How to submit a End of Trial Notification and a Clinical Trial Report Notification
The end of trial notifications are made by the sponsor, through RNEC, within 90 days counting from the participation of the last study subject in the clinical trial.
If the clinical study has ended earlier, the timeframe mentioned above is reduced to 15 days, and the reasons should be clearly explained in the notification.
The investigator or the sponsor shall provide to INFARMED and CEIC the final results of clinical trials registered in RNEC, in the form of a final report, publications or presentations. The final report should be made available to INFARMED and CEIC, through RNEC, within 12 months after the end of the participation of the last subject in the clinical trial.
The end of trial and clinical trial report notifications regarding clinical trials that were not submitted to INFARMED and CEIC via RNEC, should be done independently to these two entities, through the usual pathways.
- Law n.º 21/2014, of 16th april, modified by Law n.º 73/2015, of 27th July.
- Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial (CT-1)
- Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use (CT-2)