臨床試験の効率化を目的とした電子カルテからｅ‐ＣＲＦへのデータ転送の方向性

• 吉冨 克則

  金沢大学大学院自然科学研究科

• 古川 裕之

  金沢大学附属病院臨床試験管理センター

• 宮本 謙一

  金沢大学附属病院臨床試験管理センター

書誌事項

タイトル別名

• Directivity of Data Transmission from EMR to e-CRF for Improving Efficiency of Clinical Research

抄録

In the current clinical trials, clinical data which was originally recorded on source data is transcribed into CRF by physicians or CRCs, and CRAs verify source data and CRF. However, transcription and verification are labor-intensive jobs. If the information of source data could be electronically transmitted to CRF, transcription and verification jobs are unnecessary. However, transmission of all necessary data is difficult. Therefore, we carried out surveys for CRCs and CRAs about which data items should be transmitted and what problems might occur. We obtained responses from 370 CRCs and 252 CRAs. It was suggested that data items which can improve efficiency of clinical trials are “Concomitant Medications”, “Medical History/Complications”, “Laboratory Test Results”, “Adverse Event”, and “Vital Signs”. And various problems were listed; in paticular, CRCs were concerned about “Security” and CRAs were concerned about “Reliability and Assurance of the System”.

収録刊行物

• 臨床薬理

  臨床薬理 39 (3), 91-97, 2008

  一般社団法人 日本臨床薬理学会

キーワード

• clinical trial
• data transmission
• electronic medical record
• electronic data capture
• case report form

詳細情報

• CRID: 1390282680344438656
• NII論文ID: 10024443910
• NII書誌ID: AN0025404X
• DOI: 10.3999/jscpt.39.91
• ISSN: 18828272
• ISSN: 03881601
• Web Site: http://hdl.handle.net/2297/18243
• Web Site: https://search.jamas.or.jp/link/ui/2008253692
• 本文言語コード: ja
• データソース種別:
  • JaLC
  • IRDB
  • Crossref
  • CiNii Articles
  • KAKEN
• 抄録ライセンスフラグ: 使用不可