Assessment of good clinical practice in the development of clinical trials, March 2015 to March 2018

Abstract

The guides to good clinical practices define a series of guidelines through which they can be designed, implemented, finalized, analysed and reported, as well as ensuring confidentiality. Its compliance publicly ensures the protection of the rights, safety and welfare of the people who participate in accordance with the Helsinki principles, as well as the credibility of the data obtained. A retrospective descriptive study of the documentation generated during the conduction of the clinical trials that were in execution in the period from March 2015 to March 2018, Hospital Celia Sánchez Manduley, with the objective of assessing the compliance with the standards of good clinical practices in the development and execution of clinical trials. The certification or accreditation, of established quality controls or external assistance or other validation of the laboratory, represented 5.8 % of non-compliance with the required documentation. The documentation required for the development of clinical trials showed that 88.4 % and poor participation of the members of the ethics committee in the workshops were trained in good clinical practices. We ensure compliance with good clinical practices by 100 % in 2018. We conclude that the role of good clinical practice was fulfilled, helps to ensure the protection of research participants and the quality and integrity of the data that is collected. They got.