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Revista Cubana de Farmacia

Print version ISSN 0034-7515


GONZALEZ HERNANDEZ, Zoe; ALVAREZ GUERRA, Sandra  and  RIQUELME ABREU, Ibis. Internal auditing and the quality of clinical trial documentation in Cuba. Rev Cubana Farm [online]. 2013, vol.47, n.3, pp.348-352. ISSN 0034-7515.

Introduction: the National Coordinating Center for Clinical Trials guarantees the quality of the documentation issued in clinical trials with the use of tools such as auditing. It detects and/or prevents difficulties, thus assuring decision-making to eliminate deficiencies and to fulfil the requirements of national and international regulations. Objective: to show the major "nonconformities" or deficiencies identified in audits of clinical trial documentation. Methods: an analysis of 29 audits of clinical trial documentation from 2007 to 2011. The "nonconformities" of the three sections that comprise the report were considered: review of the completion of each chapter, review of the quality of the filed documentation and chronological data arrangement. Results: the main weaknesses were found in the documentary completion of chapters in the clinical trial folder in addition to outdated or incomplete data and wrongly filed documents. Conclusions: there are still deficiencies in the documentation generated during the clinical trial, and consequently, there is non-compliance of the requirements of the Guidelines on Good Clinical Practices in Cuba issued by the Center for the State Control of Drugs (CECMED) and related to the trial protocol.

Keywords : clinical trials; audits; documentation; nonconformity.

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