{"id":11008,"date":"2024-12-11T15:15:44","date_gmt":"2024-12-11T14:15:44","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-2-analyse-und-validierung\/5-2-07-risikobewertung\/"},"modified":"2025-02-04T13:38:09","modified_gmt":"2025-02-04T12:38:09","slug":"5-2-07-evaluation-des-risques","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/fr\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/5-2-07-risikobewertung\/","title":{"rendered":"5.2.07 \u00c9valuation des risques pour les essais cliniques"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"ziel_und_zweck\">Objectif et but<\/h2>\n\n\n\n<p>Une matrice des risques et des \u00e9valuations de risques (indicateurs de risques) est \u00e9tablie pour toutes les phases d'un projet de recherche, avec les mesures correspondantes de r\u00e9duction des risques. L'acceptabilit\u00e9 des risques r\u00e9siduels est estim\u00e9e. L'acceptabilit\u00e9 des risques r\u00e9siduels est estim\u00e9e. Pour la m\u00e9thode, voir 5.4.05<\/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 du d\u00e9roulement<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Risques<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"dokumentation\">Ressources <\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">Mat\u00e9riau<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\">Temps n\u00e9cessaire<\/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\">Comp\u00e9tence et qualification<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"hinweise_und_anmerkungen\">Remarques et commentaires<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"mitgeltende_unterlagen\">Documents \u00e0 joindre<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"literatur\">Documents de validation<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"begriffe\">Termes<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anlagen\">Placements<\/h2>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Ziel und Zweck Prozessbezogen wird eine \u00fcber alle Phasen eines Forschungsvorhabens eine Matrix der Risiken und den Risikobewertungen (Risikokennzahlen) mit entsprechenden Ma\u00dfnahmen zur Reduktion von Risiken erstellt. Die Annehmbarkeit der Restrisiken wird abgesch\u00e4tzt. Die Annehmbarkeit der Restrisiken wird abgesch\u00e4tzt. Zur Methode vgl. 5.4.05 Anwendung Beschreibung des Ablaufes Risiken Ressourcen Material Zeitbedarf Dokumentation Zust\u00e4ndigkeit und Qualifikation [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":10952,"menu_order":42,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-11008","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\/11008","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=11008"}],"version-history":[{"count":2,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs\/11008\/revisions"}],"predecessor-version":[{"id":15085,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs\/11008\/revisions\/15085"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs\/10952"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/media?parent=11008"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/doc_tag?post=11008"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/doc_badge?post=11008"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}