{"id":1997,"date":"2026-05-12T02:45:00","date_gmt":"2026-05-12T02:45:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2026\/05\/12\/ich-m11-expert-working-group-issues-final-overview-presentation\/"},"modified":"2026-05-12T02:45:00","modified_gmt":"2026-05-12T02:45:00","slug":"ich-m11-expert-working-group-issues-final-overview-presentation","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2026\/05\/12\/ich-m11-expert-working-group-issues-final-overview-presentation\/","title":{"rendered":"ICH M11 Expert Working Group Issues Final Overview Presentation"},"content":{"rendered":"<p>The ICH M11 Expert Working Group has issued a final overview presentation (at <em>Step 4<\/em> of the ICH harmonisation process) for ICH M11: The Clinical electronic Structured Harmonised Protocol (CeSHarP), a guideline adopted in November 2025.<\/p>\n<p>ICH M11 is a comprehensive guideline that actually consists of three interconnected documents that together standardise clinical trial protocol format, content and exchange: a harmonised guideline; a clinical trial protocol template; and a technical specification to enable the electronic exchange of protocol contents.<\/p>\n<p>These three documents apply to interventional clinical trials of medicinal products across all phases and therapeutic areas, covering pharmaceuticals, biologics, vaccines, drug-device combinations and cell or gene therapy products.<\/p>\n<p>Prior to ICH M11, there was no globally harmonised standard for clinical trial protocol format and content, leading to significant variability across trial sponsors and regions.<\/p>\n<p>Implementing a common template and technical specification for clinical trial protocols will reduce inefficiencies and difficulties in searching and reviewing protocols, and allow for electronic protocol exchange using an interoperable standard.<\/p>\n<p>&gt;&gt; Find the <em>Step 4<\/em> overview presentation on ICH M11 <a href=\"https:\/\/view.officeapps.live.com\/op\/view.aspx?src=https%3A%2F%2Fdatabase.ich.org%2Fsites%2Fdefault%2Ffiles%2FICH_M11_Step_4_Presentation_2026_04_15.pptx&amp;wdOrigin=BROWSELINK\"><strong>here<\/strong><\/a><\/p>\n<p>&gt;&gt; Find ICH M11: The Clinical Electronic Structured Harmonised Protocol (CeSHarP) and all associated documents <a href=\"https:\/\/www.ich.org\/page\/multidisciplinary-guidelines#11-1\"><strong>here<\/strong><\/a><\/p>\n<p>&gt;&gt; Find the updated page on Electronic Standards for the Transfer of Regulatory Information (ESTRI) <a href=\"https:\/\/ich.org\/page\/electronic-standards-estri\"><strong>here<\/strong><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH M11 Expert Working Group has issued a final overview presentation (at Step 4 of the ICH harmonisation process) for ICH M11: The Clinical electronic Structured Harmonised Protocol (CeSHarP), a guideline adopted in November 2025.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[27],"tags":[],"class_list":["post-1997","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/1997","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/comments?post=1997"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/1997\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1997"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=1997"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=1997"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}