CINXE.COM
Data and Safety Monitoring Plan Writing Guidance - National Institute of Mental Health (NIMH)
<!DOCTYPE html> <html lang="en" dir="ltr" prefix="og: https://ogp.me/ns#" data-nid="1447"> <head> <meta charset="utf-8" /> <meta name="description" content="Data and Safety Monitoring Plan Writing Guidance" /> <link rel="canonical" href="https://www.nimh.nih.gov/funding/clinical-research/data-and-safety-monitoring-plan-writing-guidance" /> <meta property="og:site_name" content="National Institute of Mental Health (NIMH)" /> <meta property="og:title" content="Data and Safety Monitoring Plan Writing Guidance" /> <meta property="og:description" content="Data and Safety Monitoring Plan Writing Guidance" /> <meta name="twitter:description" content="Data and Safety Monitoring Plan Writing Guidance" /> <meta name="twitter:title" content="Data and Safety Monitoring Plan Writing Guidance" /> <meta name="twitter:site" content="@nimhgov" /> <meta name="google-site-verification" content="lKfmfhtNgohd8-snRwpaLWOcbbkS_saLoN9IUJKBvUM" /> <meta name="Generator" content="Drupal 10 (https://www.drupal.org)" /> <meta name="MobileOptimized" content="width" /> <meta name="HandheldFriendly" content="true" /> <meta name="viewport" content="width=device-width, initial-scale=1.0" /> <script> var mainDomain = document.location.hostname.match(/(([^.\/]+\.[^.\/]{2,3}\.[^.\/]{2})|(([^.\/]+\.)[^.\/]{2,4}([^.\/]+\.)[^.\/]{2,4}))(\/.*)?$/)[1]; try{dataLayer.push({'baseDomain': mainDomain.toLowerCase()});} catch(err){ dataLayer = [{'baseDomain': mainDomain.toLowerCase()}];} (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start': new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0], j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src= 'https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f); })(window,document,'script','dataLayer','GTM-T58NF4'); </script> <script> window._monsido = window._monsido || { token: "VsAIOc905Tjeazm18evt9w", statistics: { enabled: true, cookieLessTracking: true, documentTracking: { enabled: true, documentCls: "", documentIgnoreCls: "", documentExt: ["doc","docx","pdf","ppt","pptx","rtf","txt","xls","xlsx"], }, }, }; </script> <script type="text/javascript" src="https://app-script.monsido.com/v2/monsido-script.js" async></script> <link rel="icon" href="/themes/nimhtheme/favicon.ico" type="image/vnd.microsoft.icon" /> <title>Data and Safety Monitoring Plan Writing Guidance - National Institute of Mental Health (NIMH)</title> <link rel="stylesheet" media="all" href="/sites/default/files/css/css_4kcBgHncYo7qBOjujOJNbeX_ivWxhFM7qkLLbUGtg5A.css?delta=0&language=en&theme=nimhtheme&include=eJxNybsNwCAMBcCFIMxkwgMs-RPFbtg-ba69OJHQ1ilQjHXnhqIt8U5SI4-wrX-4L0GdbhlFMZjaZEm8101PstsH8EMfHQ" /> <link rel="stylesheet" media="all" href="/sites/default/files/css/css_5ozhL7Zymg7aVrUD0rO0MgYz9yHkksW71cWllFieM4U.css?delta=1&language=en&theme=nimhtheme&include=eJxNybsNwCAMBcCFIMxkwgMs-RPFbtg-ba69OJHQ1ilQjHXnhqIt8U5SI4-wrX-4L0GdbhlFMZjaZEm8101PstsH8EMfHQ" /> <link rel="stylesheet" media="all" href="//fonts.googleapis.com/css?family=Open+Sans:400,700|Roboto:400,500|Petit+Formal+Script" /> </head> <body> <a href="#main-content" class="visually-hidden focusable"> Skip to main content </a> <noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-T58NF4" height="0" width="0" style="display:none;visibility:hidden"></iframe> </noscript> <div class="dialog-off-canvas-main-canvas" data-off-canvas-main-canvas> <div class="layout-container"> <div class="header-wrapper"> <div class="header-container"> <header role="banner"> <div id="main-header-layout" > <div id="block-sitebranding-2" class="block block-system block-system-branding-block"> <a href="/" title="NIMH Home" rel="home"> <img src="/themes/nimhtheme/logo.png" alt="NIMH Logo" /> </a> </div> <div id="block-tagline" class="block block-block-content block-block-contentf3b653dc-7e5d-4582-8234-a93001424fde"> <div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><p id="tagline">Transforming the understanding <br> and treatment of mental illnesses. </p></div> </div> <div id="block-sitesearch" class="block block-block-content block-block-content91e5b243-d8f4-42a5-9cf8-8228e1405058"> <div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="mobile-helper-icons"><span class="hidden-md hidden-lg"><i class="fas fa-search search_icon"> </i></span> <span class="menu_icon sb-toggle-right hidden-md hidden-lg"><i class="fas fa-bars"> </i></span> </div> <form accept-charset="UTF-8" action="/search-nimh" class="search-in-banner" id="search_form" method="get" name="Search" role="search"><label for="query"><span class="hidden">Search the NIMH Website: </span></label> <input aria-label="Search the NIMH website" autocomplete="off" class="searchbox usagov-search-autocomplete ui-autocomplete-input" id="query" name="query" placeholder="Search the NIMH website" type="text"> <input type="submit" value="Search"> </form> <div class="hidden-xs hidden-sm"> <p class="small text-right m-0"><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="d6df42f3-6876-496e-918c-cc34cc7681f7" href="/health/topics/espanol">Información en español</a> </p> </div> </div> </div> </div> </header> </div> </div> <div id="menu_horizontal" class="primary-menu-container"> <div> <nav id="block-nimhtheme-main-menu" role="navigation" aria-labelledby="block-nimhtheme-main-menu-menu" id="block-nimhtheme-main-menu"> <h2 class="visually-hidden" id="block-nimhtheme-main-menu-menu">Main navigation</h2> <ul class="main-menu-content"> <li class="navmenu_link"> <a href="/health" class="main-menu__health" data-drupal-link-system-path="node/1925">Mental Health Information</a> </li> <li class="navmenu_link"> <a href="/get-involved" class="main-menu__getinvolved" data-drupal-link-system-path="node/2019">Get Involved</a> </li> <li class="navmenu_link"> <a href="/research" class="main-menu__research" data-drupal-link-system-path="node/7518">Research</a> </li> <li class="navmenu_link"> <a href="/funding" class="main-menu__funding" data-drupal-link-system-path="node/1128">Funding</a> </li> <li class="navmenu_link"> <a href="/news" class="main-menu__news" data-drupal-link-system-path="node/2128">News & Events</a> </li> <li class="navmenu_link"> <a href="/about" class="main-menu__about" data-drupal-link-system-path="node/7558">About Us</a> </li> </ul> <div class="megamenu_container"> <div id="health-megamenu" class="megamenu"> <div class="menu_flexbox_span4"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/health/topics"> <h2>Health Topics</h2> <p>NIMH offers expert-reviewed information on mental disorders and a range of topics.