Start-up, monitorização e coordenação de estudos

• Autor(a) principal: Lemos, Beatriz Urbano
• Data de Publicação: 2022
• Tipo de documento: Dissertação
• Idioma: por
• Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
• Texto Completo: http://hdl.handle.net/10362/146433
• topic: Clinical Research; Clinical studies; Data quality; Clinical research coordination; Study start-up; Clinical Research Monitoring; Research Support Unit; Academic CRO; Domínio/Área Científica::Ciências Médicas

This report was written within the scope of the internship carried out in the second year of the Master's Degree in Clinical Research Management, aimed at obtaining a master's degree of the course mentioned. The report focusses on the description and report of the activities performed during the internship in Coordination, Start-up and Monitoring of clinical studies at the departments of Associação para Investigação e Desenvolvimento da Faculdade de Medicina, Gabinete de Apoio à Investigação Cardiovascular and AIDFM-CETERA. This is followed by a reflection of the main challenges and experiences lived during the internship, as well as the main competencies acquired. This report begins with a brief overview of Clinical Research and the role of two of its key players, the study coordinator and the study monitor. In addition, it is presented a literature review regarding data quality in clinical research, comparing the impact of Source Data Verification and emerging strategies for clinical studies monitoring, such as Risk Based Monitoring, in ensuring dataquality and reliability. The internship was an opportunity to contact with a real work context and to understand how Clinical Research is developed in a dual perspective of aResearch Support Unit in a hospital centre and an academic Clinical Research Organization. The knowledge and experience developed from the internship was a great start to a career in Clinical Research.