Recommendations for quality assurance of clinical trials in emergency situations

Authors

Keywords:

quality control, clinical trials as topic, emergency medical system

Abstract

Recommendations for quality assurance of clinical trials in emergency situations

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Author Biographies

Sandra Alvarez Guerra, Centro Nacional Coordinador de Ensayos Clínicos

Jefa del Departamento de Gestión de la Calidad del Centro Nacional Coordinador de Ensayos Clínicos.  Doctora en Ciencias Farmacéuticas. Máster en Farmacia Clínica. Investigador Titular. Profesor Titular. Auditor Líder ISO 9001 con certificación de IQNet.

Zoe González Hernández, Centro Nacional Coordinador de Ensayos Clínicos

Auditora del Departamento de Gestión de la Calidad del Centro Nacional Coordinador de Ensayos Clínicos. Máster en Farmacia Clínica. Investigador Auxiliar. Profesora Auxiliar.

Lilia Saborido Martín, Centro Nacional Coordinador de Ensayos Clínicos

Auditora del Departamento de Gestión de la Calidad del Centro Nacional Coordinador de Ensayos Clínicos. Máster en Farmacia Clínica. Investigador Auxiliar. Profesora Auxiliar.

Julián Rodríguez Alvarez, Centro Nacional Coordinador de Ensayos Clínicos

Jefe del Departamento de Comercialización y asuntos regulatorios del Centro Nacional Coordinador de Ensayos Clínicos. Máster en Farmacia Clínica. Investigador Agregado. Profesor Auxiliar.

References

1. López MA, Rivero GJ, Pombert AT, López MM, Zayas IL. Cuba's National Clinical Trials Coordinating Center: emergence, evolution, and main results. Translated from the Spanish and reprinted with permission from the Revista Cubana de Farmacia. Vol. 44 No. 2 (special supplement), Apr-Jun 2010. MEDICC Review. 2011; 13(1):46-51. DOI: 10.37757/mr2011v13.n1.10

2. Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos. Directrices sobre Buenas Prácticas Clínicas en Cuba. La Habana: CECMED; 2000. [acceso: 25/04/2022]. Disponible en: https://www.cecmed.cu/sites/default/files/adjuntos/Reglamentacion/Dir_BPC.pdf

3. International Council for Harmonisation Of Technical Requirements for Pharmaceuticals for Human Use (Ich). ICH Harmonised Guideline Integrated Good Clinical Practice E6(R3). Draft version. Brusels: ICH; 2023. [acceso: 19/07/2023]. Disponible en: https://database.ich.org/sites/default/files/ICH_E6%28R3%29_DraftGuideline_2023_0-519.pdf4

4. Grupo de trabajo en Buenas Prácticas Clínicas (GT/BPC). Red PARF. Buenas Prácticas Clínicas: documento de las Américas. Washington: OPS; 2005. [acceso: 28/06/2023]. Disponible en: https://www3.paho.org/spanish/ad/ths/ev/BPC-doct-esp.doc

5. Casal, Armando M. Importancia creciente de la auditoría interna y desafíos ante la crisis de COVID-19. Buenos Aires: Editorial Errepar; 2021. [acceso: 28/06/2023]. Disponible en: https://www.consejosalta.org.ar/wp-content/uploads/IMPORTANCIA-CRECIENTE-DE-LA-AUDITORA%C2%8DA-INTERNA-Y-DESAFA%C2%8DOS-ANTE-LA-CRISIS-DE-COVID-19.pdf

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Published

2023-07-24

How to Cite

1.
Alvarez Guerra S, González Hernández Z, Saborido Martín L, Rodríguez Alvarez J. Recommendations for quality assurance of clinical trials in emergency situations. Rev Cubana Med Milit [Internet]. 2023 Jul. 24 [cited 2025 Jul. 2];52(3):e023014204. Available from: https://revmedmilitar.sld.cu/index.php/mil/article/view/14204

Issue

Vol. 52 No. 3 (2023): July - september

Section

Editorial

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