This article describes the experiences of the Medical University of Vienna with the Directive 2001/20/EC (CTD) regarding academic clinical research and reflects on the changes introduced by the Regulation (EU) 536/2014 (CTR).
Ernst A. Singer, MD
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Articles by Ernst A. Singer, MD
Applied Clinical Trials
The language in Europe's Regulation (EU) 536/2014 regarding ethical review of protocols is concerning.
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Ethics Under the Clinical Trials RegulationApril 1st 2017
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