Relatório de estágio curricular numa unidade de investigação clínica
Autor(a) principal: | |
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Data de Publicação: | 2016 |
Tipo de documento: | Dissertação |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | http://hdl.handle.net/10773/16575 |
Resumo: | This report presents the activities and projects developed during the curricular internship in a clinical research unit, the Laboratory of Clinical Pharmacology, part of the Institute of Molecular Medicine. The internship had a duration of 10 months, being that the most relevant activity was the coordination of clinical trials in the area of neurology. I also collaborated in medical writing activities, namely systematic reviews on cardiology, paediatrics and clinical pharmacology. I had also the opportunity to participate in the management of clinical databases, in the monitoring and coordination of observational studies and in pharmacovigilance activities. In the State-of-the-Art section is referred the process of Research and Development of new drugs and are characterized some aspects of clinical research in Portugal, namely the framework of the activity, with a focus in Neurology. Furthermore, the current context of Pharmacovigilance in the system of drug safety evaluation, in Portugal, is presented. This training period enabled me not only to put into practice the knowledge acquired at the University, but also expanding it. During this internship, I could closely observe the logistical difficulties that a research centre faces during the conduction of clinical trials. I also increased my knowledge in clinical research while expanding my areas of professional interest. I could improve my writing skills of scientific documents, through the elaboration of several systematic reviews and meta-analysis. I also realized the importance of clinical research units as well as the crucial role of clinical trial coordinators in the rigorous implementation of all the studies’ procedures and in the communication between team members. This specific training focused on clinical studies, namely phases II and III clinical trials and observational studies in neurodegenerative diseases. I supported the coordination of four studies in Familial Amyloidotic Polyneuropathy, two in Huntington's disease, two in Parkinson's disease, one in Alzheimer's disease and one in Idiopathic Cervical Dystonia. The contact with patients was a very important part of my experience in clinical trials coordination. I consider that this internship was a very enriching experience, where I started to perform clinical research activities. Thus, I finish the internship with motivation and interest to work in the area of clinical trials coordination and project management. |
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Relatório de estágio curricular numa unidade de investigação clínicaBiomedicina farmacêuticaInvestigação médica - Relatórios de estágioEnsaios clínicos - MonitorizaçãoThis report presents the activities and projects developed during the curricular internship in a clinical research unit, the Laboratory of Clinical Pharmacology, part of the Institute of Molecular Medicine. The internship had a duration of 10 months, being that the most relevant activity was the coordination of clinical trials in the area of neurology. I also collaborated in medical writing activities, namely systematic reviews on cardiology, paediatrics and clinical pharmacology. I had also the opportunity to participate in the management of clinical databases, in the monitoring and coordination of observational studies and in pharmacovigilance activities. In the State-of-the-Art section is referred the process of Research and Development of new drugs and are characterized some aspects of clinical research in Portugal, namely the framework of the activity, with a focus in Neurology. Furthermore, the current context of Pharmacovigilance in the system of drug safety evaluation, in Portugal, is presented. This training period enabled me not only to put into practice the knowledge acquired at the University, but also expanding it. During this internship, I could closely observe the logistical difficulties that a research centre faces during the conduction of clinical trials. I also increased my knowledge in clinical research while expanding my areas of professional interest. I could improve my writing skills of scientific documents, through the elaboration of several systematic reviews and meta-analysis. I also realized the importance of clinical research units as well as the crucial role of clinical trial coordinators in the rigorous implementation of all the studies’ procedures and in the communication between team members. This specific training focused on clinical studies, namely phases II and III clinical trials and observational studies in neurodegenerative diseases. I supported the coordination of four studies in Familial Amyloidotic Polyneuropathy, two in Huntington's disease, two in Parkinson's disease, one in Alzheimer's disease and one in Idiopathic Cervical Dystonia. The contact with patients was a very important part of my experience in clinical trials coordination. I consider that this internship was a very enriching experience, where I started to perform clinical research activities. Thus, I finish the internship with motivation and interest to work in the area of clinical trials coordination and project management.Este relatório apresenta as atividades e projetos desenvolvidos durante o estágio curricular numa unidade de investigação clínica, o Laboratório de Farmacologia Clínica, parte do Instituto de Medicina Molecular. O estágio teve a duração de 10 meses, sendo que a atividade mais relevante foi a coordenação de ensaios clínicos na área de neurologia. Também colaborei em atividades de escrita científica, nomeadamente revisões sistemáticas em cardiologia, pediatria e farmacologia clínica. Tive ainda a oportunidade de participar na gestão de bases de dados clínicos, na monitorização e coordenação de estudos observacionais e em atividades de farmacovigilância. Refere-se, no estado da arte, o processo de Investigação e Desenvolvimento de novos medicamentos e são caracterizados alguns aspetos da investigação clínica em Portugal, nomeadamente o enquadramento da atividade, com enfoque na Neurologia. É ainda contextualizada a Farmacovigilância no atual sistema de avaliação da segurança dos medicamentos em Portugal. Este período de estágio possibilitou colocar em prática os conhecimentos que adquiri