Abstract

SAUMELL-NAPOLES, Yaimarelis; BATISTA ROMAGOSA, Maritza  and  TORRES GEMEIL, Olga. Modification to knowledge and professionals performance on the management of product security in clinical trials. MEDISAN [online]. 2015, vol.19, n.6, pp.738-746. ISSN 1029-3019.

An educational intervention was carried out in 19 professionals, belonging to 2 polyclinics from Santiago de Cuba who participated in carrying out clinical trials with products of the Molecular Immunology Center, from September, 2013 to the same month of 2014, with the aim of evaluating the level of their knowledge and performance on the management of the product security, from a training on the topic. Before and after the training a survey of knowledge was applied, and an indicator for each identified pèrformance variable was measured. Standards were stablished for each indicator keeping in mind their relevance and the effective regulating requirements. McNemar test was used to evaluate the significance of changes. A satisfactory modification of the knowledge was obtained (84.2%) and the performance indicators improved in more than 30%, but they didn't reach the proposed standard

Keywords : security management; investigation product; performance indicators; educational intervention; primary health care.

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