{"id":6734,"date":"2025-09-11T22:01:59","date_gmt":"2025-09-11T20:01:59","guid":{"rendered":"https:\/\/fgk-group.com\/?post_type=knowledge-hub-mag&#038;p=6734"},"modified":"2025-11-20T10:32:54","modified_gmt":"2025-11-20T09:32:54","slug":"gcp-snippets-a-revamped-ich-gcp-enters-its-fourth-decade","status":"publish","type":"knowledge-hub-mag","link":"https:\/\/fgk-group.com\/de\/knowledge-hub\/magazin\/gcp-snippets-a-revamped-ich-gcp-enters-its-fourth-decade\/","title":{"rendered":"GCP Snippets: A Revamped ICH GCP Enters its Fourth Decade"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6734\" class=\"elementor elementor-6734 elementor-2011\" data-elementor-post-type=\"knowledge-hub-mag\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9319831 e-flex e-con-boxed e-con e-parent\" data-id=\"9319831\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-87a0190 elementor-widget elementor-widget-text-editor\" data-id=\"87a0190\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"color: #000000;\">Are you also trying to correctly interpret the wording of the new ICH GCP E6(R3) guideline? &#8211; Picture by FGK generated with AI<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3368584 elementor-widget elementor-widget-heading\" data-id=\"3368584\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Come with us on a journey through the depths of the GCP jungle in search of truths ... and puns<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0276296 elementor-widget elementor-widget-text-editor\" data-id=\"0276296\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>We start with an overview of the changes which will be followed by various topics that our FGK regulatory expert (100% human, not AI!) will take apart and bring back together for you.\u00a0<\/p><p>Here we go:<br \/>The 30 year old\u00a0<strong><a href=\"\/de\/knowledge-hub\/glossar\/ich-richtlinie-e6-gcp\/\">ICH E6<\/a><\/strong>\u00a0guideline, issued by the \u201cInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use\u201d with the title \u201cGuideline for Good Clinical Practice\u201d that is often referred to as \u201c<strong><a href=\"\/de\/knowledge-hub\/glossar\/gute-klinische-praxis\/\">Good Clinical Practice<\/a><\/strong>\u201d, \u201cICH GCP\u201d, \u201cICH\/GCP\u201d, \u201cGCP\u201d is completely revamped, resulting in the 2025 version called ICH E6 (R3), which will probably be completed until 2026 with Annex 2.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ef8d3db elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"ef8d3db\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">ICH E6(R3) has a new structure starting with an introduction and the principles of ICH GCP as in previous versions, but the glossary is stapled carelessly at the end of the booklet, it has even lost section numbers.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">The section with ICH GCP principles is followed by Annex 1, containing the familiar chapters about the ethics committees, sponsor, investigator, investigator\u2019s brochure, clinical trial protocol, essential records and a new chapter on data governance, which accounts for most of the text expansion from 68 to 71 pages.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Annex 1 describes principles for \u201ctraditional\u201d interventional clinical trials. ICH GCP will be supplemented with Annex 2, which describes principles for clinical trials that incorporate decentralised and pragmatic elements and\/or real-world data.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d270667 elementor-widget elementor-widget-text-editor\" data-id=\"d270667\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><strong>Apart from changes in the overall structure, the familiar topics of the larger chapters are still there. However, with only few sentences left unmodified, content and wording was revised and updated in a comprehensive way. For example:<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e36bdbb elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"e36bdbb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">The previous <strong><a href=\"\/de\/knowledge-hub\/glossar\/proband-studienteilnehmer\/\">\"subjects\"<\/a><\/strong> are now called \u201cparticipants\u201d, adverse events are now \u201cunfavourable\u201d instead of \u201cuntoward\u201d.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Unlike the versions of ICH GCP until ICH E6 (R2), ICH E6 (R3) no longer assumes that the interaction with the ethics committee may be made by the investigator alone, but acknowledges that this might be the task of the sponsor.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">The provision to retain essential documents \u201cuntil at least 2-years after the last approval of a marketing application [\u2026] or at least 2-years have elapsed since the formal discontinuation of clinical development\u201d is replaced by a reference to \u201capplicable regulatory requirement(s)\u201d.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">This type of reference is a general feature: ICH E6 (R3) refers to \u201capplicable regulatory requirement[s]\u201d 108 times, but ICH E6 (R2) only 52 times.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">In addition, in ICH E6 (R3) you find \u201cremote\u201d or \u201cremotely\u201d 10 times, in ICH E6 (R2) only 2 times. This is associated with new options to obtain consent outside of the trial centers, ship medication directly to patients, conduct remote monitoring.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Finally, while ICH E6 (R2) has 127 hits for \u201cdata\u201d, ICH E6 (R3) has 306. In a series of short articles we shed some light on new aspects of ICH E6 or on recently emerged points of friction with the <strong><a href=\"\/de\/knowledge-hub\/glossar\/verordnung-ueber-klinische-studien\/\">EU Clinical Trials Regulation<\/a><\/strong>.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b921191 elementor-widget elementor-widget-text-editor\" data-id=\"b921191\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>In the EU, ICH E6 (R3) with Annex 1 will become effective from 23 July 2025. Annex 2 might become effective in late 2025 or in 2026.<\/p><p>It is not clear what sponsors have to do for transition from ICH E6 (R2) to ICH E6 (R3). In the EU, authorised protocols, investigator brochures, consent forms and SOPs about authorisation processes do not need to be updated to add new items and update definitions (since this is governed by the EU Clinical Trials Regulation and national rules). However, sponsors might revise their processes for data and document handling, for oversight, monitoring, risk management, etc.\u00a0<\/p><p>Does this have to be done even for a clinical trial that will end in two months? Traditionally, unlike legal acts, ICH guidelines have no provisions for transitions that allow the conduct of ongoing clinical trials according to the recently superseded guidelines. However, since ICH guidelines are only guidelines, sponsors could probably prepare justifications for not transition clinical trials that, e.g., have already entered their second half.<\/p><p><strong><span style=\"color: #000000;\">Read the guideline for yourself:<\/span>\u00a0<a href=\"https:\/\/database.ich.org\/sites\/default\/files\/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">ICH E6(R3)<\/a><\/strong><\/p><p><strong><a href=\"\/de\/knowledge-hub\/magazin\/\">&gt; More GCP Snippets by FGK&#8217;s Regulatory Affairs Expert<\/a><\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>This is an exemplary article reader.<\/p>\n","protected":false},"featured_media":6733,"template":"","class_list":["post-6734","knowledge-hub-mag","type-knowledge-hub-mag","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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