设计了药物临床试验信息管理系统并介绍了其功能实测情况。结果:通过信息化管理,实现了对药物和项目的全程管理,方便研究者开具药物、检验检查医嘱;并且与医院信息系统、检验科的实验室信息系统、心电图室的心电信息系统建立了接口,实现了数据共享;避免了检验科室烦琐的手工录入,研究者可及时查阅到受试者的检验结果;解决了心电图图像信息不能溯源的问题。结论:药物临床试验信息化管理使项目管理更加规范,减少了差错发生机会,加强了关键环节的质量管理,从而有效地提升了药物临床试验机构的管理水平。

OBJECTIVE：To investigate the application of information management in the management of drug clinical trials.METHODS：In the combination of the running characteristics,process and drugs usually used in clinical trials,doctor advice and problems of inspection and management during the drug clinical trials,the drug clinical trial information management system was designed and its function was introduced. RESULTS：Information management achieved the whole process management over trial projects and drugs,making it easy for the investigators to give their orders;and it realized data sharing with hospital information system,the laboratory information system of dept. of clinical laboratories and the ECG information system of electrocardiography room by connecting with such systems;dept. of laboratory could be saved from tedious data input by hand,the investigators might refer to the lab data of the subjects in time;ECG image data could be traced to the source. CONCLUSIONS：Drug clinical trial information management can make project management more standard,reduce the mistake rate and strengthen the quality management of key links,and thus effectively enhance the management levels of clinical drug trial institutions.