生体医工学研究における臨床研究法への該当性判断の原理
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| Published in | 生体医工学 Vol. 58; no. 4-5; pp. 134 - 146 |
|---|---|
| Main Authors | , , , , |
| Format | Journal Article |
| Language | Japanese |
| Published |
公益社団法人 日本生体医工学会
10.09.2020
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| Online Access | Get full text |
| ISSN | 1347-443X 1881-4379 |
| DOI | 10.11239/jsmbe.58.134 |
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| Author | 木村, 裕一 中村, 英夫 杉町, 勝 櫻井, 理紗 黒田, 知宏 |
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| Author_xml | – sequence: 1 fullname: 木村, 裕一 organization: 近畿大学生物理工学部生命情報工学科 – sequence: 1 fullname: 杉町, 勝 organization: 国立循環器病研究センター循環動態制御部 – sequence: 1 fullname: 黒田, 知宏 organization: 京都大学医学部附属病院医療情報企画部 – sequence: 1 fullname: 中村, 英夫 organization: 大阪電気通信大学医療健康科学部健康スポーツ科学科 – sequence: 1 fullname: 櫻井, 理紗 organization: 国立循環器病研究センター情報統括部 |
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| Copyright | 2020 社団法人日本生体医工学会 |
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| DOI | 10.11239/jsmbe.58.134 |
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| Discipline | Engineering |
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| EndPage | 146 |
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| References | 5. Ministry of Health, Labour and Welfare:Collection of cases on clinical trials as defined in the Clinical Trials Act. 〈https://www.mhlw.go.jp/content/10800000/000495663.pdf〉[accessed July 31, 2020]. (in Japanese) 4. Yoshida J:Clinical Trials Act:Overlooking View Centered on the Certified Review Board. RSMP. 8(3), pp.165-177, 2018. （in Japanese） 7. Ministry of Health, Labour and Welfare:Regarding regulations for enforcement of the Clinical Trials Act（2018, Ministry of Health, Labour and Welfare Ordinance No. 17）. 〈https://www.mhlw.go.jp/content/10800000/000524508.pdf〉［accessed July 31, 2020］. （in Japanese） 厚生労働省:普及促進資材 リーフレット. 〈https://www.mhlw.go.jp/file/06-Seisakujouhou-10800000-Iseikyoku/_omote.ura_03_no-ton.pdf〉［accessed 2020年7月31日］. 桑島巌:Clinical trial（臨床試験）からCriminal trial（裁判）へ—ディオバン臨床研究不正事件とは—. 薬剤疫学. 24(2), pp.67-74, 2019. 8. Ministry of Health, Labour and Welfare:Leaflet of Materials for promotion. 〈https://www.mhlw.go.jp/file/06-Seisakujouhou-10800000-Iseikyoku/_omote.ura_03_no-ton.pdf〉［accessed July 31, 2020]. (in Japanese) 吉田淳:臨床研究法について—認定臨床研究審査委員会を軸に俯瞰する—. RSMP. 8(3), pp.165-177, 2018. 厚生労働省:臨床研究法施行規則（平成30年厚生労働省令第17号）. 〈https://www.mhlw.go.jp/content/10800000/000524508.pdf〉［accessed 2020年7月31日］. 1. Ministry of Health, Labour and Welfare:Regarding the Clinical Trials Act.〈https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000163417.html〉［accessed July 31, 2020］. （in Japanese） 6. Ministry of Health, Labour and Welfare:Regarding regulations for enforcement of the Clinical Trials Act, Notification No. 1 0228 issued by the Director of Office of Economic Affairs Division, Research and Development Division Health Policy Bureau, Ministry of Health, Labour and Welfare. 〈https://www.mhlw.go.jp/file/06-Seisakujouhou-10800000-Iseikyoku/0000202843.pdf〉［accessed July 31, 2020］. （in Japanese） 9. Japanese Society for Medical and Biological Engineering:Guidelines to decide the applicability to Clinical Trials Act. 〈http://jsmbe.org/rinkenhou-guideline.html〉[accessed July 31, 2020］. （in Japanese） 3. Ministry of Health, Labour and Welfare:Study group on the ideal system for clinical trials:Report on the ideal system for clinical trials. 〈https://www.mhlw.go.jp/file/05-Shingikai-10801000-Iseikyoku-Soumuka/0000068409.pdf〉［accessed July 31, 2020］. （in Japanese） 日本生体医工学会:臨床研究法の該当性判断ガイドライン. 〈http://jsmbe.org/rinkenhou-guideline.html〉[accessed 2020年7月31日］. 厚生労働省:臨床研究法の対象となる臨床研究等の事例集. 〈https://www.mhlw.go.jp/content/10800000/000495663.pdf〉[accessed 2020年7月31日］. 厚生労働省:臨床研究法について. 〈https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000163417.html〉［accessed 2020年7月31日］. 2. Kuwajima I:An appropriate implementation of clinical trials and morality of investigators. Jpn J Pharmacoepidemiol. 24(2), pp.67-74, 2019. （in Japanese） 厚生労働省:臨床研究に係る制度の在り方に関する検討会:臨床研究に係る制度の在り方に関する報告書. 〈https://www.mhlw.go.jp/file/05-Shingikai-10801000-Iseikyoku-Soumuka/0000068409.pdf〉[accessed 2020年7月31日］. 厚生労働省:臨床研究法施行規則の施行等について. 医政経発0228第1号医政研発0228第1号. 〈https://www.mhlw.go.jp/file/06-Seisakujouhou-10800000-Iseikyoku/0000202843.pdf〉［accessed 2020年7月31日］. |
