Division and discord in the Clinical Trials Regulation

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Division and discord in the Clinical Trials Regulation

JournalArticle (Originalarbeit in einer wissenschaftlichen Zeitschrift)

ID	3706716
Author(s)	Shaw, David; Townend, David
Author(s) at UniBasel	Shaw, David
Year	2016
Title	Division and discord in the Clinical Trials Regulation
Journal	Journal of Medical Ethics
Volume	42
Number	11
Pages / Article-Number	729-732
Abstract	The Clinical Trials Regulation is intended to harmonise and streamline the review and conduct of clinical trials in the European Union. In this paper, we identify and analyse several serious issues concerning the division imposed by the Regulation between scientific review and ethical review. We conclude that these problems may compromise the objectives of the Regulation.
Publisher	BMJ Publishing Group
ISSN/ISBN	0306-6800 ; 1473-4257
edoc-URL	http://edoc.unibas.ch/52829/
Full Text on edoc	No
Digital Object Identifier DOI	10.1136/medethics-2016-103422
PubMed ID	http://www.ncbi.nlm.nih.gov/pubmed/27432911
ISI-Number	WOS:000388976500011
Document type (ISI)	Journal Article

25/04/2024

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