{"id":1074,"date":"2025-06-06T14:16:03","date_gmt":"2025-06-06T13:16:03","guid":{"rendered":"https:\/\/www.alims.gov.rs\/english\/?p=1074"},"modified":"2025-06-06T14:16:03","modified_gmt":"2025-06-06T13:16:03","slug":"use-of-the-fda-1572-form-for-clinical-trials-in-the-rs-legal-point","status":"publish","type":"post","link":"https:\/\/www.alims.gov.rs\/english\/use-of-the-fda-1572-form-for-clinical-trials-in-the-rs-legal-point\/","title":{"rendered":"Use of the FDA 1572 form for clinical trials in the RS \u2013 legal point"},"content":{"rendered":"<p>The instructions provided in the document with the title above in the subsection of the Agency&#8217;s website &#8211; Good Clinical Practice,GCP &#8211; (<em>Clinical trials subject to US regulations<\/em>) have the following specifications:<\/p>\n<ul>\n<li>cut off date &#8211; 30.04.2025. (date from which the change in the local procedure is considered)<\/li>\n<li>The transition period for adaptation intended for the CRO\/sponsor is 2 months<\/li>\n<li>The date of the procedure change refers to the date of signing the FDA 1572, and not to the date of study approval<\/li>\n<li>Signed and used FDA 1572 for clinical trials after 30.06.2025. will be considered a finding (FDA 1572 dated after 30.06.2025.)<\/li>\n<li>From 30.06.2025., the change applies to both new studies and existing ones where updates to previously signed FDA 1572 are necessary<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>The instructions provided in the document with the title above [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[13],"tags":[],"class_list":["post-1074","post","type-post","status-publish","format-standard","hentry","category-gcp-news"],"_links":{"self":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/posts\/1074","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/comments?post=1074"}],"version-history":[{"count":1,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/posts\/1074\/revisions"}],"predecessor-version":[{"id":1075,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/posts\/1074\/revisions\/1075"}],"wp:attachment":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/media?parent=1074"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/categories?post=1074"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/tags?post=1074"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}