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

• Autor(a) principal: Oliveira, João Tiago Pereira de
• 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/10773/39293
• topic: Clinical research; Clinical studies; BlueClinical; Clinical data programming; Data standardization; TFLs

The following report describes the activities performed during the internship in clinical data programming developed at BlueClinical, Ltd, with a major focus on the methodologies and regulatory issues related to the Tables, Figures and Listings (TFLs) that will be represented in the Clinical Study Report (CSR), in the scope of the Master in Clinical Bioinformatics. The report begins with a description of the company and the specific activities of a clinical data developer. It then covers fundamental aspects of Clinical Research, with emphasis on its situation in Portugal and the regulatory environment it finds itself in, as well as documents associated with clinical studies to be considered in TFLs. This report also briefly elaborates on data standardization, specifically mentioning the Study Data Tabulation Model (SDTM) and Analysis Dataset Model (ADaM), and some relevant examples of each. Finally, TFLs are explained, and examples of the processes of creating a specific Table and a specific Figure are addressed. These referred activities allowed the acquisition of practical knowledge in clinical data programming.