{"id":319,"date":"2022-05-19T16:38:44","date_gmt":"2022-05-19T14:38:44","guid":{"rendered":"https:\/\/wp.unil.ch\/hrp\/?page_id=319"},"modified":"2022-09-05T10:52:59","modified_gmt":"2022-09-05T08:52:59","slug":"les-etapes-a-suivre-pour-creer-mon-projet","status":"publish","type":"page","link":"https:\/\/wp.unil.ch\/hrp\/en\/les-etapes-a-suivre-pour-creer-mon-projet\/","title":{"rendered":"ID my project"},"content":{"rendered":"<p class=\"has-light-background-color has-text-color\" style=\"font-size:50px\">The steps to follow to create my project<\/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\">\n<p class=\"justifier has-large-font-size\">This section provides an overview of the<strong> most important regulatory processes<\/strong> in the context of the <strong>development<\/strong> and <strong>submission<\/strong> of <strong>human research projects<\/strong> (including clinical trials and clinical trials with medical devices) to <strong>ethics committees<\/strong> (EC) and public <strong>health authorities <\/strong>.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:58px\" 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\">\n<figure class=\"wp-block-image size-full is-resized\"><a href=\"https:\/\/wp.unil.ch\/hrp\/en\/lrh_oclin_orh\/\"><img alt=\"\" loading=\"lazy\" decoding=\"async\" src=\"http:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/step1_design.png\" class=\"wp-image-2033\" width=\"350\" height=\"401\" srcset=\"https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/step1_design.png 467w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/step1_design-262x300.png 262w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/step1_design-10x12.png 10w\" sizes=\"auto, (max-width: 350px) 100vw, 350px\" \/><\/a><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-full is-resized\"><a href=\"https:\/\/wp.unil.ch\/hrp\/en\/soumission\/\"><img alt=\"\" loading=\"lazy\" decoding=\"async\" src=\"http:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/step2_writing.png\" class=\"wp-image-2034\" width=\"350\" height=\"401\" srcset=\"https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/step2_writing.png 467w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/step2_writing-262x300.png 262w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/step2_writing-10x12.png 10w\" sizes=\"auto, (max-width: 350px) 100vw, 350px\" \/><\/a><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-full is-resized\"><a href=\"https:\/\/wp.unil.ch\/hrp\/en\/activation-des-centres-participants\/\"><img alt=\"\" loading=\"lazy\" decoding=\"async\" src=\"http:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/step3_study_conduct.png\" class=\"wp-image-2035\" width=\"350\" height=\"401\" srcset=\"https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/step3_study_conduct.png 467w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/step3_study_conduct-262x300.png 262w, https:\/\/wp.unil.ch\/hrp\/files\/2022\/09\/step3_study_conduct-10x12.png 10w\" sizes=\"auto, (max-width: 350px) 100vw, 350px\" \/><\/a><\/figure>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:100px\" 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\">\n<div class=\"wp-block-group is-vertical is-layout-flex wp-container-core-group-is-layout-8cf370e7 wp-block-group-is-layout-flex\">\n<p class=\"justifier has-large-font-size translation-block\">Human research projects in Switzerland are subject to the obligations stipulated by <strong>international guidelines<\/strong> and <strong>federal regulations<\/strong>. These regulations assure the public that the <strong>rights, safety and well-being of participants<\/strong> are protected and that the <strong>data collected is reliable<\/strong><\/p>\n\n\n\n<p class=\"justifier has-large-font-size\">Swiss regulations on human research projects respect the <strong>ethical principles<\/strong> described in <strong>several international guidelines<\/strong>, such as the <a rel=\"noreferrer noopener\" href=\"https:\/\/www.wma.net\/fr\/policies-post\/declaration-dhelsinki-de-lamm-principes-ethiques-applicables-a-la-recherche-medicale-impliquant-des-etres-humains\/\" data-type=\"URL\" data-id=\"https:\/\/www.wma.net\/fr\/policies-post\/declaration-dhelsinki-de-lamm-principes-ethiques-applicables-a-la-recherche-medicale-impliquant-des-etres-humains\/\" target=\"_blank\">Declaration of Helsinki<\/a> of the World medical association, the <a rel=\"noreferrer noopener\" href=\"https:\/\/cioms.ch\/wp-content\/uploads\/2017\/01\/WEB-CIOMS-EthicalGuidelines.pdf\" data-type=\"URL\" data-id=\"https:\/\/cioms.ch\/wp-content\/uploads\/2017\/01\/WEB-CIOMS-EthicalGuidelines.pdf\" target=\"_blank\">international ethical guidelines<\/a> for health research involving human subjects of the Council for International Organisations of Medical Sciences (<a rel=\"noreferrer noopener\" href=\"https:\/\/cioms.ch\/\" data-type=\"URL\" data-id=\"https:\/\/cioms.ch\/\" target=\"_blank\">CIOMS<\/a>) and the <a rel=\"noreferrer noopener\" href=\"https:\/\/ich.org\/page\/efficacy-guidelines\" data-type=\"URL\" data-id=\"https:\/\/ich.org\/page\/efficacy-guidelines\" target=\"_blank\">Good Clinical Practice<\/a> of the International Council for Harmonisation of technical requirements for pharmaceuticals for human use (<a rel=\"noreferrer noopener\" href=\"https:\/\/ich.org\/page\/efficacy-guidelines\" data-type=\"URL\" data-id=\"https:\/\/ich.org\/page\/efficacy-guidelines\" target=\"_blank\">ICH<\/a>), the latter being explicitly referred to in the Swiss legal texts.<\/p>\n<\/div>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Les \u00e9tapes \u00e0 suivre pour cr\u00e9er mon projet Cette section donne un aper\u00e7u des processus r\u00e9glementaires les plus importants dans le contexte du d\u00e9veloppement et de la soumission&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-319","page","type-page","status-publish","has-post-thumbnail"],"_links":{"self":[{"href":"https:\/\/wp.unil.ch\/hrp\/en\/wp-json\/wp\/v2\/pages\/319","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=319"}],"version-history":[{"count":0,"href":"https:\/\/wp.unil.ch\/hrp\/en\/wp-json\/wp\/v2\/pages\/319\/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=319"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}