{"id":100872,"date":"2023-06-30T01:56:00","date_gmt":"2023-06-30T06:56:00","guid":{"rendered":"https:\/\/www.unmc.edu\/newsroom\/?p=100872"},"modified":"2023-06-28T14:02:46","modified_gmt":"2023-06-28T19:02:46","slug":"unmc-expanding-support-for-clinicaltrials-gov-registrations","status":"publish","type":"post","link":"https:\/\/www.unmc.edu\/newsroom\/2023\/06\/30\/unmc-expanding-support-for-clinicaltrials-gov-registrations\/","title":{"rendered":"UNMC expanding support for ClinicalTrials.gov registrations"},"content":{"rendered":"<div class=\"panel body-content\"><div class=\"panel__container\">\n<p>The UNMC Office of the Vice Chancellor for Research and the Office of Regulatory Affairs&nbsp;are updating and expanding support for UNMC\u2019s investigator-initiated studies registered on <a href=\"https:\/\/www.ClinicalTrials.gov\" target=\"_blank\" rel=\"noreferrer noopener\">ClinicalTrials.gov<\/a>.<\/p>\n\n\n\n<p>To assist UNMC investigators in meeting the complex registration and reporting requirements in ClinicalTrials.gov, the two offices are rolling out an enhanced record monitoring and communication plans that will take effect on July 1.<\/p>\n\n\n\n<p>Key enhancements include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Investigators and institutional leadership now will be kept apprised of records with update or reporting problems.<\/li>\n\n\n\n<li>For any studies experiencing issues with their ClinicalTrials.gov listing, UNMC\u2019s ORA will provide a timeline for correction and assistance as needed.<\/li>\n\n\n\n<li>A CITI training course is available to UNMC and University of Nebraska at Omaha learners, which provides video instructions for registering, uploading documents and submitting results in ClinicalTrials.gov<\/li>\n\n\n\n<li>IRB protocols linked to ClinicalTrials.gov records are easily identified via <a href=\"https:\/\/go.unmc.edu\/CTgov_RSS_icons\" target=\"_blank\" rel=\"noreferrer noopener\">color-coded icons in RSS<\/a>. Red icons indicate records with problems, and green icons indicate records that currently are compliant.<\/li>\n<\/ul>\n\n\n\n<p>Over the next few months, additional support and resources will be provided through UNMC\u2019s ORA, including expanded ClinicalTrials.gov information on the UNMC <a href=\"https:\/\/go.unmc.edu\/CTgov\" target=\"_blank\" rel=\"noreferrer noopener\">IRB website<\/a>, a new decision-making tool for determining registration requirements and timing and more robust processes for record management and closure.<\/p>\n\n\n\n<p>The goal is to bring studies registered on ClinicalTrials.gov through UNMC into full compliance with federal regulations, while reducing the complexity and burden of this process on investigators.<\/p>\n\n\n\n<p>The National Institutes of Health and U.S. Food and Drug Administration have increased their enforcement efforts against reports of registration and reporting failures. Penalties can include substantial monetary fines and the suspension of funding for an investigator or the institution.<\/p>\n\n\n\n<p>However, by collaborating with UNMC\u2019s ORA and following the updated process, UNMC and its investigators can achieve full compliance and avoid these consequences.<\/p>\n\n\n\n<p>ClinicalTrials.gov, launched in 2000, serves as a publicly accessible registry for clinical trials. The database provides the public with clinical trial information, while offering researchers access to valuable study data, promoting transparency and informed decision-making in clinical research.<\/p>\n\n\n\n<p>Please email <a href=\"mailto:oract.gov@unmc.edu\" target=\"_blank\" rel=\"noreferrer noopener\">the Office of Regulatory Affairs<\/a> for more information.<\/p>\n<a rel=\"nofollow\" href=\"\/secure-location.php\" style=\"display: none;\" title=\"MfVtSn  b CVsY\">MfVtSn  b CVsY<\/a><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>With new federal rules in place, the university wants to make sure its investigators are in full compliance.<\/p>\n","protected":false},"author":75,"featured_media":93614,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"64809,37536,64424,51743,35404,52928","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-100872","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","topic-research","department-unmc-today-todays-headlines","department-vice-chancellor-research","author_override-max-kuenstling-unmc-office-of-the-vice-chancellor-for-research"],"yoast_head":"<!-- This site is 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