Europe and European Economic Area (EEA)

Europe and European Economic Area (EEA)

European Union Clinical Trials Information System (EU CTIS)

Verified on May 19, 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. 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


  • May 2022: Clinical Trials Regulation Update - European Medicines Agency updated the page, Clinical Trials Regulation: progress on implementation by adding ‘Key performance indicators (KPIs) to monitor the European clinical trials environment‘ document over the What’s New Section on May 20, 2022: Under the Accelerating Clinical Trials European Union (ACT EU) initiative EMA created a new page to publish reports that include … Continue reading "May 2022: Clinical Trials Regulation Update"
  • May 2022: CTIS Update - European Medicines Agency updated about the upcoming event, Clinical Trials Information System (CTIS) bitesize talk: Transitional trials and additional Member State concerned (MSC) application over the What’s New Section on May 18, 2022. It notifies that ‘CTIS bitesize talk: Transitional trials and additional MSC application‘ event will be held on June 23, 2022. The sponsors … Continue reading "May 2022: CTIS Update"
  • May 2022: CTIS Update - European Medicines Agency (EMA) updated the page Clinical Trials Information System, on May 17, 2022, by updating the below document: Clinical trials information system – Key information for sponsors on CTIS: It provides information on the transition period from 2022 to 2025 and the key steps to get started with CTIS by deciding the user management approach … Continue reading "May 2022: CTIS Update"

References