3381 lines
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<div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><!--
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[AVK] -- TO DO
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Emrul, I removed all the ID attributes as the name attributes are the only things needed to handle a form submission
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but feel free to adjust this snippet with whatever is needed to make it work.
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--><form action="//search.usa.gov/search" method="get" accept-charset="UTF-8" autocomplete="off" target="_blank"><p><input name="utf8" type="hidden" value="✓"> <input name="affiliate" type="hidden" value="grants.nih.gov"></p><div class="input-group pt-3"><input class="form-search form-control rounded-0 py-1" title="Enter the terms you wish to search for" placeholder="Search this Site" type="search" name="query" value="" maxlength="128" aria-label="Search button (required)" aria-required="true" autocomplete="off" required=""> <button class="input-group-text btn btn-primary px-3 py-1" type="submit" title="Search">
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<a href="/new-to-nih" title="As you begin your journey in search of NIH grant funding, the information in this section can help you understand the structure of NIH and why it’s important to successfully navigate the grants process." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex justify-content-lg-around" data-drupal-link-system-path="node/83">New to NIH</a>
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<a href="/funding" title="As the largest public funder of biomedical research in the world, NIH supports a variety of programs from grants and contracts to loan repayment. Learn about assistance programs, how to identify a potential funding organization, and past NIH funding." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex collapsed justify-content-between d-lg-block" data-bs-toggle="collapse" data-bs-target="#Funding" aria-expanded="false" data-drupal-link-system-path="node/23"> Funding <i class="bi bi-caret-down-fill"></i>
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<strong class="h4 d-none d-lg-block text-secondary">Funding</strong>
|
||
<p class="d-none d-lg-block">As the largest public funder of biomedical research in the world, NIH supports a variety of programs from grants and contracts to loan repayment. Learn about assistance programs, how to identify a potential funding organization, and past NIH funding.</p>
|
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<a href="/funding" title="As the largest public funder of biomedical research in the world, NIH supports a variety of programs from grants and contracts to loan repayment. Learn about assistance programs, how to identify a potential funding organization, and past NIH funding." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="node/23">Explore Funding</a>
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<a href="/funding/nih-guide-for-grants-and-contracts" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/45">NIH Guide for Grants and Contracts</a>
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<a href="/funding/funding-categories" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/21">Funding Categories</a>
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<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
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<a href="/funding/find-a-fit-for-your-research-nih-institutes-centers-offices" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/25">Find a Fit for Your Research: NIH Institutes, Centers, and Offices</a>
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<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
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|
||
<a href="/funding/explore-data-on-funded-projects" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/24">Explore Who and What NIH Funds</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static d-lg-block flex-grow-1">
|
||
|
||
|
||
|
||
<a href="/grants-process" title="Take time to learn about each step in the grants process from planning to apply through developing and submitting your application to award and post-award reporting." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex collapsed justify-content-between d-lg-block" data-bs-toggle="collapse" data-bs-target="#GrantsProcess" aria-expanded="false" data-drupal-link-system-path="node/49"> Grants Process <i class="bi bi-caret-down-fill"></i>
|
||
</a>
|
||
<div>
|
||
<div class="container-fluid rounded-0 w-100 start-0 bg-white text-black shadow position-absolute collapse z-3" id="GrantsProcess" data-bs-parent="#block-nihod5-subtheme-main-navigation">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12 col-lg-6 px-4 p-lg-5">
|
||
<strong class="h4 d-none d-lg-block text-secondary">Grants Process</strong>
|
||
<p class="d-none d-lg-block">Take time to learn about each step in the grants process from planning to apply through developing and submitting your application to award and post-award reporting.</p>
|
||
<a href="/grants-process" title="Take time to learn about each step in the grants process from planning to apply through developing and submitting your application to award and post-award reporting." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="node/49">Explore Grants Process</a>
|
||
</div>
|
||
<div class="col-12 col-lg-6 px-4 pb-3 p-lg-5 ps-lg-0">
|
||
<div class="border-start ps-4">
|
||
|
||
<ul class="bg-white p-0 start-0 ps-lg-5 border-lg-start border-light h-100 menu-level-1">
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/plan-to-apply" title="Plan ahead, assess funding opportunities, and take other early steps. Learn to work with your organization, assess resources and teammates, identify a funding opportunity, check application policies, and lay out your timeline." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1073">Plan to Apply</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/write-application" title="Find the official grant application instructions, preview application forms, get advice on grant writing, check out sample grant applications, and read our tips on specific application attachments and sections." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/670">Write Application</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/submit" title="Learn about the steps you must take after filling out your application forms to complete the submission process, how NIH checks your application for completeness prior to review, and NIH submission policies." