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ABC de Buenas Prácticas Clínicas en investigación
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Para todos los interesados en realizar investigación con medicamentos en seres humanos, el INVIMA presenta el ABC de Buenas Prácticas Clínicas, que divulga aspectos fundamentales como el concepto y contexto histórico de las buenas prácticas, el proceso de certificación y los principales componentes involucrados en el proceso de evaluación de las instituciones.
El grupo de expertos que conforma la Sala Especializada de Medicamentos y Productos Biológicos de la Comisión Revisora del INVIMA, se encarga de evaluar los aspectos científicos, metodológicos y éticos de los protocolos de investigación con medicamentos en seres humanos y dar un concepto “favorable” o “no favorable” de los mismos.
El INVIMA es quien le emite el certificado de Buenas Prácticas Clínicas, por una vigencia de cinco (5) años, que autoriza a las Instituciones Prestadoras de salud para adelantar investigación en seres humanos.
Este certificado incluye un proceso de investigación cubierto bajo un sistema, que cuenta con el diseño, conducción, realización, monitoreo, auditoría, registro, análisis y reporte de estudios clínicos.
El Comité de Ética, laboratorio clínico y patrocinador, que hacen parte del proceso de certificación, verificaran el cumplimiento de los requisitos exigidos en la Resolución 2378 de 2008.
Descargue: ABC de Buenas Prácticas Clínicas en investigación
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