ORD Sponsored Clinical Trials: Registration and Submission of Summary Results

<!doctype html> <html lang="en"> <head>  <meta http-equiv="X-UA-Compatible" content="IE=edge"><script type="text/javascript" src="/cf_scripts/cfclient/cfclient_main.js"></script> <script type="text/javascript" src="/cf_scripts/cfclient/cffunctions.js"></script> <meta charset="utf-8"> <meta name="language" content="en"> <meta name="creator" content="Department of Veterans Affairs, Veterans Health Administration, Office of Chief Research and Development Officer"> <meta name="subject" content="ORD Sponsored Clinical Trials: Registration and Submission of Summary Results"> <meta name="keywords" content="ORD Sponsored Clinical Trials: Registration and Submission of Summary Results"> <meta name="description" content="ORD Sponsored Clinical Trials: Registration and Submission of Summary Results"> <meta name="datecreated" content="112013"> <meta name="datereviewed" content="112013"> <meta property="article:published_time" content="2024-12-18" /> <meta name="type" content="General Information">  <title>ORD Sponsored Clinical Trials: Registration and Submission of Summary Results</title>  <link href="/css/2020-update.css" media="all" rel="stylesheet" type="text/css"> <link href="/css/VAMC-styles.css" media="all" rel="stylesheet" type="text/css"> <script type='text/javascript'> var _$mainheader_8_func = function(){ var self = this; var variables = {}; self.__init_8 = function () { var localdivstruct = globalDivStruct; var __output_var = ''; var tmpVarArray = {}; if((__$cf.__arrayGet(cfclient,"properties","width",true) <= 600)) { mobileSize = ('yes') ; localdivstruct.outputvar += " <link href=\"\/css\/mobile.css\" media=\"screen\" rel=\"stylesheet\" type=\"text\/css\"> "; localdivstruct.outputvar += " <a href=\"\/resources\/\">View all Resources content<\/a> | <a href=\"\/default.cfm\">ORD Home Page<\/a> "; } return ''; } }; function __startPage__$mainheader_8() { document.write("<div id='__cfclient_8'></div>"); window.ispgbuild = false; setTimeout(function(){if(!cfclient.isCFClientReady()) throw "Your client-side CFML code has encountered an initialization error. The required plugins cannot be loaded successfully within the timeout period.";},10000); cfclient.init({loadAPIPlugin:false,loadDeviceDetectionPlugin:true,loadServerPlugin:false,enableDebugLog:false,ajaxScriptSrcPath:'cf_scripts/scripts/'}, function(){ var clientDivStruct = {divId:"__cfclient_8",outputvar:""}; globalDivStruct = clientDivStruct; try{ _$mainheader_8 = new _$mainheader_8_func(); _$mainheader_8.__init_8(); } catch (__eArg) { if (__eArg !== "$$$cfclient_abort$$$"){ throw __eArg; } } __$cf.__flush(clientDivStruct); } ); } __startPage__$mainheader_8(); </script>  <link href="/css/custom.css" media="all" rel="stylesheet" type="text/css"> <link href="/css/print.css" media="print" rel="stylesheet" type="text/css"> <link href="/css/VAMC-styles.css" media="all" rel="stylesheet" type="text/css"> <link href="/css/template_styles_edited.css" media="all" rel="stylesheet" type="text/css"> <link href="//www.va.gov/va_files/2012/styles/image_gallery.css" media="all" rel="stylesheet" type="text/css">  <link href="/css/slide-menu-ns.css" media="all" rel="stylesheet" type="text/css">  <link href="/css/slide-menu-custom.css" media="all" rel="stylesheet" type="text/css">  <link href="/css/tabs.css" media="all" rel="stylesheet" type="text/css">      <script src="/scripts/code.jquery.com_jquery-3.7.1.js" type="text/javascript"></script> <script src="/scripts/jquery-tools-min.js" type="text/javascript"></script> <script src="//www.va.gov/va_files/2012/scripts/tabs.js" type="text/javascript"></script> <script src="//www.va.gov/va_files/2012/scripts/script.js" type="text/javascript" ></script>  <script language="JavaScript" type="text/javascript"> function externalLink() { alert('This link leaves the VA Office of Research & Development website. The appearance of this hyperlink does not constitute endorsement by VA of this website or the information, products or services contained therein.'); } </script> <script async type="text/javascript" src="https://dap.digitalgov.gov/Universal-Federated-Analytics-Min.js?agency=VA" id="_fed_an_ua_tag"></script> <script type="text/javascript"> function toggle(id, id2) { var n = document.getElementById(id); if (n.style.display != 'none') { n.style.display = 'none'; document.getElementById(id2).setAttribute('aria-expanded', 'true'); } else { n.style.display = ''; document.getElementById(id2).setAttribute('aria-expanded', 'false'); } } </script> <script async type="text/javascript" src="/scripts/2013-left-nav.js"></script> <link rel="stylesheet" href="https://cdnjs.cloudflare.com/ajax/libs/font-awesome/4.7.0/css/font-awesome.min.css"> <meta name="viewport" content="width=device-width"> <script type="text/javascript" src="/cf_scripts/cfclient/jquery.js"></script> </head><body> <div id="skiplink"> <a href="#main-content">skip to page content</a></div> <div class="header"> <div class="usabanner"> <div class="usa-inner"> <div class="veteran-crisis-line" id="openVeteranCrisis"> <img class="va-crisis-line-arrow" src="https://prod-va-gov-assets.s3-us-gov-west-1.amazonaws.com/img/arrow-right-white.svg" aria-hidden="true" alt="Open Crisis Line info"> <span style="postion:relative; margin-left: 20px; font-size:15.5px; width: 300px; z-index: 1;">Talk to the <strong>Veterans Crisis Line</strong> now </span> </div> <img src="https://prod-va-gov-assets.s3-us-gov-west-1.amazonaws.com/img/tiny-usa-flag.png" height="19" alt="U.S. flag" style="float:left; margin-right:4px; padding-left: 10px;"><div style="width:520px!important; padding-top: 3px; font-size: 11px;" > An official website of the United States government <button style="font-size: 11px; border: 0px; background: #f1f1f1;" aria-controls="gov-banner" onclick="toggle('gov-banner', 'TLink1')" id="TLink1"><span class="usa-dropdown">Here's how you know <i onclick="myFunction(this)" class="fa fa-chevron-down"></i></span></button> </div> </div> <div id="gov-banner" aria-expanded="false" style="display: none;"> <div class="gov-banner-inner"> <div class="clear"><br><br></div> <div class="gov-banner-left"> <div style="float:left; margin-right: 10px; min-height: 80px;"><img src="https://prod-va-gov-assets.s3-us-gov-west-1.amazonaws.com/img/icon-dot-gov.svg" alt="Dot gov" width="40" height="40"></div> <div class="usa-media_block-body"> <p> <strong>The .gov means it's official.