June 12, 2013 | By Márcio Barra
A proposed bill for clinical research, which establishes a Portuguese national register of clinical trials, will be debated today on the Parliament. With this proposal, the Government aims to create a framework for research with humans in Portugal.
This bill, already approved by the Council of Ministers, creates the National Register of Clinical Studies (Registo Nacional de Estudos Clínicos), to improve the transmission of information in the authorization, monitoring and conclusions processes of clinical trials that occur in Portugal, and promote the access of information regarding clinical trials to the healthcare community.
According to “Agência Lusa”, the bill states that the National Register is “an electronic platform for registration and disclosure of clinical studies, which promotes interaction between different partners of the clinical research area while enabling and encouraging the development of high quality research for the benefit of patients.” All investigators, sponsors and research centers must register on this platform to conduct a clinical study
This national register will work alongside INFARMED, the national competent authority. INFARMED will also have to create a database for clinical trials with medical devices conducted in Portugal, if the bill is approved.