ワンズワークスの資料翻訳シリーズ

要 約
FDA Guidance Document (旧:FDA Guides #20)
FDA Guidance #20
ガイダンス:国外臨床治験の受入れ
Guidance for industry: Acceptance of Foreign Clinical Studies.

Guidance for Industry
Acceptance of Foreign Clinical Studies
国外臨床治験の受入れ
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
Clinical Medical
March 2001  

Ⅰ.緒論 [Introduction]
Ⅱ.ヘルシンキ宣言 [Declaration of Helsinki]



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