Ateneo - UPO

Teaching provides students with the methodological knowledge and practical skills needed to design, plan, and manage biomedical research projects, from defining the scientific idea to developing a research protocol and planning the activities necessary for its implementation.

The identification of scientific needs and gaps in the literature, research and synthesis of evidence, preparation of protocols and related documentation, design of data collection tools, and use of electronic acquisition systems will be addressed, with particular reference to REDCap.

Part of the course will be devoted to the organizational and management aspects of research projects, including defining activities and responsibilities, time planning, budgeting, risk assessment, and identifying funding opportunities.

The teaching will adopt a practical approach based on the progressive development of a biomedical research project, through group activities aimed at preparing a Research Project Dossier that integrates scientific, methodological, organizational, and management aspects.

Study material will include presentations, scientific papers, examples of research protocols, methodological documentation and materials used during the exercises.

Resources and documentation related to the tools presented during the course, particularly PubMed and REDCap, will also be used.

Any further bibliographical references may be indicated during the lessons.

Teaching aims to provide students with the tools they need to transform a biomedical research idea into a structured, methodologically coherent, and concretely feasible project.

The main objective is to develop the capacity to identify a scientifically relevant question, evaluate its originality and feasibility, identify and synthesize available evidence, and develop a comprehensive research protocol for the methodological and operational elements necessary for its implementation.

The course also aims to develop skills in designing data collection tools, defining quality control procedures, and planning research activities, considering available resources, time, costs, and potential critical issues.

Particular attention will be paid to the ability to integrate scientific and methodological aspects with organizational and management ones, evaluating the overall coherence, reproducibility, sustainability and potential impact of the project.

Finally, the teaching aims to foster the development of independent judgment, teamwork, critical evaluation, and scientific communication skills, through the preparation and presentation of a project proposal.

Basic knowledge of biomedical research methodology, main study designs, and biostatistics fundamentals is useful, with particular reference to formulating research questions, defining objectives, and planning analyses.

A general knowledge of the biomedical scientific literature and the main IT tools for data organization and processing is also useful.

Previous experience in using REDCap or managing research projects is not required, as operational tools will be introduced and applied during practical activities.

The teaching includes theoretical and practical lessons integrated with guided exercises, group activities, discussion of application examples and progressive development of a biomedical research project.

Students will work in groups of 2–4 components, choosing a research topic and developing a Research Project Dossier during the course, which will include the scientific rationale, the research protocol, the data collection tools and the project implementation plan.

Practical activities will include literature search exercises with PubMed, preparation of study documentation, development of CRFs and exercises on REDCap or equivalent tools, data quality checks, and planning of activities, timeframes, budgets, and risks.

Critical peer review and presentation and discussion of developed projects will also be provided.

Practical activities involve the progressive development of a Research Project Dossier, including the initial proposal, the synthesis of scientific evidence, the protocol, data collection and control tools, the implementation plan, and the final presentation.

Computer tools for bibliographic research, data acquisition and project management may be used for the exercises. Should REDCap not be available, CRF design exercises can be carried out using spreadsheet-based tools.

The final evaluation will be divided into two components, each of which will contribute 50% of the overall vote:

Group project (50%): evaluation of the research protocol developed during group activities, with particular attention to the quality of the scientific rationale, methodological correctness, feasibility and overall coherence of the project proposal.

Individual written exam (50%): test consisting of open-ended questions on the topics covered during the course, aimed at verifying understanding of the methodological and organizational principles of biomedical research design and management.

The evaluation will consider the ability to apply the knowledge acquired, recognize potential methodological and operational criticalities, and propose appropriate solutions in the planning and management of a research project.

1. From the scientific idea to the research project
aIdentification of unmet scientific needs and gaps in available knowledge. Evaluation of the scientific relevance, originality, innovation, and feasibility of a biomedical research proposal. Definition of objectives, expected results and potential scientific and clinical impact. Transformation of the research idea into a structured project proposal.

2. Bibliographic research and synthesis of scientific evidence
Literature search strategies using PubMed, MeSH terms, and Boolean operators. Documentation and reproducibility of research. Principles of narrative, systematic, and scoping reviews and meta-analyses. Critical evaluation and synthesis of scientific evidence. Use of Artificial Intelligence tools to support bibliographic research, with attention to verifying the results and their limitations. Construction of the scientific rational and identification of the knowledge gap.

3. Development of the research protocol
Structure and fundamental elements of a biomedical research protocol. Definition of the study population, eligibility criteria, recruitment strategies and operational procedures. Planning of visits, collection of biological samples, measurements and follow-up. Operational definition of measurement variables and procedures. Justification of sample size and preparation of a preliminary statistical analysis plan.
Evaluation of the methodological consistency, feasibility and reproducibility of the protocol. Preparation of study documentation, including synopses, fact sheets and informed consent forms. Principles and procedures for ethical approval, data protection and registration of studies, where applicable.

4. Tools for data collection and management
Translation of the search protocol into tools

At the end of teaching, students will be able to:

- Identify a biomedical research problem and evaluate its relevance, originality, potential impact, and feasibility.
- Conduct and document structured bibliographic research, critically synthesizing scientific evidence.
- Develop a research protocol consistent with scientific objectives and available resources.
- Prepare essential documentation for a study and recognize key ethical and data protection requirements.
- Design CRFs and variable dictionaries and use the basic functionality of electronic data collection systems, with particular reference to REDCap.
- Define and apply simple procedures for quality control and data validation.
- Plan the activities, responsibilities, timeframes, and resources of a research project, preparing timelines, budgets, and risk management strategies.
- Understand the main elements of research funding proposals.
- Integrate scientific, methodological, and management aspects into a coherent and achievable project.
- Present and critically discuss a project proposal using appropriate scientific language.