{"id":330,"date":"2022-05-19T16:43:33","date_gmt":"2022-05-19T14:43:33","guid":{"rendered":"https:\/\/wp.unil.ch\/hrp\/?page_id=330"},"modified":"2022-10-31T11:56:02","modified_gmt":"2022-10-31T10:56:02","slug":"activation-des-centres-participants","status":"publish","type":"page","link":"https:\/\/wp.unil.ch\/hrp\/activation-des-centres-participants\/","title":{"rendered":"Conduite d&rsquo;\u00e9tude"},"content":{"rendered":"\n<div class=\"wp-block-group alignfull is-vertical is-content-justification-center is-layout-flex wp-container-core-group-is-layout-4b2eccd6 wp-block-group-is-layout-flex\">\n<div class=\"wp-block-group alignfull is-vertical is-content-justification-center is-layout-flex wp-container-core-group-is-layout-4b2eccd6 wp-block-group-is-layout-flex\">\n<div class=\"wp-block-group is-vertical is-content-justification-center is-layout-flex wp-container-core-group-is-layout-4b2eccd6 wp-block-group-is-layout-flex\">\n<p class=\"has-text-align-center has-light-background-color has-text-color\" style=\"font-size:40px\">Quelles \u00e9tapes pour la conduite d&rsquo;\u00e9tude?<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:80%\">\n<p class=\"has-text-align-center has-normal-font-size\"><em>Cette section s&rsquo;applique aux projets de recherche autre que les essais cliniques (ORH), aux essais cliniques (OClin) ainsi qu&rsquo;aux essais cliniques avec dispositifs m\u00e9dicaux (OClin-Dim)<\/em>.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:85%\">\n<p class=\"has-text-align-center has-buttons-background-color has-text-color has-large-font-size\">Une fois <strong>l&rsquo;approbation du comit\u00e9 d&rsquo;\u00e9thique re\u00e7u<\/strong> et de Swissmedic (si applicable), il est temps de pr\u00e9parer le(s) site(s) (mono\/multicentrique) <strong>pour<\/strong> <strong>ouvrir officiellement l&rsquo;\u00e9tude<\/strong>.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><\/div>\n<\/div>\n\n\n\n<div style=\"height:78px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-text-align-center has-border-background-color has-background has-larger-font-size\">Pour les projets de recherche \u00e0 l&rsquo;exception des essais cliniques (ORH):<\/p>\n\n\n\n<div class=\"wp-block-columns alignfull are-vertically-aligned-top is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-top has-light-background-background-color has-background is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-group alignwide\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"has-text-align-center has-buttons-text-color has-light-background-background-color has-text-color has-background\" style=\"font-size:26px\">Pr\u00e9paration<\/p>\n\n\n\n<ul class=\"has-primary-color has-background-background-color has-text-color has-background has-normal-font-size wp-block-list\"><li>Base de donn\u00e9e (en production)<\/li><li>Liste d&rsquo;identification des participants (cl\u00e9 de codage)<\/li><li>Contrat si applicable<\/li><\/ul>\n<\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"background-color:#3fb8b8\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-group alignwide\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"has-text-align-center has-buttons-text-color has-text-color has-background\" style=\"background-color:#38b9b9;font-size:26px\">Conduite<\/p>\n\n\n\n<ul class=\"has-primary-color has-background-background-color has-text-color has-background has-normal-font-size wp-block-list\"><li>Recueil et gestion des donn\u00e9es<\/li><li>Collecte des consentements, si applicable<\/li><li>Suivi des \u00e9v\u00e9nements ind\u00e9sirables graves (EIG) <em>(uniquement ORH Chap 2)<\/em><\/li><\/ul>\n<\/div><\/div>\n<\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"background-color:#449493\">\n<div class=\"wp-block-group alignwide\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"has-text-align-center has-background-color has-text-color has-background\" style=\"background-color:#419593;font-size:26px\">Fermeture et archivage<\/p>\n\n\n\n<ul class=\"has-primary-color has-background-background-color has-text-color has-background has-normal-font-size wp-block-list\"><li>Nettoyage de la base de donn\u00e9es<\/li><li>Verrouillage de la base de donn\u00e9es<\/li><li>Archivage des donn\u00e9es pendant minimum 10 ans<\/li><\/ul>\n<\/div><\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:116px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-text-align-center has-border-background-color has-background has-larger-font-size\">Pour les essais cliniques (OClin) &amp; les essais cliniques avec dispositifs m\u00e9dicaux (OClin-Dim):<\/p>\n\n\n\n<div class=\"wp-block-columns alignfull are-vertically-aligned-top is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-top has-light-background-background-color has-background is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-group alignwide\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"has-text-align-center has-buttons-text-color has-light-background-background-color has-text-color has-background\" style=\"font-size:26px\">Pr\u00e9paration<\/p>\n\n\n\n<ul class=\"has-primary-color has-background-background-color has-text-color