Important notice
The course guide is provisional.
The PDF version of the course guide may take a few days to become available in the DDD.
Basic Methodology in Clinical Research
Code: 42148Credits: 10
| Degree programme | Type | Course |
|---|---|---|
| Applied Clinical Research in Health Sciences | OB | 0 |
Contact lecturer
- Name :
- Javier Bracchiglione Pérez
- Email :
- javierandres.perez@uab.cat
Teaching staff
- Ignacio José Gich Saladich
- Maria Montserrat Martin Baranera
- Maria Teresa Puig Reixach
- Rosa María Antonijoan Arbos
- Ivan Sola Arnau
- Ignasi Bolibar Ribas
- Gerard Urrutia Cuchi
- Clara Selva Olid
- Laura Martinez Garcia
Teaching staff (external to UAB)
- David Rigau Comas
- Marta Roqué Fíguls
- Judit Solà Roca
- Marilina Santero
Group languages
You can consult this information at the end of the document.
Prerequisites
Requirements for admission to the master's degree and knowledge of technical english at the reading level
Objectives
The objetive of this module is to understand the methodological foundations of clinical research epidemiological reasoning to be able to design and carry out specific studies on practical problems clinical and community. In this module the student will be trained to know the types of clinical research, the main medical databases and to be able to do critical reading of articles and systematic reviews. This way the student will know the different designs of studies, the main epidemiological measures, the parameters to determine its validity and the most relevant statistical analysis for each design. Knowledge of the current legislative aspects for the conduct of the investigation and the ethical principles the they will also be an outstanding aspect to be developed in this module.
Definitely, the realization of this first module must be used so that the student is able to make judgments critics and to begin research in health sciences familiarizing with the scientific, most important methodological, ethical and legislative
Learning outcomes
- Recognize the different types of research.
- Working as part of a group along with other professionals, understand their views and cooperate constructively.
- Develop self-learning skills and motivation to continue their education at the graduate level.
- Act respecting the ethical and legal aspects of research and professional activities.
- Develop scientific knowledge, critical thinking and creativity.
- Describe the characteristics and implications of the stages of R + D + I in Health Sciences.
- Identify sources of scientific information.
- Classify the type of evidence.
- Set objectives, assumptions, operational definitions and integrate it into a theoretical framework.
- Describe the characteristics and compare the different methods used in the selection, design and information gathering in research.
- Apply the general principles of statistics.
- Raise the possible causal relationships.
- Detail the means of dissemination of scientific activity.
- Apply the general principles of Bioethics and Health Economics in scientific activity.
- Communicate and apply knowledge to the public and cultural debate.
- Identify and understand the ongoing progress and challenges in search
Contents
a) Types and stages
Paradigms in research: quantitative research and qualitative research. Terminological diversity in the type of research. Overview of the research process. Objetives. Hypothesis. Operational definitions. Integration in a theoretical framework. Preclinical development. Clinical development: phases. Post-authorization. Biomarkers and subrogated variables. Models: screening tests, bioassays, simulations. Validity (predictive, apparent, construct). Efficacy, effectiveness, efficiency, effectiveness.
b) Conceptual phase:
Sources of scientific information: MEDLINE, EMBASE, other databases. Metacercators. Criteria and tools for efficient information research. General criteria for critical reading depending on the type of design. Quality of evidence. Degrees of recommendation.
c) Methodological elements:
General characteristics of the different designs: strengths and weaknesses of each one: studies of cohorts, cases and controls, prevalence, experimental. Systematic reviews. Frequency and association measures. Internal and external validity. Description of the population and sample concepts. Explanation of the techniques of sampling. Information necessary for the calculation of the sample size. Methods for collecting information. Quality of measurement. Selection and definition of variables. Measurement scales. Types of questionnaires. Sources of information to obtain data. Types of questions. Writing and order of questions. Questionnaire format. Validation: Validity, Reliability.
d) Analysis, interpretation and dissemination
General statistical principles.Introduction to statistics. Description of the types of existing variables, as well as the most suitable statistics for each one of them. Introduction to the contrast of hypotheses. Causal criteria: individual assessment of its relevance. Scientific publications and dissemination. Checklists by authors, reviewers and editors of medical journals. Bibliometry.
e) Ethics, legislation and financing
Protection of the rights of patients and animals. International ethical codes. Ethical committees. Quality Culture: Good Practices. Autonomic, national and supranational legislation. Guidelines for biomedical research of Regulatory Agencies. The evolution of the national regulations: the new Law on Biomedical Research. Sources and types of financing. National programs. Research projects. ANEP. Patents. Conflict of interests.
