Europe and European Economic Area (EEA)

Europe and European Economic Area (EEA)

European Union Clinical Trials Information System (EU CTIS)

Verified on December 1, 2022

Clinical trials conducted in the European Union (EU) and European Economic Area (EEA) are governed by the Clinical Trials Regulation, also known as CTR (Regulation (EU) No 536/2014). CTR was implemented on January 31, 2022 along with the launch of the Clinical Trials Information System (CTIS). CTIS acts as a centralized EU portal and database for clinical trials by supporting the flow of information between clinical trial sponsors, EU Member States, EEA countries, and the European Commission. It has provisions for both protocol registration and results posting activities for clinical trials conducted in EU/EEA. Results posting also includes submission of lay langauge summary. CTIS is not a World Health Organization (WHO) recognized primary registry.

 

 

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
EU CTIS Not Applicable Competent authority, Sponsor Clinical Trial Application

Interventional

(Phase 1-4)
English
Registration and Results Requirements
Registry Activity Legal Requirement Timing
EU CTIS Registration

Yes

Prior to enrollment
Results

Yes

Intermediate summary of results - within 12 months of the interim data analysis date; Final summary of results and lay person summary - within 12 months from the end of trial in EU/EEA (Non-paediatric Studies); within 6 months from the end of trial in EU/EEA (Paediatric Studies)

Registry Updates


References