</p> </a> </div> </div> <div class="menu_flexbox_span4"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/health/statistics"> <h2>Statistics</h2> <p>NIMH statistics pages include statistics on the prevalence, treatment, and costs of mental illness for the population of the United States.</p> </a> </div> </div> <div class="menu_flexbox_span4"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/health/publications"> <h2>Brochures and Fact Sheets</h2> <p>Download, read, and order free NIMH brochures and fact sheets about mental disorders and related topics.</p> </a> </div> </div> <div class="menu_flexbox_span4"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/health/find-help"> <h2>Help for Mental Illnesses</h2> <p>If you or someone you know has a mental illness, there are ways to get help. Use these resources to find help for yourself, a friend, or a family member.</p> </a> </div> </div> <div class="menu_flexbox_span4"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/health/trials"> <h2>Clinical Trials</h2> <p>If you or a friend or family member are thinking about taking part in clinical research, this page contains basic information about clinical trials.</p> </a> </div> </div> </div> <div id="getinvolved-megamenu" class="megamenu"> <div class="menu_flexbox_span4"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/get-involved/public-involvement"> <h2>Stakeholder Engagement</h2> <p>Find out how NIMH engages a range of stakeholder organizations as part of its efforts to ensure the greatest public health impact of the research we support.</p> </a> </div> </div> <div class="menu_flexbox_span4"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/get-involved/connect-with-nimh"> <h2>Connect with NIMH</h2> <p>Learn more about NIMH newsletters, public participation in grant reviews, research funding, clinical trials, the NIMH Gift Fund, and connecting with NIMH on social media. </p> </a> </div> </div> <div class="menu_flexbox_span4"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/get-involved/digital-shareables"> <h2>Digital Shareables</h2> <p>Use these free education and outreach materials in your community and on social media to spread the word about mental health and related topics.</p> </a> </div> </div> <div class="menu_flexbox_span4"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/get-involved/science-education"> <h2>Science Education</h2> <p>Use these free digital, outreach materials in your community and on social media to spread the word about mental health.</p> </a> </div> </div> <div class="menu_flexbox_span4"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/get-involved/events"> <h2>Upcoming Observances and Related Events</h2> <p>Get Involved observances calendar</p> </a> </div> </div> </div> <div id="research-megamenu" class="megamenu"> <div class="menu_flexbox_span6"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/research/research-funded-by-nimh"> <h2>Research Funded by NIMH</h2> <p>NIMH supports research at universities, medical centers, and other institutions via grants, contracts, and cooperative agreements. Learn more about NIMH research areas, policies, resources, and initiatives.</p> </a> </div> </div> <div class="menu_flexbox_span6"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/research/research-conducted-at-nimh"> <h2>Research Conducted at NIMH (Intramural Research Program)</h2> <p>The Division of Intramural Research Programs (IRP) is the internal research division of the NIMH. Over 40 research groups conduct basic neuroscience research and clinical investigations of mental illnesses, brain function, and behavior at the NIH campus in Bethesda, Maryland. Learn more about research conducted at NIMH.</p> </a> </div> </div> <div class="menu_flexbox_span6"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/research/priority-research-areas"> <h2>Priority Research Areas</h2> <p>Learn about NIMH priority areas for research and funding that have the potential to improve mental health care over the short, medium, and long term.</p> </a> </div> </div> <div class="menu_flexbox_span6"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/research/research-funded-by-nimh/research-resources"> <h2>Resources for Researchers</h2> <p>Information about resources such as data, tissue, model organisms and imaging resources to support the NIMH research community.</p> </a> </div> </div> </div> <div id="funding-megamenu" class="megamenu"> <div class="menu_flexbox_span3"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/funding/opportunities-announcements"> <h2>Opportunities & Announcements</h2> <p>Find all NIMH and cross-NIH funding opportunities.</p> </a> </div> </div> <div class="menu_flexbox_span3"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/funding/funding-strategy-for-research-grants"> <h2>Funding Strategy for Grants</h2> <p>Read more about the NIMH Strategic Plan for Research, Strategic Research Priorities, the anatomy of NIMH funding, and our yearly funding strategy for research grants.</p> </a> </div> </div> <div class="menu_flexbox_span3"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/funding/grant-writing-and-application-process"> <h2>Application Process</h2> <p>Explore the NIMH grant application process, including how to write your grant, how to submit your grant, and how the review process works.</p> </a> </div> </div> <div class="menu_flexbox_span3"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/funding/managing-your-grant"> <h2>Managing Grants</h2> <p>Learn about how NIMH manages research grants, including policies and reporting requirements.</p> </a> </div> </div> <div class="menu_flexbox_span3"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/funding/clinical-research"> <h2>Clinical Research</h2> <p>Find the latest NIH and NIMH policies, guidance, and resources for clinical research.