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
- January 2023: EudraCT Update - On February 03, 2023, EMA updated the EudraCT homepage by providing the following update over the What’s New section: The EU Clinical Trials Register and EudraCT database are having problems with results functionalities as a result of system upgrades, preventing users to view or change results for their trials. A high-priority solution is being worked … Continue reading "January 2023: EudraCT Update"
- January 2023: EudraCT and EU CTR Frequently Asked Questions - On January 31, 2023, European Medicines Agency uploaded a document Frequently Asked Questions on the EU Clinical Trials Register: The document comprises detailed answers to all the frequently asked questions related to the EudraCT database and Clinical Trials Regulation (EU CTR) No 536/2014. The questions and answers that are added in this version related to … Continue reading "January 2023: EudraCT and EU CTR Frequently Asked Questions"
- January 2023: CTIS Update - On January 31, 2023, European Medicines Agency updated the event page Clinical Trials Information System (CTIS): Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023 over the What’s New Section. The presentation and the video recording for the CTIS event held on January 20, 2023, is now available on the event page. … Continue reading "January 2023: 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.