{"id":48988,"date":"2023-06-13T16:44:30","date_gmt":"2023-06-13T16:44:30","guid":{"rendered":"https:\/\/www.arisglobal.com\/?p=48988"},"modified":"2023-06-13T16:44:30","modified_gmt":"2023-06-13T16:44:30","slug":"eu-clinical-trial-regulation","status":"publish","type":"post","link":"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/","title":{"rendered":"3 Changes (and Benefits) of the EU Clinical Trials Regulation"},"content":{"rendered":"

The European Union (EU) Clinical Trials Regulation (CTR)<\/a> harmonizes the processes for assessment and supervision of clinical trials throughout the EU. Effective from January 2022, it means to foster innovation and research in the region.<\/p>\n

Prior to the CTR,\u202fclinical trial\u202fsponsors had to submit\u202fclinical trial\u202fapplications\u202fseparately to\u202fnational competent authorities\u202fand\u202fethics committees\u202fin each country to gain regulatory approval to run a\u202fclinical trial. With the new CTR,\u202fsponsors need only submit one\u202fapplication for\u202fapproval to run a\u202fclinical trial\u202fin several\u202fEuropean countries, making\u202fit more efficient to carry out multinational trials.\u202fMoreover, legally being a regulation rather than a directive like its predecessor means that the new CTR is binding in all EU member states immediately without any national legislation being required, ensuring the desired consistency across the region.<\/p>\n

A transition period applied to clinical trial submissions under the CTR but since January 2023,\u202fclinical trial applications must be submitted via the new online platform, the Clinical Trials Information System (CTIS). Additionally, from January 2025, any trials approved under the prior directive that are still ongoing must comply with the CTR and must have trial information captured in CTIS.<\/p>\n

<\/h2>\n

Three Impacts of CTR<\/h2>\n

While the new EU CTR is hailed as a positive change and enabler in the region, it will undoubtedly place stress on sponsors to file more data and submit in a different way. Here are three things that stand out as benefits from this revised, enhanced regulation:<\/p>\n

Increased Trial Master File (TMF) Retention Period\u00a0<\/strong><\/p>\n

There are new requirements and more documentation to be filed generally under the new CTR. However, the current TMF Reference Model artifacts seem adequate overall, perhaps with some extra sub-artifacts. The greatest impact on the TMF is regarding its long-term storage. Henceforth, the CTR mandates data to be available in a readable and usable state for 25 years from the end of the clinical trial<\/a>, which could be a costly endeavor.<\/p>\n

Personal and Company Data Protection\u00a0<\/strong><\/p>\n

Redacted, \u201cfor publication\u201d document versions are now to be created and uploaded to CTIS along with the full document versions. This will prevent publication of personal protected data, needed for patient privacy and safety. It will prevent the publication of confidential company information, which should help appease pharma\u2019s competition concerns. Regardless, the effort in producing those redacted documents will be a significant new burden.<\/p>\n

Health Literacy Empowerment\u00a0<\/strong><\/p>\n

The CTR \u2013 for the first time ever \u2013 mandates lay persons\u2019 versions of the protocol synopsis and clinical trial summary report. These lay summaries are aimed at both study participants and the public. This will go a long way to reducing complexity of clinical trial information and increasing transparency. A much-needed step toward greater patient empowerment and health literacy, though typically extra work for sponsors.<\/p>\n

As you can see, the CTR touches and evolves various areas of clinical trials. The European medicines regulatory network publishes monthly figures<\/a> on clinical trial applications and approvals to share progress on the implementation of the CTR. Data for the first quarter since the CTIS milestone is now available, and while we do not have enough data yet to hail major successes, the figures thus far show an upward trend both in applications and positive decisions.<\/p>\n

It also shows which EU member states are more active in clinical trials, commercial\/non-commercial trial splits, mono-national vs multinational trials, amongst other data. An interesting monthly read to keep abreast of progress and follow trends that are sure to surface over time.<\/p>\n

