Clinical Trials Information System (CTIS)

The Clinical Trial Information System (CTIS) is a centralized EU platform established under the Clinical Trial Regulation (EU) No 536/2014 [CTR] to streamline and harmonize clinical trial review processes across EU/EEA countries. Operational since January 31, 2022, CTIS serves as a single-entry portal for sponsors and regulatory authorities to manage clinical trials.

CTIS allows sponsors to submit in a single step applications in multiple Member States, implementing a more harmonized approach and allowing for some core documents a coordinated assessment and decision-making. The platform integrates submission, evaluation, and supervision processes, aiming at improvement of consistency across countries.

Another of the key features of CTIS is its emphasis on transparency. The public may access non-confidential data on clinical trials, including clinical trial protocols, and results, fostering trust in clinical research.