Plantilla en español para gestionar el consentimiento informado en estudios clínicos. Incluye pasos para verificar la versión aprobada por COFEPRIS, usar dos ejemplares del formato, preparar y archivar el expediente clínico, y orientar al paciente y a sus testigos. Contempla proceso ideal y alternativo para coordinadores de estudio, con control de documentos y registro adecuado en el expediente.
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