</p> </a> </div> </div> <div class="menu_flexbox_span3"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/funding/training"> <h2>Training</h2> <p>Explore NIMH research training and career development opportunities.</p> </a> </div> </div> <div class="menu_flexbox_span3"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/funding/sbir"> <h2>Small Business Research</h2> <p>Learn about funding opportunities for small businesses.</p> </a> </div> </div> <div class="menu_flexbox_span3"> <div class="menu_inner_extra"> <div class="menu_inner_pad"> <section class="box"> <h3>Quick Links</h3> <p><a href="/funding/opportunities-announcements/funding-grant-news">Funding & Grant News</a></p> <p><a href="/funding/opportunities-announcements/clinical-trials-foas">Support for Clinical Trials at NIMH</a></p> </section> </div> </div> </div> </div> <div id="news-megamenu" class="megamenu"> <div class="menu_flexbox_span4"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/news/science-news"> <h2>Science News</h2> <p>List of NIMH science news including press releases, science updates and institute announcements.</p> </a> </div> </div> <div class="menu_flexbox_span4"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/news/events"> <h2>Meetings and Events</h2> <p>Details about upcoming events—including meetings, conferences, workshops, lectures, webinars, and chats—sponsored by NIMH.</p> </a> </div> </div> <div class="menu_flexbox_span4"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/news/media"> <h2>Multimedia</h2> <p>NIMH videos and podcasts featuring science news, lecture series, meetings, seminars, and special events.</p> </a> </div> </div> <div class="menu_flexbox_span4"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/news/social-media"> <h2>Social Media</h2> <p>The latest information and resources on mental disorders shared on X, Facebook, YouTube, LinkedIn, and Instagram.</p> </a> </div> </div> <div class="menu_flexbox_span4"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/news/press-resources"> <h2>Press Resources</h2> <p>Information about NIMH, research results, summaries of scientific meetings, and mental health resources.</p> </a> </div> </div> <div class="menu_flexbox_span4"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/news/email-updates"> <h2>Email Updates</h2> <p>Updates about mental health topics, including NIMH news, upcoming events, mental disorders, funding opportunities, and research.</p> </a> </div> </div> <div class="menu_flexbox_span4"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/news/innovation-speaker-series"> <h2>Innovation Speaker Series</h2> <p>An annual lecture series dedicated to innovation, invention, and scientific discovery.</p> </a> </div> </div> <div class="menu_flexbox_span4"> <div class="menu_inner_extra"> <div class="menu_inner_pad"> <h3>Contact the Press Office</h3> <p>301-443-4536</p> <p><a class="single-link" href="mailto:NIMHpress@nih.gov">NIMHpress@nih.gov</a></p> </div> </div> </div> </div> <div id="about-megamenu" class="megamenu"> <div class="menu_flexbox_span3"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/about/director"> <h2>About the Acting NIMH Director</h2> <p>Learn more about the Acting Director of the NIMH, Shelli Avenevoli, Ph.D.</p> </a> </div> </div> <div class="menu_flexbox_span3"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/about/advisory-boards-and-groups"> <h2>Advisory Boards and Groups</h2> <p>Read about the boards and groups that advise and provide guidance to the Institute.</p> </a> </div> </div> <div class="menu_flexbox_span3"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/about/strategic-planning-reports"> <h2>Strategic Plan</h2> <p>Learn more about NIMH's roadmap for the Institute’s research priorities over the next five years.</p> </a> </div> </div> <div class="menu_flexbox_span3"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/about/organization"> <h2>Offices and Divisions</h2> <p>Learn more about the functions of each NIMH office and division.</p> </a> </div> </div> <div class="menu_flexbox_span3"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/about/budget"> <h2>Budget</h2> <p>Read the annual NIMH Congressional Justifications.</p> </a> </div> </div> <div class="menu_flexbox_span3"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/about/careers"> <h2>Careers at NIMH</h2> <p>Search for jobs, including scientific, administrative and executive careers at NIMH.</p> </a> </div> </div> <div class="menu_flexbox_span3"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/about/staff-directories"> <h2>Staff Directories</h2> <p>Find the names, telephone numbers, email addresses, and office locations of NIMH staff.</p> </a> </div> </div> <div class="menu_flexbox_span3"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/about/nimh-history"> <h2>History</h2> <p>Explore key milestones, discoveries, and the impact of NIMH-funded studies on mental health.</p> </a> </div> </div> <div class="menu_flexbox_span3"> <div class="menu_inner"> <a class="megamenu_nav_i" href="/about/connect-with-nimh"> <h2>Getting to NIMH</h2> <p>Find directions, maps, parking information, and other visitor information for NIMH.</p> </a> </div> </div> <div class="menu_flexbox_span3"> <div class="menu_inner_extra"> <div class="menu_inner_pad"> <h3>Quick Links</h3> <p><strong><a href="/about/connect-with-nimh/donate-to-mental-health-research" title="Donate to Mental Health Research">Contribute to Mental Health Research</a></strong></p> </div> </div> </div> </div> </div> </nav> <nav id="block-mobilenavigation" role="navigation" aria-labelledby="block-mobilenavigation-menu" id="block-mobilenavigation"> <h2 class="visually-hidden" id="block-mobilenavigation-menu">Mobile navigation</h2> <p class="mobile-menu-close"><i class="fas fa-times fa-2x"></i></p> <ul class="main-menu-content"> <li class="navmenu_link"> <a href="/health" class="mobile-menu-top-level health-menu" data-drupal-link-system-path="node/1925">Mental Health Information</a> <ul> <li class="navmenu_link"> <a href="/health" data-drupal-link-system-path="node/1925">Mental Health Information Home</a> </li> <li