{"id":6863,"date":"2025-04-04T14:44:53","date_gmt":"2025-04-04T12:44:53","guid":{"rendered":"https:\/\/darkgreen-crane-601020.hostingersite.com\/rek-kulmu\/answers-to-frequently-asked-questions\/"},"modified":"2026-06-01T10:22:56","modified_gmt":"2026-06-01T08:22:56","slug":"answers-to-frequently-asked-questions","status":"publish","type":"page","link":"https:\/\/rekportalen.no\/en\/rek-kulmu\/answers-to-frequently-asked-questions\/","title":{"rendered":"Answers to frequently asked questions"},"content":{"rendered":"<ul>\n<li>\u00a0There is no fee to the Norwegian ethics authorities regarding an application for prior approval of clinical trials, however, please see DMP&#8217;s website for any possible fees to DMP.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li><span class=\"TextRun SCXW134705704 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW134705704 BCX8\">In line with the\u202f<\/span><\/span><a class=\"Hyperlink SCXW134705704 BCX8\" href=\"https:\/\/www.ema.europa.eu\/en\/ich-e6-good-clinical-practice-scientific-guideline\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"SCXW134705704 BCX8\"><span class=\"TextRun Underlined SCXW134705704 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW134705704 BCX8\" data-ccp-charstyle=\"Hyperlink\">EMA guidelines<\/span><\/span><\/span><\/a><span class=\"TextRun SCXW134705704 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW134705704 BCX8\">\u202f, ICH-GCP R3 will be applicable from July 23, 2025. It is expected that investigators <\/span><span class=\"NormalTextRun SCXW134705704 BCX8\">participating<\/span><span class=\"NormalTextRun SCXW134705704 BCX8\"> in patient-related activities will attend an updated GCP course (R3) before this date. REK KULMU should not receive updated GCP documentation. For new CTR applications, it must be documented that the principal investigator(s) has updated GCP competence (R3) or it must be confirmed that they will attend a GCP course (R3) before participants are recruited to the trial.<\/span><\/span><span class=\"EOP SCXW134705704 BCX8\" data-ccp-props=\"{&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li>REK KULMU should not receive or evaluate progress reports or adverse event reports (DSUR, ASR) for ongoing studies. Only in case of serious adverse events that may affect the benefit\/risk assessment resulting in changes to approved documents such as the protocol and\/or the Informed Consent Form(s), should a substantial modification application be submitted.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li>A final report should not be submitted to REK KULMU. For medical device studies submitted via the REK-portal, a final notification must be submitted in order to close the case in the portal.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li>Annual updates of insurance certificates should not be submitted.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\">The <\/span><\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\">I<\/span><\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\">nformed <\/span><\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\">C<\/span><\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\">onsent <\/span><\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\">F<\/span><\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\">orm(s) and <\/span><span class=\"NormalTextRun SCXW124868414 BCX8\">possible recruitment<\/span><span class=\"NormalTextRun SCXW124868414 BCX8\"> material <\/span><\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\">must b<\/span><\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\">e <\/span><\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\">presented<\/span><\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\"> in a language <\/span><\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\">in which the<\/span><\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\"> potential participant language<\/span><\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\"> is proficient<\/span><\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\">. <\/span><\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\">However, <\/span><\/span><\/span><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\">REK KULMU should not receive or assess <\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\">possible <\/span><\/span><\/span><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\">translations<\/span><span class=\"NormalTextRun SCXW124868414 BCX8\"> of Informed Consent Form(s) to foreign languages. <\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\">It is recommended to use a certified translator; however, it is the responsibility of the sponsor to ensure that the translation is of <\/span><span class=\"NormalTextRun SCXW124868414 BCX8\">good quality<\/span><span class=\"NormalTextRun SCXW124868414 BCX8\"> and corresponds to the approved text in the Norwegian ICF<\/span><\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW124868414 BCX8\"><span class=\"TextRun SCXW124868414 BCX8\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124868414 BCX8\">.<\/span><\/span><\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li><span data-contrast=\"auto\">Patient cards, thank-you cards, interview guides for study personnel, or other study information that does not involve the identification or recruitment of participants should not be <\/span><span data-contrast=\"auto\">submitted as part of the application<\/span><span data-contrast=\"auto\">, as these documents are <\/span><span data-contrast=\"auto\">not review<\/span><span data-contrast=\"auto\">e<\/span><span data-contrast=\"auto\">d by<\/span><span data-contrast=\"auto\"> REK KULMU<\/span><span data-contrast=\"auto\">.