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/43">Submit</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/review" title="What happens between the time you submit the application and NIH lets you know you will be funded? Learn more about receipt and referral and NIH’s peer review process." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1082">Review</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/award" title="When NIH awards a grant, we are formalizing our partnership with the recipient to ensure compliance with federal laws, regulations and policies." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1083">Award</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/post-award-monitoring-and-reporting" title="If your organization is the recipient of a grant from the NIH, you will need to pay close attention to the terms of award to be successful stewards of federal funds. Learn about reporting and monitoring requirements." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/349">Post-Award Monitoring and Reporting</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static d-lg-block flex-grow-1">
|
||
|
||
|
||
|
||
<a href="/policy-and-compliance" title="By accepting a grant award, recipients agree to comply with the requirements in the NIH Grants Policy Statement unless the notice of award states otherwise." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex collapsed justify-content-between d-lg-block bg-gradient shadow" data-bs-toggle="collapse" data-bs-target="#PolicyCompliance" aria-expanded="false" data-drupal-link-system-path="node/3"> Policy & Compliance <i class="bi bi-caret-down-fill"></i>
|
||
</a>
|
||
<div>
|
||
<div class="container-fluid rounded-0 w-100 start-0 bg-white text-black shadow position-absolute collapse z-3" id="PolicyCompliance" data-bs-parent="#block-nihod5-subtheme-main-navigation">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12 col-lg-6 px-4 p-lg-5">
|
||
<strong class="h4 d-none d-lg-block text-secondary">Policy & Compliance</strong>
|
||
<p class="d-none d-lg-block">By accepting a grant award, recipients agree to comply with the requirements in the NIH Grants Policy Statement unless the notice of award states otherwise.</p>
|
||
<a href="/policy-and-compliance" title="By accepting a grant award, recipients agree to comply with the requirements in the NIH Grants Policy Statement unless the notice of award states otherwise." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="node/3">Explore Policy & Compliance</a>
|
||
</div>
|
||
<div class="col-12 col-lg-6 px-4 pb-3 p-lg-5 ps-lg-0">
|
||
<div class="border-start ps-4">
|
||
|
||
<ul class="bg-white p-0 start-0 ps-lg-5 border-lg-start border-light h-100 menu-level-1">
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/changes-coming-2025" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/188">Changes Coming for 2025</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/nihgps" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/216">Grants Policy Statement</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/notice-of-policy-changes" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="policy-and-compliance/notice-of-policy-changes">Notices of Policy Changes</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/compliance-and-oversight" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/259">Compliance & Oversight</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/policy-topics" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1075">Policy Topics</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static d-lg-block flex-grow-1">
|
||
|
||
|
||
|
||
<a href="/news-events" title="Get the "scoop" on the latest news related to the NIH grant application and award processes, grants policy, research funding and biomedical workforce analyses, and more." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex collapsed justify-content-between d-lg-block" data-bs-toggle="collapse" data-bs-target="#NewsEvents" aria-expanded="false" data-drupal-link-system-path="news-events"> News & Events <i class="bi bi-caret-down-fill"></i>
|
||
</a>
|
||
<div>
|
||
<div class="container-fluid rounded-0 w-100 start-0 bg-white text-black shadow position-absolute collapse z-3" id="NewsEvents" data-bs-parent="#block-nihod5-subtheme-main-navigation">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12 col-lg-6 px-4 p-lg-5">
|
||
<strong class="h4 d-none d-lg-block text-secondary">News & Events</strong>
|
||
<p class="d-none d-lg-block">Get the "scoop" on the latest news related to the NIH grant application and award processes, grants policy, research funding and biomedical workforce analyses, and more.</p>
|
||
<a href="/news-events" title="Get the "scoop" on the latest news related to the NIH grant application and award processes, grants policy, research funding and biomedical workforce analyses, and more." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="news-events">Explore News & Events</a>
|
||
</div>
|
||
<div class="col-12 col-lg-6 px-4 pb-3 p-lg-5 ps-lg-0">
|
||
<div class="border-start ps-4">
|
||
|
||
<ul class="bg-white p-0 start-0 ps-lg-5 border-lg-start border-light h-100 menu-level-1">
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/news-events/calendar-of-events" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="news-events/calendar-of-events">Calendar of Events</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/news-events/on-demand-event-resources" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/335">On-Demand Event Resources</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/news-events/subscribe-follow" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1118">Subscribe and Follow</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="https://nexus.od.nih.gov/all/category/open-mike/" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold">"Open Mike" Blog</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="https://nexus.od.nih.gov/all/" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold">Extramural Nexus (News)</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/news-events/podcasts" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/712">Podcasts</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static d-lg-block flex-grow-1">
|
||
|
||
|
||
|
||
<a href="/aboutoer" title="Office of Extramural Research (OER) provides the corporate framework for NIH research administration, ensuring scientific integrity, public accountability, and effective stewardship of the NIH extramural research portfolio." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex collapsed justify-content-between d-lg-block" data-bs-toggle="collapse" data-bs-target="#AboutUs" aria-expanded="false" data-drupal-link-system-path="node/597"> About Us <i class="bi bi-caret-down-fill"></i>
|
||
</a>
|
||
<div>
|
||
