How to conduct a Clinical Trial in Portugal
Any research that involve the participation of human subjects, particularly clinical trials, must be carried out in accordance with Good Clinical Practice (GCP) which is an international ethical and scientific quality standard for designing, conducting, recording and reporting those trials. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
Conducting clinical trials in Portugal requires prior authorization of the INFARMED, IP Management Board and favorable opinion of the National Ethics Committee for Clinical Research (CEIC).
The clinical trial application (CTA) to INFARMED, IP and CEIC require the payment of a fee, according to the type of study, and the submission of the CTA documentation or substantial amendment. The CTA submission details can be found in Information to Sponsor area.