na Universidade, mas também expandi-los. Ao longo deste estágio, pude observar de perto dificuldades logísticas com que um centro de investigação se depara durante a condução de ensaios clínicos. Aprofundei também o conhecimento em investigação clínica, enquanto expandi as minhas áreas de interesse profissional. Pude melhorar as minhas capacidades de redação de documentos científicos, através da elaboração de várias revisões sistemáticas e meta-análises. Percebi também a importância das unidades de investigação clínica, bem como o papel fundamental dos coordenadores de ensaios clínicos na rigorosa execução de todos os procedimentos dos estudos e na comunicação entre os elementos da equipa. O treino específico centrou-se em estudos clínicos, nomeadamente ensaios clínicos de fase II e III, e estudos observacionais em doenças neurodegenerativas. Apoiei a coordenação de quatro estudos em Polineuropatia Amiloidótica Familiar, dois em doença de Huntington, dois em doença de Parkinson, um em doença de Alzheimer e um em Distonia Cervical Idiopática. O contacto com os doentes foi parte muito importante da experiência em coordenação de ensaios clínicos. Considero que este estágio curricular foi uma experiência muito enriquecedora, onde comecei a executar atividades de investigação clínica. Desta forma, termino o estágio com motivação e interesse em trabalhar na área de coordenação de ensaios clínicos e gestão de projeto.Universidade de Aveiro2016-12-20T14:43:28Z2016-01-01T00:00:00Z2016info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisapplication/pdfhttp://hdl.handle.net/10773/16575TID:201590360engRodrigues, Raquel Filipa de Oliveirainfo:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-02-22T11:30:57Zoai:ria.ua.pt:10773/16575Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T02:51:41.436114Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Relatório de estágio curricular numa unidade de investigação clínica |
title |
Relatório de estágio curricular numa unidade de investigação clínica |
spellingShingle |
Relatório de estágio curricular numa unidade de investigação clínica Rodrigues, Raquel Filipa de Oliveira Biomedicina farmacêutica Investigação médica - Relatórios de estágio Ensaios clínicos - Monitorização |
title_short |
Relatório de estágio curricular numa unidade de investigação clínica |
title_full |
Relatório de estágio curricular numa unidade de investigação clínica |
title_fullStr |
Relatório de estágio curricular numa unidade de investigação clínica |
title_full_unstemmed |
Relatório de estágio curricular numa unidade de investigação clínica |
title_sort |
Relatório de estágio curricular numa unidade de investigação clínica |
author |
Rodrigues, Raquel Filipa de Oliveira |
author_facet |
Rodrigues, Raquel Filipa de Oliveira |
author_role |
author |
dc.contributor.author.fl_str_mv |
Rodrigues, Raquel Filipa de Oliveira |
dc.subject.por.fl_str_mv |
Biomedicina farmacêutica Investigação médica - Relatórios de estágio Ensaios clínicos - Monitorização |
topic |
Biomedicina farmacêutica Investigação médica - Relatórios de estágio Ensaios clínicos - Monitorização |
description |
This report presents the activities and projects developed during the curricular internship in a clinical research unit, the Laboratory of Clinical Pharmacology, part of the Institute of Molecular Medicine. The internship had a duration of 10 months, being that the most relevant activity was the coordination of clinical trials in the area of neurology. I also collaborated in medical writing activities, namely systematic reviews on cardiology, paediatrics and clinical pharmacology. I had also the opportunity to participate in the management of clinical databases, in the monitoring and coordination of observational studies and in pharmacovigilance activities. In the State-of-the-Art section is referred the process of Research and Development of new drugs and are characterized some aspects of clinical research in Portugal, namely the framework of the activity, with a focus in Neurology. Furthermore, the current context of Pharmacovigilance in the system of drug safety evaluation, in Portugal, is presented. This training period enabled me not only to put into practice the knowledge acquired at the University, but also expanding it. During this internship, I could closely observe the logistical difficulties that a research centre faces during the conduction of clinical trials. I also increased my knowledge in clinical research while expanding my areas of professional interest. I could improve my writing skills of scientific documents, through the elaboration of several systematic reviews and meta-analysis. I also realized the importance of clinical research units as well as the crucial role of clinical trial coordinators in the rigorous implementation of all the studies’ procedures and in the communication between team members. This specific training focused on clinical studies, namely phases II and III clinical trials and observational studies in neurodegenerative diseases. I supported the coordination of four studies in Familial Amyloidotic Polyneuropathy, two in Huntington's disease, two in Parkinson's disease, one in Alzheimer's disease and one in Idiopathic Cervical Dystonia. The contact with patients was a very important part of my experience in clinical trials coordination. I consider that this internship was a very enriching experience, where I started to perform clinical research activities. Thus, I finish the internship with motivation and interest to work in the area of clinical trials coordination and project management. |
publishDate |
2016 |
dc.date.none.fl_str_mv |
2016-12-20T14:43:28Z 2016-01-01T00:00:00Z 2016 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/masterThesis |
format |
masterThesis |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10773/16575 TID:201590360 |
url |
http://hdl.handle.net/10773/16575 |
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TID:201590360 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
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openAccess |
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application/pdf |
dc.publisher.none.fl_str_mv |
Universidade de Aveiro |
publisher.none.fl_str_mv |
Universidade de Aveiro |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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RCAAP |
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RCAAP |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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