<div class="container-fluid rounded-0 w-100 start-0 bg-white text-black shadow position-absolute collapse z-3" id="AboutUs" data-bs-parent="#block-nihod5-subtheme-main-navigation">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12 col-lg-6 px-4 p-lg-5">
|
||
<strong class="h4 d-none d-lg-block text-secondary">About Us</strong>
|
||
<p class="d-none d-lg-block">Office of Extramural Research (OER) provides the corporate framework for NIH research administration, ensuring scientific integrity, public accountability, and effective stewardship of the NIH extramural research portfolio.</p>
|
||
<a href="/aboutoer" title="Office of Extramural Research (OER) provides the corporate framework for NIH research administration, ensuring scientific integrity, public accountability, and effective stewardship of the NIH extramural research portfolio." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="node/597">Explore About Us</a>
|
||
</div>
|
||
<div class="col-12 col-lg-6 px-4 pb-3 p-lg-5 ps-lg-0">
|
||
<div class="border-start ps-4">
|
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|
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<ul class="bg-white p-0 start-0 ps-lg-5 border-lg-start border-light h-100 menu-level-1">
|
||
|
||
|
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|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/aboutoer/oer-offices" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/514">OER Offices</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
|
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|
||
|
||
</nav>
|
||
|
||
</div>
|
||
|
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</div>
|
||
</div>
|
||
</header>
|
||
<main role="main">
|
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<a id="main-content" tabindex="-1"></a>
|
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|
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|
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|
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<div class="container my-0 p-4 px-lg-0">
|
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<div class="region region-breadcrumb">
|
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<div id="block-nihod5-subtheme-breadcrumbs" class="block block-system block-system-breadcrumb-block">
|
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|
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|
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<nav aria-label="breadcrumb">
|
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<h2 id="system-breadcrumb" class="visually-hidden">Breadcrumb</h2>
|
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<ol class="breadcrumb">
|
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<li class="breadcrumb-item">
|
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<a href="/">Home</a>
|
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</li>
|
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<li class="breadcrumb-item">
|
||
<a href="/policy-and-compliance">Policy & Compliance</a>
|
||
</li>
|
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<li class="breadcrumb-item">
|
||
<a href="/policy-and-compliance/policy-topics">Policy Topics</a>
|
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</li>
|
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<li class="breadcrumb-item">
|
||
<a href="/policy-and-compliance/policy-topics/clinical-trials">Clinical Trial Requirements for Grants and Contracts</a>
|
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</li>
|
||
<li class="breadcrumb-item">
|
||
<a href="/policy-and-compliance/policy-topics/clinical-trials/reporting">Requirements for Registering & Reporting NIH-Funded Clinical Trials</a>
|
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</li>
|
||
<li class="breadcrumb-item">
|
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NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
|
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</li>
|
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</ol>
|
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</nav>
|
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|
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</div>
|
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|
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</div>
|
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|
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<div class="row">
|
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<div class="order-2 order-lg-1 d-none d-lg-block col-lg-3">
|
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<div class="region region-sidebar-first p-0">
|
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<nav role="navigation" aria-labelledby="block-nihod5-subtheme-mainnavigation-menu" id="block-nihod5-subtheme-mainnavigation" class="block block-menu navigation menu--main">
|
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|
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<h5 class="visually-hidden" id="block-nihod5-subtheme-mainnavigation-menu">Main navigation (Sidebar Template)</h5>
|
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|
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|
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|
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|
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|
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<ul data-block="sidebar_first" block="block-nihod5-subtheme-mainnavigation" class="navbar-nav">
|
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|
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|
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|
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<li class="level-0 py-0 px-0 border-0 dropdown">
|
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|
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|
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<a href="/policy-and-compliance" title="Expand menu Policy & Compliance" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center nav-link fs-5 mb-3 border-bottom border-3 border-primary fw-bold" role="button" data-drupal-link-system-path="node/3">Policy & Compliance</a>
|
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<div class="d-block">
|
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|
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<ul data-block="sidebar_first" block="block-nihod5-subtheme-mainnavigation" class="list-group list-group-flush">
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<li class="level-1 py-0 px-0 border-0 dropdown list-inline">
|
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<a href="/policy-and-compliance/changes-coming-2025" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center fw-bold" role="button" title="Expand menu Changes Coming for 2025" data-drupal-link-system-path="node/188"> Changes Coming for 2025 <i class="bi bi-caret-right-fill me-24"></i>
