{"id":6835,"date":"2025-04-03T08:28:21","date_gmt":"2025-04-03T06:28:21","guid":{"rendered":"https:\/\/darkgreen-crane-601020.hostingersite.com\/rek-kulmu\/clinical-trials-regulation-ctr\/general-requirements-and-recommendations-for-a-ctr-application\/part-ii-application-national-application\/"},"modified":"2025-06-25T12:32:11","modified_gmt":"2025-06-25T10:32:11","slug":"part-ii-application-national-application","status":"publish","type":"page","link":"https:\/\/rekportalen.no\/en\/rek-kulmu\/clinical-trials-regulation-ctr\/general-requirements-and-recommendations-for-a-ctr-application\/part-ii-application-national-application\/","title":{"rendered":"Part II application (national application)"},"content":{"rendered":"<p>REK KULMU is, on behalf of Norway, responsible for assessing documents submitted in the Part II application dossier.<br \/>\nIt is recommended to use the templates that are available on <u>the European Commission&#8217;s website<\/u>.<br \/>If the sponsor chooses to use other templates, it is the sponsor&#8217;s responsibility to ensure that all CTR requirements are fulfilled and that all the requested information in the EU commission&#8217;s templates is included in the submitted documents.<\/p>\n<p>Documents marked with \u201c*\u201d must be submitted for each trial site:<\/p>\n<ul>\n<li>Compensation for trial participants<\/li>\n<li>Compensation for trial participants<\/li>\n<li>Investigator Curriculum Vitae*<\/li>\n<li>Site Suitability Form*<\/li>\n<li>Recruitment and Informed consent procedure<\/li>\n<li>Compliance with applicable rules for biological samples (if relevant)<\/li>\n<\/ul>\n<p>Signature is not required for the above-mentioned documents.<\/p>\n<p><em>Part II \u2013 What should the application contain?<\/em><br \/>\nPart II documentation is adapted to each individual Member State participating in the study. All documents attached in Part II must be in English, with the exception of the informed consents and any recruitment material. <\/p>\n","protected":false},"excerpt":{"rendered":"<p>REK KULMU is, on behalf of Norway, responsible for assessing documents submitted in the Part II application dossier. It is recommended to use the templates that are available on the European Commission&#8217;s website.If the sponsor chooses to use other templates, it is the sponsor&#8217;s responsibility to ensure that all CTR requirements are fulfilled and that [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"parent":6831,"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-6835","page","type-page","status-publish","hentry","category-rek-kulmu-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Part II application (national 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\/part-ii-application-national-application\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Part II application (national application) - Rekportalen\" \/>\n<meta property=\"og:description\" content=\"REK KULMU is, on behalf of Norway, responsible for assessing documents submitted in the Part II application dossier. 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