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A pilot test of the new Swiss regulatory procedure for categorizing clinical trials by risk: A randomized controlled trial

BACKGROUND/AIMS: Several countries are working to adapt clinical trial regulations to align the approval process to the level of risk for trial participants. The optimal framework to categorize clinical trials according to risk remains unclear, however. Switzerland is the first European country to a...

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Detalles Bibliográficos
Autores principales:	Cevallos, Myriam, Züllig, Stephanie, Christen, Andri, Meier, Brigitte E, Goetz, Martin, Coslovsky, Michael, Trelle, Sven
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	SAGE Publications 2015
Materias:	Regulation and Policy
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4648234/ https://www.ncbi.nlm.nih.gov/pubmed/26122923 http://dx.doi.org/10.1177/1740774515591983

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