|
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</a>
|
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<div class="d-none">
|
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<ul data-block="sidebar_first" block="block-nihod5-subtheme-mainnavigation" class="list-group list-group-flush ps-3">
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<li class="level-2 py-0 px-0 border-0 list-inline">
|
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|
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|
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<a href="https://grants.nih.gov/policy-and-compliance/policy-topics/peer-review/simplifying-review" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Simplified Review Framework for Most Research Project Grants (RPGs) ">Simplified Review Framework for Most Research Project Grants (RPGs) </a>
|
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<div class="d-none">
|
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|
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|
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</div>
|
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</li>
|
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|
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<li class="level-2 py-0 px-0 border-0 list-inline">
|
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|
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|
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<a href="https://grants.nih.gov/policy-and-compliance/policy-topics/peer-review/revisions-nih-fellowship-application-review-process" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Revisions to the NIH Fellowship Application and Review Process ">Revisions to the NIH Fellowship Application and Review Process </a>
|
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<div class="d-none">
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|
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|
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</div>
|
||
</li>
|
||
|
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|
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|
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|
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|
||
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<a href="/policy-and-compliance/policy-topics/clinical-trials" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Clinical Trial Requirements for Grants and Contracts" data-drupal-link-system-path="node/434"> Clinical Trial Requirements for Grants and Contracts <i class="bi bi-caret-down me-24"></i>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/ct-decision" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Decision Tool: Does Your Human Subjects Study Meet the NIH Definition of a Clinical Trial?" data-drupal-link-system-path="node/711">Decision Tool: Does Your Human Subjects Study Meet the NIH Definition of a Clinical Trial?</a>
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<a href="https://www.era.nih.gov/help-tutorials/hss" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Human Subjects System">Human Subjects System</a>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/reporting" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Requirements for Registering & Reporting NIH-Funded Clinical Trials" data-drupal-link-system-path="node/298"> Requirements for Registering & Reporting NIH-Funded Clinical Trials <i class="bi bi-caret-down me-24"></i>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/reporting/nih-policy" class="dropdown-item py-2 ps-2 text-wrap is-active" role="button" title="Expand menu NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information" data-drupal-link-system-path="node/885" aria-current="page">NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information</a>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/reporting/steps" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Steps to Compliance for NIH Awardees" data-drupal-link-system-path="node/896">Steps to Compliance for NIH Awardees</a>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/reporting/understanding" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Policy and Regulation on ClinicalTrials.gov Registration and Reporting" data-drupal-link-system-path="node/452">Policy and Regulation on ClinicalTrials.gov Registration and Reporting</a>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/why-changes" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Information about NIH Clinical Trial Stewardship" data-drupal-link-system-path="node/579">Information about NIH Clinical Trial Stewardship</a>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/training-resources" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Training & Resources for NIH Clinical Trial Policies" data-drupal-link-system-path="node/873">Training & Resources for NIH Clinical Trial Policies</a>
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<a href="/policy-and-compliance/policy-topics/federal-funding" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Communicating, and Acknowledging Federal Funding" data-drupal-link-system-path="node/112">Communicating, and Acknowledging Federal Funding</a>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Early Stage Investigator Policies" data-drupal-link-system-path="node/758"> Early Stage Investigator Policies <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators/policy" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH Early Stage Investigators Policy" data-drupal-link-system-path="node/260">NIH Early Stage Investigators Policy</a>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators/determining-status" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Determining Early Stage Investigator (ESI) Status" data-drupal-link-system-path="node/215">Determining Early Stage Investigator (ESI) Status</a>
|
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators/history" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu History of NIH Support for Early Career Investigators" data-drupal-link-system-path="node/470">History of NIH Support for Early Career Investigators</a>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators/notices-laws-statements" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Related Notices, Laws, Statements and Reports" data-drupal-link-system-path="node/285">Related Notices, Laws, Statements and Reports</a>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators/list-smaller-grants" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu List of smaller grants & awards that maintain ESI status" data-drupal-link-system-path="node/907">List of smaller grants & awards that maintain ESI status</a>