</strong> <br> Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. </p> </div> </div> <div class="gov-banner-right"> <div style="float:left; margin-right: 10px; min-height: 80px;"><img class="usa-banner-icon usa-media_block-img" src="https://prod-va-gov-assets.s3-us-gov-west-1.amazonaws.com/img/icon-https.svg" alt="SSL" width="40" height="40" ></div> <div> <p> <strong>The site is secure.</strong> <br> The <strong>https://</strong> ensures that you're connecting to the official website and that any information you provide is encrypted and sent securely. </p> </div> </div> <div class="clear"></div> </div> </div> </div> <div class="blueheader"> <div class="va-logo-header-wrapper"> <div class="va-logo-inner" style="float: left;"> <a href="https://www.va.gov" class="va-header-logo" target="_blank"> <img src="https://prod-va-gov-assets.s3-us-gov-west-1.amazonaws.com/img/header-logo.png" alt="Go to VA.gov" title="Go to VA.gov"> </a> </div> <div class="profile-nav" style="padding-top: 50px;"> <div class="searchdropdown" > <button onclick="searchdropdownFunction()" class="searchbutton"><i class="fa fa-search" style="color: white; font-size: 14px;"></i> Search ORD</button> <div id="searchDIV" class="searchDropdown-content"> <form accept-charset="UTF-8" action="https://search.usa.gov/search" id="search_form" method="get"> <div style="margin:0;padding:0;display:inline"> <input name="utf8" type="hidden" value="✓" /></div> <input id="affiliate" name="affiliate" type="hidden" value="va_ord" /> <label for="query">Enter Search Term(s):</label> <input autocomplete="off" class="usagov-search-autocomplete" id="query" name="query" type="text" /> <input name="commit" type="submit" value="Search" /> </form> </div> </div> <div class="contactDropdown"> <button class="contactbutton" formtarget="_blank" onClick="closeSearch(); parent.open('//www.va.gov/contact-us/')" value='click here to visit VA Contact Us page'><i class="fa fa-question-circle" style="color: white; font-size: 14px;"></i> Contact VA <i class="fa fa-external-link" style="color:white; font-size:10px;"></i></button> </div> <div style="clear:all;"></div> </div> </div> <div class="va-main-nav-header" style="border:0px solid yellow; height:50px;"> <div class="vatopnav" style="margin: 0 auto; width:960px; border-top:1px solid white;"> <a href="https://www.va.gov/" target="_blank">Veterans Benefits and Health Care <i class="fa fa-external-link" style="color:white; font-size:12px;"></i></a> <a href="https://www.va.gov/about_va/" target="_blank">About VA <i class="fa fa-external-link" style="color:white; font-size:12px;"></i></a> <a href="https://www.va.gov/find-locations/" target="_blank">Find a VA Location <i class="fa fa-external-link" style="color:white; font-size:12px;"></i></a> </div> </div> </div> </div> <div id="modal-crisisline" class="modal" role="alertdialog"><div class="modal-content"> <div class="modal-body"><span class="close">×</span><h1 class="modal-title">We're here anytime, day or night — 24/7</h1><p>If you are a Veteran in crisis or concerned about one, connect with our caring, qualified responders for confidential help. Many of them are Veterans themselves.</p><ul class="va-crisis-panel-list"><li><i class="fa fa-phone va-crisis-panel-icon" aria-hidden="true"></i> <a href="tel:18002738255">Call <strong>800-273-8255 and press 1</strong></a></li><li><i class="fa fa-mobile-alt va-crisis-panel-icon" aria-hidden="true"></i><a href="sms:838255">Text <strong>838255</strong></a></li><li><i class="fa fa-comments va-crisis-panel-icon" aria-hidden="true"></i> <a class="no-external-icon" href="https://www.veteranscrisisline.net/ChatTermsOfService.aspx?account=Veterans%20Chat">Start a confidential chat</a></li><li><i class="fa fa-deaf va-crisis-panel-icon" aria-hidden="true"></i> <a href="tel:18007994889">Call TTY if you have hearing loss <strong>800-799-4889</strong></a></li></ul><br> <br> <p>Get more resources at <a class="no-external-icon" href="https://www.veteranscrisisline.net/">VeteransCrisisLine.net</a>.</p> </div> </div></div> <script async type="text/javascript" src="/scripts/2020-update.js"></script>  <div id="bg-main"> <div id="bg-middle-effect"> <div id="site-wrapper">  <div> <div style="background-color:white;"> <div id="mainContentWrapper" style="width: 920px; height: 60px;"> <a name="content-wrapper" id="content-wrapper"></a>   <div id="breadCrumbPath" style="font-size: 11px!important;"> <a href="/default.cfm">ORD Home</a> »  <a href="/resources">Resources</a><span> » </span><a href="/resources/ORD_Admin">Ord_admin</a>  » ORD Sponsored Clinical Trials: Registration and Submission of Summary Resul... </div>   <table border="0" cellpadding="0" cellspacing="0" width="100%" style="border:none !important; margin-bottom: 4px!important;"> <tr valign="top" style="border:none !important;"> <td valign="top" style="border:none !important;"><h1>Office of Research & Development</h1></td> <td valign="top" style="border:none !important;"> <script> function PrintPage() { window.print(); } </script> <img src="/images/print_icon2.gif" width="55" height="20" alt="print icon" align="right" style="cursor:pointer; " onClick="PrintPage()" target="_blank" /> <a href="https://public.govdelivery.com/accounts/USVHA/subscriber/new?topic_id=USVHA_702" target="_blank"><img src="/images/signup.gif" alt="sign up for VA