Europe and European Economic Area (EEA)

Europe and European Economic Area (EEA)

European Union Clinical Trials Information System (EU CTIS)

Verified on August 5, 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


  • August 2022: CTIS Update - The below update was posted on the What’s New Section of European Medicines Agency’s event page Clinical Trials Information System (CTIS): Walk-in clinic on August 03, 2022: The date for the walk-in clinic is rescheduled from August 22, 2022 to August 31, 2022 due to technical issues. Walk-in clinics provide a platform for sponsors to … Continue reading "August 2022: CTIS Update"
  • August 2022: CTIS Update - European Medicines Agency updated the event page Clinical Trials Information System (CTIS) bitesize talk: Transitional trials and additional Member State concerned (MSC) application over the What’s New Section on August 02, 2022, with the below update: The video recording of the CTIS bitesize talk held on June 23, 2022, is now available on the event … Continue reading "August 2022: CTIS Update"
  • July 2022: What’s New on EudraCT - European Medicines Agency (EMA) updated the EudraCT homepage by providing the following update over the What’s New section on July 29, 2022: There are a considerable amount of clinical trials that are currently marked as ‘ongoing’ in the EudraCT database. In view of the upcoming transition to CTIS, sponsors are encouraged to verify the overall … Continue reading "July 2022: What’s New on EudraCT"

References