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<a href="/policy-and-compliance/policy-topics/nih-family-friendly-initiative" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Family-Friendly Initiatives" data-drupal-link-system-path="node/665">Family-Friendly Initiatives</a>
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<a href="/policy-and-compliance/policy-topics/fcoi" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Financial Conflict of Interest" data-drupal-link-system-path="node/831"> Financial Conflict of Interest <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/fcoi/important-highlights" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Important Highlights of FCOI Regulatory Requirements for Foreign Institutions" data-drupal-link-system-path="node/312">Important Highlights of FCOI Regulatory Requirements for Foreign Institutions</a>
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<a href="/policy-and-compliance/policy-topics/fcoi/guide-notices" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH Guide Notices Related to Financial Conflict of Interest" data-drupal-link-system-path="node/786">NIH Guide Notices Related to Financial Conflict of Interest</a>
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<a href="/policy-and-compliance/policy-topics/foreign-interference" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Foreign Interference" data-drupal-link-system-path="node/447"> Foreign Interference <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/foreign-interference/about-foreign-interference" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu About Foreign Interference" data-drupal-link-system-path="node/326">About Foreign Interference</a>
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<a href="/policy-and-compliance/policy-topics/foreign-interference/requirements-for-disclosure" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Requirements for Disclosure of Other Support, Foreign Components and Conflicts of Interest" data-drupal-link-system-path="node/496">Requirements for Disclosure of Other Support, Foreign Components and Conflicts of Interest</a>
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<a href="/policy-and-compliance/policy-topics/foreign-interference/handling-allegations" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Process for Handling Allegations Related to Foreign Interference" data-drupal-link-system-path="node/668">Process for Handling Allegations Related to Foreign Interference</a>
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<a href="/policy-and-compliance/policy-topics/foreign-interference/notices-statements-reports" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Notices, Statements, and Reports" data-drupal-link-system-path="node/564">Notices, Statements, and Reports</a>
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<a href="/policy-and-compliance/policy-topics/foreign-interference/case-studies" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Case Studies" data-drupal-link-system-path="node/627">Case Studies</a>
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<a href="/policy-and-compliance/policy-topics/foreign-interference/fi-data" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Data" data-drupal-link-system-path="node/864">Data</a>
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<a href="/policy-and-compliance/policy-topics/human-subjects" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Human Subjects Research" data-drupal-link-system-path="node/332"> Human Subjects Research <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/human-subjects/research" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Definition of Human Subjects Research" data-drupal-link-system-path="node/696"> Definition of Human Subjects Research <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/human-subjects/hs-decision" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Decision Tool: Am I Doing Human Subjects Research?" data-drupal-link-system-path="node/777">Decision Tool: Am I Doing Human Subjects Research?</a>
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<a href="/sites/default/files/human-subjects-research-infographic.pdf" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Human Subjects Research Infographic">Human Subjects Research Infographic</a>
|
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<a href="/sites/default/files/exemption_infographic_v8_508c_1-15-2020.pdf" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Exempt Human Subjects Research Infographic">Exempt Human Subjects Research Infographic</a>
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<a href="/grants/policy/hs/private-information-biospecimens-flowchart.pdf" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Research Involving Private Information or Biospecimens Flowchart"> Research Involving Private Information or Biospecimens Flowchart</a>
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<a href="/policy-and-compliance/policy-topics/human-subjects/research/public-health" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Public Health Surveillance Exclusions" data-drupal-link-system-path="node/703">Public Health Surveillance Exclusions</a>
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<a href="/policy-and-compliance/policy-topics/human-subjects/pre-and-post-award-processes" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Pre-Award and Post-Award Processes for Projects Involving Human Subjects Research" data-drupal-link-system-path="node/547"> Pre-Award and Post-Award Processes for Projects Involving Human Subjects Research <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/human-subjects/pre-and-post-award-processes/considerations" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH Grant Application and Proposal Considerations for Human Subjects Research" data-drupal-link-system-path="node/801">NIH Grant Application and Proposal Considerations for Human Subjects Research</a>
|
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<a href="/policy-and-compliance/policy-topics/human-subjects/pre-and-post-award-processes/peer-review" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Human Subjects in Peer Review" data-drupal-link-system-path="node/252">Human Subjects in Peer Review</a>
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<a href="/policy-and-compliance/policy-topics/human-subjects/pre-and-post-award-processes/jit" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Just In Time (JIT) Information for Grants Involving Human Subjects" data-drupal-link-system-path="node/763">Just In Time (JIT) Information for Grants Involving Human Subjects</a>