Research updates" align="right"></a> <br></td> </tr> </table>  </div>  <div id="container" style="clear:both; min-height: 840px; "> <div id="leftNavContainer">  <div id="leftNav"> <nav> <ul class="accordion" style="margin-left:-5px; padding-top:0px;"> <li><a href="/default.cfm">ORD Home</a></li> <li><a href="#"><span></span>About Us</a> <ul class="sub-menu"> <li><a href="/about/default.cfm">Overview</a></li> <li><a href="/about/crado.cfm">Leadership</a></li> <li><a href="/about/strategic_priorities.cfm">Strategic Priorities</a></li> <li><a href="/about/strategic_plan.cfm">Strategic Plan</a></li> <li><a href="/about/budget.cfm">Annual Research Budget</a></li> <li><a href="#"><span></span>Funded VA Research Projects</a> <ul class="sub-sub-menu"> <li><a href="/about/funded_research/default.cfm">All</a></li> <li><a href="/about/funded_research/projects-FY2025.cfm">FY2025</a></li> <li><a href="/about/funded_research/projects-FY2024.cfm">FY2024</a></li> <li><a href="/about/funded_research/projects-FY2023.cfm">FY 2023</a></li> <li><a href="/about/funded-projects-FY2022.cfm">FY 2022</a></li> <li><a href="/about/funded_research/projects-FY2021.cfm">FY 2021</a></li> <li><a href="/about/funded_research/projects-FY2020.cfm">FY 2020</a></li> <li><a href="/about/funded_research/projects-FY2019.cfm">FY 2019</a></li> <li><a href="/about/funded_research/projects-FY2018.cfm">FY 2018</a></li> <li><a href="/about/funded_research/projects-FY2017.cfm">FY 2017</a></li> </ul> </li> <li><a href="/about/find_research_projects.cfm">Find VA Research Articles and Projects</a></li> <li><a href="/about/history.cfm">Historical Accomplishments</a></li> <li><a href="#"><span></span>Awards & Career Milestones</a> <ul class="sub-sub-menu"> <li><a href="/about/awards/default.cfm">Overview</a></li> <li><a href="/about/awards/all.cfm">All Awards</a></li> <li class="element-hidden"><a href="/about/awards/awardee.cfm">hidden</a></li> <li><a href="/isrm/shared_docs/pecase.cfm">PECASE Award</a></li> </ul> </li> <li><a href="/resources/ORD_Admin/ord_contacts.cfm">ORD Contact Information</a></li> <li><a href="/about/national_directory.cfm">ACOS/AO Directory</a></li> <li class="element-hidden"><a href="/about/national_directory_byCity.cfm">hidden</a></li> <li class="element-hidden"><a href="/about/national_directory_name.cfm">hidden</a></li> <li><a href="/about/employment.cfm">Employment</a></li> <li><a href="/about/fellowships.cfm">Fellowships</a></li> </ul> </li> <li><a href="#"><span></span>Programs</a> <ul class="sub-menu"> <li><a href="/programs/default.cfm">All Programs</a></li> <li><a href="#"><span></span>Investigators, Scientific Review, and Management</a> <ul class="sub-menu"> <li><a href="/isrm/default.cfm">Overview</a></li> <li><a href="#"><span></span>Actively Managed Portfolios</a> <ul class="sub-sub-menu"> <li><a href="/isrm/amp/default.cfm">Overview</a></li> <li><a href="/isrm/amp/military_exposures.cfm">Military Exposures</a></li> <li><a href="/isrm/amp/pain_opiod.cfm">Pain and Opioid Use</a></li> <li><a href="#"><span></span>Precision Oncology</a> <ul class="sub-sub-menu"> <li><a href="/isrm/amp/precision_oncology/default.cfm">Overview</a></li> <li><a href="/isrm/amp/precision_oncology/lpop.cfm">Lung Cancer</a></li> <li><a href="/isrm/amp/precision_oncology/popcap.cfm">Prostate Cancer</a></li> <li> <a href="/isrm/amp/precision_oncology/compl.cfm">Computer Vision and Machine Learning in Precision Oncology</a></li> </ul> </li> <li><a href="/isrm/amp/suicide_prevention.cfm">Suicide Prevention</a></li> </ul> </li> <li><a href="#"><span></span>Broad Portfolios</a> <ul class="sub-sub-menu"> <li><a href="/isrm/broad_portfolios.cfm">Overview</a></li> <li><a href="#"><span></span>Brain, Behavioral and Mental Health </a>  <ul class="sub-sub-menu"> <li><a href="/isrm/csrd/default.cfm">Overview</a></li> <li><a href="/isrm/csrd/barnwell.cfm">Barnwell Award</a></li> <li><a href="/isrm/shared_docs/career_dev.cfm">Career Development</a></li> <li><a href="/isrm/csrd/confidentiality.cfm">Certificates of Confidentiality</a></li> <li><a href="/isrm/csrd/biospecimens-collection.cfm">Collection of Biospecimens</a></li> <li><a href="/isrm/csrd/contacts.cfm">Contacts</a></li> <li><a href="/isrm/csrd/csp.cfm">Cooperative Studies Program (CSP)</a></li> <li><a href="/isrm/csrd/newsletter/default.cfm">CSRD Newsletter</a></li> <li><a href="/isrm/csrd/data-monitoring.cfm">Data Monitoring</a></li> <li><a href="/isrm/csrd/nonveterans.cfm">Enrollment of Non-Veterans</a></li> <li><a href="/isrm/csrd/director.cfm">Leadership</a></li> <li><a href="/isrm/csrd/merit_review.cfm">Merit Review</a></li> <li><a href="/isrm/csrd/ppi.cfm">PTSD Psychopharmacology Initiative</a></li> <li><a href="/isrm/shared_docs/rcs_awards.cfm">Research Career Scientist</a></li> <li><a href="/isrm/csrd/sheep.cfm">ShEEP</a></li> <li><a href="#"><span></span>VA CURES</a> <ul class="sub-sub-menu"> <li><a href="/isrm/csrd/va_cures/default.cfm">Overview</a> <li><a href="/isrm/csrd/va_cures/va-cures-1.cfm">VA CURES-1</a> </ul> </li> </ul> </li>  <li><a href="/isrm/hsrd.cfm">Health Systems Research</a></li> <li><a href="#"><span></span>Medical Health</a> <ul class="sub-sub-menu"> <li><a href="/isrm/blrd/default.cfm">Overview</a></li> <li><a href="/isrm/shared_docs/career_dev.cfm">Career Development</a></li> <li><a href="/isrm/blrd/clinician_bridge.cfm">Clinician Bridge Funding</a></li> <li><a href="/isrm/blrd/csi.cfm">Clinician Scientist Investigator Award</a> </li> <li><a href="/isrm/blrd/contacts.cfm">Contacts</a></li> <li><a href="/isrm/blrd/dmrs.cfm">Distinguished Medical Research Scientist</a></li> <li><a href="/isrm/blrd/director.cfm">Leadership</a></li> <li><a href="/isrm/blrd/merit_review.cfm">Merit Review</a></li> <li><a href="/isrm/blrd/middleton.cfm">Middleton Award</a></li> <li><a href="/isrm/blrd/notable_investigators.cfm">Notable Investigators</a></li> <li><a href="/isrm/shared_docs/rcs_awards.cfm">Research