See program 2025-26 Virtual Campus:
https://cv.uab.cat/protected/index.jsp
Learning activities and methodology
| Title | Hours | ECTS | Learning outcomes |
|---|---|---|---|
| Tutoring. Supervision and support in carrying out work | 82.5 | 3.3 | 5, 7, 8, 9, 10, 11, 12, 13 |
| Seminars for discussion of texts | 12.5 | 0.5 | 2, 3, 4, 7, 8, 9, 10, 11, 12, 13 |
| Laboratory Practices (LABP) | 3 | 0.12 | 2, 7, 8, 9, 10, 11, 12, 13 |
| Study | 60 | 2.4 | 3, 7, 8, 9, 10, 11, 12, 13 |
| Public presentation of works. Individual presentations and round of valuations | 20 | 0.8 | 2, 3, 5, 7, 8, 9, 10, 11, 12, 13 |
| Concept classes with support from ICT and group discussions | 30 | 1.2 | 1, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16 |
| Writing of works and elaborationof monographic topics | 20 | 0.8 | 5, 7, 8, 9, 10, 11, 12, 13, 15 |
| Classroom practices:Approach and resolution of practical cases | 17 | 0.68 | 2, 7, 8, 9, 10, 11, 12, 13 |
GUIDED SESSIONS: The theoretical classes will be face-to-face to explain the main concepts of the course. However, the core of the program will be based on the strategy of the learning based on problems, for that reason will require of the students a previous work of reading and critical analysis of the aspects to analyze. The classes will be supported by audiovisual media, and the student will be encouraged to deepen into the knowledge acquired in the classroom through the use of the bibliography and other elements. There will be sessions of debate on specific topics.
SEMINARS: Given the character and orientation of the subject, the seminars will play a key role in the learning of the subject, which is why the stimulation of the participation and its previous preparation is very important to ensure maximum performance in the acquisition of objectives of each one of the seminars. The student will have to carry out an electronic Evidence Based Medicine (MBE) electronic course.
SELF-LEARINING ACTIVITIES: Problem-based learning requires an important involvement of the student in the preparation of theory classes and supervised practices. A system will be assigned to have the materials, bibliography and other necessary tools to be able to develop this phase in an autonomous way, which will imply that the students must participate very actively in the classes and seminars both face-to-face or virtual.
Assessment
Continuous assessment activities
| Title | Weight | Hours | ECTS | Learning outcomes |
|---|---|---|---|---|
| Discussions and presentation in the classroom | 35% | 2 | 0.08 | 2, 3, 5, 7, 8, 9, 10, 11, 12, 13, 15 |
| Written test | 35% | 2 | 0.08 | 1, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16 |
| Delivery of work | 30% | 1 | 0.04 | 5, 7, 8, 9, 10, 11, 12, 13, 16 |
Bibliography
- Bunge M. 2004. La investigación científica. 3ª ed. Siglo XXI editores.
- Eyssautier De La Mora M. 2006. Metodología de la investigación: desarrollo de la inteligencia. 5ª ed. Thomson Editores.
- Icart Isern MT, Pulpón Segura AM. 2012. Cómo elaborar y presentar un proyecto de investigación, una tesina y una tesis. Editorial Barcelona: Publicacions i Edicions de la Universitat de Barcelona.
- Medawar PB. 2011. Título: Consejos a un joven científico. Editorial Barcelona: Publicacions i Edicions de la Universitat de Barcelona.
- Münch L, Ángeles E. 2011. Métodos y técnicas de investigación. 4ª ed. Trillas editores.
- Namakforoosh MN. 2005. Metodología de la investigación. 2ª ed. Limusa editores.
- Tamayo M. 2004. El proceso de la investigación científica: incluye evaluación y administración de proyectos de investigación. 4ª ed. Limusa editore
- Gordis L. Epidemiología, 5ª ed. Madrid: Harcourt, 2014.
- Argimon JM, Jiménez J. Métodos de investigación clínica y epidemiológica. 4ª ed. Barcelona: Elsevier, 2012
- Cabello J. Lectura crítica de la evidencia clínica. Barcelona: Elsevier, 2015.
- Evans I, Thornton H, Chalmers I, Glasciou P. Els tractaments, a prova. F. INPECS, 2016.
- Bonfill X. La medicina basada en la evidencia y la práctica clínica. En: Medicina Interna (ed. Rodés, Guàrdia), voI. 2a. ed. Ediciones Masson, pàg 13-16, 2004.
- Bonfill X. Asistencia Sanitaria Basada en la Evidencia. Barcelona: Sanidad y Ediciones (SANED); 2000.
- Cuello G, Pérez G. Medicina Basada en la Evidencia, 2ª ed. editorial Panamericana, 2018
- Porta M (ed.). A Dictionary of Epidemiology. Sixth ed. New York: Oxford University Press, 2014.
Higgins JPT, Thomas James, editors. Cochrane handbook for systematic reviews of interventions. 2a edició. Oxford: The Cochrane Collaboration, John Wiley & Sons Ltd.; 2019.
- Testing Treatments interactive [Internet].http://www.testingtreatments.org/
Software
Microsoft Teams
Course groups and languages
The information provided is provisional until November 30. After this date, you will be able to consult the language of each group through this link. To access the information, you will need to enter the course CODE
| Type of teaching | Group | Language | Semester | Shift |
|---|---|---|---|---|
| (TEm) Theory (master) | 101 | Catalan | first semester | morning-mixed |