Programming clinical data datasets for regulatory submission of phase I clinical trials

Detalhes bibliográficos
Autor(a) principal: Hanchar, Vlada
Data de Publicação: 2023
Tipo de documento: Dissertação
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10773/39366
Resumo: This report provides an overview of the experiences and insights gained during my internship as a clinical data programmer trainee at Blueclinical. This internship is within the scope of the master’s degree in Clinical Bioinformatics: Clinical Decision Support, in the University of Aveiro. It examines the company's organizational structure and functions, as well as the specific role of the Data Programming department within the company's broader mission. Furthermore, the state of the art of data standardisation is thoroughly reviewed, with a focus on regulatory requirements. Additionally, it highlights the key projects and tasks that I have developed during the time spent at Blueclinical, namely trial randomization, dataset generation and data manipulation for reporting. Understanding the regulatory requirements for good clinical practice, the importance of data standardization, and exploring algorithms in programming translated into the acquisition of necessary skills that respond to the demands of the current working industry of clinical trials.
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spelling Programming clinical data datasets for regulatory submission of phase I clinical trialsClinical dataRegulatory submissionRandomizationCDISCSDTMADaMBlueClinicalPhase IClinical trialsData standardizationThis report provides an overview of the experiences and insights gained during my internship as a clinical data programmer trainee at Blueclinical. This internship is within the scope of the master’s degree in Clinical Bioinformatics: Clinical Decision Support, in the University of Aveiro. It examines the company's organizational structure and functions, as well as the specific role of the Data Programming department within the company's broader mission. Furthermore, the state of the art of data standardisation is thoroughly reviewed, with a focus on regulatory requirements. Additionally, it highlights the key projects and tasks that I have developed during the time spent at Blueclinical, namely trial randomization, dataset generation and data manipulation for reporting. Understanding the regulatory requirements for good clinical practice, the importance of data standardization, and exploring algorithms in programming translated into the acquisition of necessary skills that respond to the demands of the current working industry of clinical trials.Este relatório fornece uma visão geral da experiência adquirida durante o estágio curricular na BlueClinical, como programadora de dados clínicos. Este estágio decorreu no âmbito do mestrado em Bioinformática Clínica: ramo de Apoio à Decisão Clínica, na Universidade de Aveiro. Descreve a estrutura organizacional da empresa e o papel específico do departamento de Programação de Dados Clínicos, bem como o seu enquadramento na missão geral da empresa. Além disso, o estado de arte da standardização dos dados é analisado, com foco nos requisitos regulamentares. Adicionalmente, este relatório detalha as atividades específicas realizadas ao longo do meu estágio na BlueClinical, nomeadamente a randomização dos ensaios, a criação de datasets e a manipulação dos dados para apresentação em relatórios. A compreensão dos requisitos regulatórios para as boas práticas clínicas, da importância da standardização dos dados e dos algoritmos de programação, permitiu a aquisição de habilidades necessárias que respondem as demandas do atual panorama de ensaios clínicos a nível mundial.2023-09-12T09:38:33Z2023-07-07T00:00:00Z2023-07-07info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisapplication/pdfhttp://hdl.handle.net/10773/39366engHanchar, Vladainfo: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:RCAAP2024-02-22T12:16:53Zoai:ria.ua.pt:10773/39366Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:09:33.869028Repositório 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 Programming clinical data datasets for regulatory submission of phase I clinical trials
title Programming clinical data datasets for regulatory submission of phase I clinical trials
spellingShingle Programming clinical data datasets for regulatory submission of phase I clinical trials
Hanchar, Vlada
Clinical data
Regulatory submission
Randomization
CDISC
SDTM
ADaM
BlueClinical
Phase I
Clinical trials
Data standardization
title_short Programming clinical data datasets for regulatory submission of phase I clinical trials
title_full Programming clinical data datasets for regulatory submission of phase I clinical trials
title_fullStr Programming clinical data datasets for regulatory submission of phase I clinical trials
title_full_unstemmed Programming clinical data datasets for regulatory submission of phase I clinical trials
title_sort Programming clinical data datasets for regulatory submission of phase I clinical trials
author Hanchar, Vlada
author_facet Hanchar, Vlada
author_role author
dc.contributor.author.fl_str_mv Hanchar, Vlada
dc.subject.por.fl_str_mv Clinical data
Regulatory submission
Randomization
CDISC
SDTM
ADaM
BlueClinical
Phase I
Clinical trials
Data standardization
topic Clinical data
Regulatory submission
Randomization
CDISC
SDTM
ADaM
BlueClinical
Phase I
Clinical trials
Data standardization
description This report provides an overview of the experiences and insights gained during my internship as a clinical data programmer trainee at Blueclinical. This internship is within the scope of the master’s degree in Clinical Bioinformatics: Clinical Decision Support, in the University of Aveiro. It examines the company's organizational structure and functions, as well as the specific role of the Data Programming department within the company's broader mission. Furthermore, the state of the art of data standardisation is thoroughly reviewed, with a focus on regulatory requirements. Additionally, it highlights the key projects and tasks that I have developed during the time spent at Blueclinical, namely trial randomization, dataset generation and data manipulation for reporting. Understanding the regulatory requirements for good clinical practice, the importance of data standardization, and exploring algorithms in programming translated into the acquisition of necessary skills that respond to the demands of the current working industry of clinical trials.
publishDate 2023
dc.date.none.fl_str_mv 2023-09-12T09:38:33Z
2023-07-07T00:00:00Z
2023-07-07
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/10773/39366
url http://hdl.handle.net/10773/39366
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
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instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
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collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
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