Efforts to Optimize Clinical Trial Management by Revising Deviation Reports and Classifying Deviation Cases for Efficient Clinical Trial Quality Improvement at Asahikawa Medical University Hospital

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  • OGAWA Masumi
    Clinical Research Support Center, Asahikawa Medical University Hospital, Japan
  • MANABE Takayuki
    Clinical Research Support Center, Asahikawa Medical University Hospital, Japan
  • KONDO Yuko
    Clinical Research Support Center, Asahikawa Medical University Hospital, Japan
  • HATAYAMA Sachie
    Clinical Research Support Center, Asahikawa Medical University Hospital, Japan
  • TANI Kanae
    Clinical Research Support Center, Asahikawa Medical University Hospital, Japan
  • SATO Miyuki
    Clinical Research Support Center, Asahikawa Medical University Hospital, Japan
  • YOKOYAMA Mariko
    Clinical Research Support Center, Asahikawa Medical University Hospital, Japan
  • YUKI Kazumi
    Clinical Research Support Center, Asahikawa Medical University Hospital, Japan
  • KAMIYAMA Naoya
    Clinical Research Support Center, Asahikawa Medical University Hospital, Japan
  • HONMA Masaru
    Clinical Research Support Center, Asahikawa Medical University Hospital, Japan
  • TASAKI Yoshikazu
    Clinical Research Support Center, Asahikawa Medical University Hospital, Japan
  • MATSUMOTO Seiji
    Clinical Research Support Center, Asahikawa Medical University Hospital, Japan

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  • 旭川医科大学病院での効率的な治験品質向上を目指した逸脱報告書の改訂と逸脱事例の分類による治験管理の最適化に関する取り組み

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<p>Face-to-face communication during on-site monitoring is important for clinical trial quality assurance. However, with the coronavirus disease early 2020 pandemic, medical institutions placed restrictions on hospital visits to secure their medical systems.</p><p>Asahikawa Medical University Hospital similarly established restrictions on outpatient and inpatient visits and legal restrictions on outside vendors. Therefore, the frequency of on-site monitoring of clinical trials conducted at our hospital was reduced. Since there was no sign of convergence at the infection units even after 2 years, we investigated the frequency of on-site monitoring and the frequency of clinical trial deviations in the review of the system.</p><p>In addition, although a clinical trial deviation report form (previous form) was prepared in the fiscal year 2019, there were many free descriptions, and many deviation reports were difficult to understand. Similarly, there were cases where deviations were not recorded on the deviation report form but only on article records (source documents), such as electronic medical records after consultation with the sponsor, and deviations were not recorded in a uniform format. Thus, the hospital experienced difficulty tabulating and classifying the number of deviation occurrences. Based on this experience, this report describes the progress of revising the clinical trial deviation report, clarifying the items to be included in the report, and establishing a system to clarify the process related to clinical trial deviation occurrences.</p>

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