class="navmenu_link"> <a href="/health/topics" data-drupal-link-system-path="node/1926">Health Topics</a> </li> <li class="navmenu_link"> <a href="/health/statistics" data-drupal-link-system-path="node/1243">Statistics</a> </li> <li class="navmenu_link"> <a href="/health/publications" data-drupal-link-system-path="node/1927">Brochures and Fact Sheets</a> </li> <li class="navmenu_link"> <a href="/health/find-help" data-drupal-link-system-path="node/1944">Help for Mental Illnesses</a> </li> <li class="navmenu_link"> <a href="/health/trials" data-drupal-link-system-path="node/2009">Clinical Trials</a> </li> </ul> </li> <li class="navmenu_link"> <a href="/get-involved" class="mobile-menu-top-level getinvolved-menu" data-drupal-link-system-path="node/2019">Get Involved</a> <ul> <li class="navmenu_link"> <a href="/get-involved" data-drupal-link-system-path="node/2019">Get Involved Home</a> </li> <li class="navmenu_link"> <a href="/get-involved/public-involvement" data-drupal-link-system-path="node/2127">Stakeholder Engagement</a> </li> <li class="navmenu_link"> <a href="/get-involved/connect-with-nimh" data-drupal-link-system-path="node/8488">Connect with NIMH</a> </li> <li class="navmenu_link"> <a href="/get-involved/digital-shareables" data-drupal-link-system-path="node/7521">Digital Shareables</a> </li> <li class="navmenu_link"> <a href="/get-involved/science-education" data-drupal-link-system-path="node/10164">Science Education</a> </li> <li class="navmenu_link"> <a href="/get-involved/events" data-drupal-link-system-path="node/8489">Upcoming Observances and Related Events</a> </li> </ul> </li> <li class="navmenu_link"> <a href="/research" class="mobile-menu-top-level research-menu" data-drupal-link-system-path="node/7518">Research</a> <ul> <li class="navmenu_link"> <a href="/research" data-drupal-link-system-path="node/7518">Research Home</a> </li> <li class="navmenu_link"> <a href="/research/research-funded-by-nimh" data-drupal-link-system-path="node/1992">Research Funded by NIMH</a> </li> <li class="navmenu_link"> <a href="/research/research-conducted-at-nimh" data-drupal-link-system-path="node/1123">Research Conducted at NIMH (Intramural Research Program)</a> </li> </ul> </li> <li class="navmenu_link"> <a href="/funding" class="mobile-menu-top-level funding-menu" data-drupal-link-system-path="node/1128">Funding</a> <ul> <li class="navmenu_link"> <a href="/funding" data-drupal-link-system-path="node/1128">Funding Home</a> </li> <li class="navmenu_link"> <a href="/funding/opportunities-announcements" data-drupal-link-system-path="node/1029">Opportunities & Announcements</a> </li> <li class="navmenu_link"> <a href="/funding/funding-strategy-for-research-grants/strategy-for-research-grants" data-drupal-link-system-path="node/1137">Strategy for Research Grants</a> </li> <li class="navmenu_link"> <a href="/funding/grant-writing-and-application-process" data-drupal-link-system-path="node/1995">Grant Writing & Approval Process</a> </li> <li class="navmenu_link"> <a href="/funding/managing-your-grant" data-drupal-link-system-path="node/1140">Managing Grants</a> </li> <li class="navmenu_link"> <a href="/funding/clinical-research" data-drupal-link-system-path="node/1190">Clinical Research</a> </li> <li class="navmenu_link"> <a href="/funding/training" data-drupal-link-system-path="node/2007">Research Training and Career Development Opportunities</a> </li> <li class="navmenu_link"> <a href="/funding/sbir" data-drupal-link-system-path="node/1674">Small Business Research</a> </li> </ul> </li> <li class="navmenu_link"> <a href="/news" class="mobile-menu-top-level news-menu" data-drupal-link-system-path="node/2128">News & Events</a> <ul> <li class="navmenu_link"> <a href="/news" data-drupal-link-system-path="node/2128">News & Events Home</a> </li> <li class="navmenu_link"> <a href="/news/science-news" data-drupal-link-system-path="node/4730">Science News</a> </li> <li class="navmenu_link"> <a href="/news/events" data-drupal-link-system-path="node/1986">Meetings and Events</a> </li> <li class="navmenu_link"> <a href="/news/media" data-drupal-link-system-path="node/5039">Multimedia</a> </li> <li class="navmenu_link"> <a href="/news/social-media" data-drupal-link-system-path="node/1659">Social Media</a> </li> <li class="navmenu_link"> <a href="/news/press-resources" data-drupal-link-system-path="node/1653">Press Resources</a> </li> <li class="navmenu_link"> <a href="/news/email-updates" data-drupal-link-system-path="node/2023">Email Updates</a> </li> <li class="navmenu_link"> <a href="/news/innovation-speaker-series" data-drupal-link-system-path="node/7539">Innovation Speaker Series</a> </li> </ul> </li> <li class="navmenu_link"> <a href="/about" class="mobile-menu-top-level about-menu" data-drupal-link-system-path="node/7558">About Us</a> <ul> <li class="navmenu_link"> <a href="/about" data-drupal-link-system-path="node/7558">About Us Home</a> </li> <li class="navmenu_link"> <a href="/about/director" data-drupal-link-system-path="node/7459">About the Acting NIMH Director</a> </li> <li class="navmenu_link"> <a href="/about/advisory-boards-and-groups" data-drupal-link-system-path="node/1964">Advisory Boards and Groups</a> </li> <li class="navmenu_link"> <a href="/about/strategic-planning-reports" data-drupal-link-system-path="node/1959">Strategic Plan</a> </li> <li class="navmenu_link"> <a href="/about/organization" data-drupal-link-system-path="node/1963">Offices and Divisions</a> </li> <li class="navmenu_link"> <a href="/about/budget" data-drupal-link-system-path="node/1967">Budget</a> </li> <li class="navmenu_link"> <a href="/about/careers" data-drupal-link-system-path="node/1960">Careers at NIMH</a> </li> <li class="navmenu_link"> <a href="/about/staff-directories" data-drupal-link-system-path="node/2030">Staff Directories</a> </li> <li class="navmenu_link"> <a href="/about/nimh-history" data-drupal-link-system-path="node/11838">History</a> </li> <li class="navmenu_link"> <a href="/about/connect-with-nimh" data-drupal-link-system-path="node/7564">Getting to NIMH</a> </li> </ul> </li> </ul> </nav> </div> </div> <div class="submenu"> <div class="container"> <div class="row"> <div class="col-md-12"> <ul class="group navbar"> <li