Clinical Trials

1. Overview and basics in clinical trials
Theoretical-practical classes (3 hours)
Historical background and 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 and regulatory framework
1.3. Drug development cycle
1.4. Fundamental concepts in clinical trials
1.5. Types and stages of clinical trials

2. Legal framework in Portugal and Europe
Theoretical-practical classes (4 hours)
European and Portuguese regulatory framework for clinical trials, detailing the specific legal requirements for clinical trials with medicinal products.
2.1. European regulation of Clinical Trials
2.2. Specific regulatory framework of Portugal

3. Good Clinical Practice (GPC)
Theoretical-practical classes (5 hours)
As one of the main international standards applicable to clinical trials, this section explores Good Clinical Practice in some detail, including the roles of ethics committees, the informed consent process, and the responsibilities of promoters and principal investigators. It highlights the importance of monitoring and security to ensure participant protection and data integrity.
3.1. Principles of Good Clinical Practice
3.2. Ethics committees and informed consent process
3.3. Responsibilities of the prosecutor and the Principal Investigator
3.4. Monitoring and security

4. 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 Practice 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.
4.1. Formulation of research questions
4.2. Clinical trial protocol structure
4.3. Definition of goals
4.4. Study design
4.5. Selection and characterization of the population
4.6. Intervention
4.7. Evaluation of efficacy and safety

5. Approval of a clinical trial in Portugal
Theoretical-practical classes (2 hours)
Discussion of guidelines for the preparation of documentation necessary for the approval of clinical trials in Portugal, emphasizing the importance of compliance with regulatory and legal requirements.
5.1. Submission process
5.2. Documentation for submission

NAO