EudraCT  
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Registering a trial in EudraCT and updating its information on EU CTR

For a trial to be conducted in the European Economic Area (EEA):

Sponsor:
  1. Requests EudraCT number
    The sponsor is advised to take a screenshot of the assigned EudraCT number, in case the confirmation email is not received.
  1. Fills in Clinical Trial Application (CTA) using the EudraCT application.
    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 creating a CTA, the Sponsor is not logged in the website). 
  1. Provides CTA package to national competent authority(ies) (NCAs)
    The XML file needs to be validated, saved and provided to every national competent authority in which the trial will be conducted.
National competent authority(ies):
  1. Receives the CTA and loads it in EudraCT.
    The trial is now present in the EudraCT Secure website, however it is not yet public.
  2. Enters the NCA and Ethics Committee approval date.
    The trial is now public in EU CTR, with the exception of phase 1 trials conducted solely in adults, see frequently asked questions (FAQs).
Sponsor, once the trial is over:
  1. Sends End of Trial (EoT) form to national competent authority(ies).
    If the trial never started, or ended prematurely, the sponsor should specify the trial has “Prematurely ended.”
National competent authority(ies):
  1. Sets the trial status to “completed” (or “prematurely ended”) in the EudraCT secure website.
    The trial status is updated in EU CTR.
Sponsor, within 1 year from EoT date or within 6 months for paediatric trials:
  1. Posts results in EudraCT by following the Tutorials on posting results.
    Results appear in EU CTR 2 weeks after posting date.

For more information on this process, see frequently asked questions.

For a trial to be conducted outside of the EEA, but part of a Paediatric Investigation Plan (PIP):

Sponsor (third country data provider, see Trial protocols Modalities and timing of posting):
  1. Requests EudraCT number
    The sponsor is advised to take a screenshot of the assigned EudraCT number, in case the confirmation email is not received.
  1. Fills in the third country file using the EudraCT application and saves the XML file.
    In order to save the third country file while completing it, the Sponsor needs to download (click on “Save as XML”). In order to continue with its completion, the Sponsor needs to upload it again (the EudraCT application is only a tool for creating a third country file, the Sponsor is not logged in the website). At the end of its completion, the XML file needs to be validated and saved.
  1. Requests a “EudraCT third country data provider” role by contacting the service desk.
    See details in the frequently asked questions. Non-registered users go to EMA account management.
  1. Logs in the EudraCT secure website and submits the third country XML file.
    The trial is now public in EU CTR.
Within 6 months from End of Trial date:
  1. Posts results in EudraCT by following the Tutorials on posting results.
    Results appear in EU CTR after 2 weeks from posting date.


For more information on this process, see frequently asked questions.

 

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EudraCT user manual


Registering a trial and updating its information
EudraCT number, CTA & Login for posting results
CTA & results documentation
Tutorials on posting results
Training
Frequently asked questions
National competent authorities
Statistics and technical documentation
EU Clinical Trials Register
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