Banca de DEFESA: THAYS DE ANDRADE MORAIS

Uma banca de DEFESA de MESTRADO foi cadastrada pelo programa.
STUDENT : THAYS DE ANDRADE MORAIS
DATE: 20/09/2024
TIME: 09:00
LOCAL: Plataforma Virtual Microsoft Teams
TITLE:

Bioethics and Scientific Integrity in the Evaluation of Clinical Research Data Quality

KEY WORDS:

Bioethics, Data Accuracy, Scientific Integrity, Clinical Protocols, Investigators.

PAGES: 100
BIG AREA: Outra
AREA: Defesa
SUMMARY:

Introduction: Clinical research plays a crucial role in the advancement of new technologies and health treatments. Scientific integrity and bioethics are fundamental in the development of clinical protocols, ensuring data reliability, participant safety, and ethical conduct. Regulatory agencies establish standards and oversee clinical studies to guarantee compliance and transparency : The main objective of this study was to analyze regulatory practices, scientific integrity, and ethical conduct in clinical studies. Methodology: This dissertation comprises a scoping review titled: "Evaluation of the Quality of Clinical Research Data: A Scoping Review Focused on Bioethics and Research Integrity." Results: The results will be presented through a study conducted during the master's program. The findings of this article demonstrated an increase in publications on ethics and integrity in science, especially in 2020. The studies were primarily conducted in the USA and included various countries and types of research, reflecting a growing global concern with these topics. Conclusions: The integrity of clinical studies is ensured by ethical and scientific regulations established by the National Research Ethics Commission and other regulatory agencies, aimed at protecting participants and ensuring data reliability. Tools such as the ALCOA principle are fundamental for maintaining data integrity. Collaboration among regulatory agencies, sponsors, researchers, and their teams is essential for the success of clinical studies, with an emphasis on participant safety and the advancement of medical science.

COMMITTEE MEMBERS:
Externa à Instituição - CHRISTIANE SANTIAGO MAIA - ANVISA
Presidente - 404501 - DIRCE BELLEZI GUILHEM
Interna - ***.616.438-** - MARIA RITA CARVALHO GARBI NOVAES - UnB
Externo à Instituição - RICARDO ECCARD DA SILVA - ANVISA