{"id":57152,"date":"2022-06-20T13:54:39","date_gmt":"2022-06-20T11:54:39","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/gestion-des-donnees-cliniques\/"},"modified":"2022-06-20T13:54:39","modified_gmt":"2022-06-20T11:54:39","slug":"gestion-des-donnees-cliniques","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/gestion-des-donnees-cliniques\/","title":{"rendered":"Gestion des donn\u00e9es cliniques"},"content":{"rendered":"<p>Les essais cliniques prennent du temps et consomment beaucoup de ressources ; ils doivent donc \u00eatre men\u00e9s apr\u00e8s une r\u00e9flexion approfondie sur l\u2019ensemble du processus. Des structures doivent \u00eatre mises en place pour garantir autant que possible la coh\u00e9rence des conditions, car cela r\u00e9duira consid\u00e9rablement les erreurs et rendra les r\u00e9sultats de la recherche fiables. Ce cours expose les bases de la gestion des donn\u00e9es cliniques en soulignant les objectifs, les outils et les processus impliqu\u00e9s. Si les donn\u00e9es obtenues lors d\u2019un exercice de recherche clinique sont jug\u00e9es peu fiables, l\u2019objectif n\u2019est pas atteint et les ressources sont gaspill\u00e9es. Vous d\u00e9couvrirez \u00e9galement le CDISC, une organisation qui r\u00e9glemente les op\u00e9rations d\u2019essais cliniques pour garantir la conformit\u00e9 aux normes internationales.    <\/p>\n<p>&nbsp;<\/p>\n<p>Ce mat\u00e9riel a \u00e9t\u00e9 \u00e9labor\u00e9 par une \u00e9quipe d\u2019experts en affaires r\u00e9glementaires dipl\u00f4m\u00e9s de l\u2019Universit\u00e9 Northeastern de Boston, pilot\u00e9e par un membre senior capable d\u2019articuler la th\u00e9orie avec la pratique.<\/p>\n<p>&nbsp;<\/p>\n<h3>Programme :<\/h3>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 1 : Aper\u00e7u des bonnes pratiques cliniques<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Les 13 principes des BPC<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 2 : Qu\u2019est-ce que la recherche clinique et l\u2019essai clinique ?<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 3 : Types et phases des essais cliniques<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 4 : Gestion des donn\u00e9es d\u2019essais cliniques et professionnels<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Qu\u2019est-ce que la gestion des essais cliniques ?<\/li>\n<li>Qu\u2019est-ce qu\u2019un syst\u00e8me de gestion des essais cliniques (CTMS) ?<\/li>\n<li>Comment comparer les syst\u00e8mes de gestion des donn\u00e9es cliniques<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 5 : Qu\u2019est-ce que la gestion des donn\u00e9es cliniques ?<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Mod\u00e8le de gestion des donn\u00e9es dans les essais cliniques<\/li>\n<li>Domaines de responsabilit\u00e9 des donn\u00e9es de recherche clinique<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 6 : R\u00f4les et responsabilit\u00e9s dans la gestion des donn\u00e9es cliniques<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Qu\u2019est-ce que la gestion des donn\u00e9es d\u2019essais cliniques (CDM) ?<\/li>\n<li>Plans de gestion des donn\u00e9es cliniques<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 7 : Plan de validation des donn\u00e9es d\u2019essais cliniques<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Flux de travail de la gestion des donn\u00e9es<\/li>\n<li>Audits des donn\u00e9es d\u2019essais cliniques<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 8 : Gestion de la qualit\u00e9 dans la gestion des donn\u00e9es cliniques<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>R\u00e9glementations, directives et normes en gestion des donn\u00e9es cliniques<\/li>\n<li>Cahiers d\u2019observation (CRF) dans la gestion des donn\u00e9es<\/li>\n<li>Introduction aux syst\u00e8mes informatis\u00e9s de gestion des essais cliniques<\/li>\n<li>Le besoin m\u00e9tier pour les CTMS<\/li>\n<li>Structure de base, contenu et fonctionnement du CTMS<\/li>\n<li>Exigences du syst\u00e8me \u00e9lectronique<\/li>\n<li>Livrables<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Glossaire<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Quiz<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Les essais cliniques prennent du temps et consomment beaucoup de ressources ; ils doivent donc \u00eatre men\u00e9s apr\u00e8s une r\u00e9flexion approfondie sur l\u2019ensemble du processus. Des structures doivent \u00eatre mises en place pour garantir autant que possible la coh\u00e9rence des conditions, car cela r\u00e9duira consid\u00e9rablement les erreurs et rendra les r\u00e9sultats de la recherche fiables. [&hellip;]<\/p>\n","protected":false},"featured_media":42858,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[255,257,274],"product_tag":[],"class_list":{"0":"post-57152","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-affaires-reglementaires","7":"product_cat-assurance-qualite","8":"product_cat-bpc-essais-cliniques","10":"first","11":"instock","12":"taxable","13":"shipping-taxable","14":"purchasable","15":"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>Gestion des donn\u00e9es cliniques - Cours en ligne et certification<\/title>\n<meta name=\"description\" content=\"Formation en gestion des donn\u00e9es cliniques. 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