| References_xml | – reference: 厚生労働省:普及促進資材 リーフレット. 〈https://www.mhlw.go.jp/file/06-Seisakujouhou-10800000-Iseikyoku/_omote.ura_03_no-ton.pdf〉［accessed 2020年7月31日］. – reference: 桑島巌:Clinical trial（臨床試験）からCriminal trial（裁判）へ—ディオバン臨床研究不正事件とは—. 薬剤疫学. 24(2), pp.67-74, 2019. – reference: 2. Kuwajima I:An appropriate implementation of clinical trials and morality of investigators. Jpn J Pharmacoepidemiol. 24(2), pp.67-74, 2019. （in Japanese） – reference: 5. Ministry of Health, Labour and Welfare:Collection of cases on clinical trials as defined in the Clinical Trials Act. 〈https://www.mhlw.go.jp/content/10800000/000495663.pdf〉[accessed July 31, 2020]. (in Japanese) – reference: 厚生労働省:臨床研究法施行規則の施行等について. 医政経発0228第1号医政研発0228第1号. 〈https://www.mhlw.go.jp/file/06-Seisakujouhou-10800000-Iseikyoku/0000202843.pdf〉［accessed 2020年7月31日］. – reference: 厚生労働省:臨床研究法の対象となる臨床研究等の事例集. 〈https://www.mhlw.go.jp/content/10800000/000495663.pdf〉[accessed 2020年7月31日］. – reference: 厚生労働省:臨床研究法について. 〈https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000163417.html〉［accessed 2020年7月31日］. – reference: 日本生体医工学会:臨床研究法の該当性判断ガイドライン. 〈http://jsmbe.org/rinkenhou-guideline.html〉[accessed 2020年7月31日］. – reference: 3. Ministry of Health, Labour and Welfare:Study group on the ideal system for clinical trials:Report on the ideal system for clinical trials. 〈https://www.mhlw.go.jp/file/05-Shingikai-10801000-Iseikyoku-Soumuka/0000068409.pdf〉［accessed July 31, 2020］. （in Japanese） – reference: 4. Yoshida J:Clinical Trials Act:Overlooking View Centered on the Certified Review Board. RSMP. 8(3), pp.165-177, 2018. （in Japanese） – reference: 吉田淳:臨床研究法について—認定臨床研究審査委員会を軸に俯瞰する—. RSMP. 8(3), pp.165-177, 2018. – reference: 1. Ministry of Health, Labour and Welfare:Regarding the Clinical Trials Act.〈https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000163417.html〉［accessed July 31, 2020］. （in Japanese） – reference: 8. Ministry of Health, Labour and Welfare:Leaflet of Materials for promotion. 〈https://www.mhlw.go.jp/file/06-Seisakujouhou-10800000-Iseikyoku/_omote.ura_03_no-ton.pdf〉［accessed July 31, 2020]. (in Japanese) – reference: 厚生労働省:臨床研究に係る制度の在り方に関する検討会:臨床研究に係る制度の在り方に関する報告書. 〈https://www.mhlw.go.jp/file/05-Shingikai-10801000-Iseikyoku-Soumuka/0000068409.pdf〉[accessed 2020年7月31日］. – reference: 6. Ministry of Health, Labour and Welfare:Regarding regulations for enforcement of the Clinical Trials Act, Notification No. 1 0228 issued by the Director of Office of Economic Affairs Division, Research and Development Division Health Policy Bureau, Ministry of Health, Labour and Welfare. 〈https://www.mhlw.go.jp/file/06-Seisakujouhou-10800000-Iseikyoku/0000202843.pdf〉［accessed July 31, 2020］. （in Japanese） – reference: 厚生労働省:臨床研究法施行規則（平成30年厚生労働省令第17号）. 〈https://www.mhlw.go.jp/content/10800000/000524508.pdf〉［accessed 2020年7月31日］. – reference: 9. Japanese Society for Medical and Biological Engineering:Guidelines to decide the applicability to Clinical Trials Act. 〈http://jsmbe.org/rinkenhou-guideline.html〉[accessed July 31, 2020］. （in Japanese） – reference: 7. Ministry of Health, Labour and Welfare:Regarding regulations for enforcement of the Clinical Trials Act（2018, Ministry of Health, Labour and Welfare Ordinance No. 17）. 〈https://www.mhlw.go.jp/content/10800000/000524508.pdf〉［accessed July 31, 2020］. （in Japanese） |
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| Title | 生体医工学研究における臨床研究法への該当性判断の原理 |
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