The course aims for students to acquire:
1) Knowledge and skills of understanding: The student will be expected to show mastery of knowledge related to clinical research methodologies, design and writing of a research protocol with emphasis on ethical aspects.
2) Applied knowledge and understanding skills: The student should show that he/she has acquired skills, tools and an informed autonomy of judgment in relation to the topics covered.
3) Autonomy of judgment: These notions will be the fundamental background to be able to independently carry out the preparation and writing of a research protocol to be submitted for approval to the university ethics committee or regional clinical.
4) Communication skills, getting used to exposition, in the classroom, of the concepts required by the lecturer, in a stimulating and interactive teaching environment. Students will always be urged to keep in mind the need for scientifically rigorous exposition and communication with colleagues and simple, yet comprehensive, with patients and their families. They will be stimulated to express themselves in correct and essential language.
5) Ability to learn: during face-to-face lectures, reference will be made mainly to the texts recommended by the reference lecturers of the individual modules, although students will be urged to consult several of them, citing the sources of the information expounded. The topics covered will always be approached from different points of view so that the student can form a clear and complete opinion.

None

The course aims to provide the essential elements to understand and design a research protocol in the clinical setting aimed at writing the dissertation, from design to submission to and approval by the ethics committee. During the course, students will be directly involved in writing a clinical research protocol.

Lecture's notes and slides

1. Definition, classification, elements and design of clinical trials
2. Regulatory agencies, approval of a clinical trial and principles of good clinical practice
3. Data sources, conduct of clinical research, experimental hypothesis testing
4. How to report and disseminate data
5. Critical review and discussion of papers prepared by students.

Frontal lectures.
Development of a written research protocol.

The recordings of the lessons are available on the Teams platform

Preparation of a written paper and classroom discussion of the result.

The evaluation grid adopted is the following:
- Excellent (30 - 30 cum laude): excellent knowledge of the topics, excellent language skills, excellent analytical skills; the student is able to brilliantly apply theoretical knowledge to concrete cases
- Very good (27 - 29): good knowledge of the topics, remarkable language skills, good analytical skills; the student is able to correctly apply theoretical knowledge to concrete cases
- Good 24-26): good knowledge of the main topics, good command of the language; the student shows an adequate ability to apply theoretical knowledge to concrete cases.
- Satisfactory (21-23): the student does not show full mastery of the main subjects of the teaching, even if he/she possesses the fundamental knowledge; however, he shows satisfactory language skills and sufficient ability to apply theoretical knowledge to concrete cases
- Sufficient (18-20): minimum knowledge of the main teaching topics and technical language, limited ability to adequately apply theoretical knowledge to concrete cases
- Insufficient: the student does not have an acceptable knowledge of the contents of the various topics of the programme

During the course some of the main issues indicated in the 2030 Agenda for sustainable development will be addressed, i.e. spreading the importance of primary and secondary prevention through the reduction of
the exposure of the population to environmental and anthropogenic risk factors, and the spread
of healthy lifestyles by strengthening prevention systems