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<a href="/policy-and-compliance/policy-topics/human-subjects/pre-and-post-award-processes/study-monitoring" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Human Subjects Study Monitoring and Progress Reporting" data-drupal-link-system-path="node/502">Human Subjects Study Monitoring and Progress Reporting</a>
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<a href="/policy-and-compliance/policy-topics/human-subjects/coc" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Certificates of Confidentiality" data-drupal-link-system-path="node/109"> Certificates of Confidentiality <i class="bi bi-caret-right me-24"></i>
|
||
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<a href="/policy-and-compliance/policy-topics/human-subjects/coc/information-protected-coc" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Information Protected by a CoC" data-drupal-link-system-path="node/420">Information Protected by a CoC</a>
|
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<a href="/policy-and-compliance/policy-topics/human-subjects/coc/information-institutional-responsibilities" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Investigator and Institutional CoC Responsibilities" data-drupal-link-system-path="node/632">Investigator and Institutional CoC Responsibilities</a>
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<a href="/policy-and-compliance/policy-topics/human-subjects/coc/nih-funded-research" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu CoCs for NIH-Funded Research" data-drupal-link-system-path="node/264">CoCs for NIH-Funded Research</a>
|
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<a href="/policy-and-compliance/policy-topics/human-subjects/coc/for-research-not-funded-by-nih" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu CoCs for Research Not Funded by NIH" data-drupal-link-system-path="node/399">CoCs for Research Not Funded by NIH</a>
|
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<a href="/policy-and-compliance/policy-topics/human-subjects/coc/background-information" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH CoC Policy Background Information" data-drupal-link-system-path="node/725">NIH CoC Policy Background Information</a>
|
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<a href="/policy-and-compliance/policy-topics/inclusion" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Inclusion Policies for Human Subjects Research" data-drupal-link-system-path="node/845"> Inclusion Policies for Human Subjects Research <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/inclusion/women-and-minorities" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Inclusion of Women and Minorities as Participants in Research Involving Human Subjects" data-drupal-link-system-path="node/430"> Inclusion of Women and Minorities as Participants in Research Involving Human Subjects <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/inclusion/women-and-minorities/analyses" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Analyses by Sex or Gender, Race and Ethnicity for NIH-defined Phase III Clinical Trials (Valid Analysis)" data-drupal-link-system-path="node/866">Analyses by Sex or Gender, Race and Ethnicity for NIH-defined Phase III Clinical Trials (Valid Analysis)</a>
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<a href="/policy-and-compliance/policy-topics/inclusion/women-and-minorities/guideline" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research" data-drupal-link-system-path="node/115">NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research</a>
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<a href="/policy-and-compliance/policy-topics/intellectual-property" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Intellectual Property Policy" data-drupal-link-system-path="node/149"> Intellectual Property Policy <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/natural-disasters/corona-virus/history-update" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Applicant/Recipient COVID-19 Update History" data-drupal-link-system-path="node/858">Applicant/Recipient COVID-19 Update History</a>
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<a href="/policy-and-compliance/policy-topics/natural-disasters/corona-virus/nih-omb-memo" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH Implementation of OMB Memorandum M-20-26 “Extension of Administrative Relief for Recipients and Applicants of Federal Financial Assistance Directly Impacted by the Novel Coronavirus (COVID-19) due to Loss of Operations” dated June 18, 2020" data-drupal-link-system-path="node/747">NIH Implementation of OMB Memorandum M-20-26 “Extension of Administrative Relief for Recipients and Applicants of Federal Financial Assistance Directly Impacted by the Novel Coronavirus (COVID-19) due to Loss of Operations” dated June 18, 2020</a>
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<a href="/policy-and-compliance/policy-topics/natural-disasters/corona-virus/impact-research-community" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu The Impact of COVID-19 on the Research Community" data-drupal-link-system-path="node/640">The Impact of COVID-19 on the Research Community</a>
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<a href="/policy-and-compliance/policy-topics/ngri" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Next Generation Researchers Initiative" data-drupal-link-system-path="node/884"> Next Generation Researchers Initiative <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/nih-fiscal-policies" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu NIH Fiscal Policies" data-drupal-link-system-path="node/510"> NIH Fiscal Policies <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/nih-fiscal-policies/stipends-summary" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Stipends Summary – NRSA (FY 2018-Present)" data-drupal-link-system-path="node/1171">Stipends Summary – NRSA (FY 2018-Present)</a>
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<a href="/policy-and-compliance/policy-topics/peer-review" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Peer Review Policies and Practices" data-drupal-link-system-path="node/744"> Peer Review Policies and Practices <i class="bi bi-caret-right me-24"></i>
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<h1><strong><span class="field field--name-title field--type-string field--label-hidden">NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information</span>
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<div class="field__item"><p>The NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information sets the expectation that all NIH-funded awardees and investigators conducting clinical trials will register and report results of their trial in Clinicaltrials.gov. Read the details of the policy below.</p></div>
