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Orientador(es)
Resumo(s)
RESUMO: No âmbito da conclusão do Mestrado em Gestão da Investigação Clínica,
optou-se pela realização de um estágio, de forma a se poder consolidar e colocar
também em prática os conhecimentos adquiridos ao longo do Mestrado.
Este estágio decorreu ao abrigo da NOVA CRU, a unidade de ensaios
clínicos da Universidade NOVA de Lisboa. No entanto, o estágio decorreu no
Centro Hospitalar de Lisboa Ocidental, E.P.E., uma vez que este teve em foco as
atividades de coordenação de estudos clínicos.
Serve então o presente relatório para descrever as atividades realizadas ao
longo do estágio e desenvolver sumariamente um tema relacionado com a
investigação clínica. Assim, o corpo do relatório encontra-se dividido em dois
capítulos. O primeiro capítulo abrange, desde uma contextualização sobre as
instituições de acolhimento e o trabalho desenvolvido pelas mesmas, até à
descrição das atividades realizadas durante o estágio, sendo aqui feita uma
abordagem dividida pelas diferentes vertentes da investigação clínica. O segundo
capítulo foca-se no enquadramento teórico sobre unidades de ensaios clínicos de
fases I e II e a sua importância, e os aspetos necessários para a implementação
deste tipo de ensaios em unidades hospitalares portuguesas.
Por fim, é feito um balanço global sobre o estágio e são indicados alguns
aspetos a implementar, relacionados com o tema abordado no segundo capítulo,
tendo em conta a experiência no Centro Hospitalar de Lisboa Ocidental.
ABSTRACT: In order to complete the Management of Clinical Research Master, an internship was chosen, in order to reinforce and practice the knowledge gained during the Master. This internship was done in NOVA CRU, the clinical trial unit of Universidade NOVA de Lisboa. However, the internship took place at Centro Hospitalar de Lisboa Ocidental, E.P.E., since it was focused on clinical research coordination activities. This report describes the internship activities and a briefly review about a topic related with clinical research. The report’s body is divided into two chapters. The first one covers, since the contextualization about the host institutions and the work developed by them, to the description of the activities carried out during the internship, where an approach is made divided by the different strands of clinical research. The second chapter is focused on the theoretical framework about phase I and II clinical trials units and its importance, and the necessary aspects to implement this type of trials at portuguese hospital units. Lastly, it’s made a global assessment of the internship and are pointed some aspects to implement, related with the topic approached in the second chapter, based on the experience at Centro Hospitalar de Lisboa Ocidental.
ABSTRACT: In order to complete the Management of Clinical Research Master, an internship was chosen, in order to reinforce and practice the knowledge gained during the Master. This internship was done in NOVA CRU, the clinical trial unit of Universidade NOVA de Lisboa. However, the internship took place at Centro Hospitalar de Lisboa Ocidental, E.P.E., since it was focused on clinical research coordination activities. This report describes the internship activities and a briefly review about a topic related with clinical research. The report’s body is divided into two chapters. The first one covers, since the contextualization about the host institutions and the work developed by them, to the description of the activities carried out during the internship, where an approach is made divided by the different strands of clinical research. The second chapter is focused on the theoretical framework about phase I and II clinical trials units and its importance, and the necessary aspects to implement this type of trials at portuguese hospital units. Lastly, it’s made a global assessment of the internship and are pointed some aspects to implement, related with the topic approached in the second chapter, based on the experience at Centro Hospitalar de Lisboa Ocidental.
Descrição
Palavras-chave
Investigação Clínica Ensaios Clínicos Hospitais Clinical Research Clinical Trials Hospitals
