The Second-level short specialisation degree in Research Methodology and Clinical Experimentation prepares specialised professionals in order to conceptualise, design, and manage all phases of research and clinical trials of medicines for human use as well as devices, and to critically analyse the results.
The course provides advanced knowledge and skills in the field, in light of current regulations and the most recent scientific advances, from the drafting of the study protocol, including the definition of the statistical analysis plan, to the conduct and management of the study, up to the processing of the data for their presentation to a regulatory agency and/or a scientific publication.
The training activities of the Second-level short specialisation degree in Research Methodology and Clinical Experimentation develop the knowledge and skills for the application of the theoretical and practical tools necessary for the correct design, conduct and management of a clinical trial.
The course is developed through the acquisition of knowledge based on methodologies, but also on the design of the study protocol in all its phases, on the monitoring of the study, on the evaluation of the effectiveness and tolerability of the treatment and on the analysis of the results obtained with state-of-the-art techniques.
The Second-level short specialisation degree includes theoretical and practical activities and includes an internship period during which the student will have the opportunity to gain clinical research experience in the field by studying specific aspects addressed in class.
The Second-level short specialisation degree in Research Methodology and Clinical Experimentation trains professionals to be experts, capable of conceiving, designing, and managing all phases of research and clinical trials of medicines for human use as well as devices, and of critically analysing the results.
These skills can be used in either the private or public sector, qualifying students as specialised professionals in healthcare companies, hospitals, clinical research support units, clinical trial centres, and contract research organisations (CROs).
The Second-level short specialisation degree in Research Methodology and Clinical Experimentation includes the following modules:
MODULE I: THE DESIGN OF A MEDICINAL PRODUCT
- Introduction to the drug design and development process
MODULE II: CLINICAL RESEARCH METHODOLOGY
- Design and conduct of randomized clinical trials
- Design and conduct of observational studies
- Evaluation of scientific evidence
- Sample size
MODULE III: REGULATIONS AND BIOETHICS
- GDPR/GCP Regulations
- Ethics
MODULE IV: PLANNING AND ORGANISING AN EXPERIMENT
- Study protocol
- Data management
- Outcome assessment
- Data monitoring
- Pharmacovigilance
MODULE V: STATISTICS APPLIED TO CLINICAL RESEARCH
- Statistical analysis for a randomised clinical trial
- Statistical analysis for an observational study
- Advanced methods (Machine Learning Techniques) for designing, conducting, and analysing clinical studies: opportunities and applications
In compliance with the general criteria set out in the annex to Decree-law no. 1255 of 26/11/2021, unlike other Short specialisation degree’s courses in the Biostatistics Unit of the Department of Cardio-Thoracic-Vascular Sciences and Public Health, all the training, theoretical and practical activities will be carried out in person and including internships at participating institutions:
- Clinical Trial Centre – internship at a university or hospital clinical research centre involved in the management or conduct of clinical trials
- Clinical research support unit – internship at a clinical research unit or other clinical research support facility
- Hospital pharmacy or hospital analytical laboratory – internship in a hospital pharmacy or analytical laboratory involved in the management of clinical studies
- Clinical unit (inpatient or outpatient unit) – internship at a hospital operating unit (inpatient and/or outpatient unit) involved in the conduct of clinical studies
- Cros – internship at a contract research organisation
The general ranking of merit for the academic year 2024/25 will be published on the Italian page of this Second-level short specialisation degree according to the timing provided in the Call.
Information
FAQ
Yes, the percentage is 75%, including the internship or apprenticeship period.
The Second-level short specialisation degree takes place in person, in modernly equipped classrooms at the University of Padua.
At the end of each module, students will have to take an exam to test the skills acquired, and this will contribute to the overall grade.
The course will conclude with a final exam (oral), where diploma candidates will present their papers written with the support and guidance of a tutor during the apprenticeship or internship.
- There is no registration fee for students with disabilities, who have a disability with invalidity between 66% and 100% or with certification pursuant to law n.104, who will therefore only pay the pre-enrolment fee, the insurance and stamp duty
- PA110 with Honors: Public Administration employees who enroll in our master’s degree enjoy a discount of 330 euros on the contribution of the second installment
- There is the possibility of registration for permanent University staff. The registration fee for the University’s Technical-Administrative Staff is linked to the minimum registration fee set in art. 24, co. 1 of the University Regulations for University Masters, Specialization Courses and Higher Education Courses of the University of Padua, and is equal to 20% of the expected fee. In the event that permanent staff meet the admission requirements for the Course, once the course has been completed, they will be able to obtain the relevant Diploma or certificate; if they do not meet the admission requirements, they may be admitted as an auditor and obtain a certificate of participation. The registration fee for listeners is equal to 50% of the course registration fee.