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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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Formato: | Online Artículo Texto |
Lenguaje: | English |
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German Medical Science GMS Publishing House
2015
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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 |