1. Executive Summary
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1. Executive Summary
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This guidebook provides an overview of the current and proposed regulatory landscape applicable in the EU/EEA in relation to Decentralized Clinical Trials (“DCT”) through the European Medicines Agency (“EMA”) and the Clinical Trials Regulation (EU) No 536/2014 (“EU CTR”), which came into effect in January 2022. Until January 2023 (and in some cases longer), the provisions of the Clinical Trials Directive 2001/20/EC (“CTD”), which have been replaced by those of the EU CTR, are applicable to clinical trials in certain instances as described in this guidebook.
Important Note
The following sections showcase a typical outline for the DCT guidebooks. For access to the full EMA | DCT Feasibility Assessment Guidebook, please contact your respective RegAsk representative.
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