{"id":73,"date":"2023-12-05T10:34:09","date_gmt":"2023-12-05T09:34:09","guid":{"rendered":"https:\/\/www.gimema.it\/en\/?page_id=73"},"modified":"2024-06-19T22:50:26","modified_gmt":"2024-06-19T20:50:26","slug":"quality-and-certification-system","status":"publish","type":"page","link":"https:\/\/www.gimema.it\/en\/quality-and-certification-system\/","title":{"rendered":"Quality and certification system"},"content":{"rendered":"<style>.kadence-column73_0d4041-81 > .kt-inside-inner-col{padding-bottom:var(--global-kb-spacing-xl, 4rem);}.kadence-column73_0d4041-81 > .kt-inside-inner-col,.kadence-column73_0d4041-81 > .kt-inside-inner-col:before{border-top-left-radius:0px;border-top-right-radius:0px;border-bottom-right-radius:0px;border-bottom-left-radius:0px;}.kadence-column73_0d4041-81 > .kt-inside-inner-col{column-gap:var(--global-kb-gap-sm, 1rem);}.kadence-column73_0d4041-81 > .kt-inside-inner-col{flex-direction:column;}.kadence-column73_0d4041-81 > .kt-inside-inner-col > .aligncenter{width:100%;}.kadence-column73_0d4041-81 > .kt-inside-inner-col:before{opacity:0.3;}.kadence-column73_0d4041-81{position:relative;}@media all and (max-width: 1024px){.kadence-column73_0d4041-81 > .kt-inside-inner-col{flex-direction:column;}}@media all and (max-width: 767px){.kadence-column73_0d4041-81 > .kt-inside-inner-col{flex-direction:column;}}<\/style>\n<div class=\"wp-block-kadence-column kadence-column73_0d4041-81\"><div class=\"kt-inside-inner-col\">\n<p>The activities of the Data Centre, the operating centre that coordinates all of the Foundation\u2019s research activities, are performed according to a Quality System that is structured around a series of standard operating procedures (SOPs), compliant with international regulations and good clinical practice (GCP), that guarantee the consistency, effectiveness and uniformity of the activities performed within the facility. These SOPs are backed by the system procedures that establish the operating processes of the Data Centre infrastructure.<\/p>\n\n\n\n<p>As a result of the recurrent external validation processes, the Data Centre is certified according to the EN ISO 9001:2015 standard for activities related to the &nbsp;\u201cDesign, implementation and management of clinical trials\u201d and for the \u201cDesign and provision of events and training courses\u201d.<\/p>\n<\/div><\/div>\n\n\n<style>.kadence-column73_492da7-33 > .kt-inside-inner-col,.kadence-column73_492da7-33 > .kt-inside-inner-col:before{border-top-left-radius:0px;border-top-right-radius:0px;border-bottom-right-radius:0px;border-bottom-left-radius:0px;}.kadence-column73_492da7-33 > .kt-inside-inner-col{column-gap:var(--global-kb-gap-sm, 1rem);}.kadence-column73_492da7-33 > .kt-inside-inner-col{flex-direction:column;}.kadence-column73_492da7-33 > .kt-inside-inner-col > .aligncenter{width:100%;}.kadence-column73_492da7-33 > .kt-inside-inner-col:before{opacity:0.3;}.kadence-column73_492da7-33{position:relative;}@media all and (max-width: 1024px){.kadence-column73_492da7-33 > .kt-inside-inner-col{flex-direction:column;}}@media all and (max-width: 767px){.kadence-column73_492da7-33 > .kt-inside-inner-col{flex-direction:column;}}<\/style>\n<div class=\"wp-block-kadence-column kadence-column73_492da7-33\"><div class=\"kt-inside-inner-col\">\n<h2 class=\"wp-block-heading\"><strong>ECRIN Certification<\/strong><\/h2>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile\" style=\"grid-template-columns:24% auto\"><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"404\" src=\"https:\/\/www.gimema.it\/en\/wp-content\/uploads\/2024\/05\/logoecrin-1-1024x404.webp\" alt=\"\" class=\"wp-image-361 size-full\" srcset=\"https:\/\/www.gimema.it\/en\/wp-content\/uploads\/2024\/05\/logoecrin-1-1024x404.webp 1024w, https:\/\/www.gimema.it\/en\/wp-content\/uploads\/2024\/05\/logoecrin-1-300x118.webp 300w, https:\/\/www.gimema.it\/en\/wp-content\/uploads\/2024\/05\/logoecrin-1-768x303.webp 768w, https:\/\/www.gimema.it\/en\/wp-content\/uploads\/2024\/05\/logoecrin-1-1536x606.webp 1536w, https:\/\/www.gimema.it\/en\/wp-content\/uploads\/2024\/05\/logoecrin-1-2048x808.webp 2048w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure><div class=\"wp-block-media-text__content\">\n<p>Since 2015 the Data Centre is one of the Clinical Trial Units certified at a European level by the <a href=\"https:\/\/ecrin.org\/\"  target=\"_blank\">ECRIN<\/a> consortium for its capacity to provide <em>data management <\/em>services in clinical studies that are compliance with regulations, effective and efficient.<\/p>\n<\/div><\/div>\n\n\n\n<p><a href=\"https:\/\/ecrin.org\/data-centre-certification\"  target=\"_blank\">The certification programme<\/a> assesses the unit\u2019s compliance to ECRIN quality standards by carrying out an audit on the data management activities of the unit and IT infrastructure used to support these activities.<\/p>\n\n\n\n<p>In 2021, following a second audit, the certification was renewed for another five-year cycle.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The activities of the Data Centre, the operating centre that coordinates all of the Foundation\u2019s research activities, are performed according to a Quality System that is structured around a series of standard operating procedures (SOPs), compliant with international regulations and good clinical practice (GCP), that guarantee the consistency, effectiveness and uniformity of the activities performed&hellip; <a class=\"more-link\" href=\"https:\/\/www.gimema.it\/en\/quality-and-certification-system\/\">Continue reading <span class=\"screen-reader-text\">Quality and certification system<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-73","page","type-page","status-publish","hentry","entry"],"_links":{"self":[{"href":"https:\/\/www.gimema.it\/en\/wp-json\/wp\/v2\/pages\/73","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.gimema.it\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.gimema.it\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.gimema.it\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.gimema.it\/en\/wp-json\/wp\/v2\/comments?post=73"}],"version-history":[{"count":7,"href":"https:\/\/www.gimema.it\/en\/wp-json\/wp\/v2\/pages\/73\/revisions"}],"predecessor-version":[{"id":476,"href":"https:\/\/www.gimema.it\/en\/wp-json\/wp\/v2\/pages\/73\/revisions\/476"}],"wp:attachment":[{"href":"https:\/\/www.gimema.it\/en\/wp-json\/wp\/v2\/media?parent=73"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}