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PhactaManager: A Clinical Trial Management System Incorporating an XML Layer as a Database-Independent Processing Platform

Young Shin Kim|Hwa Jung Kim|Ju Han Kim|Byung Joo Park|박유랑|Okgu Kim|Seon Ha Kim
대한의료정보학회 (The Korean Society Of Medical Informatics)|2007.06|Healthcare Informatics Research|제13권 제2호|pp. 99-113

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Abstract

Objective: Clinical trials are the most time-consuming and expensive part of the drug development process. Clinical Trial Management Systems (CTMSs) help sponsors of clinical trials manage all aspects of planning, performance, and reporting. Most conventional systems provide data processing functions using database management system (DBMS) procedures, which cause DBMS dependency problems. Thus, it is hard to handle the system by researchers who are unfamiliar with database. It is also difficult to share Electronic Case Report Forms (eCRFs) between institutions because conventional systems rely on specific software. Methods: PhactaManager was developed for solving these problems by introducing an XML Layer in the application tier using an Entity-Attribute-Value model in the database tier. Results: PhactaManager is a three-tier clinical trial management system that has an XML layer. The XML Layer provides a common DBMS independent eCRF document processing platform. Also we developed XML based eCRF Grammar to describe eCRF documents. The XML data elements described by eCRF grammar was constitute to eCRF by PhactaDesigner which an eCRF document design program. Conclusion: We achieved DBMS independency by implementing the XML Layer in PhactaManager. The Development of the eCRF Grammar enables the standardization of eCRF design, data correction and data sharing in multicenter clinical trial. (Journal of Korean Society of Medical Informatics 13-2, 99-113, 2007)

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