class="span navbarli"><a href="/funding/opportunities-announcements" class="navbari topnav subroot">Opportunities & Announcements</a></li> <li class="span navbarli"><a href="/funding/funding-strategy-for-research-grants" class="navbari topnav subroot">Funding Strategy for Grants</a></li> <li class="span navbarli"><a href="/funding/grant-writing-and-application-process" class="navbari topnav subroot">Grant Writing & Approval Process</a></li> <li class="span navbarli"><a href="/funding/managing-your-grant" class="navbari topnav subroot">Managing Grants</a></li> <li class="span navbarli"><a href="/funding/clinical-research" class="navbari topnav subroot">Clinical Research</a></li> <li class="span navbarli"><a href="/funding/training" class="navbari topnav subroot">Training</a></li> <li class="span navbarli"><a href="/funding/sbir" class="navbari topnav subroot">Small Business Research</a></li> </ul> </div> </div> </div> </div> <div> <div data-drupal-messages-fallback class="hidden"></div> </div> <div id="wrapper" class="pt-3 pt-sm-3 pt-md-3 pt-lg-0"> <div class="container pt-5 pt-sm-5 pt-md-5 pt-lg-0"> <div class="row"><div class="col-md-12 hidden-xs"><div class="breadcrumbs"><nav id="breadcrumbs" class="breadcrumbs__nav" aria-label="breadcrumb links" data-dirids="2290 2466"><a href="/" data-dirlevel="0">Home</a> > <a href="/funding" data-refid="1128" data-dirlevel="1" data-dirid="2290" >Funding</a> > <a href="/funding/clinical-research" data-refid="1190" data-dirlevel="2" data-dirid="2466" >Clinical Research</a> > <span data-refid="1447" data-dirlevel="3" data-dirid="2466" data-isleaf="1">Data and Safety Monitoring Plan Writing Guidance</span></nav></div></div></div> <div id="main_container"> <section class="share_links_wrap"> <div class="share_links_wrap_inner"> <h6 class="share_links_header">Share Page</h6> <div class="share_links"> <a href="https://www.facebook.com/dialog/share?app_id=1086499805165807&display=popup&href=https://www.nimh.nih.gov%2Ffunding%2Fclinical-research%2Fdata-and-safety-monitoring-plan-writing-guidance&redirect_uri=https://www.nimh.nih.gov%2Ffunding%2Fclinical-research%2Fdata-and-safety-monitoring-plan-writing-guidance" rel="external noopener noreferrer" target="_blank" class="external-disclaimer" aria-label="Share this page on Facebook"><span class="facebook-share"><i class="fab fa-facebook-f"></i></span></a> <a href="https://x.com/intent/post?url=https://www.nimh.nih.gov%2Ffunding%2Fclinical-research%2Fdata-and-safety-monitoring-plan-writing-guidance&text=Data%20and%20Safety%20Monitoring%20Plan%20Writing%20Guidance" rel="external noopener noreferrer" target="_blank" class="external-disclaimer" aria-label="Share this page on X"><span class="twitter-share"><i class="fab fa-x-twitter"></i></span></a> <a href="https://www.linkedin.com/shareArticle?mini=true&url=https://www.nimh.nih.gov%2Ffunding%2Fclinical-research%2Fdata-and-safety-monitoring-plan-writing-guidance&title=Data%20and%20Safety%20Monitoring%20Plan%20Writing%20Guidance" rel="external noopener noreferrer" target="_blank" class="external-disclaimer" aria-label="Share this page on LinkedIn"><span class="linkedin-share"><i class="fa-brands fa-linkedin-in"></i></span></a> <a href="mailto:?subject=I%20Saw%20This%20on%20www.nimh.nih.gov%20--%20Data%20and%20Safety%20Monitoring%20Plan%20Writing%20Guidance&body=https://www.nimh.nih.gov%2Ffunding%2Fclinical-research%2Fdata-and-safety-monitoring-plan-writing-guidance" aria-label="Share this page by email"><span class="email-share"><i class="fas fa-envelope"></i></span></a> <button class="print_icon" aria-label="Open print helper modal"><i class="fas fa-print"></i></button> </div> </div> </section> <div class="row"> <div class="flex_main_container col-md-12"> <div class="visible-xs sidebar-menu-helper"> <p class="leftnav_menu_toggle sb-toggle-left">Menu <i class="fas fa-long-arrow-alt-right" aria-hidden="true"></i> </p> </div> <aside class="layout-sidebar-first" role="complementary"> <nav> <div class="areanav"> <ul> <li><a href="/funding/clinical-research">Clinical Research</a></li> <li><a href="/funding/clinical-research/clinical-research-toolbox/nimh-clinical-research-toolbox">NIMH Clinical Research Toolbox</a></li> <li><a href="/funding/clinical-research/nimh-policy-governing-the-monitoring-of-clinical-trials">NIMH Policy Governing the Monitoring of Clinical Trials</a></li> <li><a href="/funding/clinical-research/nimh-reportable-events-policy">NIMH Reportable Events Policy</a></li> <li><a href="/funding/clinical-research/policy-governing-independent-safety-monitors-and-independent-data-and-safety-monitoring-boards">Policy Governing Independent Safety Monitors and Independent Data and Safety Monitoring Boards</a></li> <li class="current-page">Data and Safety Monitoring Plan Writing Guidance</li> <li><a href="/funding/clinical-research/nimh-clinical-research-education-support-and-training-crest-program">NIMH Clinical Research Education, Support, and Training (CREST) Program</a></li> </ul> </div> </nav> </aside> <div id="main_content" class="areanav-true sidebar-true"> <main id="main-content"> <article id="main_content_inner"> <div> <div id="block-nimhtheme-page-title" class="block block-core block-page-title-block"> <h1 class="splashBanner__title" >Data and Safety Monitoring Plan Writing Guidance</h1> </div> <div id="block-nimhtheme-content" class="block block-system block-system-main-block"> <!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd"> <html><body><div data-history-node-id="1447" class="node node--type-basic-page node--view-mode-full clearfix"> <div class="node__content clearfix"> <div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><h2>Guidance for Developing a Data and Safety Monitoring Plan for Clinical Trials Sponsored by NIMH</h2> <p>(Version date: April 16, 2015)</p> <h2>Purpose</h2> <p>The National Institute of Mental Health (NIMH) has developed the following guidance for investigators developing a data and safety monitoring plan (DSMP) to ensure the safety of research participants and protecting the validity and integrity of study data in clinical trials supported by NIMH.