{"id":57193,"date":"2022-05-27T11:55:12","date_gmt":"2022-05-27T09:55:12","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/gestion-clinique-des-etudes-non-interventionnelles\/"},"modified":"2022-05-27T11:55:12","modified_gmt":"2022-05-27T09:55:12","slug":"gestion-clinique-des-etudes-non-interventionnelles","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/gestion-clinique-des-etudes-non-interventionnelles\/","title":{"rendered":"Gestion clinique des \u00e9tudes non interventionnelles"},"content":{"rendered":"<p>Les \u00e9tudes non interventionnelles (ENI) sont des travaux de recherche clinique qui s\u2019appuient sur des programmes de traitement d\u00e9j\u00e0 pleinement en cours. Elles s\u2019opposent aux <a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/bpc-essais-cliniques\/\">essais cliniques<\/a>, qui impliquent l\u2019administration d\u2019agents th\u00e9rapeutiques ou de dispositifs dans un cadre clinique contr\u00f4l\u00e9\/non contr\u00f4l\u00e9 afin d\u2019\u00e9valuer l\u2019efficacit\u00e9 et la s\u00e9curit\u00e9. Les ENI portent g\u00e9n\u00e9ralement sur l\u2019effet de plans de traitement et de produits \u00e9prouv\u00e9s sur les r\u00e9ponses des patients, sur les plans clinique et comportemental.  <\/p>\n<p>Ce cours distingue ces cat\u00e9gories de recherche clinique et enseigne les \u00e9l\u00e9ments d\u2019une ENI \u00e9thique. La l\u00e9gislation encadrant les ENI \u00e9voluant dans le monde, environ tous les six mois, il est n\u00e9cessaire de mettre en \u00e9vidence les \u00e9l\u00e9ments importants des processus et la mani\u00e8re d\u2019effectuer la diligence raisonnable \u00e0 leur sujet. <\/p>\n<p>&nbsp;<\/p>\n<p>Dans ce cours, nous proposons une synth\u00e8se du sujet \u00e0 travers une exp\u00e9rience en ligne interactive. Ce contenu a \u00e9t\u00e9 \u00e9labor\u00e9 par une \u00e9quipe d\u2019experts en affaires r\u00e9glementaires titulaires d\u2019une qualification de la Northeastern University (Boston), pilot\u00e9e par un membre senior capable d\u2019articuler la th\u00e9orie et la pratique. <\/p>\n<p>&nbsp;<\/p>\n<h3>Programme<\/h3>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 1 : Qu\u2019est-ce que la recherche clinique ?<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>En quoi la recherche clinique diff\u00e8re-t-elle des soins standards ?<\/li>\n<li>Pourquoi menons-nous des recherches cliniques ?<\/li>\n<li>Introduction : points cl\u00e9s \u00e0 retenir<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 2 : Quels sont les principaux principes de l\u2019\u00e9thique de la recherche ?<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Qu\u2019est-ce que le consentement \u00e9clair\u00e9 et pourquoi est-il n\u00e9cessaire ?<\/li>\n<li>Pourquoi les personnes participent-elles \u00e0 la recherche clinique et quels sont les b\u00e9n\u00e9fices et les risques associ\u00e9s ?<\/li>\n<li>\u00c9thique de la recherche : points cl\u00e9s \u00e0 retenir<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 3 : Donn\u00e9es probantes en vie r\u00e9elle<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Donn\u00e9es en vie r\u00e9elle : un \u00e9l\u00e9ment cl\u00e9 pour la prise de d\u00e9cision en sant\u00e9<\/li>\n<li>Le besoin de donn\u00e9es plus larges<\/li>\n<li>L\u2019essentiel sur les \u00e9tudes non interventionnelles<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 4 : Assurance qualit\u00e9 dans les<a href=\"https:\/\/gxp-training.com\/online-course\/gxp0629-nis-module-1-general-principles\/\"> \u00e9tudes non interventionnelles<\/a><\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Mesures d\u2019assurance qualit\u00e9 aux diff\u00e9rentes \u00e9tapes des ENI<\/li>\n<li>Mesures en phase de planification<\/li>\n<li>Plan d\u2019\u00e9tude<\/li>\n<li>Plan qualit\u00e9<\/li>\n<li>Conception des cahiers d\u2019observation (CRF, eCRF)<\/li>\n<li>Garantir la repr\u00e9sentativit\u00e9<\/li>\n<li>Formation<\/li>\n<li>Garantir la transparence<\/li>\n<li>Mesures pour la collecte et la saisie des donn\u00e9es<\/li>\n<li>Premier contr\u00f4le d\u2019exhaustivit\u00e9<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 5 : V\u00e9rification et validation<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Mesures pendant l\u2019analyse<\/li>\n<li>Mesures lors de la r\u00e9daction des rapports d\u2019ENI<\/li>\n<li>Mesures d\u2019archivage des ENI<\/li>\n<li>Protection des donn\u00e9es<\/li>\n<li>Validation des syst\u00e8mes<\/li>\n<li>Acc\u00e8s direct aux syst\u00e8mes informatis\u00e9s<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 6 : \u00c9tudes observationnelles : consid\u00e9rations r\u00e9glementaires<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>R\u00e9glementations applicables aux ENI<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 7 : Soumissions r\u00e9glementaires des \u00e9tudes de s\u00e9curit\u00e9 post-autorisation non interventionnelles : d\u00e9fis d\u2019interpr\u00e9tation des donn\u00e9es et comparaisons avec les donn\u00e9es cliniques<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Disponibilit\u00e9 des donn\u00e9es et crit\u00e8res d\u2019\u00e9valuation de s\u00e9curit\u00e9<\/li>\n<li>Donn\u00e9es d\u00e9mographiques<\/li>\n<li>Efficacit\u00e9 ou effectivit\u00e9<\/li>\n<li>Biais de s\u00e9lection<\/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 \u00e9tudes non interventionnelles (ENI) sont des travaux de recherche clinique qui s\u2019appuient sur des programmes de traitement d\u00e9j\u00e0 pleinement en cours. Elles s\u2019opposent aux essais cliniques, qui impliquent l\u2019administration d\u2019agents th\u00e9rapeutiques ou de dispositifs dans un cadre clinique contr\u00f4l\u00e9\/non contr\u00f4l\u00e9 afin d\u2019\u00e9valuer l\u2019efficacit\u00e9 et la s\u00e9curit\u00e9. Les ENI portent g\u00e9n\u00e9ralement sur l\u2019effet de plans [&hellip;]<\/p>\n","protected":false},"featured_media":44452,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[274,262,263,258,267],"product_tag":[],"class_list":{"0":"post-57193","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-bpc-essais-cliniques","7":"product_cat-hopitaux-et-etablissements-de-sante","8":"product_cat-organisme-de-recherche-sous-contrat-cro","9":"product_cat-pharmaceutique","10":"product_cat-pharmacovigilance","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>\u00c9tudes non interventionnelles : certification en gestion clinique<\/title>\n<meta name=\"description\" content=\"D\u00e9couvrez les subtilit\u00e9s \u00e9thiques des \u00e9tudes non interventionnelles et leur pertinence pour les soins de sant\u00e9. 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