The first edition of the course “Estudos Clínicos de Iniciativa do Investigador com Ferramentas Digitais” (Investigator-Initiated Clinical Studies with Digital Tools) was successfully concluded in December 2025. Running from November 3rd to December 11th, the program provided an in-depth look at the implementation and management of clinical studies.
The course was a significant collaborative effort, bringing together 20 students, 10 teachers from the Faculty of Medicine, University of Porto (FMUP), and 17 invited speakers from various prestigious institutions, including:
- Pedro Barata, President of the National Ethics Committee for Clinical Research (CEIC – “Comissão de Ética para a Investigação Clínica”);
- Joana Batuca, Portuguese European Correspondent for the European Clinical Research Infrastructure Network (ECRIN);
- João Massano, Head of the Clinical Trials Center (CIEC – “Centro de Investigação e Ensaios Clínicos”) of São João University Hospital Center;
- Leonor Nogueira, Pharmacovigilance of the Clinical Trial Unit of the National Authority of Medicines and Health Products (INFARMED);
- Lúcia Domingues, Coordinator of NOVA Clinical Research Unit (NOVA CRU);
- Mónica Gonçalves, Executive Director of the Clinical Academic Center of Braga (2CA-BRAGA);
- Margarida Nogueira, Scientific Affairs Specialist of the Consulting Research Organisation (CRO) CETERA;
- Patrícia Calado, Head of Clinical Innovation at NTT DATA Portugal;
- Vanessa dos Reis, Founder and Team Operations Leader of Humanized Solutions.
The training was divided into two main modules designed to equip researchers with modern skills:
- Module 1 focused on the implementation of Investigator-Initiated Clinical Studies. Topics included the fundamentals of Pragmatic and Target Trials, regulatory differences between clinical trials and observational studies, and the submission process in the CTIS system according to European regulations. It also covered essential ethical considerations, such as Good Clinical Practices (ICH-GCP) and informed consent.
- Module 2 shifted focus to the conduct of studies using digital tools. This section explored the lifecycle of data, the use of Electronic Data Capture platforms (CRFs), and study management via CTMS. It also highlighted the importance of investigator and patient engagement, quality assurance, and pharmacovigilance.
This successful first edition marks a step forward in training researchers to navigate the complexities of modern clinical studies using advanced digital tools.
