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Estágio de coordenação de estudos & atividades de monitorização e start-up de ensaios clínicos na AIDFM-Associação para a Investigação e Desenvolvimento da Faculdade de Medicina
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Resumo(s)
In the scope of obtaining the master's degree in Clinical Research Management, a curricular internship was completed to consolidate and apply the theoretical knowledge
acquired during the study cycle.
Over one academic year and under the guidance of Doctor Inês Zimbarra Cabrita
and Doctor Rita Torrão, were performed activities in coordination of clinical studies in the
Cardiovascular Research Support Unit and start-up and monitoring activities,
accomplished in the Contract Research Organization, AIDFM-CETERA.
This report is organised into 2 major sections, the first of which presents an
overview of clinical research, including a framework for the roles of a Study Coordinator
and a Clinical Trial Monitor. Secondly, the topic of "Investigator-initiated Studies" is
reviewed, exploring some of the key aspects related with them, including the impact of
their conduct on clinical practice, funding sources and strategies and several initiatives
that may enhance and simplify the development and conduct of studies with this profile.
The second chapter of the report, which focuses entirely on the curricular
internship, presents the objectives defined for the internship and the host institutions
mentioned above. Subsequently, are described the activities of coordination, start-up and
monitoring of clinical studies performed during this period.
Descrição
Palavras-chave
Clinical Studies coordination