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Reporting Results on ClinicalTrials.gov | Office of Ethics and Compliance
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<a href="/">Home</a> </li> <li class="breadcrumb-item"> Reporting Results On ClinicalTrials.gov </li> </ol> </nav> </div> <div class="layout-content"> <div data-drupal-messages-fallback class="hidden"></div> <div id="block-echo-page-title" class="block block-core block-page-title-block"> <div class="node-owner-group"> <h1 class="page-title"> Reporting Results on ClinicalTrials.gov </h1> <p class="node-owner-group__info"> <span class="node-owner-group__subheading">Questions?</span> <span class="node-owner-group__link">Contact <a href="/teams/clinical-trials-regulatory-support">Clinical Trials Regulatory Support</a><span> </p> </div> </div> <div id="block-echo-content" class="block block-system block-system-main-block"> <article class="node node--type-knowledge-base node--view-mode-full knowledge-base"> <div class="l-basic l-container-offset "> <nav class="l-sidebar knowledge-base__sidebar" aria-label="Table of contents"> <input type="checkbox" id="check"> <label for="check" class="box-shadow knowledge-base__mobile-overview-toggle">In this article</label> <h2 class="l-sidebar knowledge-base__sidebar-title">In this article</h2> <ul class="knowledge-base__nav"> <li> <a href="#field-overview"> Overview </a> </li> <li> <a href="#paragraph-1831"> Requirements for Reporting Results </a> </li> <li> <a href="#paragraph-2651"> Potential Regulatory Consequences of Failing to Report Timely Results </a> </li> <li> <a href="#paragraph-1836"> Assistance with Reporting Results </a> </li> <li> <a href="#field-related-sections"> Related Information </a> </li> </ul> </nav> <div class="l-content"> <div class="box-shadow knowledge-base__content background-white"> <h2 id="field-overview">Overview</h2> <div class="node__overview"><p>Requirements and resources for reporting study results on ClincalTrials.gov.</p> </div> <div class="section-panel paragraph paragraph--type--text-block paragraph--view-mode--default" id="paragraph-1831"> <h2>Requirements for Reporting Results</h2> <div class="clearfix text-formatted field field--name-field-section-body field--type-text-long field--label-hidden field__item"><div> <p>Results are required to be reported <strong>within one year</strong> of the <a href="https://clinicaltrials.gov/policy/protocol-definitions#PrimaryCompletionDate">Primary Completion Date</a> for:</p> <ul> <li>A clinical investigation of an FDA-regulated product. Otherwise known as an <strong>Applicable Clinical Trial (ACT)</strong> or <strong>Probable Applicable Clinical Trial (pACT) </strong>per FDAAA. (For complete definitions of Applicable Drug and Applicable Device Clinical Trials, see the <a href="https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf">ACT checklist </a>and <a href="https://clinicaltrials.gov/ct2/manage-recs/faq#Content42CFRPart11">FAQs</a>.</li> <li><strong>An NIH-funded clinical trial</strong> (<a href="https://grants.nih.gov/policy/clinical-trials.htm">NIH Clinical Trial Requirements for Grants and Contracts</a>).</li> <li><strong>A clinical trial</strong> f<strong>unded by a grant agency that requires results reporting on ClinicalTrials.gov</strong> (e.g., PCORI).</li> </ul> <p>For more details on results reporting for ACTs, see <a href="https://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhenDoINeedToSubmitResults">FDAAA 801 and the Final Rule: When Do I Need to Submit Results</a>.</p> <p>For more details on results reporting for NIH-funded clinical trials, see <a href="https://grants.nih.gov/policy/clinical-trials/reporting/understanding/nih-policy.htm">the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information</a>.</p> </div> </div> </div> <div class="section-panel paragraph paragraph--type--text-block paragraph--view-mode--default" id="paragraph-2651"> <h2>Potential Regulatory Consequences of Failing to Report Timely Results</h2> <div class="clearfix text-formatted field field--name-field-section-body field--type-text-long field--label-hidden field__item"><div> <ul> <li>If results information is not submitted to PRS for review by the date results are expected, it will be flagged as <em>Late Results – per FDAAA</em> on ClinicalTrials.gov.