</p> <h2>Scope</h2> <p>This guidance applies to data and safety monitoring for all NIMH-supported clinical trials (including grants, cooperative agreements, and contracts).</p> <h2>Introduction</h2> <p>It is the policy of the National Institutes of Health (NIH) that each Institute and Center (I/C) have a system in place for the appropriate oversight and monitoring of NIH-funded <a href="http://grants.nih.gov/grants/glossary.htm#ClinicalTrial" onclick=" dataLayer.push({'event': 'eventTracker', 'eventCat': 'Outbound Links', 'eventAct': 'Click', 'eventLbl': 'grants.nih.gov/grants/glossary.htm#ClinicalTrial', 'eventVal': 0});" rel="external">clinical trials <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a>. Accordingly, the NIMH has developed a <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="17e69009-1f1f-4eb1-9a56-c448d8afb785" href="/funding/clinical-research/nimh-policy-governing-the-monitoring-of-clinical-trials" title="NIMH Policy Governing the Monitoring of Clinical Trials">Policy Governing the Monitoring of Clinical Trials</a>. All grant applications and contract proposals for clinical trials submitted for <a href="http://grants.nih.gov/grants/policy/nihgps_2013/nihgps_ch4.htm#human_subjects_data_safety_monitoring" onclick=" dataLayer.push({'event': 'eventTracker', 'eventCat': 'Outbound Links', 'eventAct': 'Click', 'eventLbl': 'grants.nih.gov/grants/policy/nihgps_2013/nihgps_ch4.htm#human_subjects_data_safety_monitoring', 'eventVal': 0});" rel="external">NIMH Extramural funding <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a> must include a proposed <a href="http://grants.nih.gov/grants/glossary.htm#DataandSafetyMonitoringPlan" onclick=" dataLayer.push({'event': 'eventTracker', 'eventCat': 'Outbound Links', 'eventAct': 'Click', 'eventLbl': 'grants.nih.gov/grants/glossary.htm#DataandSafetyMonitoringPlan', 'eventVal': 0});" rel="external">DSMP <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a> as part of the research application’s “Human Subjects” section. In an effort to facilitate the development of a DSMP, the following guidelines have been provided to assist in protecting the health, rights, and safety of research participants.</p> <h2>Determining the Appropriate Level of Monitoring</h2> <p>The type of monitoring entity or monitoring plan may differ greatly between studies. All clinical trials will be monitored, at minimum, by the <a href="http://grants.nih.gov/grants/glossary.htm#ProgramDirector/PrincipalInvestigator(PD/PI)" onclick=" dataLayer.push({'event': 'eventTracker', 'eventCat': 'Outbound Links', 'eventAct': 'Click', 'eventLbl': 'grants.nih.gov/grants/glossary.htm#ProgramDirector/PrincipalInvestigator(PD/PI)', 'eventVal': 0});" rel="external">Principal Investigator (PI) <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a> and <a href="http://grants.nih.gov/grants/glossary.htm#InstitutionalReviewBoard(IRB)" onclick=" dataLayer.push({'event': 'eventTracker', 'eventCat': 'Outbound Links', 'eventAct': 'Click', 'eventLbl': 'grants.nih.gov/grants/glossary.htm#InstitutionalReviewBoard(IRB)', 'eventVal': 0});" rel="external">Institutional Review Board (IRB) <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a> and may require additional monitoring by an Independent Safety Monitor (ISM) or <a href="http://grants.nih.gov/grants/guide/notice-files/not98-084.html" onclick=" dataLayer.push({'event': 'eventTracker', 'eventCat': 'Outbound Links', 'eventAct': 'Click', 'eventLbl': 'grants.nih.gov/grants/guide/notice-files/not98-084.html', 'eventVal': 0});" rel="external">Data Safety Monitoring Board <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a> (DSMB) (See <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="17e69009-1f1f-4eb1-9a56-c448d8afb785" href="/funding/clinical-research/nimh-policy-governing-the-monitoring-of-clinical-trials">Policy Governing Monitoring of Clinical Trials</a>). The method or level of monitoring should correspond to the risk involved; the population being studied; and the size, scope, and complexity of the trial. For example, close monitoring by the PI may be an appropriate format for monitoring studies with low-risk interventions, however, in some instances, the <a href="http://grants.nih.gov/grants/glossary.htm#ProgramOfficial(PO)/ProgramOfficer/ProjectOfficer" onclick=" dataLayer.push({'event': 'eventTracker', 'eventCat': 'Outbound Links', 'eventAct': 'Click', 'eventLbl': 'grants.nih.gov/grants/glossary.htm#ProgramOfficial(PO)/ProgramOfficer/ProjectOfficer', 'eventVal': 0});" rel="external">Program Official (PO) <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a>, PI or the IRB may determine that an ISM may be required. The NIH requires data and safety monitoring for all clinical trials. Multi-site clinical trials and most phase III clinical trials will require monitoring in the form of DSMBs. In June 2000, the NIH issued <a href="http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html" onclick=" dataLayer.push({'event': 'eventTracker', 'eventCat': 'Outbound Links', 'eventAct': 'Click', 'eventLbl': 'grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html', 'eventVal': 0});" rel="external">further guidance on data and safety monitoring for phase I and phase II trials <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a>. The NIMH has developed <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="4dcead14-8d1e-4c15-b985-da3e9d17b899" href="/funding/clinical-research/nimh-guidance-on-risk-based-monitoring">guidance on risk-based monitoring</a> to assist investigators with determining the appropriate level of monitoring for a given study.</p> <h2>Required Elements of a Data and Safety Monitoring Plan</h2> <p>A DSMP should include a general description of a plan establishing the overall framework for the oversight and monitoring of a study. When formulating the DSMP, the PI, and the study team should consider the protocol, phase, intervention(s), target population, subject safety and privacy, risks and benefits involved in the study, data integrity and confidentiality, study coordination, and how the team will address each of these elements. When modifications to the DSMP are made before the trial begins (e.g., in response to the peer review or IRB review), a final IRB-approved monitoring plan must be submitted to the NIMH PO prior to the commencement of human subjects activities. The minimum required DSMP content should include the following elements.