Europe and European Economic Area (EEA)

Europe and European Economic Area (EEA)

European Clinical Trial Database (EudraCT)

Verified on May 19, 2022

It is a World Health Organization (WHO) recognized primary registry. The clinical trial information posted on EudraCT is available for public view on European Clinical Trial Registry (EU CTR). The clinical trials registered on this registry fulfill the criteria for publication of a manuscript in an International Committee of Medical Journal Editors (ICMJE) accredited journals and feed into the WHO International Clinical Trials Registry Platform (ICTRP). It includes interventional clinical trials on medicines conducted in the European Union (EU), or the European Economic Area (EEA). On EudraCT, the registration of protocol and posting of results is governed by Directive 2001/20/EC which has been in effect since May 01, 2004.

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
EudraCT EU CTR via Clinical Trial Applications Competent authority Clinical Trial Application

Interventional

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

Yes

Prior to enrollment
Results

Yes

Within 6 months of the trial completion (Paediatric trial); Within 12 months of the trial completion (Non-paediatric trial)

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


  1. Clinical Trial Application Form. European Clinical Trials Database. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/application-form_en.pdf. Published November 28, 2019. Accessed November 28, 2019.
  2. EudraCT Results Full Data Set. European Clinical Trials Database. https://eudract.ema.europa.eu/docs/technical/EudraCT%20result%20related%20data%20Dictionary_V2_for%20publication.xlsx. Published January 25, 2019. Accessed January 25, 2019.