Notification of the study termination and final report
The notification of the termination of a clinical study with medical devices (declaration of close out) must be sent to INFARMED, I.P. and to the CEIC - National Ethics Committee for Clinical Research, within 90 days from the date of completion of the participation of the last subject of the study.
Whenever a clinical study is terminated early, the sponsor must notify the Infarmed and the CEIC within 15 days and clearly expose the reasons of this premature termination.
The investigator or the sponsor provide the final results of the clinical study as final report, publications or presentations.
All relevant documentation should be submitted via RNEC, as provided in the "Technical and Functional Specifications", in accordance with article 10 of Ordinance No. 65/2015 of March 5.