{"id":825963,"date":"2023-03-30T15:37:17","date_gmt":"2023-03-30T13:37:17","guid":{"rendered":"https:\/\/www.capgemini.com\/?post_type=research-and-insight&#038;p=878031"},"modified":"2025-03-05T04:46:57","modified_gmt":"2025-03-05T04:46:57","slug":"drafting-a-clinical-study-protocol","status":"publish","type":"research-and-insight","link":"https:\/\/www.capgemini.com\/de-de\/insights\/research\/drafting-a-clinical-study-protocol\/","title":{"rendered":"Erstellung eines klinischen Studienprotokolls"},"content":{"rendered":"\n<header class=\"wp-block-cg-blocks-hero-reusable header heroReusable  \"><div class=\"header-bgs\"><picture><source srcset=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2023\/03\/Banner-Clinical-Study-Protocol.jpg?w=2880&amp;quality=70 1x, https:\/\/www.capgemini.com\/wp-content\/uploads\/2023\/03\/Banner-Clinical-Study-Protocol.jpg?w=2880&amp;quality=70 2x\" media=\"(min-width: 1500px)\"\/><source srcset=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2023\/03\/Banner-Clinical-Study-Protocol.jpg?w=1440&amp;quality=70 1x, https:\/\/www.capgemini.com\/wp-content\/uploads\/2023\/03\/Banner-Clinical-Study-Protocol.jpg?w=2880&amp;quality=70 2x\" media=\"(min-width: 992px)\"\/><source srcset=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2023\/03\/Banner-Clinical-Study-Protocol.jpg?w=1024&amp;quality=70 1x, https:\/\/www.capgemini.com\/wp-content\/uploads\/2023\/03\/Banner-Clinical-Study-Protocol.jpg?w=1024&amp;quality=70 2x\" media=\"(min-width: 768px)\"\/><source srcset=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2023\/03\/Banner-Clinical-Study-Protocol.jpg?w=768&amp;quality=70 1x, https:\/\/www.capgemini.com\/wp-content\/uploads\/2023\/03\/Banner-Clinical-Study-Protocol.jpg?w=768&amp;quality=70 2x\" media=\"(min-width: 0)\"\/><img decoding=\"async\" src=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2023\/03\/Banner-Clinical-Study-Protocol.jpg\" class=\"header-img header-img-d\" alt=\"\" style=\"object-fit:cover;object-position:60% 36%\" loading=\"eager\"\/><\/picture><\/div><div class=\"heroPictureCardHeaderShape\"><\/div><div class=\"container\"><div class=\"row\"><div class=\"col-md-12\"><div class=\"box\"><div class=\"boxTagWrapper\"><div class=\"tagInfo\"><div><span class=\"box-tag\">Healthcare<\/span><\/div><\/div><div class=\"brandInfo\"><div class=\"brandLogo\"><img decoding=\"async\" loading=\"lazy\" src=\"\/wp-content\/themes\/capgemini2020\/assets\/images\/capgemini-invent.svg\" alt=\"capgemini-invent\"\/><\/div><\/div><\/div><div class=\"box-title\"><h1 data-maxlength=\"34\">Erstellung eines klinischen Studienprotokolls<\/h1><\/div><div class=\"inner-row-insight download-btn\"><div class=\"col-md-4 downloadFiles addPadding\"><a class=\"button-download--small\" type=\"download\" href=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2023\/03\/Drafting-a-clinical-study_protocol.pdf\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"In neuem Fenster \u00f6ffnen\"><span>Download Artikel<\/span><span class=\"type\">963 KB  pdf<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/header>\n\n\n\n<section class=\"wp-block-cg-blocks-group undefined section section--article-content\"><div class=\"article-main-content\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-md-1\"><nav class=\"article-social\"><ul class=\"social-nav\"><li class=\"ip-order-fb\"><a href=\"https:\/\/www.facebook.com\/sharer\/sharer.php?u=https:\/\/www.capgemini.com\/?post_type=research-and-insight&amp;p=878031\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"In neuem Fenster \u00f6ffnen\"><i aria-hidden=\"true\" class=\"icon-fb\"><\/i><span class=\"sr-only\">Facebook<\/span><\/a><\/li><li class=\"ip-order-tw\"><a href=\"https:\/\/twitter.com\/intent\/tweet?url=https:\/\/www.capgemini.com\/?post_type=research-and-insight&amp;p=878031&amp;text=Drafting%20a%20Clinical%20Study%20Protocol\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"In neuem Fenster \u00f6ffnen\"><i aria-hidden=\"true\" class=\"icon-tw\"><\/i><span class=\"sr-only\">Twitter<\/span><\/a><\/li><li class=\"ip-order-li\"><a href=\"https:\/\/www.linkedin.com\/shareArticle?url=https:\/\/www.capgemini.com\/?post_type=research-and-insight&amp;p=878031&amp;text=Drafting%20a%20Clinical%20Study%20Protocol\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"In neuem Fenster \u00f6ffnen\"><i aria-hidden=\"true\" class=\"icon-li\"><\/i><span class=\"sr-only\">Linkedin<\/span><\/a><\/li><\/ul><\/nav><\/div><div class=\"col-12 col-md-11 col-lg-10\"><div class=\"article-text article-quote-text\">\n<p>Die Bedeutung klinischer Studien ist in den letzten Jahren immer deutlicher geworden. Leider wird COVID-19 m\u00f6glicherweise nicht die letzte Pandemie in unserer modernen globalen Gesellschaft sein. F\u00fcr die Zukunft ist es von entscheidender Bedeutung, dass wir neue Wege finden, um ihre Genauigkeit, Legitimit\u00e4t und Wirksamkeit zu gew\u00e4hrleisten. Klinische Studien sind ein wichtiger Bestandteil der Biowissenschaften, und die neuen Anforderungen an eine gr\u00f6\u00dfere Vielfalt und die Durchf\u00fchrung aus der Ferne erfordern ein hohes Ma\u00df an Fachwissen, Konzentration und Planung. In diesem ersten Teil einer zweiteiligen Serie werden wir die grundlegenden Anforderungen an klinische Protokolle skizzieren. Im zweiten Teil werden wir die Auswirkungen des sich ver\u00e4ndernden Umfelds, einschlie\u00dflich Diversit\u00e4t und dezentralisierter klinischer Studien, diskutieren und hervorheben.