</p> <p><strong>If these elements are noted elsewhere in the application or proposal, they need not be repeated but should be referenced in the DSMP section</strong>:</p> <ol> <li>Summary of the Protocol: <ul> <li>A brief description of the study design (e.g., <a href="http://grants.nih.gov/grants/glossary.htm#Intervention" rel="external">interventions <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a>, procedures, tests and scans, biospecimen collection, interviews and focus groups, study visits)</li> <li>Primary and secondary outcome measures/endpoints</li> <li>Sample size and target population</li> <li>Inclusion/exclusion criteria and how the criteria will be evaluated</li> <li>For multi-site trials, a list of proposed participating clinical sites and data coordinating centers and a description of each site’s role</li> </ul> </li> <li>Roles and Responsibilities (Note this must be listed in DSMP section): <ul> <li>Identification and description of individuals responsible for monitoring the trial (e.g., PI, ISM, DSMB), their roles, qualifications, and the frequency of the monitoring activities. If the monitoring entity is an ISM or a DSMB, provide the NIMH PO and Office of Clinical Research (OCR) review with a list of the proposed membership and assurances to ensure that there are no conflicts of interest with the study team or proposed institutions.</li> </ul> </li> <li>Trial Safety: <ul> <li>Description of any specific events that would preclude a participant from continuing the intervention</li> <li>Description of any procedures in place for managing any medication related issues (e.g., medication washout, allergic reactions, drug interactions, discontinuation/stoppage of medication, use of rescue mediations)</li> <li>Description of the potential risks and the measures in place to protect participants against foreseeable risks</li> <li>Description of the consent/assent procedures (e.g., by whom, how and under what conditions will a subject be consented)</li> <li>Description of the mechanisms in place to protect subject privacy (e.g., interviews will take place in a private room, whether results of testing data will be shared with participant’s legally authorized representative, privacy for minors, secure means of communication between investigators and participant, e.g., telephone, web portal)</li> <li>Description of the trial stopping rules for the study, if any (e.g., increased suicidal ideation, greater than expected morbidity or mortality rate)</li> <li>Description of the plan for management of <a href="https://grants.nih.gov/faqs#/hs-informed-consent.htm" rel="external">incidental findings <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a> (e.g., a brain tumor or potential structural abnormality discovered during a scan)</li> <li>Description of the process for the disclosure of any conflicts of interest that may potentially challenge participant safety or bias the data and how the conflict will be managed</li> <li>For multi-center studies, a description of the procedures for ensuring compliance with the monitoring plan including requirements for data reporting across study sites</li> <li>Description of the data security in place to protect the confidentiality of the data (e.g., password protected encrypted electronic records) and any limits to confidentiality (e.g., suicidal ideation, child abuse)</li> </ul> </li> <li>Reportable Events: <ul> <li>Description of the process and timelines (e.g., hours, days) for collecting and reporting Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Problems Involving Risks to Subjects or Others to appropriate monitoring and regulatory entities (See <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="514f7ab4-f157-49af-a21b-57bbaa29143e" href="/funding/clinical-research/nimh-reportable-events-policy">NIMH Reportable Events Policy for definitions and timeframes</a>)</li> <li>Specific plan and timeframe for reporting IRB and/or ISM/DSMB actions to the NIMH (e.g., protocol violations, non-compliance, suspensions, terminations)</li> </ul> </li> <li>Data Management, Analysis, and Quality Assurance: <ul> <li>Identification of data sources (e.g., questionnaires, medical records, biospecimen collections, audio/video recordings)</li> <li>Description of the security measures in place to protect data sources including how the data will be labeled and stored</li> <li>Quality assurance measures for subject recruitment, enrollment, enrollment targets, and for the validity and integrity of the data. <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1" rel="external">E6 Good Clinical Practice (R2): 1.46 <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a> defines quality assurance as “All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s)”</li> </ul> </li> </ol> </div> </div> </div> </body></html> </div> </div> </article> </main> </div> <aside id="sidebar" class="layout-sidebar-second" role="complementary"> <!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd"> <html><body><div class="box" data-nid="7649"> <p><a href="/funding/opportunities-announcements/clinical-trials-foas" data-entity-type="node" data-entity-uuid="2081f459-fc87-415e-a149-2c01c5305cf5" data-entity-substitution="canonical">Clinical Trials Funding Opportunity Announcements</a></p><a href="/funding/opportunities-announcements/clinical-trials-foas" data-entity-type="node" data-entity-uuid="2081f459-fc87-415e-a149-2c01c5305cf5" data-entity-substitution="canonical"><article class="media media--type-image media--view-mode-default"> <span class="field field--name-field-media-image field--type-image field--label-hidden field__item"> <img loading="lazy" src="/sites/default/files/images/funding/opportunities-announcements/clinical-trials-foas/images/clinical-trials.png" width="166" height="166" alt="Collage"> </span> </article> </a><p><a href="http://ndct.nimh.nih.gov/">NIMH Data Archive (NDA)</a></p> </div> </body></html> <!