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.
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Correction notice This article has been corrected since it first published Online First. The title has been amended.
Contributors DS and DT conceived the article together and DS wrote the first draft. Both authors revised the intellectual content.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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