The Pharmaceutical Regulatory Compliance of Electronic Records in Medical Information Systems―Quality Managements for Computerized System―

DOI
  • Tanigawa M
    Department of Medical Informatics, Kagawa University Hospital
  • Nakano K
    eClinical Forum
  • Aoyagi Y
    Information Technology Management Section, Office of Clinical Research Support, National Cancer Center Hospital East
  • Yokoi H
    Department of Medical Informatics, Kagawa University Hospital

Bibliographic Information

Other Title
  • 「医療情報システム」における電磁的記録の薬事利用への対応　―コンピュータ化システムの品質マネジメント―

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Description

<p>　In Japan and overseas, the electronic records relating to patient health status and/or the delivery of healthcare routine in medical information systems are increasingly used as the real world data for pharmaceutical approval applications and safety monitoring. While the relevancy and quality of the data are important for such use, there are few evaluations of the data quality of medical information systems from the viewpoint of pharmaceutical regulatory compliance. We analyzed the data quality of electronic records required in medical information systems against pharmaceutical regulations and guidelines on computerized systems using a questionnaire (eSRA) provided by the eClinical Forum. We found that data quality of electronic records in medical information systems would mostly satisfy relevant pharmaceutical regulations by complying with the “Guidelines for the medical information systems” established by the Ministry of Health, Labor and Welfare. However, it was suggested that the additional measures would also be desired regarding data integrity and validation of computerized systems.</p>

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Details 詳細情報について

  • CRID
    1390293334799651328
  • DOI
    10.14948/jami.41.143
  • ISSN
    21888469
    02898055
  • Text Lang
    ja
  • Data Source
    • JaLC
  • Abstract License Flag
    Disallowed

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