<\/p>\n\n\n\n<p>Grunds\u00e4tzlich m\u00fcssen die Pr\u00fcf\u00e4rzte die Ziele, das Design, die Methodik, die statistischen \u00dcberlegungen und die Organisation einer Studie beschreiben und gleichzeitig sicherstellen, dass die strengen beh\u00f6rdlichen Richtlinien eingehalten werden. Im Wesentlichen handelt es sich dabei um ein klinisches Studienprotokoll.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td class=\"has-text-align-center\" data-align=\"center\">\u2714 What is a clinical study<br> protocol?<\/td><td class=\"has-text-align-center\" data-align=\"center\">\u2714 When is a clinical study protocol drafted?<\/td><td class=\"has-text-align-center\" data-align=\"center\">\u2714 How is a clinical study protocol drafted?<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">\u2714 Why is a clinical study protocol important?<\/td><td class=\"has-text-align-center\" data-align=\"center\">\u2714 Who drafts a clinical study protocol?<\/td><td class=\"has-text-align-center\" data-align=\"center\">\u2714 What are the constituents of a clinical study protocol as per ICH-GCP?<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Der Pr\u00fcfplan einer klinischen Pr\u00fcfung ist ein wesentlicher Parameter f\u00fcr die Pr\u00fcfer, um alle Kriterien f\u00fcr eine erfolgreiche klinische Pr\u00fcfung zu erf\u00fcllen. Er ist das erste Dokument, das bei der Konzeption und Planung einer klinischen Pr\u00fcfung erstellt wird. Alle zugeh\u00f6rigen und involvierten Dokumente, Vorlagen und Formulare, digitale Interventionen etc. sind auf den Pr\u00fcfplan abgestimmt. Dar\u00fcber hinaus erm\u00f6glicht ein klinischer Pr\u00fcfplan allen an einer Studie Beteiligten die Einhaltung strenger beh\u00f6rdlicher Richtlinien. Dies ist entscheidend f\u00fcr den Erfolg der Studie, weshalb mehrere Parteien an der Erstellung eines Pr\u00fcfplans beteiligt sind. Klinische Studien stehen derzeit im Rampenlicht der \u00d6ffentlichkeit. Deshalb ist es wichtig, dass die Pr\u00fcfer alles richtig machen.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-uberblick-uber-die-erstellung-eines-klinischen-studienprotokolls-auf-hohem-niveau\">\u00dcberblick \u00fcber die Erstellung eines klinischen Studienprotokolls auf hohem Niveau<\/h3>\n\n\n\n<p>Der Entwurf und die Entwicklung eines Protokolls erfolgen in mehreren Schritten. Das folgende Diagramm zeigt eine vereinfachte Darstellung auf hoher Ebene:<\/p>\n\n\n\n<figure class=\"wp-block-image aligncenter size-full is-resized\"><img decoding=\"async\" src=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2023\/03\/Diagram-1.png\" alt=\"\" class=\"wp-image-878188\" style=\"width:647px;height:544px\"\/><\/figure>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-thought-leadership\">Thought leadership<\/h3>\n\n\n\n<div class=\"wp-block-media-text alignwide has-media-on-the-right is-stacked-on-mobile\" style=\"grid-template-columns:auto 56%\"><div class=\"wp-block-media-text__content\">\n<h4 class=\"wp-block-heading\">Entwurf eines Protokolls f\u00fcr eine klinische Studie &#8211; ein \u00dcberblick<\/h4>\n\n\n\n<p>Unter den verschiedenen Parametern, die zur Durchf\u00fchrung erfolgreicher klinischer Studien beitragen, ist ein gut definiertes klinisches Studienprotokoll ein wesentlicher Faktor.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2023\/03\/Drafting-a-clinical-study_protocol.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Download Artikel<\/a><\/div>\n<\/div>\n<\/div><figure class=\"wp-block-media-text__media\"><img decoding=\"async\" src=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2023\/03\/Book-Clinical-Study-Protocol.png?w=960\" alt=\"\" class=\"wp-image-878043 size-full\"\/><\/figure><\/div>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Kompetenzen von Capgemini Invent im Bereich klinischer Studien<\/h3>\n\n\n\n<p>Capgemini Invent verf\u00fcgt \u00fcber mehr als 50 Jahre Erfahrung in der Unterst\u00fctzung von Life-Sciences-Organisationen bei wichtigen Transformationen. Wir verf\u00fcgen \u00fcber langj\u00e4hrige Erfahrung in der Konzeption klinischer Studien und der anschlie\u00dfenden Erstellung klinischer Studienprotokolle. Unterst\u00fctzt durch unsere firmeneigene Smart Trial Plattform k\u00f6nnen unsere Experten bei der Entwicklung von Protokollen helfen, die detailliert, patientenorientiert, operativ durchf\u00fchrbar und vollst\u00e4ndig sind und den geltenden gesetzlichen und anderen regulatorischen Anforderungen entsprechen.<\/p>\n\n\n\n<p><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/section>\n\n\n","protected":false},"excerpt":{"rendered":"<p>A clinical study protocol is an essential parameter for trial investigators, enabling them to tick all the necessary boxes for a successful clinical 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