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Revista Cubana de Salud Pública

versión impresa ISSN 0864-3466

Resumen

MARANON CARDONNE, Tatiana et al. Certification of Good Clinical Practice of a clinical center. Rev Cubana Salud Pública [online]. 2014, vol.40, n.4, pp.392-402. ISSN 0864-3466.

The developed world with its increasing competitiveness imposes even greater demands in meeting the medical product registration standards and certification. According to this, it has begun the certification of the clinical centers conducting clinical trials, which gives more credibility to the results from research carried out there and therefore greater prestige and competitiveness to the product. The objective of this paper was to show the implementation of a Good Clinical Practice system in the performance of clinical trials in order to attain the Certification. A descriptive study was made in "Dr Juan Bruno Zayas Alfonso" general hospital from June 2010 and August 2011 in Santiago de Cuba province. The research consisted of three stages and included all the actions taken during the implementation. Finally, a Good Clinical Practice system was put in place that allowed the Certification of Good Clinical Practices for conduction of clinical trials to be given to the hospital by the Regulatory Center of State Control of Drugs and Medical Equipment and Devices.

Palabras clave : clinical trials; Certification of Good Clinical Practice; Good Clinical Practices.

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