Division and discord in the Clinical Trials Regulation
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 con...
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| Contributors: | |
| Format: | Electronic Article |
| Language: | English |
| Check availability: | HBZ Gateway |
| Journals Online & Print: | Drawer...
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| Interlibrary Loan: | Interlibrary Loan for the Fachinformationsdienste (Specialized Information Services in Germany) |
| Published: |
2016
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| In: |
Journal of medical ethics
Year: 2016, Volume: 42, Issue: 11, Pages: 729-732 |
| Online Access: |
Volltext (lizenzpflichtig) Volltext (lizenzpflichtig) |
| Summary: | 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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| ISSN: | 1473-4257 |
| Contains: | Enthalten in: Journal of medical ethics
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| Persistent identifiers: | DOI: 10.1136/medethics-2016-103422 |