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Relatório de Estágio em Monitorização de Estudos Clínicos
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| 2.34 MB | Adobe PDF |
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Orientador(es)
Resumo(s)
RESUMO: A monitorização de estudos clínicos tem como propósito assegurar a proteção
dos direitos e do bem-estar dos seres humanos e garantir a qualidade e
integridade dos dados recolhidos no âmbito dos estudos clínicos. Nos últimos
anos, houve uma alteração do paradigma relativamente à atividade de
monitorização, tendo esta deixado de ser uma atividade realizada apenas
presencialmente para passar a contar também com atividades de monitorização
central e monitorização remota.
Realizou-se um estágio na área da monitorização de estudos clínicos na
empresa Keypoint – Consultoria Científica onde se desempenharam diversas
atividades no âmbito de estudos observacionais e ensaios clínicos, relacionadas
com assuntos regulamentares, monitorização e de gestão de estudos clínicos.
Esta experiência possibilitou a aplicação e consolidação dos conteúdos
adquiridos durante a formação académica e o desenvolvimento de diversas
competências a nível pessoal e profissional
ABSTRACT: The monitoring of clinical studies aims to ensure the protection of the rights and well-being of human subjects and to guarantee the quality and integrity of the data collected in the context of clinical studies. In the past years, there has been a change in the paradigm in relation to the monitoring activity, which has ceased to be an activity carried out only on-site and started to include central monitoring and remote monitoring activities. An internship was carried out in the area of monitoring clinical studies at the company Keypoint - Consultoria Científica where several activities were carried out in the scope of observational studies and clinical trials, related to regulatory affairs, monitoring, and management of clinical studies. This experience enabled the application and consolidation of the content acquired at the academic level and the development of several skills at a personal and professional level
ABSTRACT: The monitoring of clinical studies aims to ensure the protection of the rights and well-being of human subjects and to guarantee the quality and integrity of the data collected in the context of clinical studies. In the past years, there has been a change in the paradigm in relation to the monitoring activity, which has ceased to be an activity carried out only on-site and started to include central monitoring and remote monitoring activities. An internship was carried out in the area of monitoring clinical studies at the company Keypoint - Consultoria Científica where several activities were carried out in the scope of observational studies and clinical trials, related to regulatory affairs, monitoring, and management of clinical studies. This experience enabled the application and consolidation of the content acquired at the academic level and the development of several skills at a personal and professional level
Descrição
Palavras-chave
Gestão de casos clínicos Management of clinical studies