{"id":6744,"date":"2025-09-07T23:07:39","date_gmt":"2025-09-07T21:07:39","guid":{"rendered":"https:\/\/fgk-group.com\/?post_type=knowledge-hub-mag&#038;p=6744"},"modified":"2025-11-20T10:45:35","modified_gmt":"2025-11-20T09:45:35","slug":"gcp-snippets-investigators-out-of-site","status":"publish","type":"knowledge-hub-mag","link":"https:\/\/fgk-group.com\/de\/knowledge-hub\/magazin\/gcp-snippets-investigators-out-of-site\/","title":{"rendered":"GCP Snippets: Investigators Out of Site"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6744\" class=\"elementor elementor-6744 elementor-2005\" data-elementor-post-type=\"knowledge-hub-mag\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dab3ce3 e-flex e-con-boxed e-con e-parent\" data-id=\"dab3ce3\" 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-6219343 elementor-widget elementor-widget-text-editor\" data-id=\"6219343\" 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;\">Will study participants ever see the investigator face to face in the future? &#8211; Picture by FGK generated with the help of AI<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9b3c364 elementor-widget elementor-widget-heading\" data-id=\"9b3c364\" 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\">WHO can be defined as investigator of a clinical study?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2cf04da elementor-widget elementor-widget-text-editor\" data-id=\"2cf04da\" 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>The new version of ICH GCP supports the conduct of clinical trials in ways that convey the gloss of modern times. While the mid-90ies version of ICH E6 depicted the\u00a0<strong><a href=\"\/de\/knowledge-hub\/glossar\/informierte-einwilligung\/\">informed consent<\/a><\/strong>\u00a0with pen and paper (<em>\u201cInformed consent is documented by means of a written, signed and dated informed consent form\u201d<\/em>) the brand new ICH E6 (R3) shows that it can handle cutting edge technology with ease:<\/p><p><em>\u201cVaried approaches to the provision of information and the discussion about the trial can be used. This may include, for example, providing text in different formats, images and videos and using telephone or video conferencing with investigator site staff. Informed consent is documented by means of a written (paper or electronic), signed and dated informed consent form. Obtaining consent remotely may be considered when appropriate.\u201d<\/em><\/p><p>In line with this, the investigators are released from their vintage study centers: ICH E6 (R2) defined \u201c<a href=\"\/de\/knowledge-hub\/glossar\/pruefer\/\"><strong>Investigator<\/strong><\/a>\u201d as\u00a0<em>\u201cA person responsible for the conduct of the clinical trial at a trial site\u201d<\/em>, but ICH E6 (R3) refurbishes this 30 years old concept and presents the investigator as\u00a0<strong><em>\u201c<span style=\"color: #000000;\">A person responsible for the conduct of the clinical trial, including the trial participants for whom that person has responsibility during the conduct of the trial<\/span>\u201d.<\/em><\/strong><\/p><p>With the\u00a0<a href=\"\/de\/knowledge-hub\/glossar\/pruefzentrum-studienzentrum\/\"><strong>trial site<\/strong><\/a>\u00a0still present, ICH E6 (R2) saw it as\u00a0<em>\u201cThe location(s) where trial-related activities are actually conducted\u201d<\/em>, while the new ICH E6 (R3) describes it as<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eb930ab elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"eb930ab\" 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\">\u201cThe location(s) where trial-related activities are conducted and\/or coordinated under the investigator\u2019s\/institution\u2019s oversight\u201d.<\/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-c0fa3a0 elementor-widget elementor-widget-text-editor\" data-id=\"c0fa3a0\" 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>(Well, to be accurate, ICH E6 (R3) names this location \u201cInvestigator Site\u201d while the old name \u201ctrial site\u201d appears only once in section 3.16.1, where it probably resisted consolidation of the text.)