PhactaX - A package for data management system and related web sites for conducting medical researches and clinical trials

Okgu Kim1), Sun-Ha Kim2)3), Young-Shin Kim2), Hee-Jung Ahn2), Young Koh2), Hyoung-Joo Lim2), Jin-Young Jang2), Ju Han Kim1)4), Byung Joo Park*1)2)3)

1)Interdisciplinary Program in Bioinformatics, Seoul National
2)Seoul National University Hospital Clinical Trial Center
3)Departement of Preventive Medicine, Seoul National Universit
4)Seoul National University Biomedical Informatics

Abstract : Medical research and clinical trial process includes the flow of data from investigational sites to the data management center for statistical analysis. Therefore data management has a key role due to its impact on the whole process of the research. To support data management of middle and small-size data management center, we have developed a data management system and web sites for adverse event vocabularies and common electronic case report forms, which we collectively call PhactaX. The data management system, PhactaManager, provides a web interface for remote data entry with online data validity check support using XML based electronic case report form description language. PhactaDictionary, a web site managing adverse event vocabularies, includes MedDRA and COSTART for browsing and searching. PhactaForm is a web site managing common data elements, sample case report forms, and questionnaire papers. These three programs are integrated using Simple Object Access Protocol for remote procedure call and data exchange. PhactaX is going to be distributed to the domestic pharmaceutical companies as well as research institutes conducting new drug development freely after internal tests.
keyword : Medical research, Clinical trial, Data management system, Case report form, Adverse event


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