{"id":473,"date":"2024-10-21T11:47:22","date_gmt":"2024-10-21T15:47:22","guid":{"rendered":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=473"},"modified":"2024-10-21T11:47:24","modified_gmt":"2024-10-21T15:47:24","slug":"fdas-final-guidance-on-decentralized-clinical-trials-published","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2024\/10\/21\/fdas-final-guidance-on-decentralized-clinical-trials-published\/","title":{"rendered":"FDA&#8217;s Final Guidance on Decentralized Clinical Trials Published"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">On September 18, 2024, the U.S. Food and Drug Administration (FDA) issued&nbsp;<a href=\"https:\/\/www.fda.gov\/media\/167696\/download\" target=\"_blank\" rel=\"noreferrer noopener\">final Guidance<\/a>&nbsp;on recommendations for conducting decentralized clinical trials (DCTs) for drugs, devices or biological products. Instead of using traditional clinical trial sites, DCTs hold some or all trial activities remotely at locations convenient for trial participants by, for example, using telehealth appointments, outsourcing visits to local healthcare providers, or conducting laboratory tests at outside facilities.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Read the<em> Alert <\/em>on the <a href=\"https:\/\/www.duanemorris.com\/alerts\/fda_issues_guidance_remote_clinical_trial_activities_1024.html\">Duane Morris LLP website<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On September 18, 2024, the U.S. Food and Drug Administration (FDA) issued&nbsp;final Guidance&nbsp;on recommendations for conducting decentralized clinical trials (DCTs) for drugs, devices or biological products. Instead of using traditional clinical trial sites, DCTs hold some or all trial activities remotely at locations convenient for trial participants by, for example, using telehealth appointments, outsourcing visits &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2024\/10\/21\/fdas-final-guidance-on-decentralized-clinical-trials-published\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA&#8217;s Final Guidance on Decentralized Clinical Trials Published&#8221;<\/span><\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[403,494,605,304,29,209,707],"ppma_author":[521],"class_list":["post-473","post","type-post","status-publish","format-standard","hentry","category-general","tag-clinical-studies","tag-clinical-trial-reporting-requirements","tag-coleen-hill","tag-erin-duffy","tag-fda","tag-frederick-ball","tag-telehealth"],"authors":[{"term_id":521,"user_id":6,"is_guest":0,"slug":"duanemorris3","display_name":"Duane Morris","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/843ff6e7a8fe5fc92109b47a45f34b6cf0ea499e6e788db23456c838b0ae6747?s=96&d=blank&r=g","author_category":"1","last_name":"Sullivan","first_name":"Margaret","job_title":"","user_url":"http:\/\/www.duanemorris.com","description":"<a href=\"http:\/\/www.duanemorris.com\">Visit the Duane Morris website.<\/a>"}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/473","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/comments?post=473"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/473\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=473"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=473"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=473"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=473"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}