Coordination and Management of Clinical Studies

Master
1st level vocational master
A.Y. 2025/2026
Study area
Medicine and Healthcare
1st level vocational master
60
ECTS
1
Year
Language
Italian
This vocational master programme is designed to provide a methodological and regulatory training to all those who wish to enter the field of clinical research support. In particular, the programme aims to boost the professional skills of research coordinators by integrating knowledge of oncological pathology. The goal is to complement training in clinical trial methodology and regulations with an overview of clinical oncology, considering the quantitative dimension of oncological research. The programme adopts a practical approach, focusing on the operational aspects of clinical research support: from the proper management of clinical data for the preparation of submission dossiers to ethics committees, to study archive maintenance, up to the finalisation of contracts with sponsors. This ensures a comprehensive hands-on training.

The programme, which will begin in the first semester of a. y. 2025/2026, includes 384 hours (corresponding to 40 academic credits, or CFU) of face-to-face teaching and 116 hours (7 CFU) of other forms of training. All activities will take place in the teaching facilities of Fondazione IRCCS Istituto Nazionale Tumori.

Rounding out the programme activities are a 300-hour internship (12 CFU) and a final exam (1 CFU), for which students will have to produce and defend a paper on the topics covered during classes or on the internship experience.
To be eligible for the programme, candidates must hold a degree in any of the following classes under former Ministerial Decree no. 270/2004: L-2 Biotechnology, L-13 Biological Sciences, L-24 Psychological Sciences and Techniques, L-27 Chemical Sciences and Technologies, L-29 Pharmaceutical Sciences and Technologies, L-41 Statistics, SNT/01 Class of Degrees in Nursing Health Professions and Obstetric Health Profession, SNT/04 Class of Degrees in Prevention Health Professions, LM-41 Medicine and Surgery.
The programme aims to prepare students to hold the following positions: Clinical Data Manager in healthcare institutions, pharmaceutical companies and Contract Research Organisations (CROs); Clinical Research Associate (CRA) for coordinating and monitoring clinical trials in healthcare institutions or within pharmaceutical companies and CROs; study coordinator, qualified as a Project Manager for clinical trials in non-profit healthcare institutions or for pharmaceutical companies conducting for-profit research; research nurse dedicated to patient care within clinical studies.

Courses list

Open sessions
Courses or activities Professor(s) ECTS Total hours Language
Compulsory
Aspetti regolatori per avvio e conduzione della sperimentazione clinica 8 80 Italian
Data management: raccolta, trascrizione, verifica dei dati di studi clinici
5 48 Italian
Esercitazioni su aspetti regolatori
2 30 Italian
Esercitazioni su data management
2 30 Italian
Esercitazioni su ich-gcp
2 30 Italian
Esercitazioni su informatica e project management
1 26 Italian
Ich-gcp: il sistema qualità nella sperimentazione clinica
5 52 Italian
Informatica: principi di base di informatica applicata agli studi clinici
3 24 Italian
Metodologia clinica oncologica 5 68 Italian
Metodologia ed etica nella ricerca clinica 5 38 Italian
Project management: pianificazione e controllo attività di uno studio clinico
5 38 Italian
Statistica di base applicata agli studi clinici
4 36 Italian

Enrolment

Call for applications

The call for applications is being finalized. Please refer to the call, once it is available, for admission test dates and contents, and how to register.

Application for admission: application deadlines will be published shortly.

The call for applications is being finalized