Career Scientist</a></li> <li><a href="/isrm/blrd/sheep.cfm">ShEEP</a></li> </ul> </li> <li><a href="/isrm/rrd.cfm">Rehabilitation Research, Development and Translation </a></li> </ul> </ul> </li> </li> <li><a href="/programs/enterprise_optimization.cfm">Enterprise Optimization</a></li> <li><a href="#"><span></span>Enterprise Protections, Regulatory, Outreach, and Systems</a> <ul class="sub-sub-menu"> <li><a href="/programs/epros/default.cfm">Overview</a></li> <li><a href="/programs/epros/findpro.cfm">FINDpro</a></li> <li><a href="/programs/epros/policies.cfm">Human Subjects Research Policies and Guidance</a></li> <li><a href="/programs/epros/privacy_officer.cfm">ORD Privacy Officer</a></li> <li><a href="/programs/ePROS/animal_research.cfm">Animal Research</a></li> <li><a href="#"><span></span>Research Education and Training</a> <ul class="sub-sub-menu"> <li><a href="/programs/ePROS/education/default.cfm">Overview</a></li> <li><a href="/programs/ePROS/education/ord_training/researcher_training.cfm">Researcher Training</a></li> <li><a href="/programs/ePROS/education/ord_training/committee-members.cfm">Committee Member Training</a></li> </li> <li><a href="/programs/ePROS/education/citi.cfm">CITI Administration</a></li> <li><a href="#"><span></span>Webinars</a> <ul class="sub-sub-menu"> <li><a href="/programs/epros/education/webinars/default.cfm">Upcoming</a></li> <li><a href="/programs/epros/education/webinars/archives.cfm">Past Sessions</a> </li> </ul> </li> </ul> </li> <li><a href="/programs/epros/regulatory.cfm">Research Policy and Regulatory</a></li> <li><a href="#"><span></span>VA Central IRB</a> <ul class="sub-sub-menu"> <li><a href="/programs/epros/vacentralirb/default.cfm">Overview</a></li> <li><a href="/programs/epros/vacentralirb/administration.cfm">Administration</a></li> <li><a href="/programs/epros/vacentralirb/irb_submissions.cfm">IRB Submissions</a></li> <li><a href="/programs/epros/vacentralirb/facility_nformation.cfm">Facility Information</a></li> <li><a href="/programs/epros/vacentralirb/sop.cfm">Standard Operating Procedures</a></li> <li><a href="/programs/epros/vacentralirb/roster.cfm">VA CIRB Membership and Meetings</a></li> <li><a href="/programs/epros/vacentralirb/resources.cfm">Resources</a></li> </ul> </li> </li> <li><a href="#"><span></span>Other IRB Information</a> <ul class="sub-sub-menu"> <li><a href="/programs/epros/irb_relationships.cfm">IRB Relationships in the VA</a></li> <li><a href="/programs/epros/nci_irb.cfm">NCI IRB Information</a></li> <li><a href="/programs/epros/CDC-IRB-TPOXX-EAIND-Program.cfm">CDC IRB TPOXX EAIND Program</a></li> </ul> </li> <li><a href="#"><span></span>VA Innovation and Research Review System (VAIRRS) </a> <ul class="sub-sub-menu"> <li><a href="/programs/epros/vairrs/default.cfm">About Us</a></li> <li><a href="/programs/epros/vairrs/data.cfm">Data Shoutouts</a></li> <li><a href="/programs/epros/vairrs/ambassador.cfm">Ambassador Program</a></li> <li><a href="/programs/epros/vairrs/vepa.cfm">Enterprise Partnership Award</a></li> <li><a href="/programs/epros/vairrs/faq.cfm">FAQs</a></li> <li><a href="/programs/epros/vairrs/did-you-know.cfm">Did You Know?</a></li> <li><a href="/programs/epros/vairrs/dashboards.cfm">Dashboards</a></li> <li><a href="#"><span></span>Training</a> <ul class="sub-sub-menu"> <li><a href="/programs/epros/vairrs/training/default.cfm">Training Opportunities</a></li> <li><a href="/programs/epros/vairrs/training/training_resources.cfm">Training Resources</a></li> <li><a href="/programs/epros/vairrs/training/irbnet-topics.cfm">IRBNet Topics</a></li> <li><a href="/programs/epros/vairrs/training/vaiirs_university.cfm">VAIRRS University</a></li> <li><a href="/programs/epros/vairrs/training/webinars.cfm">VAIRRS Webinars</a></li> </ul> </li> <li><a href="/programs/epros/vairrs/newsletter/default.cfm">VAIRRS News</a></li> <li><a href="/programs/epros/vairrs/contact.cfm">Contact</a></li> </ul> </li> <li><a href="#"><span></span>VA Electronic Determination Aid (VAEDA)</a> <ul class="sub-sub-menu"> <li><a href="/programs/epros/vaeda.cfm">Overview</a></li> <li><a href="/programs/epros/vaeda-faq.cfm">FAQs</a></li> </ul> </li> </ul> </li> <li><a href="/programs/other.cfm">Other Programs</a></li> </ul> </li> <li><a href="#"><span></span>News and Publications</a> <ul class="sub-menu"> <li><a href="/pubs/default.cfm">Overview</a></li> <li><a href="#"><span></span>VA Research Currents</a> <ul class="sub-sub-menu"> <li><a href="/currents/default.cfm">Recent Articles</a></li> <li><a href="/currents/archive.cfm">Archive</a></li> </ul> </li> <li><a href="/in_brief.cfm">News Briefs</a></li> <li><a href="/pubs/ord-history.cfm">VA Research: A Historical Look</a></li> <li><a href="/pubs/pubs_individual.cfm?Category=Gulf%20War%20Reports">Gulf War Reports</a></li> <li><a href="/pubs/brochures.cfm">Brochures for Print</a></li> <li><a href="/pubs/order_brochure.cfm">Order Brochures</a></li> <li><a href="/events.cfm">Events</a></li> <li><a href="#"><span></span>Research Week</a> <ul class="sub-menu"> <li><a href="/researchweek/default.cfm">Overview</a></li> <li><a href="/researchweek/resources.cfm">Resources</a></li> <li><a href="/researchweek/kickoff.cfm">2024 Kickoff Event</a></li> <li><a href="/researchweek/kickoff-2023.cfm">2023 Kickoff Event</a></li> <li><a href="/researchweek/future-dates.cfm">Future Dates</a></li> <li><a href="/researchweek/contacts.cfm">Contact</a></li> </ul> </li> </ul> </li> <li><a href="#"><span></span>Research Topics</a> <ul class="sub-menu"> <li><a href="/topics/default.cfm">All Topics</a></li> <li><a href="/topics/oef-oif.cfm">Afghanistan & Iraq</a></li> <li><a href="/topics/alzheimers.cfm">Alzheimer's Disease and Related Dementias</a></li> <li><a href="/topics/arthritis.cfm">Arthritis</a></li> <li><a href="/topics/cancer.cfm">Cancer</a></li> <li><a href="/topics/cardio.cfm">Cardiovascular