{"id":57267,"date":"2022-05-24T11:07:58","date_gmt":"2022-05-24T09:07:58","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/gestion-du-tmf-et-de-lisf\/"},"modified":"2022-05-24T11:07:58","modified_gmt":"2022-05-24T09:07:58","slug":"gestion-du-tmf-et-de-lisf","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/gestion-du-tmf-et-de-lisf\/","title":{"rendered":"Gestion du TMF et de l&rsquo;ISF"},"content":{"rendered":"<p>Le Trial Master File (TMF) et l&rsquo;Investigator Site File (ISF) sont des documents importants. Ils contiennent les directives et les informations sur le d\u00e9roulement d&rsquo;un essai clinique depuis son initiation. Ces dossiers sont essentiels \u00e0 des fins de surveillance et d&rsquo;\u00e9valuation tout au long de l&rsquo;essai, ce qui contribue \u00e0 maintenir l&rsquo;ordre.  <\/p>\n<p>Ils comprennent les documents pertinents que les auditeurs, les inspecteurs et les \u00e9valuateurs de projet souhaitent consulter lors de la v\u00e9rification de la conformit\u00e9 de l&rsquo;essai aux <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/ich-gcp-introduction-aux-bonnes-pratiques-cliniques\/\">BPC<\/a>, entre autres exigences. Cette formation pr\u00e9sente aux participants les types de ces dossiers et les situations dans lesquelles ils sont consid\u00e9r\u00e9s comme appropri\u00e9s. Vous apprendrez \u00e9galement les meilleures pratiques pour chaque type.  <\/p>\n<p>Dans cette formation, 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&rsquo;experts en affaires r\u00e9glementaires qualifi\u00e9s de la Northeastern University, Boston, dirig\u00e9e par un membre senior capable d&rsquo;articuler th\u00e9orie et pratique. <\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3>Programme<\/h3>\n<p>&nbsp;<\/p>\n<p><strong>Introduction<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 1 : Responsabilit\u00e9s et proc\u00e9dures<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Trial Master File (TMF)<\/li>\n<li>Investigator&rsquo;s Site File (ISF)<\/li>\n<li>Exigences pour l&rsquo;eTMF<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 2 : Contenu du TMF et de l&rsquo;ISF<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Avant l&rsquo;initiation de l&rsquo;\u00e9tude<\/li>\n<li>Pendant l&rsquo;exp\u00e9rimentation<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 3 : Stockage, cl\u00f4ture de l&rsquo;essai et archivage du TMF\/ISF<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Stockage<\/li>\n<li>Cl\u00f4ture de l&rsquo;essai<\/li>\n<li>Archivage du TMF\/ISF<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 4 : S\u00e9curit\u00e9 et qualit\u00e9 du TMF et de l&rsquo;ISF<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>S\u00e9curit\u00e9 des eTMF<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 5 : S\u00e9curit\u00e9, qualit\u00e9 et inspection de l&rsquo;ISF<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>S\u00e9curit\u00e9<\/li>\n<li>Qualit\u00e9 du TMF<\/li>\n<li>Inspection du TMF<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 6 : Num\u00e9risation ou transfert vers d&rsquo;autres supports<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Copies certifi\u00e9es conformes<\/li>\n<li>Autres copies<\/li>\n<li>Validation du processus de num\u00e9risation et de transfert<\/li>\n<li>Destruction des documents originaux apr\u00e8s num\u00e9risation et transfert<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Glossaire<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>D\u00e9finitions<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Conclusion<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Quiz<\/strong><\/p>\n<p><strong> <\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Le Trial Master File (TMF) et l&rsquo;Investigator Site File (ISF) sont des documents importants. Ils contiennent les directives et les informations sur le d\u00e9roulement d&rsquo;un essai clinique depuis son initiation. Ces dossiers sont essentiels \u00e0 des fins de surveillance et d&rsquo;\u00e9valuation tout au long de l&rsquo;essai, ce qui contribue \u00e0 maintenir l&rsquo;ordre. Ils comprennent les [&hellip;]<\/p>\n","protected":false},"featured_media":44592,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[255,274,262,263,258],"product_tag":[],"class_list":{"0":"post-57267","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-hopitaux-et-etablissements-de-sante","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-simple"},"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 du TMF et de l&#039;ISF : Formation en ligne et certification<\/title>\n<meta name=\"description\" content=\"D\u00e9couvrez comment l&#039;ordre et la qualit\u00e9 sont maintenus dans la recherche scientifique gr\u00e2ce au TMF et \u00e0 l&#039;ISF. 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