Fialho, Helena Sofia Canento
Estágio de monitorização de estudos na Keypoint, group evidenze / Helena Sofia Canento Fialho ; orient. Bruno Miguel Rodrigues das Neves
Estágio de monitorização de estudos na Keypoint, group evidenze / Helena Sofia Canento Fialho ; orient. Bruno Miguel Rodrigues das Neves . - Lisboa : NOVA Medical School, 2022 . - 73 p. . -
This document is divided into two chapters. Chapter I covers the topic selected for the literature review. This chapter explores the stakeholders in the context of clinical research. It highlights the role of the monitor during the conduction of a clinical trial and the relationship that the monitor establishes with the research teams at the study sites. It also assesses the importance for monitors of developing soft skills that enable them to optimise their ability to build and maintain productive relationships with research teams. Chapter II contains a description of the experience developed during the internship conducted at Keypoint - group Evidenze. During the internship, different activities were conducted, with a special focus on the monitoring of clinical studies. Additionally, the internship covered activities and tasks around regulatory affairs, study dossier management, pharmacovigilance, medical writing, and project management. This report and the internship made possible the consolidation and development of professional and personal skills, essential for teamwork and for the implementation and conduction of a clinical study. Clinical Research
Clinical Study Monitoring
Academic Dissertation
Portugal
Estágio de monitorização de estudos na Keypoint, group evidenze / Helena Sofia Canento Fialho ; orient. Bruno Miguel Rodrigues das Neves . - Lisboa : NOVA Medical School, 2022 . - 73 p. . -
This document is divided into two chapters. Chapter I covers the topic selected for the literature review. This chapter explores the stakeholders in the context of clinical research. It highlights the role of the monitor during the conduction of a clinical trial and the relationship that the monitor establishes with the research teams at the study sites. It also assesses the importance for monitors of developing soft skills that enable them to optimise their ability to build and maintain productive relationships with research teams. Chapter II contains a description of the experience developed during the internship conducted at Keypoint - group Evidenze. During the internship, different activities were conducted, with a special focus on the monitoring of clinical studies. Additionally, the internship covered activities and tasks around regulatory affairs, study dossier management, pharmacovigilance, medical writing, and project management. This report and the internship made possible the consolidation and development of professional and personal skills, essential for teamwork and for the implementation and conduction of a clinical study. Clinical Research
Clinical Study Monitoring
Academic Dissertation
Portugal
