Europe and European Economic Area (EEA)

Europe and European Economic Area (EEA)

European Clinical Trial Database (EudraCT)

Verified on September 23, 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


  • September 2022: CTIS Update - European Medicines Agency updated the page Clinical Trials Information System: training and support by adding the document ‘Clinical Trial Information System (CTIS) evaluation timelines‘ over the What’s New Section on September 23, 2022: This document provides an overview of the timelines and deadlines for the activities across the Clinical Trial Application (CTA) evaluation process including initial … Continue reading "September 2022: CTIS Update"
  • September 2022: CTIS Update - European Medicines Agency updated the event page Organisation Management System (OMS) Trouble Shooting Session for CTIS users – July 2022 over the What’s New Section on September 21, 2022: The video recording of the CTIS webinar held on July 21, 2022, is now available on the event page. OMS is a workspace collaboration system used … Continue reading "September 2022: CTIS Update"
  • September 2022: CTIS Update - European Medicines Agency updated the event page Organisation Management System (OMS) Trouble Shooting Session for CTIS users – September 2022 over the What’s New Section on September 16, 2022: This event, previously scheduled on September 09, 2022, has been canceled due to technical issues. The next OMS trouble shooting session will be held on October 19, … Continue reading "September 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.