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O presente relatório descreve a experiência de estágio curricular na área de coordenação de estudos clínicos no Hospital CUF Tejo. O estágio teve como principal objetivo proporcionar uma compreensão abrangente das práticas e procedimentos envolvidos na implementação de estudos clínicos. Ao longo do estágio, foi possível ter contacto com uma grande diversidade de atividades relacionadas com a coordenação de estudos clínicos. Algumas destas atividades incluíram a preparação e acompanhamento das visitas dos participantes, processamento e envio de amostras biológicas para os laboratórios centrais, a gestão do dossiê do investigador, o reporte de eventos adversos e a garantia de que os estudos são conduzidos conformidade os protocolos de investigação e os requisitos ético-regulamentares em vigor. Uma parte significativa deste relatório é dedicada à revisão de literatura acerca do envolvimento do doente na Investigação Clínica. A revisão abrangeu estudos e artigos científicos que exploram diferentes aspetos do envolvimento do doente, incluindo na definição das prioridades de investigação, desenho e planeamento, condução da investigação e disseminação e comunicação de resultados. Os conhecimentos e competências adquiridos durante o estágio foram amplos e abrangentes, envolvendo competências práticas na gestão de estudos clínicos e uma compreensão aprofundada dos principais desafios para contribuir para uma experiência centrada no doente para os participantes dos estudos. As contribuições deste trabalho para o Hospital CUF Tejo incluíram: i) a colaboração na resolução de questões operacionais do dia-a-dia e ii) a otimização de circuitos internos. O estágio em coordenação de estudos clínicos no Hospital CUF Tejo foi uma experiência altamente enriquecedora. Os conhecimentos adquiridos ao longo do estágio e através da revisão de literatura realizada destacaram a importância de uma abordagem de envolvimento do doente para o desenvolvimento de terapias mais eficazes, seguras e centradas no doente. As competências desenvolvidas nesta etapa contribuirão seguramente para a futura trajetória profissional na área da Investigação Clínica.
This report describes the experience of a curricular internship in study coordination at CUF Tejo Hospital. The main objective of the internship was to provide a comprehensive understanding of the practices and procedures involved in the implementation of clinical studies Throughout the internship, it was developed a variety of activities related to the coordination of clinical studies. These activities included supporting the recruitment of participants, managing regulatory documentation, preparing and monitoring the visits of participants, and ensuring compliance with existing research protocols and ethical-regulatory requirements. A significant part of this report is dedicated to the literature review on patient involvement in Clinical Research. The review covered studies and scientific articles exploring different aspects of patient involvement, including in defining research priorities, research design and planning, research conduct and operations, and dissemination and communication. The knowledge and skills acquired during the internship were broad and comprehensive, involving practical competencies in clinical studies management and an in-depth understanding of the key challenges to ensuring a patient-centric experience for the study participants. The student’s contributions to the CUF Tejo Hospital included assistance in the preparation of essential documents for the implementation of the study, collaboration in the resolution of operational day-to-day issues and the optimization of internal circuits. The internship in study coordination at the CUF Tejo Hospital was a highly enriching experience. The knowledge acquired during the internship and through the literature review highlighted the importance of a patient-centred approach to the development of more effective, safe and patient-centred therapies. Thus, the skills developed at this stage will surely contribute to the future career of the student in the field of Clinical Research.
This report describes the experience of a curricular internship in study coordination at CUF Tejo Hospital. The main objective of the internship was to provide a comprehensive understanding of the practices and procedures involved in the implementation of clinical studies Throughout the internship, it was developed a variety of activities related to the coordination of clinical studies. These activities included supporting the recruitment of participants, managing regulatory documentation, preparing and monitoring the visits of participants, and ensuring compliance with existing research protocols and ethical-regulatory requirements. A significant part of this report is dedicated to the literature review on patient involvement in Clinical Research. The review covered studies and scientific articles exploring different aspects of patient involvement, including in defining research priorities, research design and planning, research conduct and operations, and dissemination and communication. The knowledge and skills acquired during the internship were broad and comprehensive, involving practical competencies in clinical studies management and an in-depth understanding of the key challenges to ensuring a patient-centric experience for the study participants. The student’s contributions to the CUF Tejo Hospital included assistance in the preparation of essential documents for the implementation of the study, collaboration in the resolution of operational day-to-day issues and the optimization of internal circuits. The internship in study coordination at the CUF Tejo Hospital was a highly enriching experience. The knowledge acquired during the internship and through the literature review highlighted the importance of a patient-centred approach to the development of more effective, safe and patient-centred therapies. Thus, the skills developed at this stage will surely contribute to the future career of the student in the field of Clinical Research.
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Clinical Research