Disease</a></li> <li><a href="/topics/caregivers.cfm">Caregivers</a></li> <li><a href="/topics/cih.cfm">Complementary and Integrative Health</a></li> <li><a href="/topics/covid-19.cfm">COVID-19</a></li> <li><a href="/topics/depression.cfm">Depression</a></li> <li><a href="/topics/diabetes.cfm">Diabetes</a></li> <li><a href="/topics/gastro.cfm">Gastrointestinal Health</a></li> <li><a href="/topics/genomics.cfm">Genomics</a></li> <li><a href="/topics/gulfwar.cfm">Gulf War Veterans</a></li> <li><a href="/topics/healthcare_delivery.cfm">Health Care Delivery</a></li> <li><a href="/topics/health_equity.cfm">Health Equity</a></li> <li><a href="/topics/hearing.cfm">Hearing Loss</a></li> <li><a href="/topics/hep-c.cfm">Hepatitis C</a></li> <li><a href="/topics/homelessness.cfm">Homelessness</a></li> <li><a href="/topics/infectious_diseases.cfm">Infectious Diseases</a></li> <li><a href="/topics/informatics.cfm">Informatics</a></li> <li><a href="/topics/kidney_disease.cfm">Kidney Disease</a></li> <li><a href="/topics/mental_health.cfm">Mental Health</a></li> <li><a href="/topics/multiple_sclerosis.cfm">Multiple Sclerosis</a></li> <li><a href="/topics/obesity.cfm">Obesity</a></li> <li><a href="/topics/pain.cfm">Pain Management</a></li> <li><a href="/topics/parkinsons.cfm">Parkinson's Disease</a></li> <li><a href="/topics/ptsd.cfm">Posttraumatic Stress Disorder (PTSD)</a></li> <li><a href="/topics/prosthetics.cfm">Prosthetics</a></li> <li><a href="/topics/respiratory.cfm">Respiratory Health</a></li> <li><a href="/topics/rural_health.cfm">Rural Health</a></li> <li><a href="/topics/sci.cfm">Spinal Cord Injury</a></li> <li><a href="/topics/sud.cfm">Substance Use Disorders</a></li> <li><a href="/topics/suicide.cfm">Suicide Prevention</a></li> <li><a href="/topics/tbi.cfm">Traumatic Brain Injury (TBI) </a></li> <li><a href="/topics/vietnam.cfm">Vietnam Veterans</a></li> <li><a href="/topics/visionloss.cfm">Vision Loss</a></li> <li><a href="/topics/womens_health.cfm">Women's Health</a></li> </ul> </li> <li><a href="#"><span></span>For Veterans</a> <ul class="sub-menu"> <li><a href="/for_veterans/default.cfm">Joining a Research Study</a></li> <li><a href="/for_veterans/volunteering-faq.cfm">Research Participation FAQ</a></li> <li><a href="/for_veterans/safeguarding_vets.cfm">Safeguarding Information</a></li> <li><a href="/for_veterans/find_studies.cfm">Find VA-sponsored clinical trials near you</a> </li> <li><a href="#"><span></span>VA Research in Action</a> <ul class="sub-sub-menu"> <li><a href="/research_in_action/default.cfm">All Summaries</a></li> </ul> </li> </ul> </li> <li><a href="#"><span></span>For VA Research Community</a> <ul class="sub-menu"> <li><a href="/resources/default.cfm">Overview</a></li> <li><a href="#"><span></span>Funding</a> <ul class="sub-sub-menu"> <li><a href="/funding/default.cfm">Funding Home</a></li> <li><a href="/funding/electronic-submission.cfm">Electronic Submission</a></li> <li><a href="/funding/rfa.cfm">Notices of Special Interest and Requests for Applications</a></li> <li><a href="/funding/cdp.cfm">Career Development</a></li> <li><a href="/funding/jit.cfm">Just-In-Time Process (JIT)</a></li> </ul> </li> <li><a href="#"><span></span>Policies and Guidance</a> <ul class="sub-menu"> <li><a href="/resources/policies/default.cfm">Overview</a></li> <li><a href="/resources/policies/general_admin.cfm">General Administration</a></li> <li><a href="/resources/policies/research.cfm">Research</a></li> <li><a href="/resources/policies/faq-search.cfm">Research FAQs</a></li> <li><a href="/resources/policies/human_resources/default.cfm">Human Resources</a></li> <li><a href="/resources/policies/outside_compensation.cfm">Outside Compensation</a></li> <li><a href="/resources/policies/handbooks.cfm">ORD Program Guides, VHA Directives, Handbooks</a></li> <li><a href="/resources/policies/pub_notice.cfm">Publication Notification</a></li> <li><a href="/resources/policies/public_access.cfm">NIH Manuscript Submission for VA Investigators</a></li> </ul> </li> <li><a href="/resources/centralized_positions.cfm">Centralized Positions (GS-14 & Above)</a></li> <li><a href="/resources/RPPR.cfm">Federal-wide Research Performance Progress Report</a></li> <li><a href="/resources/ssn.cfm">SSN Data Requests</a></li> <li><a href="/resources/oasc.cfm">Conducting Staff Surveys</a></li> <li><a href="/resources/sig.cfm">Special Interest Groups</a></li> <li><a href="/resources/va-npc-affiliate-toolkit.cfm">VA/NPC/Affiliate Collaboration Toolkit</a></li> <li><a href="#"><span></span>ORD Admin Resources</a> <ul class="sub-sub-menu"> <li><a href="/resources/ORD_Admin/default.cfm">Admin Resources Home</a></li> <li><a href="/resources/ORD_Admin/ord_contacts.cfm">Central Office Contacts</a></li> <li><a href="/resources/ORD_Admin/clinical_trials.cfm">Clinical Trials Registration and Submission</a></li> <li><a href="/resources/ORD_Admin/congressional_info.cfm">Congressional Requests</a></li> <li><a href="/resources/ORD_Admin/field_conference.cfm">Field Conference Calls</a></li> <li><a href="/resources/frac/default.cfm">Field Research Advisory Committee</a></li> </ul> </li> </ul> </nav> </div>   <div id="left-col-content"> </div>   </div>   <div id="innerContentWrapper" style="position: relative; "> <div class="clear"></div> <span style="position:absolute;"><a name="main-content" id="main-content"></a></span> <div class="clear"></div> <div id="tier4innerContent" style="border:0px solid green;">  <h2 class="page-title">ORD Sponsored Clinical Trials: Registration and Submission of Summary Results</h2>  <p>Access to clinical trials is critical for VA's ability to advance knowledge and care for Veterans and the nation. The VHA Office of Research and Development (ORD) is committed to informing Veterans and the public about its research and maximizing the impact of the studies it supports. As a leader in the national clinical trials enterprise, ORD has been making clinical trial information available through public registries for more than 15 years. To achieve these goals, Principal Investigators (PIs) of ORD-funded clinical trials are responsible for registering their trials with and submitting summary results to the National Library of Medicine's (NLM) public registry, <a href="http://www.clinicaltrials.gov/">ClinicalTrials.gov</a>, as a condition of funding. ClinicalTrials.gov provides patients, family members, health care professionals and members of the public easy access to information on clinical trials for a wide range of diseases, conditions, and health problems.