<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li><span data-contrast=\"auto\">The d<\/span><span data-contrast=\"auto\">ocument<\/span><span data-contrast=\"auto\">(<\/span><span data-contrast=\"auto\">s<\/span><span data-contrast=\"auto\">)<\/span><span data-contrast=\"auto\"> that inform<\/span><span data-contrast=\"auto\">s<\/span><span data-contrast=\"auto\"> participants about the institution\u2019s and sponsor\u2019s legal basis for data processing are regulated by the General Data Protection Regulation (GDPR). Therefore, these documents should not be submitted as part of the application for studies regulated under CTR, MDR, or IVDR.<\/span><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>\u00a0There is no fee to the Norwegian ethics authorities regarding an application for prior approval of clinical trials, however, please see DMP&#8217;s website for any possible fees to DMP. &nbsp; In line with the\u202fEMA guidelines\u202f, ICH-GCP R3 will be applicable from July 23, 2025. It is expected that investigators participating in patient-related activities will attend [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"parent":5868,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_cn_metabox_post_checkbox_dont_send_once":false,"_cn_metabox_post_checkbox_dont_send_ever":false,"inline_featured_image":false,"footnotes":""},"categories":[62],"tags":[],"class_list":["post-6863","page","type-page","status-publish","hentry","category-rek-kulmu-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Answers to frequently asked questions - Rekportalen<\/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:\/\/rekportalen.no\/en\/rek-kulmu\/answers-to-frequently-asked-questions\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Answers to frequently asked questions - Rekportalen\" \/>\n<meta property=\"og:description\" content=\"\u00a0There is no fee to the Norwegian ethics authorities regarding an application for prior approval of clinical trials, however, please see DMP&#8217;s website for any possible fees to DMP. &nbsp; In line with the\u202fEMA guidelines\u202f, ICH-GCP R3 will be applicable from July 23, 2025. It is expected that investigators participating in patient-related activities will attend [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/rekportalen.no\/en\/rek-kulmu\/answers-to-frequently-asked-questions\/\" \/>\n<meta property=\"og:site_name\" content=\"Rekportalen\" \/>\n<meta property=\"article:modified_time\" content=\"2026-06-01T08:22:56+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/rekportalen.no\/wp-content\/uploads\/2025\/07\/rek.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"573\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/rekportalen.no\\\/en\\\/rek-kulmu\\\/answers-to-frequently-asked-questions\\\/\",\"url\":\"https:\\\/\\\/rekportalen.no\\\/en\\\/rek-kulmu\\\/answers-to-frequently-asked-questions\\\/\",\"name\":\"Answers to frequently asked questions - Rekportalen\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/rekportalen.no\\\/en\\\/#website\"},\"datePublished\":\"2025-04-04T12:44:53+00:00\",\"dateModified\":\"2026-06-01T08:22:56+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/rekportalen.no\\\/en\\\/rek-kulmu\\\/answers-to-frequently-asked-questions\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/rekportalen.no\\\/en\\\/rek-kulmu\\\/answers-to-frequently-asked-questions\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/rekportalen.no\\\/en\\\/rek-kulmu\\\/answers-to-frequently-asked-questions\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/rekportalen.no\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"REK KULMU\",\"item\":\"https:\\\/\\\/rekportalen.no\\\/en\\\/rek-kulmu\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Answers to frequently asked questions\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/rekportalen.no\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/rekportalen.no\\\/en\\\/\",\"name\":\"Rekportalen\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\\\/\\\/rekportalen.no\\\/en\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/rekportalen.no\\\/en\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/rekportalen.no\\\/en\\\/#organization\",\"name\":\"Rekportalen\",\"url\":\"https:\\\/\\\/rekportalen.no\\\/en\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/rekportalen.no\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/rekportalen.no\\\/wp-content\\\/uploads\\\/2025\\\/01\\\/logo_pms.svg\",\"contentUrl\":\"https:\\\/\\\/rekportalen.no\\\/wp-content\\\/uploads\\\/2025\\\/01\\\/logo_pms.svg\",\"width\":100,\"height\":100,\"caption\":\"Rekportalen\"},\"image\":{\"@id\":\"https:\\\/\\\/rekportalen.no\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Answers to frequently asked questions - Rekportalen","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:\/\/rekportalen.no\/en\/rek-kulmu\/answers-to-frequently-asked-questions\/","og_locale":"en_US","og_type":"article","og_title":"Answers to frequently asked questions - Rekportalen","og_description":"\u00a0There is no fee to the Norwegian ethics authorities regarding an application for prior approval of clinical trials, however, please see DMP&#8217;s website for any possible fees to DMP. &nbsp; In line with the\u202fEMA guidelines\u202f, ICH-GCP R3 will be applicable from July 23, 2025. 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