{"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-reporting-rapports","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/fr\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/handbuch-klinische-pruefung\/14-reporting-berichterstattung\/","title":{"rendered":"14 Reporting Rapports"},"content":{"rendered":"

REP\/01 Rapport d'\u00e9tude<\/p>\n\n\n\n

REP\/01_01 Mod\u00e8le de rapport en anglais<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
REP\/01_02 Rapport type fran\u00e7ais<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
REP\/01_03 Exigences du rapport BPL<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
REP\/02 Rapports sur les \u00e9v\u00e9nements ind\u00e9sirables<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
REP\/02-01 \u00c9l\u00e9ment de texte CRF<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
REP\/02-01 \u00c9l\u00e9ment de texte CRF<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
REP\/02-02 Formulaire de rapport<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
REP\/02-03 \u00c9l\u00e9ment de texte du plan de contr\u00f4le<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
REP\/02-04 Feuille de rapport UE alternative<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n

Rapport d'un probl\u00e8me de m\u00e9dicament ou de dispositif m\u00e9dical \u00e0 la FDA<\/a>
Pour le codage des effets ind\u00e9sirables des m\u00e9dicaments, j'utilise le logiciel MedDRA<\/a> Dictionnaire m\u00e9dical pour les activit\u00e9s de r\u00e9glementation<\/p>\n\n\n\n

REP\/03 Rapport \u00e0 la commission d'\u00e9thique<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
REP\/04-01 Mod\u00e8le de rapport clinique<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
REP\/05 Rapport sur l'interruption des \u00e9tudes d'un sujet de recherche<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n

REP\/06 Rapport final apr\u00e8s un essai clinique
REP\/07 Rapport final : particularit\u00e9s de l'\u00e9tude de bio\u00e9quivalence<\/p>\n\n\n\n

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

REP\/01 Rapport d'\u00e9tude Rapport d'un probl\u00e8me de m\u00e9dicament ou de dispositif m\u00e9dical \u00e0 la FDAPour le codage des effets ind\u00e9sirables, utiliser MedDRA Medical Dictionary for Regulatory Activities REP\/06 Rapport final apr\u00e8s un essai cliniqueREP\/07 Rapport final : particularit\u00e9s \u00e9tude de bio\u00e9quivalence<\/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\/fr\/wp-json\/wp\/v2\/docs\/10982","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs"}],"about":[{"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/types\/docs"}],"author":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/comments?post=10982"}],"version-history":[{"count":1,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs\/10982\/revisions"}],"predecessor-version":[{"id":15055,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs\/10982\/revisions\/15055"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs\/10954"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/media?parent=10982"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/doc_tag?post=10982"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/doc_badge?post=10982"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}