</li> <li>FDA recently issued <a href="https://www.fda.gov/science-research/fdas-role-clinicaltrialsgov-information/clinicaltrialsgov-notices-noncompliance-and-civil-money-penalty-actions">Notices of Noncompliance</a> with FDAAA to responsible parties for failure to submit required clinical trial information.</li> <li>Non-compliant study records could appear on the <a href="https://urldefense.proofpoint.com/v2/url?u=http-3A__fdaaa.trialstracker.net_sponsor_university-2Dof-2Dcalifornia-2Dsan-2Dfrancisco_-3Fstatus-255B-255D-3Doverdue-26sponsor-3Duniversity-2Dof-2Dcalifornia-2Dsan-2Dfrancisco&d=DwMFaQ&c=iORugZls2LlYyCAZRB3XLg&r=XAhGIfT-plUIC_o_KUGl8A&m=SAnPgPu3yUbQdVjSzTGo_GcJ0Oxf4dMK44Idn1L07KQ&s=OZMDRzRtbGpG6CSYhPq8jAsZCOndlUUvyf3jmMYpRq0&e=">FDAAA Trials Tracker </a>website as overdue.</li> <li>If results reporting is required per FDAAA, failing to meet the requirement to post summary results within 12 months of the Study Completion Date may incur <a href="https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM607698.pdf">penalties under the Federal Food, Drug, and Cosmetic Act</a>, including civil monetary penalties or criminal actions.</li> <li>If results reporting is required per NIH, failing to meet the requirement to post summary results within 12 months of the Study Completion Date may cause NIH to withhold future grant funding for the institution.</li> </ul> </div> </div> </div> <div class="section-panel paragraph paragraph--type--text-block paragraph--view-mode--default" id="paragraph-1836"> <h2>Assistance with Reporting Results</h2> <div class="clearfix text-formatted field field--name-field-section-body field--type-text-long field--label-hidden field__item"><div> <p>Review the ClinicalTrials.gov <a href="https://prsinfo.clinicaltrials.gov/tutorial/content/index.html#/">Results Reporting Guided Tutorial</a> and the <a href="https://urldefense.proofpoint.com/v2/url?u=https-3A__prsinfo.clinicaltrials.gov_ResultsDetailedReviewItems.pdf&d=DwMFaQ&c=iORugZls2LlYyCAZRB3XLg&r=XAhGIfT-plUIC_o_KUGl8A&m=SAnPgPu3yUbQdVjSzTGo_GcJ0Oxf4dMK44Idn1L07KQ&s=zUJ3EFMaKBBblETW9wp81bZG0EhnMzkpJ_Ay5LXttO4&e=">Results Quality Control Review Criteria</a>.</p> <p>PRS provides <a href="https://clinicaltrials.gov/ct2/manage-recs/present#ResultsExamplStudies">Example Studies for Results Data Entry</a>.</p> <p>For expert help on data analysis, interpretation of results, and other biostatistical issues, request a <a href="https://consult.ucsf.edu/biostatistics" title="https://consult.ucsf.edu/biostatistics">Biostatistics Consultation </a>from CTSI Consultation Services.</p> <p>Contact <a href="/cdn-cgi/l/email-protection#1e5d4a307971685e6b7d6d78307b7a6b"><span class="__cf_email__" data-cfemail="4a091e642d253c0a3f29392c642f2e3f">[email protected]</span> </a>for ClinicalTrials.gov help at UCSF, including Results Reporting assistance.</p> <p>Contact ClinicalTrials.gov PRS at <a href="/cdn-cgi/l/email-protection#552730323c262130271536393c3b3c36343921273c3439267b323a23"><span class="__cf_email__" data-cfemail="562433313f2522332416353a3f383f35373a22243f373a2578313920">[email protected]</span></a>.</p> </div> </div> </div> </div> <section class="background-gray related-text-block l-container"> <div class="related-text-block-section"> <div id="field-related-sections" class="related"> <h2 class="related__title">Related Information</h2> <ul class="related__info"> <li><a href="/registering-study-clinicaltrialsgov" hreflang="en">Registering a Study on ClinicalTrials.gov</a></li> <li><a href="/maintaining-study-clinicaltrialsgov" hreflang="en">Maintaining a Study on ClinicalTrials.gov</a></li> <li><a href="/clinicaltrialsgov-applicable-definitions" hreflang="en">ClinicalTrials.gov Applicable Definitions</a></li> </ul> </div> </div> </section> </div> </div> </article> </div> </div> </main> <footer class="footer"> <a href="/" rel="home" title="Office of Ethics and Compliance homepage" class="footer__logo"> <img src="/themes/custom/echo/images/logos/compliance.svg" alt="Office of Ethics and Compliance homepage" height="53" width="189"/> </a> <div class="footer__menus"> <nav aria-label="Footer" class="footer__columns"> </nav> </div><nav class="footer__legal" aria-label="Legal Information"> <p class="footer__copyright">© 2024 The Regents of the University of California</p> <ul class="footer__legal-nav"> <li> 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