Good Clinical Ptactice certification: the need to prepare the clinical sites and services involved in clinical trials to achieve this status

Authors

  • Rayza Méndez Triana Universidad de Ciencias Médicas “Dr. Serafín Ruiz de Zárate Ruiz”, Villa Clara
  • Migdalia Rodríguez Rivas Universidad de Ciencias Médicas “Dr. Serafín Ruiz de Zárate Ruiz”, Villa Clara
  • Emilia Botello Ramírez Universidad de Ciencias Médicas “Dr. Serafín Ruiz de Zárate Ruiz”, Villa Clara

Keywords:

clinical trial, clinical clerkship/standards

Abstract

Certify compliance with Good Clinical Practice of one or more clinical sites and services that perform clinical trials (or both) should be the aspiration of health institutions linked to these investigations. This letter provides an approach to the certification process of Good Clinical Ptactice from the 52nd Regulation issued in 2008 by the Drug Regulatory Agency of Cuba, the Center for State Control of the Quality of Medicines, Equipment and Medical Devices, which establishes the requirements for clinical sites. The role of the National Clinical Trials Coordinating Center is specified in the diagnosis of compliance with the requirements of the "Manual of Methods for the preparation of clinical sites with a view to their certification in Good Clinical Practice" and an assessment is offered Provincial Clinical Trials Group of Villa Clara on the preparation of University Provincial Hospital " health institution with the greatest potential in the territory to face this process.

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Author Biographies

Rayza Méndez Triana, Universidad de Ciencias Médicas “Dr. Serafín Ruiz de Zárate Ruiz”, Villa Clara

Licenciada en Ciencias Farmacéuticas. Máster en Bioquímica General. Profesora Auxiliar de la Universidad de Ciencias Médicas de Villa Clara “Dr. Serafín Ruiz de Zárate Ruiz”.

Migdalia Rodríguez Rivas, Universidad de Ciencias Médicas “Dr. Serafín Ruiz de Zárate Ruiz”, Villa Clara

Especialista de I y II Grado en Farmacología. Máster en Medicina Bioenergética y Natural. Profesora Auxiliar de la Universidad de Ciencias Médicas de Villa Clara “Dr. Serafín Ruiz de Zárate Ruiz”.

References

1. Ministerio de Salud Pública. Directrices sobre buenas prácticas clínicas en Cuba. Centro para el control estatal de la calidad de los medicamentos. La Habana: MINSAP; 2000.

2. Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos. [Internet]. Cuba: Web de Salud; c1997-2014 [actualizado 7 Jul 2014; citado 8 Jul 2014]. Disponible en: http://www.cecmed.cu/Docs/RegFarm/DRA/EvalDC/Reg/Reg_52-08.pdf

3. Centro Nacional Coordinador de Ensayos Clínicos [Internet]. Cuba: Web de Salud; c2013 [actualizado 1 Jul 2014; citado 8 Jul 2014]. Disponible en: http://www.cencec.sld.cu/pgs/servicios.htm

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How to Cite

1.
Méndez Triana R, Rodríguez Rivas M, Botello Ramírez E. Good Clinical Ptactice certification: the need to prepare the clinical sites and services involved in clinical trials to achieve this status. Acta Méd Centro [Internet]. 2015 Jun. 12 [cited 2025 Jul. 1];9(2):59-62. Available from: https://revactamedicacentro.sld.cu/index.php/amc/article/view/264

Issue

Vol. 9 No. 2 (2015): April-June

Section

Letters to the Editor

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