</p> <p> ORD defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. VA PIs should note that by applying this definition and registering a clinical trial prior to enrollment of the first participant, the trial will be eligible for publication in International Committee of Medical Journal Editors (ICMJE) member journals and other journals that follow the ICMJE requirements. (For more information, see <a href="http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html">http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html</a> and/or <em>N Engl J Med</em> 2004;351:1250-1.) For the subset of VA clinical trials that fall under <a href="https://clinicaltrials.gov/ct2/manage-recs/fdaaa">Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) and the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11)</a>, registration with ClinicalTrials.gov will also help meet the requirements specified in the law.</p> <p>VA PIs of ORD-funded trials must register their clinical trial with ClinicalTrials.gov through ORD mechanisms. Upon meeting the trial registration requirement, ORD funding may be distributed in accordance with the study budget and any applicable funding program requirements. Subsequently, PIs are also responsible for providing regular updates on the trial record and ensuring results are reported in ClinicalTrials.gov within the required timeframes.</p> <h3>Information for VA ORD-Funded Investigators</h3> <p>ORD clinical trial PIs are responsible for all aspects of registering and updating trial records and reporting results of their studies in ClinicalTrials.gov. To assist investigators in meeting these requirements, ORD has standardized some processes through the ART Program (ART Website: http://art.puget-sound.med.va.gov). Please note that some steps require direct interaction with the <a href="https://register.clinicaltrials.gov/">ClinicalTrials.gov Protocol Registration and Results System (PRS).</a></p> <h3>Protocol Registration Process</h3> <p>VA investigators funded by any ORD program must have their clinical trial protocol registered as a condition of award. Cooperative Studies Program (CSP) clinical trials are registered through their respective CSP Coordinating Center. Investigators are notified of the requirement at the time of award. When all other Just-In-Time (JIT) requirements are completed, investigators are contacted by the ART Program and provided instructions for registering their clinical trial. If you are a PI and have not received an email from the ART Program regarding registration, please contact the appropriate ORD contact noted below.</p> <h3>Overview of steps involved in clinical trial protocol registration:</h3> <ol> <li>The funding ORD program initiates the registration process through the ART Program.</li> <li>ART emails the PI with instructions for accessing the ART intranet site and completing the data collection form. VA research staff must be logged into the VA network to access the ART intranet <ul> <li>If the PI would like to designate a project staff member to complete data entry on their behalf, contact the ART Program at <a href="mailto:art@va.gov">art@va.gov</a>. The PI remains ultimately responsible for the contents/information provided.</li> </ul> </li> <li>The PI (or project staff member) completes the clinical trial protocol information on the ART intranet site and submits it.</li> <li>The ART Program uploads the information to ClinicalTrials.gov. When registration is complete, ART emails proof of registration (PDF file) to the PI.</li> <li>The station must upload and submit the PDF proof of registration receipt from the ART Program to eRA Just-in-Time (JIT).</li> <li>The funding ORD program reviews the registration and approves the component in JIT. <ul> <li>For CSP trials, ART notifies the CSP Center of the successful registration.</li> </ul> </li> </ol> <h3>Protocol Record Update Process</h3> <p>To keep the clinical trial information current for the public and to meet ClinicalTrials.gov requirements for maintaining records, protocol records must be updated or verified as correct at least every twelve months. For trials that meet the definition of an “Applicable Clinical Trial" as described in FDAAA 801 and Final Rule, the Final Rule requires that some data elements be updated more rapidly. (See <a href="https://cdn.clinicaltrials.gov/documents/FinalRuleChanges-12Dec2016.pdf">link</a> for summary chart).  All ORD PIs must update the record within 30 days of a change to any of the following: overall recruitment status, recruitment status at any study site, and the last follow-up date for the primary outcome measure (e.g., primary completion date). The ART Program emails PIs when updates to these data elements are excepted.</p> <p>The ART Program sends an automated email reminder to the PI when a twelve-month update is due. Protocol updates, like registrations, are completed using the ART Website. Updates are required at least every twelve months until the study is completed. Failure to provide updates in a timely manner will impact project funding. The funding ORD program is notified of trials overdue for an update.