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

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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Bibliographic Details
Main Author: Ramirez, Isabelle
Format: Article
Language:deu
Published: German Medical Science GMS Publishing House 2015-11-01
Series:GMS German Medical Science
Subjects:
non-interventional studies
observational studies
ethics committee
competent authorities
data protection authorities
regulatory approval
Online Access:http://www.egms.de/static/en/journals/gms/2015-13/000225.shtml

Internet

http://www.egms.de/static/en/journals/gms/2015-13/000225.shtml

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