Validação e Auditoria da Informação Obtida em Ensaios Clínicos
Código
21246
Unidade Orgânica
Faculdade de Ciências Médicas
Departamento
Gabinete de Estudos Pós-Graduados
Créditos
4,5
Professor responsável
Nancy Anne Lass
Língua de ensino
Inglês
Objectivos
Students will have the opportunity to become knowledgeable about Good Clinical
Practices (GCP) and Quality Systems as they relate to aspects of validation and auditing clinical trial data including:
- Role of Institutional Review Boards (IRBs), informed consent and study protocol development
- Initiation of the clinical trial and participating sites
- Data collection & management; statistical plan and systems validations
- Role of Data Safety Monitoring Boards (DSMBs)
- Study site monitoring and clinical audits
- Students will also have the opportunity to apply learnings through case-based assignments, designed to demonstrate real-life application to clinical drug development.
Pré-requisitos
Os exigidos para a frequência de um programa de mestrado da Faculdade de Ciências Médicas.
Conteúdo
Regulatory agencies and clinical study sponsors are intensifying their global efforts to validate and audit clinical study data. This course provides a comprehensive overview of the management of quality assurance in clinical trials, Good Clinical Practices (GCP), and management of audit outcomes as well as current issues and trends in the validation and auditing of clinical studies.
Bibliografia
There are no required textbooks for this course. Required readings will be provided.
Método de ensino
Palestras intensivas e workshops.
Método de avaliação
Apresentação e discussão de um protocolo de investigação, case-studies, exame.