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http://dx.doi.org/10.5392/JKCA.2011.11.1.350

Effect Analysis of Electronic Clinical Trial Systems  

Lee, Hyun-Ju (가톨릭대학교 의료경영대학원)
Choi, In-Young (가톨릭대학교 의료경영대학원)
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Abstract
The purpose of this study is to empirically examine how much the electronic clinical trial data management system actually enhances its efficiency. While the development of clinical trial markets highlights the significance of data management with increasing rate of adoption of electronic systems, its effects have not been fully supported with rigorous evidences. Particularly, the adoption rate of electronic clinical trial systems is low in domestic clinical trials markets. This study attempts to analyze the effect of the systems for reminding the importance of e-data management in clinical trials. The measurement indicator is experimented with the time related data collected from a multi-center clinical trial case. The result showed that the speed of the electronic clinical trial processes can be improved. The implication of this study lies in its first attempt to empirically analyze the effect of electronic clinical data management systems. Furthermore, application of the indicator in conjunction with electronic clinical trial processes is expected to facilitate strategic data management.
Keywords
MITE-ECT; Data Management; eCRF; Multi-center Clinical Trials;
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