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Division and discord in the Clinical Trials Regulation

Shaw, David and Townend, David. (2016) Division and discord in the Clinical Trials Regulation. Journal of Medical Ethics.

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Official URL: http://edoc.unibas.ch/52829/

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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.
Faculties and Departments:08 Cross-disciplinary Subjects > Ethik > Institut für Bio- und Medizinethik > Bio- und Medizinethik (Elger)
03 Faculty of Medicine > Departement Public Health > Ethik in der Medizin > Bio- und Medizinethik (Elger)
UniBasel Contributors:Shaw, David
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:BMJ Publishing Group
ISSN:0306-6800
e-ISSN:1473-4257
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:27 Oct 2017 14:43
Deposited On:27 Oct 2017 14:43

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