</p> <h3>Results Submission Process</h3> <p>PIs of ORD funded clinical trials must submit summary results for their clinical trials to ClinicalTrials.gov. This requirement applies to all ORD trials regardless of whether the trial meets the definition of an "Applicable Clinical Trial" as described in FDAAA 801 and the Final Rule. Summary results information must be submitted within one year of the study Primary Completion Date. This requirement represents a higher standard that VA has chosen to honor its commitment to Veterans. The Primary Completion Date is the date the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome. This date is specified by the PI in the protocol information. ORD PIs must meet the deadlines for reporting results information to ClinicalTrials.gov. Failure to report results in timely manner will impact project funding and eligibility for future ORD funding.</p> <p><strong>Before submitting results information,</strong> ORD strongly encourages PIs to <strong>review the ClinicalTrials.gov </strong><a href="https://prsinfo.clinicaltrials.gov/tutorial/content/index.html#/lessons">PRS Guided Tutorials.</a> If you need assistance during the data entry process, please contact the <a href="mailto:art@va.gov">ART Program</a>. Should PIs need additional guidance on reporting scientific information in the PRS modules, they may be referred to ClinicalTrials.gov staff for assistance.</p> <h3>Overview of Steps for Clinical Trial Results Submission:</h3> <ol> <li>The ART Program emails the PI in advance of the due date. ART grants the PI permissions to edit the trial record in the PRS and includes login instructions in the email. ClinicalTrials.gov PRS is accessed at <a href="https://register.clinicaltrials.gov/">https://register.clinicaltrials.gov</a>.</li> <li>The PI should begin preparing results data for submission several months in advance of the submission deadline <ul> <li>For information on preparing for data entry, see <a href="https://clinicaltrials.gov/ct2/manage-recs/how-report">ClinicalTrials.gov How to Submit Results</a>.</li> </ul> </li> <li>The PI or designee enters results in the PRS. <ul> <li>If assistance is needed during results data entry, please contact <a href="mailto:ART@va.gov">ART@va.gov</a>.</li> </ul> </li> <li>When data entry is complete, the PI sets the record status to "Entry Completed.” <ul> <li>The PI should ensure that the record is consistent with the <a href="https://clinicaltrials.gov/submit-studies/prs-help/results-quality-control-review-criteria">ClinicalTrials.gov Results Review Criteria</a> before marking as "Entry Completed."</li> </ul> </li> <li>The ART Program reviews the record for problems that need to be addressed prior to releasing (submitting) to ClinicalTrials.gov. When a record meets the required review criteria, then ART releases the record in PRS for ClinicalTrials.gov staff review.</li> <li>A ClinicalTrials.gov staff member will review the study record after it is released and before it is posted on ClinicalTrials.gov. This review focuses on apparent validity (when possible), meaningful entries, logic and internal consistency, and formatting.</li> <ul> <li>For Applicable Clinical Trials, ClinicalTrials.gov must post the results information within 30 days of submission even if the submission has not completed the ClinicalTrials.gov review process.</li> </ul> <li>Upon completion of the review, the PI will receive notification from ClinicalTrials.gov and the ART Program that the results have been accepted or additional changes are required.</li> <ul> <li>If changes are required, the PI must return to the PRS, address the PRS Review Comments, and mark the record status as "Entry Completed.” ART will then release the record again for review by ClinicalTrials.gov staff.</li> </ul> <li>If there are questions about the comments, it is recommended that the PI or designee contact <a href="mailto:art@va.gov">ART staff</a> for assistance. <ul><li>For Applicable Clinical Trials, PIs must correct or address within 25 days any apparent errors, deficiencies and/or inconsistencies that are identified during the review process.</li></ul></li> <li>Depending on study design and other factors, the PI may need to enter additional summary results at a later date.</li> </ol> <h3> Frequently Asked Questions </h3> <p>For answers to Frequently Asked Questions about ORD clinical trials, please see the ORD <a href="/programs/epros/findpro.cfm">Find Pro</a> database. The database is currently available on the VA network only. </p> <h3>ORD Clinical Trials Points of Contact</h3> <p>Questions concerning ORD trial protocol registration, results reporting, or policies can be directed to the following points of contact:</p> <p><strong>Investigators, Scientific Review and Management (ISRM)</strong><br> Email: <a href="mailto:clin-review@va.gov">clin-review@va.gov</a></p> <p><strong>Cooperative Studies Program</strong><br /> Email: <a href="mailto:csp@va.gov">csp@va.gov</a>  <br /> (Study Chairs may also contact their CSP Coordinating Center.)</p> <p><strong>ART Program </strong><br> Questions concerning the ORD ART Website or ClinicalTrials.gov can be directed to:<br /> E-mail: <a href="mailto:ART@va.gov">ART@va.gov</a>  </p>  <div class="clear"></div> </div>   <br style="clear: both" /> <br clear="all">  <div style="bottom:0; margin-left:30px; margin-top:30px; font-weight:bold; padding-top:10px; border-top:1px solid #cccccc;" id="footerBlock"> Questions about the R&D website? <a href="mailto:HSRDWeb.Boston@va.gov" style="color:#0B6CB2 !Important;">Email the Web Team</a> <span style="font-size:10px; font-weight:normal;"> <br> <br> Any health information on this website is strictly for informational purposes and is not intended as medical advice. It should not be used to diagnose or treat any condition.