{"id":6838,"date":"2025-04-04T11:54:24","date_gmt":"2025-04-04T09:54:24","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\/suitability-of-the-investigator\/"},"modified":"2025-06-25T12:32:11","modified_gmt":"2025-06-25T10:32:11","slug":"suitability-of-the-investigator","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\/suitability-of-the-investigator\/","title":{"rendered":"Suitability of the investigator"},"content":{"rendered":"<ul>\n<li><u>Presentation of the project&#8217;s overall organization<\/u>, cf. CTR Appendix 1, M (64). If section 1 of the European Commission\u2019s template for <em>Site Suitability<\/em> is completed, this requirement will be met. Alternatively, an <a href=\"https:\/\/rekportalen.no\/rest\/public\/attachmentsByPub\/123223740?.png\">enrolment plan<\/a> can be attached if the number of planned study participants per study site is not stated elsewhere in the application.  <\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li><u>CV for principal investigators (PIs)<\/u> at each trial site in Norway. It is recommended to use the European Commission&#8217;s <em>Investigator Curriculum Vitae template<\/em>. The CV must clearly state what clinical competence the PI has, including: prior experience with clinical trials, experience with patient care and a description of any training in good clinical practice (ICH-GCP).  <\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li><u>Conflict of interest statements <\/u>for PIs at each trial site in Norway. It is recommended to use the European Commission&#8217;s <em>Declaration of Interest Template<\/em>. <\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Presentation of the project&#8217;s overall organization, cf. CTR Appendix 1, M (64). If section 1 of the European Commission\u2019s template for Site Suitability is completed, this requirement will be met. Alternatively, an enrolment plan can be attached if the number of planned study participants per study site is not stated elsewhere in the application. &nbsp; [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"parent":6835,"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-6838","page","type-page","status-publish","hentry","category-rek-kulmu-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Suitability of the investigator - 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\/suitability-of-the-investigator\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Suitability of the investigator - Rekportalen\" \/>\n<meta property=\"og:description\" content=\"Presentation of the project&#8217;s overall organization, cf. 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