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<div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><p>In 2016, NIH published the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information in NIH Guide Notice <a href="/grants/guide/notice-files/NOT-OD-16-149.html">NOT-OD-16-149</a>. This guide notice includes a summary, background/supplemental information, and an overview of the public comments and NIH response that shaped the policy.</p></div>
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<div>For convenience, we provide the policy itself, excerpted below from <a href="/grants/guide/notice-files/NOT-OD-16-149.html">NOT-OD-16-149</a>.</div>
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<div class="clearfix text-formatted field field--name-field-body-3 field--type-text-long field--label-hidden field__item"><h2>NIH Policy on Dissemination of NIH-Funded Clinical Trial Information</h2><h3>Purpose</h3><p>The National Institutes of Health (NIH) Policy on Dissemination of NIH-funded Clinical Trial Information establishes the expectation that all NIH-funded awardees and investigators conducting clinical trials, funded in whole or in part by the NIH, will ensure that their NIH-funded clinical trials are registered at, and that summary results information is submitted to, ClinicalTrials.gov for public posting<sup>1</sup> The purpose of the policy is to promote broad and responsible dissemination of information from NIH-funded clinical trials through ClinicalTrials.gov. Disseminating this information supports the NIH mission to advance the translation of research results into knowledge, products, and procedures that improve human health.<br><br>This policy is complementary to requirements in the Clinical Trial Registration and Results Information Submission regulation at 42 CFR Part 11, hereinafter referred to as the regulation <sup>2</sup>. Clinical trials that are subject to the regulation are, in general, clinical trials of drug, biological, and device products regulated by the Food and Drug Administration (FDA), except phase 1 trials of drug and biological products and small feasibility studies of device products. A pediatric post-market surveillance study of a device product required by the FDA is also subject to the regulation. Clinical trials subject to the regulation are generally called "applicable clinical trials." Applicable clinical trials are required to be registered in ClinicalTrials.gov not later than 21 calendar days after the enrollment of the first participant. Results information from those trials generally must be submitted not later than one year after the trial's primary completion date. Submission of results information can be delayed in certain circumstances for up to two additional years for trials of products regulated by the FDA that are unapproved, unlicensed, or uncleared or for trials of products for which approval, licensure, or clearance of a new use is being sought.</p><h3>Scope and Applicability</h3><p>This policy applies to all NIH-funded clinical trials regardless of study phase, type of intervention, or whether they are subject to the regulation. For example, NIH-funded phase 1 clinical trials of an FDA-regulated product are covered by this policy as are clinical trials studying interventions not regulated by the FDA, such as behavioral interventions. As such, the policy encompasses all NIH-funded clinical trials, including applicable clinical trials subject to the regulation. All NIH-funded clinical trials will be expected to register and submit results information to ClinicalTrials.gov.<br><br>This policy applies to clinical trials funded in whole or in part through the NIH extramural and intramural programs. For the NIH extramural program, the policy applies to applications for funding including for grants, other transactions, and contracts submitted on or after the policy's effective date that request support for the conduct of a clinical trial that is initiated on or after the policy's effective date. For the NIH intramural program, the policy applies to clinical trials initiated on or after the policy's effective date. <br><br>This policy does not apply to a clinical trial that uses NIH-supported infrastructure but does not receive NIH funds to support its conduct.</p><h3>Responsibilities</h3><p>As part of their applications or proposals, applicants and offerors seeking NIH funding will be required to submit a plan for the dissemination of NIH-funded clinical trial information that will address how the expectations of this policy will be met. NIH-funded awardees and investigators conducting clinical trials funded in whole or in part by the NIH will be required to comply with all terms and conditions of award, including following their plan for the dissemination of NIH-funded clinical trial information. <br>Consistent with those terms and conditions, the responsibilities of such awardees and investigators will fall within one of the three categories. The category depends on whether, under the regulation, the clinical trial is also an "applicable clinical trial" and the awardee or investigator is the "responsible party." </p><ol><li>If the NIH-funded clinical trial is an applicable clinical trial under the regulation and the awardee or investigator is the responsible party, the awardee or investigator will ensure that all regulatory requirements are met.</li><li>If the NIH-funded clinical trial is an applicable clinical trial under the regulation but the awardee or investigator is not the responsible party, the awardee or investigator will coordinate with the responsible party to ensure that all regulatory requirements are met.</li><li>If the NIH-funded clinical trial is not an applicable clinical trial under the regulation, the awardee or investigator will be responsible for carrying out the tasks and meeting the timelines described in regulation. Such tasks include registering the clinical trial in ClinicalTrials.gov and submitting results information to ClinicalTrials.gov. </li></ol><p>In addition, informed consent documents for clinical trials within all three categories are to include a specific statement relating to posting of clinical trial information at ClinicalTrials.gov.<br><br>Each NIH-funded clinical trial should have only one entry in ClinicalTrials.gov that contains its registration and results information. Awardees and investigators need not and should not create a separate record of the applicable clinical trial to comply with this policy. <br><br>The NIH will publicly post registration information and results information in ClinicalTrials.gov.</p><h3>Definitions</h3><p><em>Clinical Trial.