Alvarez-Lopes AT, Soares-Barbosa MC, Vasconcelos-Azevedo N, Alves-Moreira CTG, Barros I

Language: Spanish
References: 9
Page: 116-123
PDF size: 215.39 Kb.

ABSTRACT

The main proposal of the mixed practice of predictive and agile methodologies in the construction of the routine of a Clinical Research Center was to use the methodologies together with other quality tools in order to minimize the occurrence of errors or failures, called protocol deviations in clinical research, or even errors or near misses that directly or indirectly affect the patients participating in the research. In clinical research, the focus remains on the research participant, so one of the methods used as a resource for the development of this project was an Excel spreadsheet with the care and follow-up data of the participants of the aforementioned Research Center considered as the project's database. It was possible to consolidate with this proposal, the demonstration that the use of multiple quality tools combined with agile and predictive methodologies in the day to day of the sector and respecting the particularity of each clinical trial protocol, could ensure a quality management of the processes in the Research Center, helping the rapid mitigation of errors and failures and in the contribution of quality management.

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