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What is CTR?
The EMA Clinical Trials Regulation (CTR) aims to create an environment that is favorable to conducting clinical trials in the European Union (EU)/European Economic Area (EEA), with the highest standards of safety for participants and increased transparency of trial information.
What is CTIS?
The regulation harmonises the assessment and supervision processes for clinical trials throughout Europe, via a Clinical Trials Information System (CTIS) – a centralised portal and database for clinical trials. CTIS is the entry point to submit all the required data for a clinical trial following CTR, and is the interface between Sponsors and Member States.
How can I stay on top of CTR updates?
Subscribe to the EMA CTIS newsletter for updates on CTIS usage, key facts, tips, and reference materials.