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http://dx.doi.org/10.5392/JKCA.2012.12.12.714

Status Report on Usage of Electronic Case Report Form for Clinical Study  

Baek, Young-Hwa (한국한의학연구원)
Kim, Ho-Seok (한국한의학연구원)
Lee, Si-Woo (한국한의학연구원)
Jin, Hee-Jeong (한국한의학연구원)
Publication Information
The Journal of the Korea Contents Association / v.12, no.12, 2012 , pp. 714-720 More about this Journal
Abstract
With the help of information technology, it is the most important to collect clinical data correctly in clinical trials. For this, recently, in many pharmaceutical companies and Clinical Research Organizations (CRO) have tried to adopt an Electronic Case Report Form (eCRF) system. The eCRF system is a computerized system designed for collecting and managing clinical data in clinical trials. Although the eCRF is recognized as a significant system for clinical trials, until now there are no widely useable, due to the huge effort and expense at the initiatory stage of adopting eCRF system. In this study, we inquired the use of eCRF system developed for clinical trial at Korea Institute of Oriental Medicine. Especially, we focused on the time required for entering clinical data into the eCRF, hours of use, and the number of queries according to the time flow.
Keywords
eCRF; Data Management; Clinical Study; Korean Medicine;
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Times Cited By KSCI : 6  (Citation Analysis)
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1 국가임상시험사업단. http://www.konect.or.kr.
2 이현주, 김영옥, 조혜영, 정면우, 최인영, "임상시험 전자 자료 관리의 해외 규정 비교를 통한 전자자료 관리 기준 고찰," 한국보건정보통계학회지, 제35권, 제1호, pp.17-27, 2010.
3 김상혁, 김윤정, 김호석, 정경식, 이시우, "증례기록지를 이용한 체질처방 사용빈도 조사", 한국한의학 연구원논문집, 제17권, 제2호, pp.101-106, 2011.   과학기술학회마을
4 식품의약품안전청, 임상시험에서의 자료관리, 2010.
5 N. Banik, "Evaluation of EDC versus Paper in a Multinational Asthma Trial," Presented at the DIA European Data Management Meeting, Berlin, 1998.
6 D. Borfitz, "Conspiring Forces Behind EDC Adoption," CenterWatch, 2003.
7 K. El Emam, E. Jonker, M. Sampson, K. Krleza-Jeric, and A. Neisa, "The Use of Electronic Data Capture Tools in Clinical Trials: Web-Survey of 259 Canadian Trials," J Med Internet Res, Vol.11, No.1, e8(doi: 10.2196/jmir.1120), 2009.   DOI   ScienceOn
8 N. Anderson, E. S. Lee, J. S. Brockenbrough, M. E. Minie, S. Fuller, J. F. Brinkley, and P. Tarczy-Hornoch, "Issues in biomedical research data management and analysis: needs and barriers," Journal of the American Medical Informatics Association, Vol.14, No.4, pp.478-488, 2007.   DOI   ScienceOn
9 J. D. Franklin, A. Guidry, and J. F. Brinkley, "A partnership approach for Electronic Data Capture in small-scale clinical trials," Journal of Biomedical Informatics, Vol.44, Supp.1, pp.103-108, 2011.   DOI   ScienceOn
10 R. Edwards, S. Edwards, J. Bryner, K.Cunningham, A. Rogers, and M. Slattery, "A Computer-assisted Data Collection System for Use in a Multicenter Study of American Indians and Alaska Natives," Computer Methods Programs Biomed, Vol.90, No.1, pp.38-50, 2008.   DOI   ScienceOn
11 이현주, "임상시험 전자자료 관리를 위한 평가 프레임웍," 인터넷정보학회논문지, 제13권, 제1호, pp.45-55, 2012.   과학기술학회마을   DOI   ScienceOn
12 진희정, 유종향, 장은수, 이시우, "체질임상정보 수집을 위한 eCRF 시스템 구축", 사상체질의학회지, 제16권, 제2호, pp.101-108, 2010.   과학기술학회마을
13 이현주, 최인영, "효율성 측정지표를 활용한 전자적 임상시험프로세스 효과분석", 한국콘텐츠학회논문지, 제11권, 제1호, pp.350-356, 2011.   과학기술학회마을   DOI   ScienceOn
14 수잔 프록스카 지음, 최인영, 방근수, 고희중, 김민지 옮기, 임상시험 데이터관리, 김영사, 2010.
15 최인영, "Practical Guide to Clinical Data Management by Susanne Prokscha, 2007," 대한의료정보학회지, 제15권, 제4호, pp.501-502, 2009.   과학기술학회마을
16 정순옥, 권수경, 최인영, "임상시험정보시스템 현황분석과 적용방안 모색", 대한임상약리학회지, 제16권, 제2호, pp.129-136, 2008.   과학기술학회마을
17 J. Welker, "Implementation of Electronic Data Capture Systems: Barriers and Solutions," Contemporary Clinical Trials, Vol.28, pp.329-336, 2007.   DOI   ScienceOn