{"id":11002,"date":"2024-12-11T15:14:15","date_gmt":"2024-12-11T14:14:15","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-2-analyse-und-validierung\/5-2-04-klinisch-experimentelles-forschungsprogramm\/"},"modified":"2025-02-04T13:38:07","modified_gmt":"2025-02-04T12:38:07","slug":"5-2-04-clinical-experimental-research-programme","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/en\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/5-2-04-klinisch-experimentelles-forschungsprogramm\/","title":{"rendered":"5.2.04 Clinical-experimental research programme"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"ziel_und_zweck\">Goal and purpose<\/h2>\n\n\n\n<p>If a new product (treatment method) is developed by the organisation or if it is involved in a new development, an appropriate research programme is drawn up. The clinical studies should be conducted in accordance with the applicable rules of clinical research. A research department is commissioned to conduct the study in accordance with the rules of \"Good Clinical Practice (GCP)\" (see also VA 3.2.4 and 5.2.6).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anwendungsbereich\">Application<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Description of the process<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Risks<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"dokumentation\">Resources <\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">Material<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\">Time required<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"ressourcen\">Documentation<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"zustaendigkeit_und_qualifikation\">Responsibility and qualification<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"hinweise_und_anmerkungen\">Notes and comments<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"mitgeltende_unterlagen\">Applicable documents<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"literatur\">Validation documents<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"begriffe\">Terms<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anlagen\">Attachments<\/h2>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Ziel und Zweck Wird ein neues Produkt (Behandlungsverfahren) von der Organisation entwickelt oder beteiligt sie sich an einer Neuentwicklung, wird ein angemessenes Untersuchungsprogramm erstellt. Die Klinischen Studien sollen sich an den geltenden Regeln der klinischen Forschung durchgef\u00fchrt werden. Eine Forschungsabteilung wird mit der Durchf\u00fchrung nach den Regeln der \u201eGuten Klinischen Praxis (GCP)\u201c beauftragt (siehe auch [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":10952,"menu_order":39,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-11002","docs","type-docs","status-publish","hentry","no-post-thumbnail"],"acf":[],"author_avatar":"https:\/\/secure.gravatar.com\/avatar\/c6b2616140d9fcd6a1c5d6d2ebbf43422308c9322c032ef03f88ec3235855dcf?s=96&d=mm&r=g","author_name":"admin","_links":{"self":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11002","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs"}],"about":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/types\/docs"}],"author":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/comments?post=11002"}],"version-history":[{"count":2,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11002\/revisions"}],"predecessor-version":[{"id":15080,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11002\/revisions\/15080"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10952"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/media?parent=11002"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_tag?post=11002"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_badge?post=11002"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}