{"id":57667,"date":"2023-08-04T17:05:35","date_gmt":"2023-08-04T16:05:35","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/21-cfr-parte-50-consentimiento-informado-de-sujetos-humanos\/"},"modified":"2023-08-04T17:05:35","modified_gmt":"2023-08-04T15:05:35","slug":"21-cfr-parte-50-consentimiento-informado-de-sujetos-humanos","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/es\/online-course\/21-cfr-parte-50-consentimiento-informado-de-sujetos-humanos\/","title":{"rendered":"21 CFR PARTE 50 Consentimiento Informado de Sujetos Humanos"},"content":{"rendered":"

El tratamiento \u00e9tico y la salvaguarda de los derechos y el bienestar de los participantes en la investigaci\u00f3n cl\u00ednica<\/a> son primordiales. 21 CFR Parte 50 es un conjunto de regulaciones emitidas por la FDA en Estados Unidos, centrado en la protecci\u00f3n de los sujetos humanos en ensayos cl\u00ednicos. Esta regulaci\u00f3n garantiza el proceso de consentimiento informado, asegurando que los participantes tengan una comprensi\u00f3n clara de los riesgos y beneficios de un estudio antes de decidir participar. <\/p>\n

Este curso certificado profundiza en la importancia de 21 CFR Parte 50, explorando incidentes hist\u00f3ricos que hicieron necesaria la elaboraci\u00f3n de estas regulaciones. A trav\u00e9s de varias lecciones, el curso cubre todos los aspectos de 21 CFR Parte 50, desde su alcance y aplicabilidad hasta los componentes espec\u00edficos del consentimiento informado, incluyendo las directrices para eximir el consentimiento bajo ciertas circunstancias. <\/p>\n

Plan de estudios:<\/strong><\/h2>\n

Introducci\u00f3n<\/strong><\/p>\n

Lecci\u00f3n 1: El amplio alcance de la regulaci\u00f3n<\/strong><\/p>\n

Lecci\u00f3n 2: Fundamentos del consentimiento informado<\/strong><\/p>\n

Lecci\u00f3n 3: Desglosando los elementos del consentimiento informado<\/strong><\/p>\n

Lecci\u00f3n 4: Dominio de la documentaci\u00f3n para el consentimiento informado<\/strong><\/p>\n

Lecci\u00f3n 5: Exenci\u00f3n del consentimiento informado – \u00bfCu\u00e1ndo y c\u00f3mo?<\/strong><\/p>\n

Lecci\u00f3n 6: Profundizando en las regulaciones de investigaci\u00f3n de emergencia<\/strong><\/p>\n

Lecci\u00f3n 7: Protecci\u00f3n de los ni\u00f1os en la investigaci\u00f3n<\/strong><\/p>\n

Conclusi\u00f3n<\/strong><\/p>\n

Glosario<\/strong><\/p>\n

Evaluaci\u00f3n<\/strong><\/p>\n

 <\/p>\n

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Este curso es esencial para investigadores, miembros de IRB, profesionales de cumplimiento normativo y cualquier persona involucrada en la conducta \u00e9tica de la investigaci\u00f3n cl\u00ednica con sujetos humanos. Proporciona una visi\u00f3n completa tanto de los principios de 21 CFR Parte 50 como de las implicaciones pr\u00e1cticas de adherirse a estas regulaciones. Enfatiza la importancia cr\u00edtica del consentimiento informado y el contexto hist\u00f3rico que hace que estas regulaciones sean necesarias en el complejo panorama actual de la investigaci\u00f3n con sujetos humanos. <\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

El tratamiento \u00e9tico y la salvaguarda de los derechos y el bienestar de los participantes en la investigaci\u00f3n cl\u00ednica son primordiales. 21 CFR Parte 50 es un conjunto de regulaciones emitidas por la FDA en Estados Unidos, centrado en la protecci\u00f3n de los sujetos humanos en ensayos cl\u00ednicos. Esta regulaci\u00f3n garantiza el proceso de consentimiento […]<\/p>\n","protected":false},"featured_media":44147,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[276,275,270,269,266],"product_tag":[],"class_list":{"0":"post-57667","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-asuntos-regulatorios","7":"product_cat-gcp-ensayos-clinicos","8":"product_cat-organizacion-de-investigacion-por-contrato-cro","9":"product_cat-productos-farmaceuticos","10":"product_cat-productos-sanitarios","12":"first","13":"instock","14":"taxable","15":"shipping-taxable","16":"purchasable","17":"product-type-subscription"},"bundled_by":[],"bundle_stock_status":"instock","bundle_stock_quantity":null,"bundle_virtual":false,"bundle_layout":"","bundle_add_to_cart_form_location":"","bundle_editable_in_cart":false,"bundle_sold_individually_context":"","bundle_item_grouping":"","bundle_min_size":"","bundle_max_size":"","bundle_price":[],"bundled_items":[],"bundle_sell_ids":[],"acf":[],"yoast_head":"\n21 CFR PARTE 50 Curso y Formaci\u00f3n Certificados Online - \u00a1Obtenga su Certificaci\u00f3n ahora!<\/title>\n<meta name=\"description\" content=\"21 CFR PARTE 50 Curso Certificado Online sobre Consentimiento Informado de Sujetos Humanos. 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