Fundamentals of Clinical Research

Objectives

The learning objectives are of the cognitive domain and provide ability to perform specific tasks and solve problems, namely:

· To describe, justifying the general organization of the master course;

· Distinguish the clinical research from other types of research;

· Identify the differences between the different types of clinical research;

· Enumerate the scientific and regulatory requirements for each type of clinical research study;

· Identify the different stakeholders and partners of a clinical research study;

· Characterize the national scientific production of clinical research, compare it with the international one, and identify the information sources;

· Describe the organization of clinical research infrastructures and enumerate the respective functional content;

· Plan a specific clinical research project by phases: planning, implementation, monitoring and ending.

General characterization

Code

191000

Credits

Responsible teacher

Doutora Nélia Gouveia

Hours

Weekly - Available soon

Total - Available soon

Teaching language

Portuguese or English

Prerequisites

Bibliography

· ICH-GCP ICH Harmonised Tripartide Guideline. Guideline for Clinical Practice E6(R2), 2016.

· Legislação nacional em vigor, relacionada com Investigação Clínica, Proteção de dados.

· Legislação nacional em vigor relativa a Proteção de dados genéticos e colheita de amostras biológicas.

· Regulamentação Europeia em vigor.

Teaching method

The course comprises:

· 30 sessions of classroom lectures with expository method, 50 minutes directed to all students. The corresponding learning of these contents will be assessed using a multiple response test (50%)

· 5 sessions of theoretical and practical (2h) comprising an expository component and an interactive component, that address cases and problems and may include a technical demonstration or prepare and discuss the fieldwork activities. The corresponding learning of these contents will be evaluated through short answers test (25%).

· 15 tutorials sessions aimed at monitoring students in the execution of exercises to fulfill the learning objective number 9: to identify and plan a specific clinical research project by phases: planning, implementation, monitoring and ending. The corresponding learning of these contents will be assessed by oral presentation in a public proof test (25%).

Evaluation method

· Written Final exam (concerning the theoretical and practical components): 50% final grade.

· Continuous evaluation of presentations and discussion of the cases corresponding to the 25% practical sessions (excluding the final project): 25% final grade.

· Report and oral presentation where the students will demonstrate that they have understood the objectives of the Curricular Unit and are familiar with the management of the research process: 25% final grade.

Subject matter

· Overview of the course program and the relationship with future employability.

· The importance of clinical research and levels of scientific evidence.

· General concepts and definitions of clinical research. Types of clinical studies. Special features of clinical trials, surgery studies, medical devices and nutrition.

· The concepts of good practices (clinical, laboratory and manufacturing). Stakeholders and infrastructures in clinical research. Requirements of sites, support and management structures, regulatory authorities. Examples of national and international organizations. National scientific research. Sources of information, results and comparison with the international context.

· Topics of a clinical study and a of clinical trial.

· General organization of clinical research studies according to the different phases: planning, implementation, monitoring, and closure.

Programs

Programs where the course is taught:

Master in Clinical Research Management