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From 31 January 2022, clinical trials of medicines should not be registered at the Danish Medicines Agency and the National Committees on Health Research Ethics anymore, but at a common European system: the Clinical Trials Information System.
2021.11.15 |
On 31 January 2022, the new European Clinical Trials Regulation (Regulation (EU) No 536/2014) of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC will go live. This changes how we as researchers should register new clinical trials on medicines.
Remember our internal pages about clinical research, where you can find information and instructions when preparing formalities in relation to clinical research.
Thomas Decker Christensen, MD PhD DMSc
Clinical Professor and Chair
Department of Cardiothoracic and Vascular Surgery
Aarhus University Hospital
Palle Juul-Jensens Boulevard 99
8200 Aarhus N
Mail: tdc@clin.au.dk