González HZ, Álvarez GS, Riquelme AI

Language: Spanish
References: 5
Page: 348-352
PDF size: 126.81 Kb.

ABSTRACT

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:z/b> the main weaknesses were found in the documentary completion of chapters in the clinical trial folder in addition to outdated or incomplete data and wrongly filed documents.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.

REFERENCES

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2. Declaración de Helsinki de la Asociación Médica Mundial. Disponible en: http://www.conamed.gob.mx/prof_salud/pdf/helsinki.pdf

3. Grupo Experto de Trabajo de la Conferencia Internacional de Armonización. Normas de Buenas Prácticas Clínicas. Conferencia Internacional de Armonización sobre Requerimientos técnicos para el registro de productos farmacéuticos para uso en humanos. 1997. Disponible en: http://www.fda.gov/cder/guidance/959fnl-spanish.pdf

4. Centro para el Control Estatal de los Medicamentos. Directrices sobre Buenas Prácticas Clínicas en Cuba. La Habana: CECMED; 2000.

5. Aldea A. Análisis descriptivo de los hallazgos en auditorías de ensayos clínicos (2001-2007). Med Clín (Barc). 2010;134(10):462-6.