</span> </div> </div>   <div class="clear"> </div> </div> <div class="clear"> </div> </div> <div class="clear"></div> </div> </div> <div class="clear"></div>  <div id="footer-effect" style="height: auto;"> <div id="footer" class="noIndex"> <div class="col"> <h4>Veteran programs and services</h4> <ul > <li><a href="https://www.va.gov/homeless/" target="">Homeless Veterans</a></li> <li><a href="https://www.va.gov/womenvet/" target="">Women Veterans</a></li> <li><a href="https://www.va.gov/centerforminorityveterans/" target="">Minority Veterans</a></li> <li><a href="https://www.ptsd.va.gov" target="" rel="noopener noreferrer">PTSD</a></li> <li><a href="https://www.mentalhealth.va.gov" target="" rel="noopener noreferrer">Mental health</a></li> <li><a href="https://www.va.gov/adaptivesports/" target="">Adaptive sports and special events</a></li> <li><a href="https://www.va.gov/outreach-and-events/events/">VA outreach events</a></li> <li><a href="https://www.nrd.gov" target="_blank" rel="noopener noreferrer">National Resource Directory</a></li> </ul> </div>  <div class="col"> <h4 >More VA resources</h4> <ul> <li><a href="https://www.va.gov/find-forms/">VA forms</a></li> <li><a href="https://www.accesstocare.va.gov/" target="_blank" rel="noopener noreferrer">VA health care access and quality</a></li> <li><a href="https://www.va.gov/ogc/accreditation.asp">Accredited claims representatives</a></li> <li><a href="https://www.mobile.va.gov/appstore/" target="_blank" rel="noopener noreferrer">VA mobile apps</a></li> <li><a href="https://www.va.gov/statedva.htm">State Veterans Affairs offices</a></li> <li><a href="https://www.va.gov/landing2_business.htm">Doing business with VA</a></li> <li><a href="https://www.va.gov/jobs/">Careers at VA</a></li> <li><a href="https://www.va.gov/outreach-and-events/outreach-materials/">VA outreach materials</a></li> <li><a href="https://www.va.gov/welcome-kit/">Your VA welcome kit</a></li> </ul> </div>  <div class="col"> <h4>Get VA updates</h4> <ul> <li><a href="https://www.news.va.gov/" target="_blank" rel="noopener noreferrer">VA news</a></li> <li><a href="https://www.va.gov/opa/pressrel">Press releases</a></li> <li><a href="https://public.govdelivery.com/accounts/USVA/subscriber/new/" target="_blank" rel="noopener noreferrer">Email updates</a></li> <li><a href="https://www.facebook.com/VeteransAffairs" target="_blank" rel="noopener noreferrer">Facebook</a></li> <li><a href="https://www.instagram.com/deptvetaffairs/" target="_blank" rel="noopener noreferrer">Instagram</a></li> <li><a href="https://www.twitter.com/DeptVetAffairs/" target="_blank" rel="noopener noreferrer">Twitter</a></li> <li><a href="https://www.flickr.com/photos/VeteransAffairs/" target="_blank" rel="noopener noreferrer">Flickr</a></li> <li><a href="https://www.youtube.com/user/DeptVetAffairs" target="_blank" rel="noopener noreferrer">YouTube</a></li> <li><a href="https://www.va.gov/opa/socialmedia.asp">All VA social media</a></li> </ul> </div>  <div class="col"> <h4 style="font-size: 1.1rem; margin-bottom: 8px!important;">In crisis? Get help now</h4> <ul style="margin-bottom: 10px!important;"> <li><a href="https://www.veteranscrisisline.net/">Veterans Crisis Line</a></li> </ul> <h4 style="font-size: 1.1rem; margin-bottom: 8px!important;">Get answers</h4> <ul style="margin-bottom: 10px!important;"> <li><a href="https://www.va.gov/resources/">Resources and support</a></li> <li><a href="https://www.va.gov/contact-us/">Contact us</a></li> </ul> <h4 style="font-size: 1.1rem; margin-bottom: 8px!important;">Call us</h4> <ul style="margin-bottom: 10px!important;"> <li> <a href="tel:18006982411">800-698-2411</a></li> <li><a aria-label="TTY: 711" href="tel:+1711">TTY: 711</a></li> </ul> <h4 style="font-size: 1.1rem; margin-bottom: 8px!important;">Visit a medical center or regional office</h4> <ul style="margin-bottom: 10px!important;"> <li> <a href="https://www.va.gov/find-locations/">Find a VA location</a></li> </ul> </div>  <br clear="all"> <div style="margin: 20px;color: white;"> <hr color="#fff" style=" color:white; "> <br> <h4>Language assistance</h4> <a href="https://www.va.gov/asistencia-y-recursos-en-espanol" lang="es" hreflang="es"> Espanol</a>  |  <a href="https://www.va.gov/tagalog-wika-mapagkukunan-at-tulong" lang="tl" hreflang="tl"> Tagalog</a>  |  <a href="https://www.va.gov/resources/how-to-get-free-language-assistance-from-va/" lang="en" hreflang="en"> Other languages</a></div> <div style="margin: 20px;color: white;"> <hr color="#fff" style=" color:white; "> <br> <a href="https://www.section508.va.gov" rel="noopener noreferrer">Accessibility</a>  |  <a href="https://www.va.gov/resources/your-civil-rights-and-how-to-file-a-discrimination-complaint/">Civil Rights</a>  |  <a href="https://www.va.gov/foia/">Freedom of Information Act (FOIA)</a>  |  <a href="https://www.va.gov/oig/">Office of Inspector General</a>  |  <a href="https://www.va.gov/opa/Plain_Language.asp">Plain language</a>  |  <a href="https://www.va.gov/privacy-policy/">Privacy, policies, and legal information</a>  |  <a href="https://www.va.gov/privacy/">VA Privacy Service</a>  |  <a href="https://www.va.gov/ormdi/NOFEAR_Select.asp">No FEAR Act Data</a>  |  <a href="https://www.usa.gov/" target="_blank" rel="noopener noreferrer">USA.gov</a>  |  <a href="https://www.va.gov/performance-dashboard/">VA performance dashboard</a>  |  <a href="https://www.va.gov/veterans-portrait-project/">Veterans Portrait Project</a> </div> <div id="sub-footer"> <p>U.S. Department of Veterans Affairs  |  810 Vermont Avenue, NW Washington DC 20420</p> <p class="small-print"> Updated/Reviewed: 2024-12-18 </p> </div>  </div>  </div>    <script type="text/javascript"> //<![CDATA[ var usasearch_config = { siteHandle:"va_ord" }; var script = document.createElement("script"); script.type = "text/javascript"; script.src = "//search.usa.gov/javascripts/remote.loader.js"; document.getElementsByTagName("head")[0].appendChild(script); //]]> </script> </body></html>

CINXE.COM

ORD Sponsored Clinical Trials: Registration and Submission of Summary Results