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Navigating the maze of requirements for obtaining approval of non-interventional studies (NIS) in the European Union

Objective: The purpose of this article is to give an overview of the complexities and unexpected regulatory requirements for obtaining approval of multinational and multicentre non-interventional studies (NIS) in the European Union (EU). Methods: The websites of national competent authorities (CAs),...

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Detalles Bibliográficos
Autor principal:	Ramirez, Isabelle
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	German Medical Science GMS Publishing House 2015
Materias:	Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4649795/ https://www.ncbi.nlm.nih.gov/pubmed/26633964 http://dx.doi.org/10.3205/000225

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