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EudraCT step-by-step guide

For a trial conducted in the European Economic Area:

As of 31 January 2023, all initial trial applications in the European Union (EU)/European Economic Area (EEA) must be submitted through CTIS. In case a new EU/EEA-country needs to be added to a EudraCT trial, the EudraCT trial needs to be transitioned to CTIS first: see Guidance for the Transition of clinical trials.

The procedure below is applicable to all EudraCT Clinical Trial Applications that were submitted to EU/EEA National Competent Authorities (NCAs) before January 31st, 2023.

Sponsor, if an amendment to a EudraCT CTA is needed:

Uploads, amends and validates the XML file of each EU/EEA Clinical Trial Application (CTA) of the EudraCT trial that needs to be amended
In order to save the CTA 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 amending a CTA, the Sponsor is not logged in the website).

Provides CTA package to National Competent Authority(ies)
The XML file needs to be validated, saved and provided to every national competent authority that had authorised the trial.

Each National Competent Authority, if receiving a EudraCT CTA amendment from a sponsor:

Verifies that the initial CTA XML file of the trial is already uploaded for their member state, assesses and loads the CTA amendment in EudraCT

Verifies that NCA and Ethics Committee approval dates are inserted
The trial is public on EU CTR, with the exception of phase 1 trials conducted solely on adults, see Frequently Asked Questions

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.