Clinical Trials I

Year
3
Academic year
2019-2020
Code
01550936
Subject Area
HEALTH SCIENCES AND TECHNOLOGIES
Language of Instruction
Portuguese
Mode of Delivery
Face-to-face
Duration
SEMESTRIAL
ECTS Credits
7.0
Type
Compulsory
Level
1st Cycle Studies

Recommended Prerequisites

Physiology, Physiopathology and Pharmarmacology.

Teaching Methods

Each topic is explained in lectures the masterful type , but with great interaction with students .
The evaluation was conducted at the end of the semester, through final exam for the theoretical part .
The attendance at lectures is optional but there will be appreciation of the presence and collaboration ( continuous assessment) .
Attendance to practical classes is compulsory , students must attend at least 2/3 of lectured. Each topic is explained in practical classes and an application of theoretical concepts .

Learning Outcomes

It is expected that the end of the school students master fundamental principles of clinical trials, in particular refers to its safety and efficacy profile. They should also acquire skills necessary for critical assessment regarding the underlying regulatory component to this type of testing.
At the end of the semester the student must have:
Knowledge: Knowing the fundamental characteristics for a clinical trial can be considered robust. You must be able to describe an exploratory, explanatory or pragmatic clinical trial. You should know how to make monitoring a clinical trial.
Skills: Must have critical thinking about the publications of clinical trials. You should be able to apply the various scales for analysis of a clinical trial.
Attitudes: Information Research leading to use, an adequate form, individually or in groups, all the human and technological resources available for learning in this area.

Work Placement(s)

No

Syllabus

Pharmacological rationale and clinical trials. Clinical research.
R & D. Development of a medicament. Clinical trials and observational studies and Evidence Based Medicine. Type of procedures for marketing authorization. Adverse reactions; Pharmacovigilance. Ethics and clinical studies. Placebo question. "Investigational medicinal product circuit". Sources / standards (guidelines) for clinical trials; CONSORT. Legislation. Clinical trials and observational studies. Types of observational studies. Phase I clinical trials, II, III and IV. Testing of non-inferiority, equivalence and superiority, bioequivalence
Good Clinics Practices. Registration of a clinical trial. Logistics and human conditions for a clinical trial; a trial site. Development of a clinical trial . Good clinical practice. The investigator's brochure: rules to follow
Experimental medicine. Rights and duties of those responsible for conducting the test and obligations of participants. Monitoring a clinical trial.

Head Lecturer(s)

Maria Dulce Ferreira Cotrim

Assessment Methods

Assessment
Other: 15.0%
Mini Tests: 15.0%
Exam: 70.0%

Bibliography

-Tom Brody. Clinical Trials. Academic Press, 1st edition, 2012
-Richard Chin & Bruce Y. Lee. Principles and Practice of Clinical Trials Medicine, Elsevier, 2008
- Normas / Guidelines da EMA (www.ema.europa.eu)
- Directiva 2005/28/CE da CE de 8 Abril 2005
- Lei n.º 21/2014 de 16 de Abril de 2014 – Lei da investigação clínica
- Lei que cria as Comissões de Ética para a Saúde (CES) – Decreto Lei nº 97/95.
- Lei da Protecção de Dados Pessoais – Decreto lei nº 67/98 - transpõe para a ordem jurídica nacional a Directiva nº 95/46/CE.
- Lei que cria a Comissão de Ética para a Investigação Clínica (CEIC) – Portaria nº57/2005 – transpõe para a ordem jurídica nacional a Directiva nº 2001/20/CE.
-EudraLex - Volume 10 - Clinical trials guidelines
- Declaração de Helsinquia de 2013.