{"id":57360,"date":"2022-05-24T10:46:14","date_gmt":"2022-05-24T08:46:14","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/registro-de-ensayos-en-clinicaltrials-gov\/"},"modified":"2022-05-24T10:46:14","modified_gmt":"2022-05-24T08:46:14","slug":"registro-de-ensayos-en-clinicaltrials-gov","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/es\/online-course\/registro-de-ensayos-en-clinicaltrials-gov\/","title":{"rendered":"Registro de ensayos en clinicaltrials.gov"},"content":{"rendered":"<p>Los ensayos cl\u00ednicos contribuyen enormemente al conjunto de conocimientos que facilita la pr\u00e1ctica sanitaria basada en la evidencia. En ocasiones, los ensayos son para sustancias farmacol\u00f3gicas novedosas y, en otras, buscan probar aplicaciones novedosas de sustancias farmacol\u00f3gicas existentes. Dado que estos ensayos contribuyen a un conjunto global, deben registrarse adecuadamente en una base de datos donde toda la informaci\u00f3n relativa a ellos pueda ser consultada por todos aquellos que la necesiten.  <\/p>\n<p>En este curso, aprender\u00e1 sobre las responsabilidades de los promotores, investigadores y editores de revistas cient\u00edficas para garantizar que los ensayos cl\u00ednicos se registren incluso antes de su inicio. Tambi\u00e9n aprender\u00e1 sobre el ICTRP y los criterios de la OMS para el registro de ensayos. <\/p>\n<p>&nbsp;<\/p>\n<p>En este curso, proporcionamos una s\u00edntesis del tema a trav\u00e9s de una experiencia interactiva en l\u00ednea. Este material ha sido elaborado por un equipo de expertos en asuntos regulatorios con titulaci\u00f3n de Northeastern University, Boston, dirigido por un miembro s\u00e9nior capaz de articular la teor\u00eda con la pr\u00e1ctica. <\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3>Programa<\/h3>\n<p>&nbsp;<\/p>\n<p><strong>Introducci\u00f3n<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 1: Responsabilidades del promotor y del investigador<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Responsabilidades del promotor<\/li>\n<li>Responsabilidades del investigador<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 2: Sistema de aprobaci\u00f3n y notificaci\u00f3n<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Sistema de aprobaci\u00f3n<\/li>\n<li>Notificaci\u00f3n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 3: Registro<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Criterios de la OMS<\/li>\n<li>\u00bfQui\u00e9n debe registrarse?<\/li>\n<li>\u00bfCu\u00e1ndo registrarse en ClinicalTrials.gov?<\/li>\n<li>\u00bfQu\u00e9 debe hacer despu\u00e9s del registro?<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 4: Normas, propiedad intelectual (PI) y datos, identificaci\u00f3n inequ\u00edvoca<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Contenido<\/li>\n<li>Propiedad intelectual (PI) y datos<\/li>\n<li>Identificaci\u00f3n inequ\u00edvoca<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 5: Calidad, validez y accesibilidad<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Calidad y validez<\/li>\n<li>Accesibilidad<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 6: Normas de intercambio de datos y auditor\u00eda<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Intercambio de datos<\/li>\n<li>Implementaci\u00f3n de normas<\/li>\n<li>Auditor\u00eda<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Conclusi\u00f3n<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Glosario<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Cuestionario<\/strong><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Los ensayos cl\u00ednicos contribuyen enormemente al conjunto de conocimientos que facilita la pr\u00e1ctica sanitaria basada en la evidencia. En ocasiones, los ensayos son para sustancias farmacol\u00f3gicas novedosas y, en otras, buscan probar aplicaciones novedosas de sustancias farmacol\u00f3gicas existentes. Dado que estos ensayos contribuyen a un conjunto global, deben registrarse adecuadamente en una base de datos [&hellip;]<\/p>\n","protected":false},"featured_media":51334,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[276,275,279,270,269,266],"product_tag":[],"class_list":{"0":"post-57360","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","11":"product_cat-productos-sanitarios","13":"first","14":"instock","15":"taxable","16":"shipping-taxable","17":"purchasable","18":"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":"<!-- 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