{"id":4241,"date":"2025-08-13T14:30:24","date_gmt":"2025-08-13T12:30:24","guid":{"rendered":"https:\/\/fgk-group.com\/?post_type=knowledge-hub&#038;p=4241"},"modified":"2025-11-21T10:16:14","modified_gmt":"2025-11-21T09:16:14","slug":"monitoring","status":"publish","type":"knowledge-hub","link":"https:\/\/fgk-group.com\/de\/knowledge-hub\/glossar\/monitoring\/","title":{"rendered":"Monitoring"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"4241\" class=\"elementor elementor-4241 elementor-571\" data-elementor-post-type=\"knowledge-hub\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2e18709 e-flex e-con-boxed e-con e-parent\" data-id=\"2e18709\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3ed4292 elementor-widget elementor-widget-text-editor\" data-id=\"3ed4292\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Die \u00dcberwachung des Fortschritts einer\u00a0<a href=\"\/de\/knowledge-hub\/glossar\/klinische-studie\/\"><strong>klinischen Studie<\/strong><\/a>\u00a0und die Sicherstellung, dass die klinische Studie in \u00dcbereinstimmung mit dem\u00a0<strong><a href=\"\/de\/knowledge-hub\/glossar\/protokoll\/\">Protokoll<\/a>, <span style=\"color: #000000;\">der<\/span>\u00a0<a href=\"\/de\/knowledge-hub\/glossar\/gute-klinische-praxis\/\">Guten klinischen Praxis (GCP)<\/a>, <span style=\"color: #000000;\">den regulatorischen Anforderungen sowie den ethischen Richtlinien und SOPs durchgef\u00fchrt, aufgezeichnet und gemeldet wird. Sie wird in der Regel von klinischen Forschungsmitarbeitern (Clinical Research Associates, CRAs) (auch als Clinical Trial Monitors bekannt) im Auftrag des\u00a0<\/span><a href=\"\/de\/knowledge-hub\/glossar\/sponsor\/\">Sponsors<\/a>\u00a0<span style=\"color: #000000;\">oder der<\/span>\u00a0<a href=\"\/de\/knowledge-hub\/glossar\/auftragsforschungsinstitut-cro\/\">Auftragsforschungsinstitute (Contract Research Organization, CRO)<\/a>\u00a0<span style=\"color: #000000;\">durchgef\u00fchrt.<\/span><\/strong><\/p><p>Monitoring umfasst eine\u00a0<span style=\"color: #000000;\"><strong>Vielzahl von Aktivit\u00e4ten<\/strong>,<\/span> darunter die<span style=\"color: #000000;\">\u00a0<\/span><strong><span style=\"color: #000000;\">Kommunikation mit dem\u00a0<\/span><a href=\"\/de\/knowledge-hub\/glossar\/pruefer\/\">Pr\u00fcfarzt<\/a><span style=\"color: #000000;\">\u00a0und den<\/span>\u00a0<a href=\"\/de\/knowledge-hub\/glossar\/pruefzentrum-studienzentrum\/\">Studienzentren<\/a><\/strong>, die\u00a0<span style=\"color: #000000;\"><strong>\u00dcberpr\u00fcfung der Qualifikationen des Pr\u00fcfers und des Personals der Studienzentren sowie der Ressourcen der Studienzentren<\/strong>,<\/span> die\u00a0<span style=\"color: #000000;\"><strong>Schulung<\/strong>,<\/span> die\u00a0<strong><span style=\"color: #000000;\">\u00dcberpr\u00fcfung der Studienunterlagen<\/span>\u00a0<\/strong>und Informationen unter Verwendung einer Reihe von Ans\u00e4tzen, darunter die \u00dcberpr\u00fcfung der Quelldaten, die\u00a0<span style=\"color: #000000;\"><strong>Verifizierung der Quelldaten<\/strong>,<\/span> die\u00a0<span style=\"color: #000000;\"><strong>Datenanalyse<\/strong><\/span>\u00a0und Besuche in Einrichtungen, die studienbezogene Aktivit\u00e4ten durchf\u00fchren.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Die \u00dcberwachung des Fortschritts einer klinischen Studie, um die Einhaltung von Protokollen, SOPs, GCP und regulatorischen Anforderungen sicherzustellen.<\/p>\n","protected":false},"featured_media":0,"template":"","knowledge-hub-categories":[],"class_list":["post-4241","knowledge-hub","type-knowledge-hub","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - 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