{"id":1892,"date":"2022-08-11T13:58:56","date_gmt":"2022-08-11T11:58:56","guid":{"rendered":"https:\/\/wp.unil.ch\/hrp\/?page_id=1892"},"modified":"2025-06-30T14:47:54","modified_gmt":"2025-06-30T12:47:54","slug":"monitoring","status":"publish","type":"page","link":"https:\/\/wp.unil.ch\/hrp\/en\/monitoring\/","title":{"rendered":"Monitoring"},"content":{"rendered":"<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<div class=\"wp-block-group justifier is-vertical is-layout-flex wp-container-core-group-is-layout-8cf370e7 wp-block-group-is-layout-flex\">\n<p style=\"font-size:20px\" class=\"translation-block\">The purpose of the monitoring activity is to <strong>ensure that the rights and welfare of the subjects are protected,<\/strong> and that the clinical trial (ClinO) or clinical trial with medical device (ClinO-MD) <strong>data<\/strong> entered into the database is <strong>accurate, complete and verifiable from the source documents.<\/strong><\/p>\n\n\n\n<p style=\"font-size:20px\" class=\"translation-block\">It also oversees the conduct of a clinical trial or a clinical trial with a medical device and ensures that it is <strong>conducted, recorded and reported<\/strong> in accordance with the study <strong>protocol<\/strong>, <strong>applicable quality documents<\/strong>, <strong>Good Clinical Practice (GCP)<\/strong> (<em>ICH E6 GCP 5.18)<\/em> and <strong>applicable regulations.<\/strong><\/p>\n<\/div>\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:4px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/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-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:70%\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img alt=\"\" loading=\"lazy\" decoding=\"async\" width=\"4507\" height=\"1336\" src=\"http:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/monitoring_en.png\" class=\"wp-image-2734\" srcset=\"https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/monitoring_en.png 4507w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/monitoring_en-300x89.png 300w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/monitoring_en-1024x304.png 1024w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/monitoring_en-768x228.png 768w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/monitoring_en-1536x455.png 1536w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/monitoring_en-2048x607.png 2048w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/monitoring_en-18x5.png 18w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/monitoring_en-540x160.png 540w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/monitoring_en-1080x320.png 1080w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/monitoring_en-1980x587.png 1980w\" sizes=\"auto, (max-width: 4507px) 100vw, 4507px\" \/><\/figure>\n<\/div><\/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:5px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/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=\"justifier\" style=\"font-size:20px\">Contact us to find out more about how the monitoring should be set up.<\/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:46px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><a href=\"https:\/\/wp.unil.ch\/hrp\/en\/prestations\/\"><img alt=\"\" loading=\"lazy\" decoding=\"async\" width=\"467\" height=\"534\" src=\"http:\/\/wp.unil.ch\/hrp\/files\/2022\/07\/Monitor_textEN.png\" class=\"wp-image-1667\" style=\"width:234px;height:267px\" srcset=\"https:\/\/wp.unil.ch\/hrp\/files\/2022\/07\/Monitor_textEN.png 467w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/07\/Monitor_textEN-262x300.png 262w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/07\/Monitor_textEN-10x12.png 10w\" sizes=\"auto, (max-width: 467px) 100vw, 467px\" \/><\/a><\/figure>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>L\u2019 activit\u00e9 de monitoring a pour but de garantir que les droits et le bien-\u00eatre des sujets sont prot\u00e9g\u00e9s, et que les donn\u00e9es de l&rsquo;essai clinique (OClin) ou&hellip;<\/p>","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-1892","page","type-page","status-publish","has-post-thumbnail"],"_links":{"self":[{"href":"https:\/\/wp.unil.ch\/hrp\/en\/wp-json\/wp\/v2\/pages\/1892","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/wp.unil.ch\/hrp\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/wp.unil.ch\/hrp\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/wp.unil.ch\/hrp\/en\/wp-json\/wp\/v2\/users\/1002441"}],"replies":[{"embeddable":true,"href":"https:\/\/wp.unil.ch\/hrp\/en\/wp-json\/wp\/v2\/comments?post=1892"}],"version-history":[{"count":1,"href":"https:\/\/wp.unil.ch\/hrp\/en\/wp-json\/wp\/v2\/pages\/1892\/revisions"}],"predecessor-version":[{"id":3370,"href":"https:\/\/wp.unil.ch\/hrp\/en\/wp-json\/wp\/v2\/pages\/1892\/revisions\/3370"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/wp.unil.ch\/hrp\/en\/wp-json\/wp\/v2\/media\/2260"}],"wp:attachment":[{"href":"https:\/\/wp.unil.ch\/hrp\/en\/wp-json\/wp\/v2\/media?parent=1892"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}