{"id":57297,"date":"2022-05-24T11:07:58","date_gmt":"2022-05-24T09:07:58","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/gestion-del-tmf-y-el-isf\/"},"modified":"2022-05-24T11:07:58","modified_gmt":"2022-05-24T09:07:58","slug":"gestion-del-tmf-y-el-isf","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/es\/online-course\/gestion-del-tmf-y-el-isf\/","title":{"rendered":"Gesti\u00f3n del TMF y el ISF"},"content":{"rendered":"<p>El Expediente Maestro del Ensayo (TMF) y el Expediente del Investigador en el Centro (ISF) son documentos importantes. Contienen las directrices y la informaci\u00f3n sobre la progresi\u00f3n de un ensayo cl\u00ednico desde su inicio. Estos expedientes son fundamentales para fines de seguimiento y evaluaci\u00f3n a lo largo del cronograma del ensayo, lo que ayuda a mantener el orden.  <\/p>\n<p>Incluyen documentos relevantes que los auditores, inspectores y evaluadores de proyectos querr\u00edan ver al verificar el ensayo para el cumplimiento de las <a href=\"https:\/\/gxp-training.com\/es\/online-course\/ich-gcp-introduccion-a-las-buenas-practicas-clinicas\/\">BPC<\/a>, entre otros requisitos. Este curso introduce a los estudiantes a los tipos de estos expedientes y las situaciones en las que se consideran apropiados. Tambi\u00e9n aprender\u00e1 las mejores pr\u00e1cticas para cada tipo.  <\/p>\n<p>En este curso, ofrecemos una s\u00edntesis del tema a trav\u00e9s de una experiencia interactiva online. Este material fue elaborado por un equipo de Expertos en Asuntos Regulatorios con una cualificaci\u00f3n de la Northeastern University, Boston, y pilotado por un Miembro Senior capaz de articular la teor\u00eda con la pr\u00e1ctica. <\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3>Plan de estudios<\/h3>\n<p>&nbsp;<\/p>\n<p><strong>Introducci\u00f3n<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 1: Responsabilidades y Procedimientos<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Expediente Maestro del Ensayo (TMF)<\/li>\n<li>Expediente del Investigador en el Centro (ISF)<\/li>\n<li>Requisitos para el eTMF<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 2: Contenidos para el TMF y el ISF<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Antes del inicio del estudio<\/li>\n<li>Durante la experimentaci\u00f3n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 3: Almacenamiento, Cierre del Ensayo y Archivo del TMF\/ISF<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Almacenamiento<\/li>\n<li>Cierre del ensayo<\/li>\n<li>Archivo del TMF\/ISF<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 4: Seguridad del TMF y el ISF y Calidad<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Seguridad para eTMFs<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 5: Seguridad, Calidad e Inspecci\u00f3n del ISF<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Seguridad<\/li>\n<li>Calidad del TMF<\/li>\n<li>Inspecci\u00f3n del TMF<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 6: Escaneo o Transferencias a Otros Medios<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Copias certificadas<\/li>\n<li>Otras copias<\/li>\n<li>Validaci\u00f3n del proceso de digitalizaci\u00f3n y transferencia<\/li>\n<li>Destrucci\u00f3n de documentos originales tras la digitalizaci\u00f3n y transferencia<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Glosario<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Definiciones<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Conclusi\u00f3n<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Cuestionario<\/strong><\/p>\n<p><strong> <\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El Expediente Maestro del Ensayo (TMF) y el Expediente del Investigador en el Centro (ISF) son documentos importantes. Contienen las directrices y la informaci\u00f3n sobre la progresi\u00f3n de un ensayo cl\u00ednico desde su inicio. Estos expedientes son fundamentales para fines de seguimiento y evaluaci\u00f3n a lo largo del cronograma del ensayo, lo que ayuda a [&hellip;]<\/p>\n","protected":false},"featured_media":44592,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[276,275,279,270,269],"product_tag":[],"class_list":{"0":"post-57297","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-hospitales-e-instituciones-sanitarias","9":"product_cat-organizacion-de-investigacion-por-contrato-cro","10":"product_cat-productos-farmaceuticos","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>Gesti\u00f3n del TMF y el ISF: Formaci\u00f3n y Certificaci\u00f3n Online<\/title>\n<meta name=\"description\" content=\"Aprenda c\u00f3mo se mantienen el orden y la calidad en la investigaci\u00f3n cient\u00edfica utilizando el TMF y el ISF. 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