Modeling an IT Support for Handling Serious Adverse Events in Clinical Trials

摘要：

　　Serious adverse events(AE)or reactions(AR)may occur in clinical trials and require particularly regulated reporting.Manual management is inefficient and ineffective.Based on a description of regulations,we have developed a data model with class-,state-,use-case-and activity diagrams,which can be used for automatic code generation of an assisting software tool for AE/AR data management.

关键词： Clinical Trial Adverse Event Software Engineering

作者: Simon Fonck Thomas Deserno

作者单位: Department of Medical Informatics,Uniklinik RWTH Aachen,Aachen,Germany

会议类型: 国际会议

会议名称: 第十六届世界医药健康信息学大会((MEDINFO2017)、第二届世界医药健康信息学华语论坛(WCHIS 2017)、第15届全国医药信息学大会(CMIA 2017)

会议地点: 苏州

会议语种:英文

页码: 1262-1262

在线出版日期: 2017-08-21（万方平台首次上网日期，不代表论文的发表时间）