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

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