Electronic portal for submission and management of Clinical Studies
Recognizing the huge relevance that human clinical research has for medical and economic outcomes, Law n.er 21/2014, of April 16, brought a new regulatory framework on this matter.
One of the news introduced was the creation of a National Registry for Clinical Studies (RNEC) to serve as a tool for registry and publication of all clinical studies undergoing in Portugal and that involve human beings, namely, clinical trials and other studies of clinical nature involving investigational products, medicines, medical devices and cosmetic products, allowing for a better interaction with all the stakeholders.
However, and taking into consideration the scope amplification brought by Law n.er 21/2014, RNEC incorporates information regarding much more that INFARMED's regulation matters, incorporating also, and amongst others, studies that use human biological samples, the clinical studies of food regimes and the clinical studies of unconventional therapies.
RNEC's functioning rules are published in Governmental Decree n.er 65/2015, of March 5.
RNEC is coordinated by an interinstitutional Commission that includes INFARMED, I.P., that presided, the Ethics Committee for Clinical Research (CEIC), and for the National Institute of Health Dr. Ricardo Jorge.
RNEC's objectives are laid down in its regulation and include the creation of an information databank of clinical studies, to facilitate the transmission and monitoring of information (privileging electronic processes to do so) for authorization and notification procedures presented to competent authorities and ethics committees, as well as to increase access and knowledge to the research community, healthcare professionals and society in general to all clinical studies undergoing in Portugal. This is a very challenging project for Portugal, but we are sure that it will be accomplished with great success, for the benefit of professionals and researchers, as well as the public in general.
RNEC is available since 5 December 2016 and, at this stage, allows the electronic submission of the following clinical studies:
- Clinical trials with human medicines;
- Clinical studies with the use of medical devices;
- Clinical studies with the use of cosmetic products;
- Post-Authorization efficacy studies (PAES) without intervention;
- Post-Authorization Safety Studies (PASS) without intervention;
There will be a transition period from 05-12-2016 to 31-12-2016, in which the applicant may choose to make a submission through RNEC or by the usual procedures. From 01-01-2017, all clinical trials referred to above, shall be submitted exclusively through RNEC.
- A free access area - allowing the publishing of the clinical trial and other relevant information
- A restricted access area (FrontOffice) - allowing the sponsor to manage the Clinical Trial development through the submission of notifications, substantial amendments, end of trials notifications, withdrawls and serious adverse events. Furthermore the sponsor or applicant will be able to monitor the current state of each notification/submission.
INFARMED, I.P. - Information Center of Medicines and Health Products (CIMI)
Telephone: (+351) 217987373 e Linha do Medicamento: 800222444 (gratuita)
Microsoft Internet Explorer 8.x and above