{"id":10974,"date":"2024-12-11T15:11:48","date_gmt":"2024-12-11T14:11:48","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-2-analyse-und-validierung\/handbuch-klinische-pruefung\/10-prc-process-control-prozesslenkung-monitoring\/"},"modified":"2025-02-04T13:38:01","modified_gmt":"2025-02-04T12:38:01","slug":"10-prc-process-control-controle-du-processus-monitoring","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/fr\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/handbuch-klinische-pruefung\/10-prc-process-control-prozesslenkung-monitoring\/","title":{"rendered":"10 PRC Process Control Contr\u00f4le de processus Monitoring"},"content":{"rendered":"
PRC\/00 Ma\u00eetrise des processus<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
PRC\/01 Planification de l'essai clinique de phase 1 Biodisponibilit\u00e9<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
PRC\/01-01 Feuille de d\u00e9roulement<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
PRC\/02 Gestion de projets<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
PRC\/02-01 \u00c9tapes individuelles du d\u00e9roulement du projet<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
PRC\/02-02 Plan d'action pour les essais cliniques<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
PRC\/03 Notification d'un essai clinique<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
PRC03-01 Lettre de l'autorit\u00e9<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
PRC\/04 D\u00e9p\u00f4t conform\u00e9ment au \u00a7 40 AMG<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
PRC\/04-01 Premi\u00e8re pr\u00e9sentation du formulaire<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
PRC\/05 Pr\u00e9paration d'un essai clinique<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
PRC\/06 Planification du temps<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/01 T\u00e2ches du moniteur<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/03 S\u00e9lection du centre d'essai<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/03-01 Liste de contr\u00f4le du centre d'essai<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/03-02 Liste de contr\u00f4le pour le premier contact<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/03-03 Exigences relatives \u00e0 un centre d'essai<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/04 Accord avec l'investigateur clinique<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/04-01 Entretien avec un investigateur clinique<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/05 Premi\u00e8re visite du centre d'essai<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/05-01 Entretien avec le personnel<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/05-02 Examen des documents au centre d'examen<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/06 Demande et transmission d'\u00e9chantillons de contr\u00f4le<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/06-01 Bon de livraison \u00e9chantillon de contr\u00f4le<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/07-01 Preuve de l'\u00e9chantillon de contr\u00f4le<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/07 Contr\u00f4le du devenir des \u00e9chantillons d'essai<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/08 Monitoring au centre d'essai<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/08-01 Note d'entretien<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/08-02 Liste de contr\u00f4le du suivi<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/08-03 Fiche d'\u00e9tat de l'\u00e9tude en cours<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/08-04 Tableau des \u00e9chantillons de test<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/08-05 Court audit du centre de contr\u00f4le<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/09 Fin des \u00e9tudes<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/09-01 R\u00e9union de fin d'\u00e9tudes<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/09-02 Sujets de discussion R\u00e9union de cl\u00f4ture<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n
MON\/09-03 Archivage de la documentation de contr\u00f4le<\/a>T\u00e9l\u00e9charger<\/a><\/div>\n\n\n\n

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