How to submit a End of Trial Notification and a Clinical Trial Report Notification

 

The submission of the notification of completion of a clinical trial must be made exclusively through the European portal CTIS (Clinical Trials Information System), under Regulation (EU) No 536/2014.

The sponsor must notify the completion of the trial within the following timeframes:

  • In the Member State (Portugal): Within 15 days of the end of the trial in the Member State
  • In the EU/EEA: Within 15 days of completion in all Member States involved.

The Global End of Trial notification: Within 15 days of completion in all countries (including outside the EU), where applicable.

The sponsor must submit the summary of the Clinical Trial results, in all Member States where the trial was conducted, within the following timeframes:

  • Within 1 year of the completion of the clinical trial in all Member States involved.
  • Paediatric Trials: The deadline is reduced to 6 months after completion.

 

Applicable Regulatory Provisions:

Regulatory provisions applicable to the submission of applications to conduct a Clinical Trial as well as applications for Substantial Modification, Notification of Clinical Trial Completion and Final Report and other Notifications: