J Korean Soc Med Inform.  2007 Jun;13(2):99-113.

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

• Kim O
• Park YR
• Kim YS
• Kim SH
• Kim HJ
• Kim JH
• Park BJ

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.

Keyword

Clinical Trial; XML; Case Report Form; Clinical Trial Management System; Entity-Attribute-Value Model

MeSH Terms

Database Management Systems
Information Dissemination