{"id":13452,"date":"2025-01-30T13:36:06","date_gmt":"2025-01-30T18:36:06","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?p=13452"},"modified":"2025-02-05T15:14:07","modified_gmt":"2025-02-05T20:14:07","slug":"ich-gcp-e6-revisions-resources","status":"publish","type":"post","link":"https:\/\/www.rochester.edu\/ohsp\/ich-gcp-e6-revisions-resources\/","title":{"rendered":"ICH GCP E6 Revisions &#038; Resources"},"content":{"rendered":"<p>The <a href=\"https:\/\/www.ich.org\/\">International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)<\/a> adopted revisions to their Guideline for Good Clinical Practice (GCP) on January 6, 2025; the newly adopted version (R3) is available on the <a href=\"https:\/\/www.ich.org\/page\/efficacy-guidelines\">ICH website<\/a>. Note that the final version of these revisions have not yet been adopted as guidance by the Food &amp; Drug Administration (FDA) and the timing of such adoption is currently unknown. For additional information on these updates:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.advarra.com\/blog\/the-evolution-of-clinical-quality-key-considerations-from-ich-e6-r3\/\">Advarra<\/a> and the <a href=\"https:\/\/about.citiprogram.org\/blog\/ich-releases-final-version-of-e6r3-good-clinical-practice-guideline\/\">Collaborative Institutional Training Initiative (CITI)<\/a> have published summaries on their respective blogs.<\/li>\n<li>The WIRB-Copernicus Group (WCG) recently hosted a webinar highlighting key updates, <a href=\"https:\/\/www.wcgclinical.com\/insights\/ich-e6-r3-is-here-what-you-need-to-know\/\">the recording of which is available on their website<\/a>.<\/li>\n<li>The <a href=\"https:\/\/acrpnet.org\/learning\/courses\/crack-the-code-a-comparison-of-ich-e6r2-and-ich-e6r3\">Association of Clinical Research Professionals (ACRP)<\/a> will host a webinar to review key components of the revised guidance document on February 13.<\/li>\n<li><a href=\"https:\/\/www.transceleratebiopharmainc.com\/events\/navigating-ich-e6r3-tools-resources-for-understanding-changes-and-supporting-adoption\/\">Transcelerate BioPharma, Inc.<\/a> will host a webinar to discuss tools and resources available for understanding and implementing revisions on March 4.<\/li>\n<\/ul>\n<p>For additional information on GCP generally (e.g., what GCP is and how it applies to research), see <a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/gcp\/\">OHSP\u2019s GCP FAQ website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) adopted revisions to their Guideline for Good Clinical Practice (GCP) on January 6, 2025; the newly&hellip;<\/p>\n","protected":false},"author":52,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[106],"tags":[412,222,422],"class_list":["post-13452","post","type-post","status-publish","format-standard","hentry","category-updates","tag-gcp","tag-resources","tag-responsibilities"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ICH GCP E6 Revisions &amp; Resources - Office for Human Subject Protection<\/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.rochester.edu\/ohsp\/ich-gcp-e6-revisions-resources\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ICH GCP E6 Revisions &amp; Resources - Office for Human Subject Protection\" \/>\n<meta property=\"og:description\" content=\"The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) adopted revisions to their Guideline for Good Clinical Practice (GCP) on January 6, 2025; the newly&hellip;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.rochester.edu\/ohsp\/ich-gcp-e6-revisions-resources\/\" \/>\n<meta property=\"og:site_name\" content=\"Office for Human Subject Protection\" \/>\n<meta property=\"article:published_time\" content=\"2025-01-30T18:36:06+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-02-05T20:14:07+00:00\" \/>\n<meta name=\"author\" content=\"Kelly Unsworth\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Kelly Unsworth\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/ich-gcp-e6-revisions-resources\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/ich-gcp-e6-revisions-resources\\\/\"},\"author\":{\"name\":\"Kelly Unsworth\",\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/#\\\/schema\\\/person\\\/8c57830686cf5373103b04fb69430f2a\"},\"headline\":\"ICH GCP E6 Revisions &#038; Resources\",\"datePublished\":\"2025-01-30T18:36:06+00:00\",\"dateModified\":\"2025-02-05T20:14:07+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/ich-gcp-e6-revisions-resources\\\/\"},\"wordCount\":179,\"keywords\":[\"GCP\",\"Resources\",\"Responsibilities\"],\"articleSection\":[\"Updates\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/ich-gcp-e6-revisions-resources\\\/\",\"url\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/ich-gcp-e6-revisions-resources\\\/\",\"name\":\"ICH