Internship in clinical data management at a clinical research organization

Detalhes bibliográficos
Autor(a) principal: Farrica, Anabela de Jesus Prates
Data de Publicação: 2015
Tipo de documento: Dissertação
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10773/15136
Resumo: The aim of this report is to describe the training activities carried out at the Data Management Sub-Unit of Eurotrials, Scientific Consultants, as part of the 2nd year of the Master’s Program in Pharmaceutical Medicine. This internship was focused on the development of skills and on gaining experience in Clinical Data Management activities. Over the course of this internship, I had the opportunity to build upon the knowledge obtained in the Bachelor’s Degree in Biomedical Sciences and in the Master’s Program in Pharmaceutical Medicine. Concepts, requirements and practices related to Clinical Data Management were explored and strengthened throghout. Furthermore, an unique perspective on the lifecycle of clinical research projects was obtained – that of a CRO. Besides the acquisition of theoretical knowledge, this training period was paramount for the development of a number of social and personal skills that contributed for my profissional growth within the host institution. This document begins by a description of the theoretical principles that set the ground for the Clinical Data Manager’s work. Then, the generic and specific training elements of the curricular training are detailed. After presenting my training activities, I discuss the various challenges I had to overcome during these 9 months. Finally, some personal remarks and conclusions are presented.
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spelling Internship in clinical data management at a clinical research organizationBiomedicina farmacêuticaInvestigação médicaEnsaios clínicos - Processamento de dadosThe aim of this report is to describe the training activities carried out at the Data Management Sub-Unit of Eurotrials, Scientific Consultants, as part of the 2nd year of the Master’s Program in Pharmaceutical Medicine. This internship was focused on the development of skills and on gaining experience in Clinical Data Management activities. Over the course of this internship, I had the opportunity to build upon the knowledge obtained in the Bachelor’s Degree in Biomedical Sciences and in the Master’s Program in Pharmaceutical Medicine. Concepts, requirements and practices related to Clinical Data Management were explored and strengthened throghout. Furthermore, an unique perspective on the lifecycle of clinical research projects was obtained – that of a CRO. Besides the acquisition of theoretical knowledge, this training period was paramount for the development of a number of social and personal skills that contributed for my profissional growth within the host institution. This document begins by a description of the theoretical principles that set the ground for the Clinical Data Manager’s work. Then, the generic and specific training elements of the curricular training are detailed. After presenting my training activities, I discuss the various challenges I had to overcome during these 9 months. Finally, some personal remarks and conclusions are presented.Este relatório tem como objetivo descrever as atividades de estágio realizadas na Unidade de Gestão de Dados da Eurotrials, Consultores Científicos, como parte do 2º ano do Mestrado em Biomedicina Farmacêutica. Este estágio focou-se no desenvolvimento de competências e obtenção de experiência em atividades de Gestão de Dados Clínicos. No decurso do estágio tive oportunidade de complementar o conhecimento obtido na Licenciatura em Ciências Biomédicas e no Mestrado em Biomedicina Farmacêutica. Foram aprofundados e explorados os conceitos, requisitos e práticas inerentes à Gestão de Dados Clínicos e obteve-se uma visão única do ciclo de vida de um projeto de investigação clínica – a de uma CRO. Para além da aquisição de conhecimentos teóricos, este período de estágio foi fundamental para o desenvolvimento de um conjunto de aptidões sociais e pessoais que contribuíram para o meu crescimento profissional dentro da instituição de acolhimento. O presente documento começa por expôr os príncipios teóricos que servem de base à atividade do Gestor de Dados Clínicos. Seguidamente, são detalhados os componentes genéricos e específicos de treino adquiridos durante o período de estágio. Depois da apresentação das atividades de estágio, são discutidos os vários desafios enfrentados e é feito um balanço pessoal desta experiência.Universidade de Aveiro2016-02-03T12:23:12Z2015-01-01T00:00:00Z2015info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisapplication/pdfhttp://hdl.handle.net/10773/15136TID:201565129engFarrica, Anabela de Jesus Pratesinfo: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:RCAAP2024-02-22T11:27:57Zoai:ria.ua.pt:10773/15136Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T02:50:34.536475Repositório 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 Internship in clinical data management at a clinical research organization
title Internship in clinical data management at a clinical research organization
spellingShingle Internship in clinical data management at a clinical research organization
Farrica, Anabela de Jesus Prates
Biomedicina farmacêutica
Investigação médica
Ensaios clínicos - Processamento de dados
title_short Internship in clinical data management at a clinical research organization
title_full Internship in clinical data management at a clinical research organization
title_fullStr Internship in clinical data management at a clinical research organization
title_full_unstemmed Internship in clinical data management at a clinical research organization
title_sort Internship in clinical data management at a clinical research organization
author Farrica, Anabela de Jesus Prates
author_facet Farrica, Anabela de Jesus Prates
author_role author
dc.contributor.author.fl_str_mv Farrica, Anabela de Jesus Prates
dc.subject.por.fl_str_mv Biomedicina farmacêutica
Investigação médica
Ensaios clínicos - Processamento de dados
topic Biomedicina farmacêutica
Investigação médica
Ensaios clínicos - Processamento de dados
description The aim of this report is to describe the training activities carried out at the Data Management Sub-Unit of Eurotrials, Scientific Consultants, as part of the 2nd year of the Master’s Program in Pharmaceutical Medicine. This internship was focused on the development of skills and on gaining experience in Clinical Data Management activities. Over the course of this internship, I had the opportunity to build upon the knowledge obtained in the Bachelor’s Degree in Biomedical Sciences and in the Master’s Program in Pharmaceutical Medicine. Concepts, requirements and practices related to Clinical Data Management were explored and strengthened throghout. Furthermore, an unique perspective on the lifecycle of clinical research projects was obtained – that of a CRO. Besides the acquisition of theoretical knowledge, this training period was paramount for the development of a number of social and personal skills that contributed for my profissional growth within the host institution. This document begins by a description of the theoretical principles that set the ground for the Clinical Data Manager’s work. Then, the generic and specific training elements of the curricular training are detailed. After presenting my training activities, I discuss the various challenges I had to overcome during these 9 months. Finally, some personal remarks and conclusions are presented.
publishDate 2015
dc.date.none.fl_str_mv 2015-01-01T00:00:00Z
2015
2016-02-03T12:23:12Z
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dc.publisher.none.fl_str_mv Universidade de Aveiro
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