{"id":3582,"date":"2022-02-09T15:25:51","date_gmt":"2022-02-09T20:25:51","guid":{"rendered":"https:\/\/www.med.unc.edu\/spo\/?p=3582"},"modified":"2022-02-09T15:25:51","modified_gmt":"2022-02-09T20:25:51","slug":"forms-g-changes-to-be-reflected-in-human-subjects-clinical-trials-form-on-february-10-action-required-by-users","status":"publish","type":"post","link":"https:\/\/www.med.unc.edu\/spo\/2022\/02\/forms-g-changes-to-be-reflected-in-human-subjects-clinical-trials-form-on-february-10-action-required-by-users\/","title":{"rendered":"FORMS-G Changes to be Reflected in Human Subjects Clinical Trials Form on February 10 \u2013 Action Required by Users"},"content":{"rendered":"<h4>eRA Information: FORMS-G Changes to be Reflected in Human Subjects Clinical Trials Form on February 10 \u2013 Action Required by Users<\/h4>\n<p>Wednesday, February 9, 2022<br \/>\nFollowing a release on Thursday, February 10, the Human Subjects System (HSS) will transition to using the FORMS-G version of the post-submission Human Subjects Clinical Trial (HSCT) form. HSCT forms will have new expiration dates and a new OMB number on the Inclusion Enrollment Report, as well as the following changes:<\/p>\n<ul>\n<li>New country codes, detailed here, incorporated in country drop-down lists on the Inclusion Enrollment Report form; see Figure 2.<\/li>\n<li>The label for question 3.2 will change from <strong>If yes, describe single IRB plan<\/strong> to <strong>Single IRB plan attachment<\/strong>. (Note, this field is currently required for AHRQ applicants only).<\/li>\n<li>.csv files listing large numbers of enrollees (over 100,000) can now be uploaded on the Inclusion Enrollment Report using the <strong>Upload Participant Level Data Attachment<\/strong> button.<\/li>\n<\/ul>\n<p>IMPORTANT: Re-Save Study Records That Are in Work in Progress Applications<\/p>\n<p><strong><em>After the release date, but prior to application submission, users should re-save Study Records in Work in Progress applications<\/em> (without necessarily making any changes). This is to update the underlying data to match the new FORMS-G version. This is because as we transition to the new FORMS-G version of the HSCT, any Work in Progress record will be migrated behind the scenes so users will need to save again before submitting the form.<\/strong><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>eRA Information: FORMS-G Changes to be Reflected in Human Subjects Clinical Trials Form on February 10 \u2013 Action Required by Users Wednesday, February 9, 2022 Following a release on Thursday, February 10, the Human Subjects System (HSS) will transition to using the FORMS-G version of the post-submission Human Subjects Clinical Trial (HSCT) form. HSCT forms &hellip; <a href=\"https:\/\/www.med.unc.edu\/spo\/2022\/02\/forms-g-changes-to-be-reflected-in-human-subjects-clinical-trials-form-on-february-10-action-required-by-users\/\" aria-label=\"Read more about FORMS-G Changes to be Reflected in Human Subjects Clinical Trials Form on February 10 \u2013 Action Required by Users\">Read more<\/a><\/p>\n","protected":false},"author":3716,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[1],"tags":[],"class_list":["post-3582","post","type-post","status-publish","format-standard","hentry","category-news","odd"],"acf":[],"featured_image":false,"featured_image_medium":false,"featured_image_medium_large":false,"featured_image_large":false,"featured_image_thumbnail":false,"featured_image_alt":false,"category_details":[{"name":"News","link":"https:\/\/www.med.unc.edu\/spo\/category\/news\/"}],"tag_details":[],"_links_to":[],"_links_to_target":[],"_links":{"self":[{"href":"https:\/\/www.med.unc.edu\/spo\/wp-json\/wp\/v2\/posts\/3582","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.med.unc.edu\/spo\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.med.unc.edu\/spo\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.med.unc.edu\/spo\/wp-json\/wp\/v2\/users\/3716"}],"replies":[{"embeddable":true,"href":"https:\/\/www.med.unc.edu\/spo\/wp-json\/wp\/v2\/comments?post=3582"}],"version-history":[{"count":0,"href":"https:\/\/www.med.unc.edu\/spo\/wp-json\/wp\/v2\/posts\/3582\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.med.unc.edu\/spo\/wp-json\/wp\/v2\/media?parent=3582"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.med.unc.edu\/spo\/wp-json\/wp\/v2\/categories?post=3582"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.med.unc.edu\/spo\/wp-json\/wp\/v2\/tags?post=3582"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}