Development of new computer system validation method for ICH-GCP clinical trial
| Project/Area Number |
26560270
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| Research Category |
Grant-in-Aid for Challenging Exploratory Research
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| Allocation Type | Multi-year Fund |
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| Research Field |
Medical engineering assessment
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| Research Institution | Osaka City University (2016-2017)
Osaka University (2014-2015) |
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Principal Investigator |
YAMAMOTO Keiichi 大阪市立大学, 大学院医学研究科, 特任准教授 (70416387)
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| Project Period (FY) |
2014-04-01 – 2018-03-31
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| Project Status |
Completed (Fiscal Year 2017)
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| Budget Amount *help |
¥3,770,000 (Direct Cost: ¥2,900,000、Indirect Cost: ¥870,000)
Fiscal Year 2016: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2015: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2014: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
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| Keywords | 医療技術評価 / 治験 / 規制適合 / 信頼性保証 / 臨床試験 / GCP / システムバリデーション / 医師主導治験 / コンピュータ・システム・バリデーション / レギュラトリー / 国際ハーモナイゼーション / コンピュータシステムバリデーション |
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| Outline of Final Research Achievements |
For the investigator-initiated clinical trial, we finished the system validation project with a new validation method. We also built a group to conduct validation in the academia. In addition, he advocated a new validation method in academia, gave academic presentations and writings, raised awareness of its importance until the symposium was held at related academic conferences. Therefore we believe that we achieved our initial goal of this research. Utilization of IT technology is indispensable for increasing efficiency of clinical research. We hope that the establishment of a CSV methods based on the current situation of ARO in our country which will be addressed in this research leads to improvement of reliability of clinical research in Japan.
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Report
(5 results)
Research Products
(14 results)
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[Presentation] アカデミア向けEDC REDCapについての効率的なシステムバリデーション体制の構築2018
Author(s)
坂梨健二,吉田尚生, 髙栁直美, 木島真一, 賀川美詠子, 山本景一, 若林由美, 太田恵子,宮本潤哉,藤本匡志,西村千穂, 佐藤菊枝, 松丸真美, 古市浩史, 石守伸崇, 小野山あづさ,岩本浩司, 船越公太, 戸高浩司,中西洋一
Organizer
日本臨床試験学会第9回学術集会総会 in 仙台
Related Report
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