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
- October 2021: EU PAS Webinar Update - The European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) will hold its virtual annual plenary meeting on 18 November 2021. Registration is open to ENCePP Partners (centres and networks) until 26 October 2021. The event is for ENCePP Partners only, registration from other individuals will not be accepted. Along with other objectives of the … Continue reading "October 2021: EU PAS Webinar Update"
- October 2021: European Union CTIS Go-live Planning - On 08 October 2021, EMA published a Go-Live plan for European Union CTIS system. On 21 April 2021, following an independent successful audit of CTIS, the EMA’s Management Board confirmed that CTIS is fully functional and meets the agreed functional specifications. The European Commission subsequently issued a Commission Decision which specifies that the entry into … Continue reading "October 2021: European Union CTIS Go-live Planning"
- October 2021: Highlights of Management Board Meeting - The Management Board heard an update on recent activities in response to the pandemic. The Board was updated on the status of the Agency’s ongoing COVID-19 lessons learned exercise. As part of this exercise, some of the measures and actions taken by EMA and the network in response to the pandemic are being discussed and … Continue reading "October 2021: Highlights of Management Board Meeting"
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.