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, also via practical application of the statistical methods studied, from the writing of protocols to integrating them into the SAP, and presenting results to a regulatory agency.
At the end of the course, the student will be able to apply advanced statistical methods to analysing clinical trial data and communicating study results, as well as implementing statistical analysis in the writing of protocols.
The Second-level short specialisation degree in Research Methodology and Clinical Experimentation develops knowledge and skills for the application of the theoretical and practical tools necessary for the proper design, conduct, and management of a research and clinical trial of medicines for human use as well as devices.
The course allows students to gain knowledge on methodologies as well as on the design of the study protocol in all of its phases, monitoring the study, evaluating the efficacy and tolerability of the treatment, and analysis of the results obtained via state-of-the-art techniques.
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:
I MODULE: DESIGN AND DEVELOPMENT OF A DRUG OR DEVICE
- Design and development of a drug
- Design and development of a device
II MODULE: CLINICAL RESEARCH METHODOLOGY
- Study design, sample size, evaluating evidence
- Design and conduct of randomised clinical trials (includes topical seminars on conducting clinical trials in specific clinical specialities)
- Design and conduct of observational studies (includes topical seminars dedicated to the conduct of observational studies within specific clinical specialities)
III MODULE: REGULATIONS AND BIOETHICS
- GDPR/GCP Regulations
IV MODULE: PLANNING AND ORGANISING A CLINICAL STUDY
- Study protocol
- Data management
- Outcome assessment
- Data monitoring
V MODULE: STATISTICAL ANALYSIS (WITH PRACTICAL EXERCISES) OF CLINICAL STUDIES, AND WRITING A SCIENTIFIC ARTICLE
- 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
Seminar: scientific article writing
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 2023/24 will be published on the Italian page of this Second-level short specialisation degree according to the timing provided in the Call.
There is no admission test. Candidates who meet the requirements as per the Short specialisation degree’s selection process for 2023-24 will be admitted. The Steering Committee evaluates candidates based on degrees, theses, other publications, and/or other qualifications that the candidate deems useful.
Pursuant to Article 24.6 of of the Regulation for University Short specialisation degree, Postgraduate Course and Higher Education Courses, there is the option of supernumerary admission for University staff, to the extent of 10% of the maximum quantity of applicants that can be enrolled in each Short specialisation degree’s Course. The enrolment quota for the University administrative-technical staff (PTA) is equal to 20% of the quota provided for each Short specialisation degree course.
Yes, the percentage is 75%, including the internship or apprenticeship period.
The Short specialisation degree takes place in person, classrooms at the University of Padua boasting modern equipment.
Lectures will be concentrated over two days, possibly Thursday afternoon and all day Friday, so that those who work or don’t live locally can attend. Saturday lessons, to take place about once a month, will be devoted to in-depth seminars with lecturers who are experts in clinical research.
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.