Program
1.Overview and basics in clinical trials
Theoretical-practical classes (3 hours)
Historical background and the essential principles of clinical research, including the ethical and regulatory contexts that govern this area of Medicine.
1.1. Historical perspective and evolution of Clinical Research
1.2. Ethical principles in clinical research
1.3. Integrity in clinical research
1.4. Development cycle in medicines research
1.5. Fundamental concepts in clinical trials
1.6. Types of studies and phases of clinical trials
1.7. Exercises in groups with application of concepts
2. Legal and regulatory framework in Portugal and Europe
Theoretical-practical classes (4 hours)
2.1. European regulation of Clinical Trials
2.2. Specific regulatory framework of Portugal
2.3. General Data Protection Regulation
2.4. Data security
2.5. Good Clinical Practice
2.6. Approval of a clinical trial
2.7. Exercises in groups with application of concepts
3-design of a clinical trial
Theoretical-practical classes (6 hours)
The challenges of designing a clinical trial. The formulation of the research question and structure of a study protocol according to Good Clinical Practices will be addressed. In this context, the foundations for the definition of objectives, design, population, intervention and methods of evaluation of the results of efficacy and safety of the study will be explored.
3.1. Formulation of research questions
3.2. Clinical trial protocol structure
3.3. Definition of goals
3.4. Study design
3.5. Selection and characterization of the population
3.6. Intervention
3.7. Evaluation of efficacy and safety
3.8. Exercises in groups with application of concepts
4-management of a Clinical Investigation
Role of the researcher in a team and its ethical and operational challenges
4.1. Planning
4.2. Team management
4.3. Organizational chart and schedule
4.4. Organizational culture
4.5. Exercises in groups with application of concepts
5-Artificial Intelligence and Clinical Research
Theoretical-practical classes (2 hours)
5.1. Definition of AI concepts and historical evolution
5.2. AI in clinical and Pharmacological Research
5.3. AI models and scientific evidence
5.4. The importance of the patient and citizen in research
5.5. Exercises in groups with application of concepts
Internship(s)
NAO