The ISO 9001 standard, good clinical and laboratory practices in clinical trials

Authors

Keywords:

good clinical practices, good clinical laboratory practices, quality management system, clinical trial.

Abstract

The ISO 9001 standard, good clinical and laboratory practices in clinical trials

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Author Biography

Sandra Alvarez Guerra, Centro Nacional Coordinador de Ensayos Clínicos

Jefa del departamento de Gestión de la Calidad.

Doctora en Ciencias Farmacéuticas.

Investigadora Titular.

Profesora Titular.

 

References

1. Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos. Directrices sobre Buenas Prácticas Clínicas en Cuba. La Habana: CECMED; 2000 [acceso: 25/4/2022]. Disponible en: https://www.cecmed.cu/sites/default/files/adjuntos/Reglamentacion/Dir_BPC.pdf

2. Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos. Regulación D 03-21. Buenas Prácticas de Laboratorio Clínico. La Habana: CECMED; 2021 [acceso: 25/4/2022]. Disponible en: https://www.cecmed.cu/sites/default/files/adjuntos/Reglamentacion/ResRegBPLC%20firmada.pdf

3. Grupo de trabajo Spanish Translation Task Force. Norma Internacional ISO 9001. Sistemas de Gestión de la Calidad-Requisitos. Traducción certificada. 5ª. ed. Ginebra: Suiza; 2015.

4. International Conference on Harmonisation. Integrated Addendum to E6 (R1): Guideline for Good Clinical Practice E6 (R2). Bruselas: ICH; 2016 [acceso: 26/4/2022]. Disponible en: https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf

5. Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos. Regulación M 82-15 Requerimientos para la certificación de Buenas Prácticas Clínicas. La Habana: CECMED; 2015 [acceso: 27/4/2022]. Disponible en: https://www.cecmed.cu/sites/default/files/adjuntos/Reglamentacion/resolucion_219_-_15_regulacion_m_82-15_certificacion_buenas_practicas_clinicas.pdf

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Published

2022-07-15

How to Cite

1.
Alvarez Guerra S. The ISO 9001 standard, good clinical and laboratory practices in clinical trials. Rev Cubana Med Milit [Internet]. 2022 Jul. 15 [cited 2025 Jun. 21];51(3):e02202093. Available from: https://revmedmilitar.sld.cu/index.php/mil/article/view/2093

Issue

Vol. 51 No. 3 (2022): July - September

Section

Editorial

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