The First-level short specialisation degree in Research nursing prepares the new healthcare professional figures called clinical research nurses or study nurses, who carry out their activities in clinical contexts, focusing on caring for patients enrolled in experimental protocols. In this field, more than any others, the work of a research nurse is carried out in close relationship with several other professionals: doctors, medical research coordinators, data managers, biologists, pharmacists, CRA (Clinical Research Associates) and contract-based CRO (Clinical Research Organizations). The Master offers a distance learning mode that, through the use of multimedia and interactive tools, provides attendees the theoretical and hands-on tools necessary for a modern and up-to-date training on clinical trial conduction.
The First-level short specialisation degree in Research Nursing explores the fundamentals of clinical research, including an overview on study plans, promotes the autonomous development and management of a clinical study, from project to practice, focusing on the role of the research nurse, and ends with a module on data analysis and clinical epidemiology.
The First-level short specialisation degree in Research Nursing is addressed to nurses, and provides the theoretical and practical tools required for modern training on clinical trial conduction, by analysing the ethical principles that inspire this method, the national regulations that govern its conduction, and the operational/managerial aspects. The figures formed can find occupational placement as data manager, study or research nurse, within hospital, healthcare, pharmaceutical CRO or research settings.
After completing the Master, attendees will be able of participating in drafting protocols in different fields; working in agreement with the principles of Good Clinical Practice (GCP) and current regulations; coordinating a clinical trial in their relevant fields, and in accordance with the protocol; working in compliance with the participants’ safety and rights; correctly managing data and their quality checks; coordinating the operative aspects of profit and non-profit trials. The Master trains professional figures to support clinical study coordinators and data managers, research nurses for hospital units, university hospitals, university clinics, IRCCS, local healthcare units, private healthcare facilities, pharmaceutical companies and CRO.
The First-level short specialisation degree in Research Nursing provides training on:
Module 1 – CLINICAL RESEARCH: FUNDAMENTAL
Clinical and research question; quantitative, qualitative research, mixed methods; nursing research (case reports and case series, clinical trials); patient reported outcomes (life quality and PCOR); efficacy vs effectiveness (real world data and health service research); randomization methods, sampling; data measuring and quality; research regulating bodies; territorial medicine, independent and non-profit research.
Module 2 – STUDY PLANS IN CLINICAL RESEARCH
Intervening vs observing; observational studies vs interventional studies; SWOT analysis in designing a clinical study; observational and descriptive studies; cross-cutting and cohort analytical studies; control case study; interventional studies; clinical testing with DM; clinical drug trials, cross-over studies, washout screening, follow-up and post-trial care; drug development phases and related interventional studies.
Module 3 – CLINICAL STUDY COURSE: FROM DESIGN TO PRACTICAL CONDUCTION
Bioethical horizons in clinical research; introduction to bioethics; critical assessment of ethical research aspects; how a clinical study protocol is created; design and planning key points; object definition, variability and sampling; drop out; measurement appropriateness; biomarker endpoints, surrogate endpoints, composite endpoints; validation, general protocol structure; item standard – SPIRIT; administrative and scientific information; review process and authorizations; background and rationale; safety; clinical study documentation; section 8 of ICH GCP R2 guidelines; electronic trial master files; site file investigator; study registration; clinicaltrials.gov; regulatory activities; ethical committee; regulatory course of an interventional study and of an observational study; European and national regulations; regional and corporate rules; AIFA guidelines; European data protection regulation (GDPR); clinical research team definition.
Module 4 – NURSING SUPPORT IN CLINICAL RESEARCH – ROLE OF THE RESEARCH NURSE
The research nurse (CNR) figure: from clinic aspects to clinical trials, how to identify the role of the CNR: the clinical trial nurse questionnaire (CTQN), role of the CNR in the informed consent process; role of the CNR in managing trial study materials: drugs (IMP or NIMP), medical devices, biological samples, study diaries; role of the CNR in implementing a clinical study.
Module 5 – DATA MANAGEMENT AND ANALYSIS AND CLINICAL EPIDEMIOLOGY
Statistics applied to clinical research. Confounding factors and how to balance them; data measurement and quality; descriptive statistics, statistic inference, statistical data; multivariate analysis, study reports, result interpretation; data analysis software (Jamovi), standard operative procedures; PPE, compliance and patient engagement.
To get to know the Directors and professors and for more useful info on the First-level short specialisation degree in Research Nursing: Research Nursing | Department of Cardiothoracic-Vascular | University of Padua (unipd.it)
Before the beginning of the Master’s course, there will be a “zero” – alignment module. The module was designed to allow all students to rapidly gain the basic knowledge required for the educational activities.
The contents include: clinical question and research question; quantitative and qualitative research; mixed methods; nursing research; clinical study plans; observational and interventional studies.
After completing all mandatory activities, students have the option – before achieving their diploma – to follow two additional optional modules. The first module is an introduction to REDCap – a web-based and very user-friendly system to draw and use data and survey collection sheets. The second module concerning the ICH Good Clinical Practice guidelines, with the option of receiving the related training certification at the end of the course, and after passing the evaluation test.
The general ranking of merit for the academic year 2023/24 will be published on the Italian page of this Master according to the timing provided in the Call.
There will be no stages/traineeship, as they are deemed to be irreconcilable with the profile of the Master’s attendees. However, students will have the chance to tackle actual scientific matters and databases, proposed by the Direction during the lessons and the project works. At the end of the lessons, a project work will be assigned, which may also be based on the attendees’ personal and professional interest, in agreement with the professors and tutors. The project work will be during the summer, and it will be the basis for the diploma-awarding discussion in September, on the Zoom platform.
The project work replaces the stage/traineeship.
The Master is provided online, and it can be followed also by full-time workers, because it is provided online on-demand, through UniPD’s Moodle multimedia platform – Department of Cardiothoracic-Vascular Sciences and Public Health (PM-DSCTVSP). It has been conceived for students and professionals who want to conciliate other activities and professions with the need to qualify or further specialize. There will be an easy and frequent interaction between students and professors, through Moodle’s Forum. Video-lessons will take place between November and May, and attendees will be instructed on how to use the platforms. The course is divided into 4-week long modules. At the end of each module, attendees will have the time to rewatch the video-lessons, followed by homework in asynchronous mode, to test the competencies acquired. Homework too will be issued on demand. The project work to discuss the final exam will be completed between June and July, even on cases that specifically interest the students, in agreement with the tutor. The project work is discussed online, on the Zoom platform.
PA 110 e lode: starting from A.Y. 2022/23, public administration employees who enrol in our Master’s programme enjoy a 20% reduction on the enrolment fee. During the pre-enrolment procedure in PICA there is a special question “Are you an employee in an Italian Public Administration?” which allows you to enter this information.