Impulso Mais Digital Programme – Strengthening Digital Skills, funded by the Recovery and Resilience Plan (PRR)

The course “Investigator-Initiated Clinical Studies with Digital Tools” has been developed to equip professionals with the skills to lead investigator-initiated clinical studies—both interventional (clinical trials) and observational—with a strong emphasis on European regulatory compliance, the use of digital tools, and active participant engagement.

The training will be delivered in an e-learning format, incorporating online components. This structure helps overcome geographical and scheduling constraints, thereby facilitating access to specialised content.

The course covers a broad range of essential topics, including Pragmatic Trials, Target Trials, trial submission through the CTIS system, development of Statistical Analysis Plans (SAP), data management using tools such as eCRFs/EDC and CTMS, Good Clinical Practice (ICH-GCP), and compliance with the General Data Protection Regulation (GDPR).

The aim of this training is not only to address methodological and operational gaps frequently observed in investigator-initiated clinical studies but also to foster greater involvement in independent clinical research, thereby enhancing the quality, rigour, and relevance of the studies conducted.

The course objectives are aligned with the mission of the University of Porto, promoting the production and application of scientific knowledge, the social and economic value of research, and the development of advanced competencies in the health sector.

Mode of delivery: E-learning

Language of instruction: Portuguese

Target audience: Health professionals or individuals with an interest in acquiring practical skills in investigator-initiated clinical research

Tuition fee: ¤200

Information

SCHOLARSHIPS:

It is possible to apply for a scholarship under the "Impulso Mais Digital" Programme of the Recovery and Resilience Plan (PRR).

Individuals are eligible for a scholarship if they meet all of the following criteria:

• Are residents in national territory (this includes anyone with permanent residence in Portugal or a valid residence permit during the application period and duration of the course/training, as well as a Portuguese Tax Identification Number, with a tax representative domiciled in Portugal);

• Are at least 18 years old at the start date of the course/training;

• Have submitted a formal application, been admitted, and completed enrolment in the course/training for which the scholarship is granted; and

• Have a prior academic background in a non-STEM field (i.e., outside the areas of natural sciences, mathematics and statistics, information and communication technologies, engineering, manufacturing and construction, and arts and humanities).

Please consult the regulations for further details.





   Plano de Recuperação e Resiliência

Contacts

Academic Management Office
Continuing Education - Non-degree courses
Tel: 220426574
E-mail: prr.academico@med.up.pt

General information

Study Plan

Certificates

Predominant Scientific Areas