Recommendations for quality assurance of clinical trials in emergency situations
Keywords:
quality control, clinical trials as topic, emergency medical systemAbstract
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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
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
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 Jan. 23];52(3):e023014204. Available from: https://revmedmilitar.sld.cu/index.php/mil/article/view/14204
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Editorial
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