GCP E6 Revisions & Resources - Office for Human Subject Protection\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/#website\"},\"datePublished\":\"2025-01-30T18:36:06+00:00\",\"dateModified\":\"2025-02-05T20:14:07+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/#\\\/schema\\\/person\\\/8c57830686cf5373103b04fb69430f2a\"},\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/ich-gcp-e6-revisions-resources\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/ich-gcp-e6-revisions-resources\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/ich-gcp-e6-revisions-resources\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"ICH GCP E6 Revisions &#038; Resources\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/#website\",\"url\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/\",\"name\":\"Office for Human Subject Protection\",\"description\":\"University of Rochester\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/#\\\/schema\\\/person\\\/8c57830686cf5373103b04fb69430f2a\",\"name\":\"Kelly Unsworth\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"ICH GCP E6 Revisions & Resources - Office for Human Subject Protection","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.rochester.edu\/ohsp\/ich-gcp-e6-revisions-resources\/","og_locale":"en_US","og_type":"article","og_title":"ICH GCP E6 Revisions & Resources - Office for Human Subject Protection","og_description":"The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) adopted revisions to their Guideline for Good Clinical Practice (GCP) on January 6, 2025; the newly&hellip;","og_url":"https:\/\/www.rochester.edu\/ohsp\/ich-gcp-e6-revisions-resources\/","og_site_name":"Office for Human Subject Protection","article_published_time":"2025-01-30T18:36:06+00:00","article_modified_time":"2025-02-05T20:14:07+00:00","author":"Kelly Unsworth","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Kelly Unsworth","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.rochester.edu\/ohsp\/ich-gcp-e6-revisions-resources\/#article","isPartOf":{"@id":"https:\/\/www.rochester.edu\/ohsp\/ich-gcp-e6-revisions-resources\/"},"author":{"name":"Kelly Unsworth","@id":"https:\/\/www.rochester.edu\/ohsp\/#\/schema\/person\/8c57830686cf5373103b04fb69430f2a"},"headline":"ICH GCP E6 Revisions &#038; Resources","datePublished":"2025-01-30T18:36:06+00:00","dateModified":"2025-02-05T20:14:07+00:00","mainEntityOfPage":{"@id":"https:\/\/www.rochester.edu\/ohsp\/ich-gcp-e6-revisions-resources\/"},"wordCount":179,"keywords":["GCP","Resources","Responsibilities"],"articleSection":["Updates"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.rochester.edu\/ohsp\/ich-gcp-e6-revisions-resources\/","url":"https:\/\/www.rochester.edu\/ohsp\/ich-gcp-e6-revisions-resources\/","name":"ICH GCP E6 Revisions & Resources - Office for Human Subject Protection","isPartOf":{"@id":"https:\/\/www.rochester.edu\/ohsp\/#website"},"datePublished":"2025-01-30T18:36:06+00:00","dateModified":"2025-02-05T20:14:07+00:00","author":{"@id":"https:\/\/www.rochester.edu\/ohsp\/#\/schema\/person\/8c57830686cf5373103b04fb69430f2a"},"breadcrumb":{"@id":"https:\/\/www.rochester.edu\/ohsp\/ich-gcp-e6-revisions-resources\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.rochester.edu\/ohsp\/ich-gcp-e6-revisions-resources\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.rochester.edu\/ohsp\/ich-gcp-e6-revisions-resources\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.rochester.edu\/ohsp\/"},{"@type":"ListItem","position":2,"name":"ICH GCP E6 Revisions &#038; Resources"}]},{"@type":"WebSite","@id":"https:\/\/www.rochester.edu\/ohsp\/#website","url":"https:\/\/www.rochester.edu\/ohsp\/","name":"Office for Human Subject Protection","description":"University of Rochester","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.rochester.edu\/ohsp\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.rochester.edu\/ohsp\/#\/schema\/person\/8c57830686cf5373103b04fb69430f2a","name":"Kelly Unsworth"}]}},"_links":{"self":[{"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/posts\/13452","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/users\/52"}],"replies":[{"embeddable":true,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/comments?post=13452"}],"version-history":[{"count":4,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/posts\/13452\/revisions"}],"predecessor-version":[{"id":13542,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/posts\/13452\/revisions\/13542"}],"wp:attachment":[{"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/media?parent=13452"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/categories?post=13452"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/tags?post=13452"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}