\u00a0<\/p><p>The new definitions \u2013 theoretically \u2013 would allow investigators to never see participants directly and clinical trials to become decentralised. It also would allow, in my interpretation, that the investigator is not defined by responsibility for trial participants, but could spend his time on coordination only. The new definitions could indeed have some probably unintended consequences. The introduction of ICH E6 (R3) clarifies that \u201ctrial conduct\u201d<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-61271a9 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"61271a9\" 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\">\u201cincludes processes from planning to reporting, including planning, initiating, performing, recording, oversight, evaluation, analysis and reporting activities\u201d.<\/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-0dbb695 elementor-widget elementor-widget-text-editor\" data-id=\"0dbb695\" 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>Given that, any person planning a trial is by definition an investigator and the cubbyhole used for making medical research plans is an investigator site. Therefore, taking the wording of the definitions seriously, also the sponsor\u2019s medical monitor or employees of members of ethics committees could be investigators. Would this necessitate that ethics committees have to review, in accordance with ICH E6 (R3), the \u201ccurrent curriculum vitae\u201d of such investigators?<br \/>Since Section 2 of Annex 1 of ICH E6 (R3) presents the investigator in the familiar traditional context (recruiting patients, available of adequate facilities), something is probably wrong with the new set of definitions. I assume it is the much too broad concept of trial conduct.<\/p><p>Worse than failed definitions are wry ethics. Which is the responsible ethics committee for an investigator without direct contact to patients and with a location used only for coordination? Could an investigator in Laputa obtain approval from an ethics committee in Balnibarbi for a clinical trial conducted in Luggnagg?<\/p><p>Fortunately, this is not possible once these places get absorbed by the EU. Article 2.2 (15)\u00a0<strong><a href=\"\/de\/knowledge-hub\/glossar\/verordnung-ueber-klinische-studien\/\">CTR<\/a><\/strong>\u00a0clearly defines \u201cInvestigator\u201d in the old way as\u00a0<em>\u201can individual responsible for the conduct of a clinical trial at a clinical trial site\u201d<\/em>. For clinical trials that are subject to the CTR you have to stick to that. Some of the airy concepts of ICH E6 (R3) do not apply, but on the other hand\u00a0<a href=\"\/de\/knowledge-hub\/glossar\/dezentrale-klinische-studien\/\"><strong>decentralised trials<\/strong><\/a>\u00a0are also possible in the EU.<\/p><p>Links and further reading:<br \/>CTCG, EMA, et al.:\u00a0<strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/2ccc46bf-2739-4b9a-ab6b-6f425db78c61_en?filename=mp_decentralised-elements_clinical-trials_rec_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Recommendation paper on decentralised elements in clinical trials<\/a><\/strong><br \/>AEMPS:\u00a0<strong><a href=\"https:\/\/www.aemps.gob.es\/informa\/la-aemps-publica-la-guia-para-la-realizacion-de-elementos-descentralizados-en-ensayos-clinicos\/\" target=\"_blank\" rel=\"noopener noreferrer\">Gu\u00eda para la realizaci\u00f3n de elementos descentralizados en ensayos cl\u00ednicos<\/a><\/strong><br \/><strong><a href=\"https:\/\/www.radial.eu\/en\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/www.radial.eu\/en<\/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>While the mid-90ies version of ICH E6 depicted the informed consent with pen and paper the brand new ICH E6 (R3) shows that it can handle cutting edge technology with ease. In line with this, the &#8222;investigators&#8220; are released from their vintage study centers&#8230;<\/p>\n","protected":false},"featured_media":6743,"template":"","class_list":["post-6744","knowledge-hub-mag","type-knowledge-hub-mag","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>GCP Snippets: Investigators Out of Site - FGK Group<\/title>\n<meta name=\"description\" content=\"FGK Clinical Research Regulatory Affairs expert shares his opinion on ICH E6(R3) definition of clinical study &quot;investigators&quot;\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fgk-group.com\/de\/knowledge-hub\/magazin\/gcp-snippets-investigators-out-of-site\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GCP Snippets: Investigators Out of Site - 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