Europe and European Economic Area (EEA)

Europe and European Economic Area (EEA)

European Clinical Trial Database (EudraCT)

Verified on October 20, 2021

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


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.