How to participate in a Clinical Trial in Portugal and in the European Union
National Scope:
National Clinical Studies Register (RNEC)
RNEC constitutes an electronic platform for the dissemination of clinical trials authorised in Portugal. In this way, the general public, healthcare professionals and researchers will have access to information on clinical trials with medicinal products for human use authorised in Portugal, through the following search options:
- To consult Clinical Trials submitted and authorised under Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014, and Clinical Trials that were authorised under Directive 2001/20/EC and have transitioned to the Clinical Trials Information System (CTIS) under the same Regulation ¿ you may consult the RNEC via the 'Clinical Trials Search';
- To consult historical information on clinical trials authorised in Portugal under the European Clinical Trials Directive, Directive 2001/20/EC and Law No 21/2014 of 16 April 2014 (Clinical Research Law), and completed by 31 January 2025, you may consult the RNEC - through the "Clinical Trials Search ended until 31 January 2025 (Directive)", or consult the European Clinical Trials Register.
RNEC allows you to search for information on:
- Phase II-IV clinical trials that are conducted in Portugal;
- Paediatric clinical trials that are conducted in Portugal.
European Scope
Clinical Trials Information System - CTIS:
Clinical Trials Information System (CTIS), which is the single entry point for the submission of information relating to clinical trials in the EU and the European Economic Area (EEA), makes available on its public page information on all clinical trials in the European Union and EEA authorised under Regulation (EU) No 536/2014, including all clinical trials authorised under previous legislation that transitioned to CTIS during the transitional period.
The CTIS public portal, launched on 18 June 2024 in an enhanced version incorporating new transparency rules, allows users to perform advanced searches, subscribe to searches, download search results and information on specific clinical trials. The search results list is translated into all European Union languages and presents important information such as the countries where each clinical trial is taking place and the respective recruitment status.
Since 3 March 2025, the CTIS Interactive Map has been available - an interactive map of clinical trials taking place in the European Union, developed under the ACT EU Initiative to improve the dissemination of clinical trials, providing participants, healthcare professionals and citizens with easy and intuitive access to relevant information on clinical trials conducted in Portugal and the EU, in real time, in the various languages of the European Union, including Portuguese.
CTIS is currently a primary registry of the World Health Organization.
