{"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\/en\/activation-des-centres-participants\/","title":{"rendered":"Study conduct"},"content":{"rendered":"<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\">What are the steps for conducting the study?<\/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>This section applies to human research with the exception of clinical trials (HRO), to clinical trials (ClinO) and clinical trials with medical devices (ClinO-MD)<\/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\">Once you received <strong>approval from the ethics committee<\/strong> and Swissmedic (if applicable), it is time to prepare the site(s) (mono\/multicentric) <strong>to<\/strong> <strong>officially open the study<\/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\">For research projects with the exception of clinical trials (HRO):<\/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\">Preparation<\/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>Database (in production)<\/li><li>Participant identification log (coding key)<\/li><li>Contract if 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\">Conduct<\/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>Data collection and management<\/li><li>Collection of consents, if applicable<\/li><li>Monitoring of serious adverse events (SAE) <em>(only HRO 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\">Close out and archiving<\/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>Database cleaning<\/li><li>Database locking<\/li><li>Data archiving for a minimum of 10 years<\/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\">For clinical trials (ClinO) &amp; clinical trials with medical devices (ClinO-MD):<\/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\">Preparation<\/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>Database (in production)<\/li><li>Monitoring plan<\/li><li>Data Management Plan (DMP), (if applicable) <\/li><li>Trial Master File (TMF)<\/li><li>Investigator Site File (ISF)<\/li><li>Source Data Location Form (SDLF) signed<\/li><li>List of delegations and training<\/li><li>Screening and inclusion list of participants<\/li><li>Participant identification log (coding key)<\/li><li>Registration : 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 and Conduct<\/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>SIV monitoring report signed<\/li><li>Green light given by the CER (and Swissmedic if applicable) and the monitor <\/li><li>Data collection and management<\/li><li>Collection of consents <\/li><li>Monitoring activities<\/li><li>Monitoring of adverse events (AE) and serious adverse events (SAE)<\/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\">Close out and archiving<\/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>Database cleaning<\/li><li>Database locking<\/li><li>Close out monitoring visit<\/li><li>Data archiving (duration depends on the category of the study)<\/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\/en\/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\" 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\/en\/nous-contacter\/\" data-type=\"page\" data-id=\"187\" target=\"_blank\" rel=\"noreferrer noopener\">I need help for study conduct<\/a><\/p>\n<\/div>\n<\/div>","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>","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\/en\/wp-json\/wp\/v2\/pages\/330","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=330"}],"version-history":[{"count":0,"href":"https:\/\/wp.unil.ch\/hrp\/en\/wp-json\/wp\/v2\/pages\/330\/revisions"}],"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=330"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}