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Open Access Journal of Clinical Trials Volume 3, 2011 - Issue
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Original Research

A data-capture system for post-marketing surveillance of drugs that integrates with hospital electronic health records

Keiichi Yamamoto1 Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, JapanCorrespondence[email protected]
,
Shigemi Matsumoto2 Outpatient Oncology Unit, Kyoto University Hospital, Kyoto, Japan
,
Kazuhiro Yanagihara2 Outpatient Oncology Unit, Kyoto University Hospital, Kyoto, Japan
,
Satoshi Teramukai1 Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan
&
Masanori Fukushima1 Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan;2 Outpatient Oncology Unit, Kyoto University Hospital, Kyoto, Japan;3 Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, Japan
Pages 21-26 | Published online: 29 Apr 2011

References

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  • Leveraging the CDISC Standards to Facilitate the use of Electronic Source Data within Clinical Trials (eSDI). Available from: http://www.cdisc.org/stuff/contentmgr/files/0/2f6eca8f0df7caac5bbd4fadfd76d575/miscdocs/esdi.pdf. November 20, 2006. Accessed March 29, 2011.
  • Cancer Biomedical Informatics Grid(caBIG). Available from: https://cabig.nci.nih.gov/. Accessed March 29, 2011.
  • BRIDG Model. Available from: http://www.bridgmodel.org/. Accessed March 29, 2011.
  • Yamamoto K, Matsumoto S, Tada H, et al. A data capture system for outcomes studies that integrates with electronic health records: development and potential uses. J Med Syst. 2008;32(5):423–427.
  • Matsumoto S, Nishimura T, Kanai M, et al. Development of a novel information technology (IT) system using the electronic medical record (EMR) in daily clinical practice. ASCO Annual Meeting Proc. Part I. J Clin Oncol. 2007;25(18S) (Supplement):17066.
  • Yamamoto K, Matsumoto S, Matsuba H, et al. Development of data capture system for clinical study by the secondary use of electronic health records. Proc Medinfo 2007 Proceedings of the 12th World Congress on Health (Medical) Informatics – Building Sustainable Health Systems, August 20–24, 2007, Brisbane, Australia 2007.
  • Yamamoto K, Matsumoto S, Tada H, et al. A data capture system for post marketing surveillance of drugs that integrates with a hospital electronic health record. Society For Clinical Trials 29th Annual Meeting; 2008:72.
  • ICH E2E: Pharmacovigilance Planning. Available from: http://www.fda.gov/RegulatoryInformation/Guidances/ucm129411.htm. April 2005. Accessed March 29, 2011.
  • CDISC: Clinical Data Acquisition Standards Harmonization (CDASH) Projects. Available from: http://www.cdisc.org/cdash. Accessed March 29, 2011.

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