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KAKEN_26670272seika.pdf
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Download
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:89.8 KB
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:Jul 30, 2019 |
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| Title |
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医薬品開発における国際競争力の向上に貢献し得るCRCの養成教育プログラムの作成
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| Kana |
イヤクヒン カイハツ ニ オケル コクサイ キョウソウリョク ノ コウジョウ ニ コウケンシウル CRC ノ ヨウセイ キョウイク プログラム ノ サクセイ
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| Romanization |
Iyakuhin kaihatsu ni okeru kokusai kyosoryoku no kojo ni kokenshiuru CRC no yosei kyoiku puroguramu no sakusei
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| Other Title |
| Title |
Development of CRC training program to improve the international competitiveness in drug development
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松嶋, 由紀子
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| Kana |
マツシマ, ユキコ
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| Romanization |
Matsushima, Yukiko
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| Affiliation |
慶應義塾大学・医学部・特任講師
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Research team head
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| Link |
科研費研究者番号 : 10618531
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| Name |
漆原, 尚巳
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| Kana |
ウルシハラ , ヒサシ
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| Romanization |
Urushihara, Hisashi
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| Affiliation |
慶應義塾大学・薬学部・准教授
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Research team member
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科研費研究者番号 : 10511917
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宇津井, 大祐
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| Kana |
ウツイ, ダイスケ
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| Romanization |
Utsui, Daisuke
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| Affiliation |
慶應義塾大学・薬学部
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Research team member
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吉谷, 安紀子
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| Kana |
ヨシタニ, アキコ
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| Romanization |
Yoshitani, Akiko
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| Affiliation |
慶應義塾大学・医学部・研究員
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Research team member
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井口, 亜橘
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| Kana |
イグチ, アキ
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| Romanization |
Iguchi, Aki
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| Affiliation |
慶應義塾大学・医学部・特任助教
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| Affiliation (Translated) |
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Research team member
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松田, 恭子
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| Kana |
マツダ, キョウコ
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| Romanization |
Matsuda, Kyoko
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| Affiliation |
国立病院機構大阪南医療センター薬剤部・治験管理室・CRC
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Research team member
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| Name |
渡邊, 真由美
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| Kana |
ワタナベ, マユミ
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| Romanization |
Watanabe, Mayumi
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| Affiliation |
日本大学医学部附属板橋病院臨床研究推進センター・CRC
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| Affiliation (Translated) |
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Research team member
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山崎, 純子
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| Kana |
ヤマサキ, ジュンコ
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| Romanization |
Yamasaki, Junko
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| Affiliation |
神戸大学医学部附属病院臨床研究推進センター・CRC
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| Affiliation (Translated) |
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Research team member
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Brosnan, Katrina
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| Affiliation |
Queensland Department of Health, Principal Policy Officer
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Research team member
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Hall, Cindy
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| Kana |
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| Affiliation |
Princess Alexandra hospital Cardiology department
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| Affiliation (Translated) |
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Research team member
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Lee, Steph
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Princess Alexandra hospital Cancer Trial unit
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| Affiliation (Translated) |
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Research team member
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2016
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科学研究費補助金研究成果報告書
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2015
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| Abstract |
本研究では, 医薬品開発における日本の国際競争力の強化のため, Clinical Research Coordinator(以下CRC)の業務及び教育内容を国際共同治験の実施経験が豊富なオーストラリアと日本で比較することで, 日本のCRC業務に追加が必要な業務内容を明確化した上で, その業務遂行のために必要な教育内容を検討した。その結果, 追加が必要な業務は「臨床研究全体のマネジメント」であり, 現状のCRC養成カリキュラムには, 臨床研究の最初のステップである「リサーチクエスチョンの作成」, 最終ステップである「総括報告書の作成・論文化」と, 「予算の立案・研究費の管理」の教育が必要であることが判明した。
In this study, we performed comparative analysis on the operations and the education contents of Clinical Research Coordinator (CRC) in Japan and Australia where global clinical trials are frequently performed. We clarified the operations that are additionally needed for the CRC duties in Japan and evaluated an appropriate education content to train such necessary options aiming to improve the global competitiveness of Japan in the drug development area. We elucidated that the operation additionally needed is 'Total Clinical trial management at Site' and the education contents for this should include the training programs for 'Formulating Research Question' and 'Development of clinical trials reports, results and publications' and 'Budget building and financial management'.
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研究種目 : 挑戦的萌芽研究
研究期間 : 2014～2015
課題番号 : 26670272
研究分野 : 臨床試験管理
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