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EudraCT step-by-step guide

For a trial conducted in the European Economic Area:

All clinical trials in the European Union (EU)/European Economic Area (EEA) that are ongoing after 30 January 2025 must comply with the Clinical Trial Regulation (EU) 536/2014 and, therefore, should have been submitted to the Clinical Trials Information System (CTIS). More information here.

The procedure below is applicable to all EudraCT Clinical Trial Applications of trials that were ended in the EU/EEA before January 31st, 2025.

Sponsor, once the trial has ended:

Sends the Declaration of End of Trial (EoT) form to NCA(s)
In case the trial never started or was ended prematurely, the Sponsor should specify that the trial has “Prematurely ended”

Each National Competent Authority, after receiving the End of Trial form:

Sets the trial status as “completed” (or “prematurely ended”) in the EudraCT Secure website
The trial status is updated on EU CTR

Sponsor, within 1 year from EoT date (or within 6 months for paediatric trials):

Posts results on EudraCT following the Tutorials on posting results
Results appear on EU CTR two weeks after posting date

Further details on the process are provided in our Frequently Asked Questions

For a trial to be conducted exclusively outside of the EEA, but part of a PIP/Art 46 of the paediatric regulation:

The below is applicable to trials that are conducted exclusively outside of the EU/EEA but, that are part of a Paediatric Investigation Plan and/or in scope of Art 46 of the paediatric regulation (EC) No 1901/2006 (“third country files”). For PIP/Art 46 trials that will be conducted in the EU/EEA as well as outside of the EU/EEA, the initial submission must be performed solely through CTIS.

Sponsor (third country data provider):

Requests EudraCT number
Sponsor is advised to take a screenshot of the EudraCT number assigned, in case the confirmation email is not received

Creates, fills in, validates and saves the Third country XML file using EudraCT application
In order to save the third country file while completing it, the Sponsor needs to download it (click on “Save as XML”). In order to go on with its completion, the Sponsor needs to upload it again (the EudraCT application is only a tool for creating a CTA, the Sponsor is not logged in to the website). At the end of its completion, the XML file needs to be validated and saved.