<\/h2>\n

Regulation Updates Require Agile Technology Solutions<\/h2>\n

The reality is that regulations will continue to change. Technology can enable organizations to speed up data gathering and compliance, but it must be agile enough to maintain compliance. For example, having a next-generation eTMF system<\/a> is an essential step for any organization, whether sponsor or CRO. \u00a0By having a solution that supports not only the clinical documentation you need but also aligns to global standards, organizations can always keep up with the latest recommendations like the EU CTR without issue.<\/p>\n

Learn more about how LifeSphere eTMF provides the next-generation solution for your organization, keeping your TMF compliant and inspection-ready\u00a0via this checklist<\/a> or contact us for a demo<\/a> today to learn more.<\/p>\n","protected":false},"excerpt":{"rendered":"

The European Union (EU) Clinical Trials Regulation (CTR) harmonizes the […]<\/p>\n","protected":false},"author":27,"featured_media":48989,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67],"tags":[84,85,147,158,171],"class_list":["post-48988","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs","tag-clinical-trial","tag-clinical","tag-etmf","tag-tmf","tag-eu-ctr"],"acf":[],"yoast_head":"\n3 Changes (and Benefits) of the EU Clinical Trials Regulation | ArisGlobal<\/title>\n<meta name=\"description\" content=\"What's next for clinical trials in the European Union? Learn what the new EU Clinical Trial Regulation changes for organizations.\" \/>\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.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"3 Changes (and Benefits) of the EU Clinical Trials Regulation\" \/>\n<meta property=\"og:description\" content=\"What's next for clinical trials in the European Union? Learn what the new EU Clinical Trial Regulation changes for organizations.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/\" \/>\n<meta property=\"og:site_name\" content=\"ArisGlobal\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/LifeSphereAG\/\" \/>\n<meta property=\"article:published_time\" content=\"2023-06-13T16:44:30+00:00\" \/>\n<meta name=\"author\" content=\"Mladen Prenc\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Mladen Prenc\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/\"},\"author\":{\"name\":\"Mladen Prenc\",\"@id\":\"https:\/\/www.arisglobal.com\/#\/schema\/person\/bb2c7aafe44a090bcd667448651eb974\"},\"headline\":\"3 Changes (and Benefits) of the EU Clinical Trials Regulation\",\"datePublished\":\"2023-06-13T16:44:30+00:00\",\"dateModified\":\"2023-06-13T16:44:30+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/\"},\"wordCount\":705,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.arisglobal.com\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/#primaryimage\"},\"thumbnailUrl\":\"\",\"keywords\":[\"Clinical Trial\",\"Clinical\",\"etmf\",\"tmf\",\"EU CTR\"],\"articleSection\":[\"Blog\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/\",\"url\":\"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/\",\"name\":\"3 Changes (and Benefits) of the EU Clinical Trials Regulation | ArisGlobal\",\"isPartOf\":{\"@id\":\"https:\/\/www.arisglobal.com\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/#primaryimage\"},\"thumbnailUrl\":\"\",\"datePublished\":\"2023-06-13T16:44:30+00:00\",\"dateModified\":\"2023-06-13T16:44:30+00:00\",\"description\":\"What's next for clinical trials in the European Union? Learn what the new EU Clinical Trial Regulation changes for organizations.\",\"breadcrumb\":{\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/#primaryimage\",\"url\":\"\",\"contentUrl\":\"\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.arisglobal.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"3 Changes (and Benefits) of the EU Clinical Trials Regulation\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.arisglobal.com\/#website\",\"url\":\"https:\/\/www.arisglobal.com\/\",\"name\":\"ArisGlobal\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\/\/www.arisglobal.com\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.arisglobal.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.arisglobal.com\/#organization\",\"name\":\"LifeSphere\",\"url\":\"https:\/\/www.arisglobal.