has-background has-normal-font-size wp-block-list\"><li>Base de donn\u00e9e (en production)<\/li><li>Plan de monitoring<\/li><li>Data Management Plan (DMP), (si applicable) <\/li><li>Trial Master File (TMF)<\/li><li>Investigator Site File (ISF)<\/li><li>Source Data Location Form (SDLF) sign\u00e9e<\/li><li>Liste de d\u00e9l\u00e9gation et formation<\/li><li>Liste de screening et d&rsquo;inclusion des participants<\/li><li>Liste d&rsquo;identification des participants (cl\u00e9 de codage)<\/li><li>Enregistrement : clinicaltrial.gov &amp; Kofam<\/li><\/ul>\n<\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"background-color:#3fb8b8\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-group alignwide\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"has-text-align-center has-buttons-text-color has-text-color has-background\" style=\"background-color:#38b9b9;font-size:26px\">Activation et Conduite<\/p>\n\n\n\n<ul class=\"has-primary-color has-background-background-color has-text-color has-background has-normal-font-size wp-block-list\"><li>Rapport de monitoring de la SIV sign\u00e9<\/li><li>Feu vert donn\u00e9 par la CER (et Swissmedic si applicable) et le moniteur <\/li><li>Recueil et gestion des donn\u00e9es<\/li><li>Collecte des consentements <\/li><li>Activit\u00e9s de monitoring<\/li><li>Suivi des \u00e9v\u00e9nements ind\u00e9sirables (EI) et des \u00e9v\u00e9nements ind\u00e9sirables graves (EIG)<\/li><\/ul>\n<\/div><\/div>\n<\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"background-color:#449493\">\n<div class=\"wp-block-group alignwide\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"has-text-align-center has-background-color has-text-color has-background\" style=\"background-color:#419593;font-size:26px\">Fermeture et archivage<\/p>\n\n\n\n<ul class=\"has-primary-color has-background-background-color has-text-color has-background has-normal-font-size wp-block-list\"><li>Nettoyage de la base de donn\u00e9es<\/li><li>Verrouillage de la base de donn\u00e9es<\/li><li>Visite de monitoring de cl\u00f4ture<\/li><li>Archivage des donn\u00e9es (la dur\u00e9e d\u00e9pend de la cat\u00e9gorie de l&rsquo;\u00e9tude)<\/li><\/ul>\n<\/div><\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<p><\/p>\n\n\n\n<div class=\"wp-block-group is-vertical is-content-justification-center is-layout-flex wp-container-core-group-is-layout-4b2eccd6 wp-block-group-is-layout-flex\">\n<figure class=\"wp-block-image size-medium is-resized\"><a href=\"https:\/\/wp.unil.ch\/hrp\/nous-contacter\/\" target=\"_blank\" rel=\"noreferrer noopener\"><img alt=\"\" loading=\"lazy\" decoding=\"async\" src=\"https:\/\/wp.unil.ch\/hrp\/files\/2022\/06\/question-edited-300x300.jpg\" alt=\"\" class=\"wp-image-953\" width=\"225\" height=\"225\" srcset=\"https:\/\/wp.unil.ch\/hrp\/files\/2022\/06\/question-edited-300x300.jpg 300w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/06\/question-edited-150x150.jpg 150w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/06\/question-edited-12x12.jpg 12w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/06\/question-edited-540x539.jpg 540w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/06\/question-edited.jpg 721w\" sizes=\"auto, (max-width: 225px) 100vw, 225px\" \/><\/a><\/figure>\n\n\n\n<div class=\"wp-block-group is-vertical is-content-justification-center is-layout-flex wp-container-core-group-is-layout-4b2eccd6 wp-block-group-is-layout-flex\">\n<p class=\"has-text-align-center w1 has-background-color has-buttons-background-background-color has-text-color has-background\"><a href=\"https:\/\/wp.unil.ch\/hrp\/nous-contacter\/\" data-type=\"page\" data-id=\"187\" target=\"_blank\" rel=\"noreferrer noopener\">J&rsquo;ai besoin d&rsquo;aide pour la conduite d&rsquo;\u00e9tude<\/a><\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Quelles \u00e9tapes pour la conduite d&rsquo;\u00e9tude? Cette section s&rsquo;applique aux projets de recherche autre que les essais cliniques (ORH), aux essais cliniques (OClin) ainsi qu&rsquo;aux essais cliniques avec&hellip;<\/p>\n","protected":false},"author":1002441,"featured_media":2260,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-full-width-cover.php","meta":{"_seopress_robots_primary_cat":"","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","footnotes":""},"class_list":["post-330","page","type-page","status-publish","has-post-thumbnail"],"_links":{"self":[{"href":"https:\/\/wp.unil.ch\/hrp\/wp-json\/wp\/v2\/pages\/330","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/wp.unil.ch\/hrp\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/wp.unil.ch\/hrp\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/wp.unil.ch\/hrp\/wp-json\/wp\/v2\/users\/1002441"}],"replies":[{"embeddable":true,"href":"https:\/\/wp.unil.ch\/hrp\/wp-json\/wp\/v2\/comments?post=330"}],"version-history":[{"count":0,"href":"https:\/\/wp.unil.ch\/hrp\/wp-json\/wp\/v2\/pages\/330\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/wp.unil.ch\/hrp\/wp-json\/wp\/v2\/media\/2260"}],"wp:attachment":[{"href":"https:\/\/wp.unil.ch\/hrp\/wp-json\/wp\/v2\/media?parent=330"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}