{"id":6831,"date":"2025-04-03T08:26:28","date_gmt":"2025-04-03T06:26:28","guid":{"rendered":"https:\/\/darkgreen-crane-601020.hostingersite.com\/rek-kulmu\/clinical-trials-regulation-ctr\/general-requirements-and-recommendations-for-a-ctr-application\/"},"modified":"2025-06-25T12:32:11","modified_gmt":"2025-06-25T10:32:11","slug":"general-requirements-and-recommendations-for-a-ctr-application","status":"publish","type":"page","link":"https:\/\/rekportalen.no\/en\/rek-kulmu\/clinical-trials-regulation-ctr\/general-requirements-and-recommendations-for-a-ctr-application\/","title":{"rendered":"General requirements and recommendations for a CTR application"},"content":{"rendered":"<p>Documents that are submitted to CTIS must be named according to <a href=\"https:\/\/www.hma.eu\/fileadmin\/dateien\/HMA_joint\/00-_About_HMA\/03-Working_Groups\/CTCG\/2022_09_CTCG_Instruction_naming_documents_CTIS_EU_v1.4.pdf\">these rules<\/a>.<br \/>\nDocuments that are part of an application in CTIS will, with a few exceptions, be made publicly available. It is the applicant&#8217;s responsibility to ensure that publicly available documents that are uploaded to CTIS do not contain sensitive information, such as signature, social security number and private address, so that submitted material and information is in accordance with the GDPR and other relevant privacy legislations. See <a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-and-development\/clinical-trials-human-medicines\/clinical-trials-information-system-training-and-support\/clinical-trials-information-system-ctis-online-training-modules\"><em>CTIS Training Program<\/em><\/a> modules 2 and 10 for further information.<br \/>Part I application   <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Documents that are submitted to CTIS must be named according to these rules. Documents that are part of an application in CTIS will, with a few exceptions, be made publicly available. It is the applicant&#8217;s responsibility to ensure that publicly available documents that are uploaded to CTIS do not contain sensitive information, such as signature, [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"parent":6353,"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-6831","page","type-page","status-publish","hentry","category-rek-kulmu-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>General requirements and recommendations for a CTR application - 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\/clinical-trials-regulation-ctr\/general-requirements-and-recommendations-for-a-ctr-application\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"General requirements and recommendations for a CTR application - Rekportalen\" \/>\n<meta property=\"og:description\" content=\"Documents that are submitted to CTIS must be named according to these rules. 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