EudraCT step-by-step guide

For a trial conducted in the European Economic Area:

1. 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”

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

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

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

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

2. 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.

3. Sets up an EMA account, requests a “EudraCT third country data provider” role through the Service Now
   See details in our Frequently Asked Questions. To know how to log in Service Now, see Contact us

4. Logs in EudraCT website and submits the third country XML file
   The trial is now public on EU CTR

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

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