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
- June 2021: EMA Update - EudraCT and EU CTR application maintenance weekend 18 to 20 June 2021 The European Medicines Agency (EMA) will be performing essential maintenance to IT infrastructure components during the weekend of 18 to 20 June 2021. As a result, EudraCT and EU CTR websites will be unavailable to users between 18:30 hrs. (Central European Time, CET) … Continue reading "June 2021: EMA Update"
- April 2021: What’s New on EudraCT - The below update was posted on EudraCT What’s New section, on April 16, 2021: A new version of the Frequently Asked Questions is now available for users and more detailed instructions are now provided in the tutorials on posting results. Changes: Q. 30: Provides more information regarding a third country trial Q. 55: Provides an additional reference for … Continue reading "April 2021: What’s New on EudraCT"
- February 2021: Clinical Trials Information System (CTIS) Update - Clinical Trials Information System (CTIS): training programme European Medical Agency (EMA) made available a page, Clinical Trials Information System (CTIS): training programme, for a variety of online training modules, on February 09, 2021. Each module contains a summary of the topics it covers and learning materials. These consist of e-Learning courses, quick guides, infographics, videos, … Continue reading "February 2021: Clinical Trials Information System (CTIS) Update"
References
- 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.
- 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.