Estágio de monitorização de estudos na Keypoint, group evidenze / Helena Sofia Canento Fialho ; orient. Bruno Miguel Rodrigues das Neves
Main Author Fialho, Helena Sofia Canento Secondary Author Neves, Bruno Miguel Rodrigues das Language Português. Country Portugal. Publication Lisboa : NOVA Medical School, 2022 Description 73 p. Abstract 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. Topical name Clinical ResearchClinical Study Monitoring
Academic Dissertation
Portugal Index terms Dissertação de Mestrado
Gestão em Investigação Clínica
NOVA Medical School
Universidade NOVA de Lisboa
2022
| Item type | Current location | Call number | url | Status | Date due | Barcode |
|---|---|---|---|---|---|---|
| Documento Eletrónico | Biblioteca NMS|FCM online | RUN | http://hdl.handle.net/10362/146125 | Available | 20220189 |
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.
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