2015, Number 06
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MediSan 2015; 19 (06)
Modification to knowledge and professionals performance on the management of product security in clinical trials
Saumell-Nápoles Y, Batista RM, Torres GO
Language: Spanish
References: 16
Page: 738-746
PDF size: 264.49 Kb.
ABSTRACT
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.
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