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.arisglobal.com\/#\/schema\/logo\/image\/\",\"url\":\"\",\"contentUrl\":\"\",\"caption\":\"LifeSphere\"},\"image\":{\"@id\":\"https:\/\/www.arisglobal.com\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.facebook.com\/LifeSphereAG\/\",\"https:\/\/www.linkedin.com\/products\/aris-global-lifesphere\/\"]},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.arisglobal.com\/#\/schema\/person\/bb2c7aafe44a090bcd667448651eb974\",\"name\":\"Mladen Prenc\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"3 Changes (and Benefits) of the EU Clinical Trials Regulation | ArisGlobal","description":"What's next for clinical trials in the European Union? Learn what the new EU Clinical Trial Regulation changes for organizations.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/","og_locale":"en_US","og_type":"article","og_title":"3 Changes (and Benefits) of the EU Clinical Trials Regulation","og_description":"What's next for clinical trials in the European Union? Learn what the new EU Clinical Trial Regulation changes for organizations.","og_url":"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/","og_site_name":"ArisGlobal","article_publisher":"https:\/\/www.facebook.com\/LifeSphereAG\/","article_published_time":"2023-06-13T16:44:30+00:00","author":"Mladen Prenc","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Mladen Prenc","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/#article","isPartOf":{"@id":"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/"},"author":{"name":"Mladen Prenc","@id":"https:\/\/www.arisglobal.com\/#\/schema\/person\/bb2c7aafe44a090bcd667448651eb974"},"headline":"3 Changes (and Benefits) of the EU Clinical Trials Regulation","datePublished":"2023-06-13T16:44:30+00:00","dateModified":"2023-06-13T16:44:30+00:00","mainEntityOfPage":{"@id":"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/"},"wordCount":705,"commentCount":0,"publisher":{"@id":"https:\/\/www.arisglobal.com\/#organization"},"image":{"@id":"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/#primaryimage"},"thumbnailUrl":"","keywords":["Clinical Trial","Clinical","etmf","tmf","EU CTR"],"articleSection":["Blog"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/","url":"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/","name":"3 Changes (and Benefits) of the EU Clinical Trials Regulation | ArisGlobal","isPartOf":{"@id":"https:\/\/www.arisglobal.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/#primaryimage"},"image":{"@id":"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/#primaryimage"},"thumbnailUrl":"","datePublished":"2023-06-13T16:44:30+00:00","dateModified":"2023-06-13T16:44:30+00:00","description":"What's next for clinical trials in the European Union? Learn what the new EU Clinical Trial Regulation changes for organizations.","breadcrumb":{"@id":"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/#primaryimage","url":"","contentUrl":""},{"@type":"BreadcrumbList","@id":"https:\/\/www.arisglobal.com\/blogs\/eu-clinical-trial-regulation\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.arisglobal.com\/"},{"@type":"ListItem","position":2,"name":"3 Changes (and Benefits) of the EU Clinical Trials Regulation"}]},{"@type":"WebSite","@id":"https:\/\/www.arisglobal.com\/#website","url":"https:\/\/www.arisglobal.com\/","name":"ArisGlobal","description":"","publisher":{"@id":"https:\/\/www.arisglobal.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.arisglobal.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.arisglobal.com\/#organization","name":"LifeSphere","url":"https:\/\/www.arisglobal.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.arisglobal.com\/#\/schema\/logo\/image\/","url":"","contentUrl":"","caption":"LifeSphere"},"image":{"@id":"https:\/\/www.arisglobal.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/LifeSphereAG\/","https:\/\/www.linkedin.com\/products\/aris-global-lifesphere\/"]},{"@type":"Person","@id":"https:\/\/www.arisglobal.com\/#\/schema\/person\/bb2c7aafe44a090bcd667448651eb974","name":"Mladen Prenc"}]}},"_links":{"self":[{"href":"https:\/\/www.arisglobal.com\/wp-json\/wp\/v2\/posts\/48988"}],"collection":[{"href":"https:\/\/www.arisglobal.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.arisglobal.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.arisglobal.com\/wp-json\/wp\/v2\/users\/27"}],"replies":[{"embeddable":true,"href":"https:\/\/www.arisglobal.com\/wp-json\/wp\/v2\/comments?post=48988"}],"version-history":[{"count":0,"href":"https:\/\/www.arisglobal.com\/wp-json\/wp\/v2\/posts\/48988\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.arisglobal.com\/wp-json\/"}],"wp:attachment":[{"href":"https:\/\/www.arisglobal.com\/wp-json\/wp\/v2\/media?parent=48988"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.arisglobal.com\/wp-json\/wp\/v2\/categories?post=48988"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.arisglobal.com\/wp-json\/wp\/v2\/tags?post=48988"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}