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- Title
INDICADORES DE QUALIDADE NA CONDUÇÃO DE ESTUDOS CLÍNICOS.
- Authors
Artifon, Milena; Scopel Guerra, Adriele; Jorge Gonçalves, Fabio Costa; Leal Zimmer, Rafael; Alves Vieira, Taiane; Lorentz de Oliveira-Freitas, Vera
- Abstract
Introduction: The generation, analysis and dissemination of relevant indicators is a fundamental strategy in the quality management process. Indicators are measurements that directly or indirectly evaluate the processes and outcomes of the care provided to research participants. Rigorous quality standards will guarantee the validity of the data obtained in clinical studies. Methods: This descriptive, analytical cross-sectional study collected data at the Clinical Research Center of a University Hospital, covering the period from November 2016 to February 2019, regarding the time of data inclusion in the electronic case report form (IID), communication of protocol deviations to the Research Ethics Committee (ICD), response time to received feasibilities (IRF) and response time to monitoring pending issues (IRP). Results: Substantial variations were found between quality scores in a period of 27 months. The overall performance of the Research Project Office team was excellent or satisfactory in 61.40% of the observations (50.87% and 10.52% respectively). Among critical observations (38.59%), 17.54% were expressed by IRP, 12.28% by ICD and 7% by IID, indicating those that did not reach the proposed target. Conclusions: The Research Project Office has listed two quality indicators, IID and IRP, which can improve the time and effectiveness of team deliveries.
- Subjects
UNIVERSITY of Colorado Hospital; REACTION time; HUMAN research subjects; RESEARCH institutes; RESEARCH &; development projects; RESEARCH ethics
- Publication
Clinical & Biomedical Research, 2019, Vol 39, Issue 4, p346
- ISSN
2357-9730
- Publication type
Article
- DOI
10.22491/2357-9730.97240