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Cited article:

Risk-proportionate approach to paediatric clinical trials: The legal requirements, challenges, and the way forward under the European Union Clinical Trials Regulation

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Clinical Trials 19 (5) 573 (2022)
https://doi.org/10.1177/17407745221093812

Clinical Trial Application in Europe: What Will Change with the New Regulation?

Viviana Giannuzzi, Annagrazia Altavilla, Lucia Ruggieri and Adriana Ceci
Science and Engineering Ethics 22 (2) 451 (2016)
https://doi.org/10.1007/s11948-015-9662-0

Beantragung der Bewilligung von akademischen Multicenterstudien bei deutschen Ethikkommissionen

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Cambios en la normativa europea de ensayos clínicos (i): una oportunidad para mejorar los trámites de autorización

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Medicina Clínica 138 (11) 493 (2012)
https://doi.org/10.1016/j.medcli.2011.12.008

Implementing clinical trials on an international platform: Challenges and perspectives

Greg Minisman, Minal Bhanushali, Robin Conwit, Gil I. Wolfe, Inmaculada Aban, Henry J. Kaminski and Gary Cutter
Journal of the Neurological Sciences 313 (1-2) 1 (2012)
https://doi.org/10.1016/j.jns.2011.10.004