Submission of substantial amendments
The sponsor must request to the competent ethics committee the substantial amendment of the protocol or of any other document that may have impact in the safety or well-being of the study subjects and/or that modifies the conduct of the study.
The study can only proceed with the favorable opinion of the ethics committee. This committee sends their opinion within 20 working days from the date of the request. In studies with the use of medical devices, and in accordance with Law No. 21/2014 of April 16, the competent ethics committee is the CEIC - National Ethics Committee for Clinical Research, unless it appoints a local ethics committee for health (CES).
In interventional clinical studies of medical devices the sponsor also needs to submit to INFARMED, I.P. a notification with the reasons and content of the proposed amendments.
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.