Abstract

ALVAREZ GUERRA, Sandra. Harmonization of quality standards for clinical trials. ISO-9001 standard and Guide of Good Clinical Practice. Rev Cubana Farm [online]. 2011, vol.45, n.3, pp.380-388. ISSN 0034-7515.

A clinical trial is an extensive, complex and necessary process to authorize the use of new medications in humans. For the purpose of assuring the quality and the standardization of this process, the International Conference of Harmonization (ICH) set the Guideline E6 for Good Clinical Practice, which has been adopted and adapted by the national regulatory agencies. There also exists another standard to guarantee quality in the organizations, namely the ISO 9001:2008 that establishes requirements for Quality Management System. The objective of this paper was to determine common elements showing the harmonization among the Good Clinical Practice of the ICH, the Cuban one and the ISO 9001:2008 in order that they can be implemented in the clinical trials. To this end, one study was performed on the Good Clinical Practice of the ICH, the Cuban and the ISO 9001:2008 standards to find out what they had in common in their use for the clinical trials. It was determined that the clients, the suppliers, the process approach, the documentation, the management, the reviews, the style of conducting the research studies and the quality improvement were common aspects for which there are several requirements set by these standards. The aforementioned allowed stating that the joint use of the studied standards in the clinical trial contributes to raise the quality, since there is not a single aspect that reveals any contradiction whatsoever; there are common aspects that make their harmonization and use possible.

Keywords : harmonization; Clinical Trials; Good Clinical Practice; ISO.

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