{"id":42299,"date":"2020-04-29T03:00:52","date_gmt":"2020-04-29T01:00:52","guid":{"rendered":"https:\/\/www.cde.ual.es\/?p=42299"},"modified":"2020-04-28T13:54:27","modified_gmt":"2020-04-28T11:54:27","slug":"coronavirus-commission-issues-guidance-to-mitigate-clinical-trial-disruption-in-the-eu","status":"publish","type":"post","link":"https:\/\/www.cde.ual.es\/en\/coronavirus-commission-issues-guidance-to-mitigate-clinical-trial-disruption-in-the-eu\/","title":{"rendered":"Coronavirus: Commission issues guidance to mitigate clinical trial disruption in the EU"},"content":{"rendered":"<p>The Commission published yesterday <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-10\/guidanceclinicaltrials_covid19_en.pdf\">guidance<\/a>\u00a0to ensure that clinical trials can continue taking place in the EU during the COVID-19 pandemic.<\/p>\n<p><a href=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/04\/laboratory.jpg\"><img decoding=\"async\" class=\"size-medium wp-image-41878 aligncenter\" src=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/04\/laboratory-300x200.jpg\" alt=\"\" width=\"300\" height=\"200\" srcset=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/04\/laboratory-300x200.jpg 300w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/04\/laboratory-1024x683.jpg 1024w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/04\/laboratory-768x512.jpg 768w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/04\/laboratory-1536x1024.jpg 1536w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/04\/laboratory.jpg 1920w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a><\/p>\n<h3>Aim<\/h3>\n<p>The aim is to <strong>mitigate the disruption of clinical research in Europe and therefore the negative effects of the pandemic<\/strong>, without compromising on quality and safety. These recommendations are an important part of the overall strategy in finding treatments and a vaccine to protect citizens against the coronavirus.<\/p>\n<p>With more than 200 coronavirus clinical trials now registered in the EU database (<a href=\"https:\/\/eudract.ema.europa.eu\/\">EudraCT<\/a>), the guidance offers recommendations <strong>for simple and flexible measures to respond to the current situation, and to ensure that patients participating in clinical trials across the EU<\/strong> can continue receiving their medicines.<\/p>\n<h3>Key recommendations<\/h3>\n<p>Key recommendations of the guidance cover:<\/p>\n<ul>\n<li>Distribution of medicines to patients in clinical trials<\/li>\n<li>Remote source data verification (SDV)<\/li>\n<li>Communication to authorities<\/li>\n<\/ul>\n<p>These measures will be used exclusively during the coronavirus pandemic, and will be revoked once the current health crisis in the EU\/EEA has been surpassed.<\/p>\n<h3>More information<\/h3>\n<p><a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/IP_20_759\">Press release &#8211; European Commission<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Commission published yesterday guidance\u00a0to ensure that clinical trials can continue taking place in the EU during the COVID-19 pandemic. Aim The aim is to mitigate the disruption of clinical research in Europe and therefore the negative effects of the pandemic, without compromising on quality and safety. These recommendations are an important part of the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":41878,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[346,4092,4064,4096],"tags":[1322],"class_list":{"0":"post-42299","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-eu-news","8":"category-health","9":"category-institutional","10":"category-tech-prof-health","11":"tag-coronavirus-en","12":"entry"},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Coronavirus: Commission issues guidance to mitigate clinical trial disruption in the EU | CDE Almer\u00eda - Centro de Documentaci\u00f3n Europea - Universidad de Almer\u00eda<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.cde.ual.es\/en\/coronavirus-commission-issues-guidance-to-mitigate-clinical-trial-disruption-in-the-eu\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Coronavirus: Commission issues guidance to mitigate clinical trial disruption in the EU | CDE Almer\u00eda - Centro de Documentaci\u00f3n Europea - Universidad de Almer\u00eda\" \/>\n<meta property=\"og:description\" content=\"The Commission published yesterday guidance\u00a0to ensure that clinical trials can continue taking place in the EU during the COVID-19 pandemic. 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