欧米における臨床研究の規制,監視制度:人を対象とした研究にかかる法令,規制機関,倫理審査,利益相反と被験者保護

冨尾淳; 冨尾淳; 佐藤元

文献

J-GLOBAL ID：201702230985992426 整理番号：17A1052057

欧米における臨床研究の規制,監視制度:人を対象とした研究にかかる法令,規制機関,倫理審査,利益相反と被験者保護

Regulation and governance on clinical studies (trials) in EU and the US: Laws, regulatory agencies, ethical approval, COI management and human protection

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著者 (3件)： , ,
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巻： 33 号： 8 ページ： 621-641 発行年： 2017年08月31日
JST資料番号： Y0906A ISSN： 0910-8211 資料種別：逐次刊行物 (A)
記事区分：短報発行国：日本 (JPN) 言語：日本語 (JA)

臨床研究の監視制度・規制のあり方について,国際的な現状と動向...

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研究開発

引用文献 (51件)：

European Medicines Agency (EMA). http://www.ema.europa.eu
European Commission (EC). Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (Clinical Trials Directive). http://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf
EC. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Community Code for medicinal products). http://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf
EC. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Clinical Trials Regulation). https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf
EC. Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (GCP Directive). https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2005_28/dir_2005_28_en.pdf

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