Efficacy of a course on Good Clinical Practices for researchers linked to clinical trials

Abstract

Background: the adequate training in Good Clinical Practices guarantees that the tests are conducted with the due protection of the subjects and the veracity of the obtained data.
Objective: to show the effectiveness of the implementation of a course on Good Clinical Practices for researchers linked to clinical trials.
Methods: a participatory action research was carried out by the Provincial Clinical Trials Group of Villa Clara, during 2016. Methods of the theoretical level were used: analysis-synthesis and induction-deduction; empirical: documentary review and survey in the form of a questionnaire to the trainees, and mathematical ones for the absolute and relative values.
Results: through the diagnosis it was obtained that most of the professionals had high needs of knowledge on Good Clinical Practices. Among the aspects with greater difficulties were the handling of adverse events and the responsibilities of the researchers in their different roles within the trial. A course was applied in which fundamental contents on the subject were addressed. Once completed, a final exam was carried out and it was shown that most reached high levels of knowledge.
Conclusions: the implemented course served as training on the topic for clinical trial researchers, so its effectiveness is considered to solve the deficiencies detected.