</em> For purposes of this policy, a "clinical trial" means "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 those interventions on health-related biomedical or behavioral outcomes."<sup>3 </sup> This definition encompasses phase 1 trials of FDA-regulated drug and biological products, small feasibility studies of FDA-regulated device products, and studies of any intervention not regulated by the FDA, e.g., behavioral interventions. This definition of "clinical trial"<sup>4</sup> is broader than the term "applicable clinical trial" as defined in the regulation.<sup>5</sup><br><br><em>Responsible Party.</em> In the policy, the awardee or the investigator is responsible for meeting the expectations of this policy. In the regulation, a "responsible party" means, in part, "with respect to a clinical trial, the sponsor of the clinical trial, as defined in 21 CFR 50.3 (or any successor regulation); or the principal investigator of such clinical trial if so designated by a sponsor, recipient, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under [42 CFR Part 11] for the submission of clinical trial information."<sup>6</sup> <br><br><em>Primary Completion Date.</em> In the policy, this term has the same meaning as the term "primary completion date" in the regulation, which is "the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated."<sup>7</sup> <br><br><em>Registration Information</em><strong>.</strong> In the policy, this term has the same meaning as the term "registration information" in the regulation. In the regulation, registration information consists of descriptive information, recruitment information, location and contact information, and administrative data.<sup>8</sup> <br><br><em>Results Information.</em> In the policy, this term has the same meaning as the term "results information" in the regulation. In the regulation, results information includes participant flow, demographic and baseline characteristics, outcomes and statistical analyses, adverse events, the protocol and statistical analysis plan, and administrative information.<sup>9</sup> </p><h3>Compliance </h3><p>If the clinical trial is NIH-funded in whole or in part, expectations for clinical trial registration and summary results submission will be included in the terms and conditions of the award. Failure to comply with the terms and conditions of the NIH award may provide a basis for enforcement actions, including termination, consistent with 45 CFR 75.371 and/or other authorities, as appropriate. If the NIH-funded clinical trial is also an applicable clinical trial, non-compliance with the requirements specified in 42 USC 282(j) and 42 CFR Part 11 may also lead to the actions described in 42 CFR 11.66.</p><h3>Effective Date </h3><p>This policy is effective January 18, 2017.</p></div>
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<h4>Footnotes</h4><p>1. ClinicalTrials.gov is operated by the National Library of Medicine within the NIH.<br>2. The Clinical Trial Registration and Results Information Submission regulation at 42 CFR Part 11 was issued in the Federal Register in September 2016. The regulation implements section 402(j) of the Public Health Service Act.<br>3. Further information about this definition is available from the NIH Office of Science Policy at <a href="http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials">http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials</a>.<br>4. Note that the regulation also includes a definition of "clinical trial." That definition is "a clinical investigation or a clinical study in which human subject(s) are prospectively assigned, according to a protocol, to one or more interventions (or no intervention) to evaluate the effect(s) of the intervention(s) on biomedical or health related outcomes" (see 42 CFR 11.10 (a)). For the purposes of this policy, the regulatory definition and the definition in this policy are treated as synonymous.<br>5. In the regulation, applicable clinical trial is defined as an applicable device clinical trial or an applicable drug clinical trial. The regulation defines an applicable device clinical trial to mean, in part, "a prospective clinical study of health outcomes comparing an intervention with a device product subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 21 U.S.C. 360e, 21 U.S.C. 360j(m)) against a control in human subjects (other than a small clinical trial to determine the feasibility of a device product, or a clinical trial to test prototype device products where the primary outcome measure relates to feasibility and not to health outcomes)." The regulation defines an applicable drug clinical trial to mean, in part, "a controlled clinical investigation, other than a phase 1 clinical investigation, of a drug product subject to section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or a biological product subject to section 351 of the Public Health Service Act (42 U.S.C. 262), where "clinical investigation" has the meaning given in 21 CFR 312.3 (or any successor regulation) and "phase 1" has the meaning given in 21 CFR 312.21 (or any successor regulation).<br>6. See 42 CFR 11.10 (a) and 42 CFR 11.4.<br>7. See the complete definition at 42 CFR 11.10 (a).<br>8. See 42 CFR 11.10 (b) and 42 CFR 11.28 for the specific data elements.<br>9. See 42 CFR 11.28 for complete results information and specific data elements.</p>
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<ul data-block="pre_footer" block="block-nihod5-subtheme-tools-3" class="navbar-nav">
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<li class="nav-item mb-2">
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<a href="https://nexus.od.nih.gov/">Nexus Blog</a>
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<li class="nav-item mb-2">
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<li class="nav-item mb-2">
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<a href="/grants/glossary.htm" data-drupal-link-system-path="node/33">Glossary</a>
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<a href="/faqs" data-drupal-link-system-path="node/1065">FAQs</a>
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<footer class="mt-auto ">
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<div class="container my-0 p-4 px-lg-0">
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<div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><!--
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<div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><!--
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Put here the code for site-wide modals that appear on more than a specific page
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For page-specifi modals, put the modal code into the page itself
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