Experiences and challenges with the new European Clinical Trials Regulation

Experiences and challenges with the new European Clinical Trials Regulation

Abstract Background The new European Medicines Agency (EMA) Clinical Trials Information System (CTIS), based on the Clinical Trials Regulation (CTR EU 536/2014), came into full effect on 31 January 2022 and was intended to provide an easier, more streamlined approach to the registration of clinical...

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Bibliographic Details
Main Authors: Thale D. J. H. Patrick-Brown, Josephine Bourner, Sabrina Kali, Marius Trøseid, Yazdan Yazdanpanah, Piero Olliaro, Inge Christoffer Olsen
Format: Article
Language:English
Published: BMC 2024-01-01
Series:Trials
Subjects:
Clinical trial
Government regulation
Pandemics
Epidemics
Multicenter trials
Online Access:https://doi.org/10.1186/s13063-023-07869-x

Internet

https://doi.org/10.1186/s13063-023-07869-x

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