{"id":11006,"date":"2024-12-11T15:15:30","date_gmt":"2024-12-11T14:15:30","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-2-analyse-und-validierung\/5-2-06-planung-und-durchfuehrung-klinischer-studien-handbuch-klinische-pruefung\/"},"modified":"2025-02-04T13:38:08","modified_gmt":"2025-02-04T12:38:08","slug":"5-2-06-planning-and-conducting-clinical-trials-clinical-trial-handbook","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/en\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/5-2-06-planung-und-durchfuehrung-klinischer-studien-handbuch-klinische-pruefung\/","title":{"rendered":"5.2.06 Planning and conducting clinical trials (Clinical Trial Manual)"},"content":{"rendered":"<div class=\"wp-block-file\"><a id=\"wp-block-file--media-7f19d922-70c8-402e-88a7-53370651f8b3\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.2.06_00_qm_durchfuehrung_klinischer_studien.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Download the VA as PDF <\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.2.06_00_qm_durchfuehrung_klinischer_studien.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-7f19d922-70c8-402e-88a7-53370651f8b3\">Download<\/a><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"ziel_und_zweck\">Goal and purpose<\/h2>\n\n\n\n<p>Clinical studies are conducted in accordance with the standard of Good Clinical Practice (GCP). An appropriate QM system is established and maintained.<\/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>Clinical Trials Manual (Table of Contents)<\/p>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-90c28d1a-da3d-48a1-ba99-7a9c0cac585d\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.2.06_02_qm_durchfuehrung_klinischer_studienanzeige.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Study advert BOB<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.2.06_02_qm_durchfuehrung_klinischer_studienanzeige.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-90c28d1a-da3d-48a1-ba99-7a9c0cac585d\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-6a68f4f9-4fae-4ccb-94cf-44724981369e\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.2.06_04_qm_anmeldung_lokalebehoerde.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Study announcement Local authority<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.2.06_04_qm_anmeldung_lokalebehoerde.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-6a68f4f9-4fae-4ccb-94cf-44724981369e\">Download<\/a><\/div>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Aim and purpose Clinical trials are conducted in accordance with the standard of Good Clinical Practice (GCP). An appropriate QM system is established and maintained. Application Description of the procedure Risks Resources Material Time required Documentation Responsibility and qualification Notes and comments Applicable documents Validation documents Terms and definitions Appendices Clinical trial manual (table of contents)<\/p>","protected":false},"author":1,"featured_media":0,"parent":10952,"menu_order":41,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-11006","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\/11006","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=11006"}],"version-history":[{"count":2,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11006\/revisions"}],"predecessor-version":[{"id":15083,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11006\/revisions\/15083"}],"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=11006"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_tag?post=11006"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_badge?post=11006"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}