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http://dx.doi.org/10.5392/JKCA.2013.13.04.281

Current State and Applications of the Electronic Clinical Trial Process in Korea  

Wang, Boram (가톨릭대학교 의료경영연구소)
Choi, Inyoung (가톨릭대학교 의료경영대학원)
Publication Information
The Journal of the Korea Contents Association / v.13, no.4, 2013 , pp. 281-289 More about this Journal
Abstract
As the number of clinical trials conducted in Korea increases, the need of the Electronic Data Capture (EDC) system for effective clinical data management is also increased. Recently, the Korea Food and Drug Association published 'Guideline for the Electronic Clinical Trial Data Management and Processing' and it would be the foundation for establishing regulation of electronic clinical data management. In this research, we conducted the survey regarding adoption rate of EDC system in clinical trials in hospitals, Contract Research Organizations (CRO), and pharmaceutical companies. And the perceived importance and the ease of application for the Guideline were investigated. The adoption rates of EDC system was 77.6% but it mostly applied to less than five trials. Also EDC system was mostly used in phase I and phase II trials and the utilization rate of CRO was the highest. The perceived importance for the Guideline was high among all three organizations but, in case of the perceived ease of its application, CRO was the highest. Also, the perceived importance of the clinical data standard was high and the standard for data collection was mostly required. However, the comprehension for the global standard of the electronic data was relatively low, so that education is required. This result would be the foundation to increase the electronic clinical trials and develop proper regulation and principles for clinical data standards in Korea.
Keywords
Clinical Trials; EDC; Electronic Clinical Trial Data Management and Processing; CDISC; Electronic Data Standard;
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Times Cited By KSCI : 4  (Citation Analysis)
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