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首页> 外文期刊>BMC Medical Informatics and Decision Making >ODM2CDA and CDA2ODM: Tools to convert documentation forms between EDC and EHR systems
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ODM2CDA and CDA2ODM: Tools to convert documentation forms between EDC and EHR systems

机译:ODM2CDA和CDA2ODM:在EDC和EHR系统之间转换文档形式的工具

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Background Clinical trials apply standards approved by regulatory agencies for Electronic Data Capture (EDC). Operational Data Model (ODM) from Clinical Data Interchange Standards Consortium (CDISC) is commonly used. Electronic Health Record (EHR) systems for patient care predominantly apply HL7 standards, specifically Clinical Document Architecture (CDA). In recent years more and more patient data is processed in electronic form. Results An open source reference implementation was designed and implemented to convert forms between ODM and CDA format. There are limitations of this conversion method due to different scope and design of ODM and CDA. Specifically, CDA has a multi-level hierarchical structure and CDA nodes can contain both XML values and XML attributes. Conclusions Automated transformation of ODM files to CDA and vice versa is technically feasible in principle.
机译:背景技术临床试验采用了监管机构批准的电子数据捕获(EDC)标准。通常使用临床数据交换标准协会(CDISC)的操作数据模型(ODM)。用于患者护理的电子健康记录(EHR)系统主要采用HL7标准,特别是临床文档架构(CDA)。近年来,越来越多的患者数据以电子形式进行处理。结果设计并实施了一个开源参考实现,以在ODM和CDA格式之间转换表单。由于ODM和CDA的范围和设计不同,因此此转换方法存在局限性。具体来说,CDA具有多层结构,CDA节点可以同时包含XML值和XML属性。结论从原理上说,将ODM文件自动转换为CDA或反之亦然是可行的。

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