XML Grammar Development for System Independent and Reusable Electronic Case Report Form Presentation

김옥구1), 김영신3), 김선하2)3), 김화정2)3), 최남경2), 정정임2), 박병주*1)2)3)

1)서울대학교 협동과정 생물정보학
2)서울대학교 의과대학 예방의학교실
3)서울대학교병원 임상시험센터

Abstract : Conventional clinical trial management systems manage Electronic Case Report Form (eCRF) using specific software packages rather than international standard language. This software package dependency limits reusability of eCRF. To solve the dependency problem, we developed eXtensible Makrup Language (XML) based eCRF grammar. By using XML for describing eCRF, we can implement and share eCRF among institutions regardless of software packages of clinical trial management system. Describing eCRFs using XML also gives more reusability of eCRFs. Common data elements and common eCRF sections described using eCRF grammar can be directly embedded into other eCRFs which were also described using the eCRF grammar. The eCRF grammar has been updated to accomodate those paper CRFs not covered at the development time, and eCRF grammar is being applied to clinical trial management system being developed at Seoul National University Hospital Clinical Trial Center.
keyword : XML, CRF, CDE, Clinical Trial, HTML

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