Report of serious adverse events

 

The investigator must report to the sponsor within 24 hours all serious adverse events (SAE), as well as the device deficiencies that may have led to the event. This does not apply to serious adverse events listed in the Clinical Investigation Plan or in the Investigator's Brochure identified as not requiring immediate reporting.

All serious adverse event (SAE) must be fully recorded and immediatly (no later than two days) notified by the sponsor to the Competent Ethics Committee (CEC), to INFARMED, I.P. and to the competent authorities of all Member States concerned (where the study is being performed).

The other types of reportable adverse events, namely device deficiencies or new information in relation with an already reported event, should also be recorded and notified to the Competent Ethics Committee, Infarmed and the competent authorities of all Member States concerned, within seven days following the date of awareness by the sponsor.

The sponsor must also notify the annual cumulative safety report, compiling the gathered data and a critical analysis.

 

Notification to INFARMED, I.P.

For pre-market clinical studies should be used the reporting form template for summary SAE tabulation attached to the guideline MEDDEV 2.7/3 - Clinical investigations: Serious adverse event reporting.

For post-market studies the sponsor must notify to Infarmed the annual cumulative safety report, safeguarding that depending on the course of the study other periodicity may be proven as necessary.

All relevant documentation must be submitted to Infarmed via RNEC, as provided in the "Technical and Functional Specifications", in accordance with article 10 of Ordinance No. 65/2015 of March 5.

It should also be noted that, in the case of post-market studies, the manufacturer must guarantee that when a serious adverse event that occur in Portugal regarding which there is a suspect of relationship to the device (i.e. meets the criteria of notification via Vigilance System) is individually notified to the Vigilance Unit of Infarmed using the appropriate European harmonized template as per MEDDEV 2.12/1 rev.8 that can be sent by e-mail to dvps@infarmed.pt .

For more information please consult:

http://www.infarmed.pt/portal/page/portal/INFARMED/PERGUNTAS_FREQUENTES/DM/VIGILANCIA_DISP_MEDICOS_EN

 

Notification to the CEIC - National Ethics Committee for Clinical Research

Notification of serious adverse events must be done in accordance with article 23 of Law No. 21/2014 of April 16, and the instructions above mentioned (reporting to Infarmed).

All reports of serious adverse events must 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.
The CEIC only requests to be notified of events occurred in Portugal.