{"id":10982,"date":"2024-12-11T15:12:25","date_gmt":"2024-12-11T14:12:25","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-2-analyse-und-validierung\/handbuch-klinische-pruefung\/14-reporting-berichterstattung\/"},"modified":"2025-02-04T13:38:02","modified_gmt":"2025-02-04T12:38:02","slug":"14-presentacion-de-informes","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/es\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/handbuch-klinische-pruefung\/14-reporting-berichterstattung\/","title":{"rendered":"14 Informes Informes"},"content":{"rendered":"

Informe del estudio REP\/01<\/p>\n\n\n\n

REP\/01_01 Ejemplo de informe Ingl\u00e9s<\/a>Descargar<\/a><\/div>\n\n\n\n
REP\/01_02 Modelo de informe alem\u00e1n<\/a>Descargar<\/a><\/div>\n\n\n\n
REP\/01_03 Requisitos Informe BPL<\/a>Descargar<\/a><\/div>\n\n\n\n
REP\/02 Notificaci\u00f3n de acontecimientos adversos<\/a>Descargar<\/a><\/div>\n\n\n\n
REP\/02-01 M\u00f3dulo de texto CRF<\/a>Descargar<\/a><\/div>\n\n\n\n
REP\/02-01 M\u00f3dulo de texto CRF<\/a>Descargar<\/a><\/div>\n\n\n\n
REP\/02-02 Formulario de informe<\/a>Descargar<\/a><\/div>\n\n\n\n
REP\/02-03 Plan de pruebas del m\u00f3dulo de texto<\/a>Descargar<\/a><\/div>\n\n\n\n
REP\/02-04 Formulario de informe UEs alternativa<\/a>Descargar<\/a><\/div>\n\n\n\n

Notificar a la FDA un problema relacionado con un medicamento o un producto sanitario<\/a>
Para la codificaci\u00f3n de las reacciones adversas a los medicamentos utilizamos MedDRA<\/a> Diccionario m\u00e9dico para actividades reguladoras<\/p>\n\n\n\n

REP\/03 Informe al Comit\u00e9 de \u00c9tica<\/a>Descargar<\/a><\/div>\n\n\n\n
REP\/04-01 Ejemplo de informe cl\u00ednico<\/a>Descargar<\/a><\/div>\n\n\n\n
REP\/05 Informe sobre el abandono de un examinado<\/a>Descargar<\/a><\/div>\n\n\n\n

REP\/06 Informe final tras un ensayo cl\u00ednico
REP\/07 Informe final: Particularidades del estudio de bioequivalencia<\/p>\n\n\n\n

<\/p>","protected":false},"excerpt":{"rendered":"

REP\/01 Informe de estudio Informe de un asunto relacionado con un medicamento o producto sanitario a la FDAUtilizar el diccionario m\u00e9dico MedDRA para actividades reguladoras para codificar las reacciones adversas a medicamentos REP\/06 Informe final tras un ensayo cl\u00ednicoREP\/07 Informe final: Particularidades del estudio de bioequivalencia<\/p>","protected":false},"author":1,"featured_media":0,"parent":10954,"menu_order":14,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-10982","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\/10982","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=10982"}],"version-history":[{"count":1,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/docs\/10982\/revisions"}],"predecessor-version":[{"id":15055,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/docs\/10982\/revisions\/15055"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/docs\/10954"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/media?parent=10982"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/doc_tag?post=10982"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/doc_badge?post=10982"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}