{"id":57659,"date":"2023-08-04T17:05:35","date_gmt":"2023-08-04T16:05:35","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/21-cfr-part-50-consentement-eclaire-des-sujets-humains\/"},"modified":"2023-08-04T17:05:35","modified_gmt":"2023-08-04T15:05:35","slug":"21-cfr-part-50-consentement-eclaire-des-sujets-humains","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/21-cfr-part-50-consentement-eclaire-des-sujets-humains\/","title":{"rendered":"21 CFR PART 50 Consentement \u00e9clair\u00e9 des sujets humains"},"content":{"rendered":"<p>Le traitement \u00e9thique et la protection des droits et du bien-\u00eatre des participants \u00e0 la <a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/bpc-essais-cliniques\/\">recherche clinique<\/a> sont primordiaux. Le 21 CFR Part 50 est un ensemble de r\u00e9glementations \u00e9mises par la FDA aux \u00c9tats-Unis, ax\u00e9es sur la protection des sujets humains dans les essais cliniques. Cette r\u00e9glementation garantit le processus de consentement \u00e9clair\u00e9, en s&rsquo;assurant que les participants comprennent clairement les risques et les b\u00e9n\u00e9fices d&rsquo;une \u00e9tude avant de d\u00e9cider d&rsquo;y participer.  <\/p>\n<p>Cette formation certifi\u00e9e examine l&rsquo;importance du 21 CFR Part 50 en explorant les incidents historiques qui ont n\u00e9cessit\u00e9 le d\u00e9veloppement de ces r\u00e9glementations. \u00c0 travers diverses le\u00e7ons, la formation couvre tous les aspects du 21 CFR Part 50, de son champ d&rsquo;application et de son applicabilit\u00e9 aux composantes sp\u00e9cifiques du consentement \u00e9clair\u00e9, y compris les directives pour renoncer au consentement dans certaines circonstances. <\/p>\n<h2><strong>Programme :<\/strong><\/h2>\n<p><strong>Introduction<\/strong><\/p>\n<p><strong>Le\u00e7on 1 : Le champ d&rsquo;application \u00e9tendu de la r\u00e9glementation<\/strong><\/p>\n<p><strong>Le\u00e7on 2 : Fondements du consentement \u00e9clair\u00e9<\/strong><\/p>\n<p><strong>Le\u00e7on 3 : D\u00e9cryptage des \u00e9l\u00e9ments du consentement \u00e9clair\u00e9<\/strong><\/p>\n<p><strong>Le\u00e7on 4 : Ma\u00eetrise de la documentation du consentement \u00e9clair\u00e9<\/strong><\/p>\n<p><strong>Le\u00e7on 5 : Renonciation au consentement \u00e9clair\u00e9 &#8211; Quand et comment ?<\/strong><\/p>\n<p><strong>Le\u00e7on 6 : Approfondissement des r\u00e9glementations sur la recherche d&rsquo;urgence<\/strong><\/p>\n<p><strong>Le\u00e7on 7 : Protection des enfants dans la recherche<\/strong><\/p>\n<p><strong>Conclusion<\/strong><\/p>\n<p><strong>Glossaire<\/strong><\/p>\n<p><strong>\u00c9valuation<\/strong><\/p>\n<p>&nbsp;<\/p>\n<div class=\"group w-full text-token-text-primary border-b border-black\/10 dark:border-gray-900\/50 bg-gray-50 dark:bg-[#444654]\">\n<div class=\"flex p-4 gap-4 text-base md:gap-6 md:max-w-2xl lg:max-w-[38rem] xl:max-w-3xl md:py-6 lg:px-0 m-auto\">\n<div class=\"relative flex w-[calc(100%-50px)] flex-col gap-1 md:gap-3 lg:w-[calc(100%-115px)]\">\n<div class=\"flex flex-grow flex-col gap-3\">\n<div class=\"min-h-[20px] flex flex-col items-start gap-3 overflow-x-auto whitespace-pre-wrap break-words\">\n<div class=\"markdown prose w-full break-words dark:prose-invert dark\">\n<p>Cette formation est essentielle pour les chercheurs, les membres de comit\u00e9s d&rsquo;\u00e9thique, les professionnels de la conformit\u00e9 r\u00e9glementaire et toute personne impliqu\u00e9e dans la conduite \u00e9thique de la recherche clinique impliquant des sujets humains. Elle fournit une compr\u00e9hension compl\u00e8te des principes du 21 CFR Part 50 et des implications pratiques du respect de ces r\u00e9glementations. Elle souligne l&rsquo;importance cruciale du consentement \u00e9clair\u00e9 et le contexte historique qui rend ces r\u00e9glementations n\u00e9cessaires dans le paysage complexe actuel de la recherche sur les sujets humains.  <\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Le traitement \u00e9thique et la protection des droits et du bien-\u00eatre des participants \u00e0 la recherche clinique sont primordiaux. Le 21 CFR Part 50 est un ensemble de r\u00e9glementations \u00e9mises par la FDA aux \u00c9tats-Unis, ax\u00e9es sur la protection des sujets humains dans les essais cliniques. Cette r\u00e9glementation garantit le processus de consentement \u00e9clair\u00e9, en [&hellip;]<\/p>\n","protected":false},"featured_media":44147,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[255,274,256,263,258],"product_tag":[],"class_list":{"0":"post-57659","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-affaires-reglementaires","7":"product_cat-bpc-essais-cliniques","8":"product_cat-dispositifs-medicaux","9":"product_cat-organisme-de-recherche-sous-contrat-cro","10":"product_cat-pharmaceutique","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":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>21 CFR PART 50 Formation certifi\u00e9e en ligne - Obtenez votre certification maintenant !<\/title>\n<meta name=\"description\" content=\"21 CFR PART 50 Consentement \u00e9clair\u00e9 des sujets humains Formation certifi\u00e9e en ligne. 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