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Regulatory changes after the enforcement of the new Clinical Trials Act in Japan

OBJECTIVE: To describe changes in Japanese clinical trial regulations after the implementation of the Clinical Trials Act in April 2018. METHODS: First, how to apply multiple regulations after the enforcement of Clinical Trials Act was described. Second, the changes in the number of clinical trials...

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Detalles Bibliográficos
Autores principales: Nakamura, Kenichi, Shibata, Taro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7160916/
https://www.ncbi.nlm.nih.gov/pubmed/32125380
http://dx.doi.org/10.1093/jjco/hyaa028