Gestão dos processos inerentes à implementação e condução de estudos clínicos

Abstract

Under the scope of the Master's Degree in Biomedical Engineering of the Faculty of Biotechnology of the Universidade Católica Portuguesa, this report aims to detail the activities developed during the curricular internship as Clinical Trial Assistant, at BlueClinical Phase I, as well as Clinical Research Coordinator at BlueClinical CRP, particularly in partnership with the Unidade Local de Saúde de Matosinhos, E.P.E. With a duration of six months – February 2023 to July 2023 –, the curricular internship main goal was to acquire knowledge and skills for the execution of functions related to the activity of trial assistance and clinical coordination, in a real work environment, but also to develop soft skills, such as communication, organization, and critical thinking, focusing on the management and conduct of clinical studies – initially Phase I clinical trials and, subsequently, observational studies and Phase II, III, and IV clinical trials. This document contains the characterization of the partner institutions, a theoretical contextualization related to clinical research, with special focus on clinical trials, followed by the different tasks performed throughout the internship and a conclusion about the work developed. During the curricular internship, besides increasing my understanding of the processes related to clinical research and achieving autonomy in all the functions assigned to me, I felt a significant improvement in my personal skills, mainly in task and time organization and communication skills, therefore the overall assessment of the experience was positive.

Date of Award	17 Oct 2023
Original language	Portuguese
Awarding Institution	Universidade Católica Portuguesa
Supervisor	Maria Pia Almeida Garrett Soares da Silva (Supervisor) & Ana Filipa Teixeira da Silva (Co-Supervisor)