{"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-planificacion-y-realizacion-de-ensayos-clinicos-manual-de-ensayos-clinicos","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/es\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/5-2-06-planung-und-durchfuehrung-klinischer-studien-handbuch-klinische-pruefung\/","title":{"rendered":"5.2.06 Planificaci\u00f3n y realizaci\u00f3n de ensayos cl\u00ednicos (Manual de ensayos cl\u00ednicos)"},"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\">Descargar la VA en 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\">Descargar<\/a><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"ziel_und_zweck\">Objetivo y finalidad<\/h2>\n\n\n\n<p>Los estudios cl\u00ednicos se llevan a cabo de acuerdo con las normas de Buenas Pr\u00e1cticas Cl\u00ednicas (BPC). Se establece y mantiene un sistema adecuado de gesti\u00f3n de la calidad.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anwendungsbereich\">Aplicaci\u00f3n<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Descripci\u00f3n del proceso<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Riesgos<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"dokumentation\">Recursos <\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">Material<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\">Tiempo necesario<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"ressourcen\">Documentaci\u00f3n<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"zustaendigkeit_und_qualifikation\">Responsabilidad y cualificaci\u00f3n<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"hinweise_und_anmerkungen\">Notas y comentarios<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"mitgeltende_unterlagen\">Documentos aplicables<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"literatur\">Documentos de validaci\u00f3n<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"begriffe\">T\u00e9rminos<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anlagen\">Archivos adjuntos<\/h2>\n\n\n\n<p>Manual de ensayos cl\u00ednicos (\u00cdndice)<\/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\">Anuncio de estudio 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\">Descargar<\/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\">Anuncio de estudio Autoridad local<\/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\">Descargar<\/a><\/div>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Objetivo y finalidad Los ensayos cl\u00ednicos se realizan de acuerdo con las normas de Buenas Pr\u00e1cticas Cl\u00ednicas (BPC). Se establece y mantiene un sistema adecuado de gesti\u00f3n de la calidad. Aplicaci\u00f3n Descripci\u00f3n del procedimiento Riesgos Recursos Material Tiempo necesario Documentaci\u00f3n Responsabilidad y cualificaci\u00f3n Notas y comentarios Documentos aplicables Documentos de validaci\u00f3n T\u00e9rminos y definiciones Ap\u00e9ndices Manual de ensayos cl\u00ednicos (\u00edndice)<\/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\/es\/wp-json\/wp\/v2\/docs\/11006","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/docs"}],"about":[{"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/types\/docs"}],"author":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/comments?post=11006"}],"version-history":[{"count":2,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/docs\/11006\/revisions"}],"predecessor-version":[{"id":15083,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/docs\/11006\/revisions\/15083"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/docs\/10952"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/media?parent=11006"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/doc_tag?post=11006"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/doc_badge?post=11006"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}