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd"> <html><body><section class="box sidebar_child sidebar_section" data-nid="3210"> <h2 id="box_3210">Cross-NIH Funding Opportunities</h2> <ul> <li><a href="https://commonfund.nih.gov/GTEx" rel="external">Genotype-Tissue Expression (GTEx) <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a></li> <li><a href="https://commonfund.nih.gov/" rel="external">NIH Common Fund <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a></li> <li><a href="http://grants1.nih.gov/grants/guide/index.html" rel="external">NIH-wide Funding Opportunities & Notices <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a></li> <li><a href="https://commonfund.nih.gov/molecularlibraries/index" rel="external">NIH Molecular Libraries Program <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a></li> <li><a href="http://neuroscienceblueprint.nih.gov/" rel="external">NIH Neuroscience Blueprint <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a></li> <li><a href="http://oppnet.nih.gov/" rel="external">OppNet (Basic Behavioral & Social Science Research) <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a></li> <li><a href="http://grants1.nih.gov/grants/funding/sbir.htm" rel="external">Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a></li> <li><a href="https://fnih.org/what-we-do/biomarkers-consortium" rel="external noreferrer">The Biomarkers Consortium <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a></li> </ul> </section> </body></html> <!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd"> <html><body><section class="box sidebar_child sidebar_section" data-nid="2185"> <h2 id="box_2185">Research and Funding: Policies & Procedures</h2> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="abb8d371-0e46-447f-a429-3b185708962a" href="/funding/grant-writing-and-application-process/animal-research-issues">Animal Research Policies</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="074f0b35-f010-474d-b3b5-98af21496bee" href="/funding/clinical-research/conducting-research-with-participants-at-elevated-risk-for-suicide-considerations-for-researchers">Conducting Research with Participants at Elevated Risk for Suicide: Considerations for Researchers</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="79be47b7-cb6d-4273-a728-4b51a17b734c" href="/research/research-funded-by-nimh/policies/guidance-for-applicants-following-the-report-of-the-national-advisory-mental-health-council-workgroup-on-genomics">Guidance for Applicants Following the Report of the National Advisory Mental Health Council Workgroup on Genomics</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="5eb6f1d9-2d88-4213-9a91-46308614bbaa" href="/funding/grant-writing-and-application-process/nimh-recruitment-of-participants-in-clinical-research-policy">Recruitment of Participants in Clinical Research Policy</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="365cc3c3-7ecc-462f-9681-d7763e5e31c4" href="/funding/managing-your-grant/human-subjects-research-issues">Human Subjects Research Issues</a></li> <li><a href="http://grants2.nih.gov/grants/intell-property.htm" rel="external">Intellectual Property & Invention Reporting <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a></li> <li><a href="http://grants.nih.gov/grants/policy/data_sharing/" rel="external">NIH-Wide Data Sharing Policy <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="5e76c174-6f77-441f-b2c1-ed193feb1692" href="/funding/grant-writing-and-application-process/nih-wide-grants-information">NIH-Wide Grants Policy</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c5c2b9b3-d96a-46c1-8319-24d0e52a37f0" href="/funding/opportunities-announcements/listings/notices">Policy Changes and Announcements</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="7a89b441-28c5-4615-bd75-2ca14b9acae8" href="/funding/clinical-research/policy-governing-independent-safety-monitors-and-independent-data-and-safety-monitoring-boards">Policy Governing Independent Safety Monitors and Independent Data and Safety Monitoring Boards</a></li> <li><a href="http://publicaccess.nih.gov/" rel="external">Public Access to NIH-Sponsored Publications Policy <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="3a8ae08a-f2ac-45b9-9150-a009fa6128bf" href="/research/research-funded-by-nimh/policies/enhancing-the-reliability-of-nimh-supported-research-through-rigorous-study-design-and-reporting">Enhancing the Reliability of NIMH-Supported Research through Rigorous Study Design and Reporting</a></li> </ul> </section> </body></html> <!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd"> <html><body><section class="box sidebar_child sidebar_section" data-nid="3209"> <h2 id="box_3209">Learn More About...</h2> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="682db662-aecf-4456-97d6-fc29ed225669" href="/research/research-funded-by-nimh/research-initiatives">Highlighted Research Initiatives</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="f39a19d7-c879-460a-8dbd-003fe354e909" href="/research/research-funded-by-nimh/therapeutics">NIH/NIMH Therapeutics Discovery Research</a></li> <li><a href="http://www.suicide-research-agenda.org/" rel="external noreferrer">A Prioritized Research Agenda for Suicide Prevention <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a></li> </ul> </section> </body></html> </aside> </div> </div> </div> </div> </div> <footer id="footer-contact"> <div class="footer-container container"> <div> <div id="block-contactusfooter" class="block block-block-content block-block-contentc7a9e7bc-56ff-41ac-8678-60f3a9a54eeb"> <div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><h2>NIMH Information Resource Center</h2><div><span class="small">Available in English and español</span></div><div class="row"><div class="col-xl-6 col-lg-6 col-md-6 col-sm-6 col-xs-12"><p class="phone"><em><i class="fas fa-phone" aria-hidden="true"> </i></em> <strong>Phone: </strong> <a href="tel:1-866-615-6464">1-866-615-6464</a> <br><em><i class="far fa-comments" aria-hidden="true"> </i></em> <strong>Live Online Chat: </strong> <a href="https://infocenter.nimh.nih.gov">Talk to a representative</a> <br><em><i class="far fa-envelope" aria-hidden="true"> </i></em> <strong>Email: </strong> <a href="mailto:nimhinfo@nih.gov">nimhinfo@nih.gov</a> <br><em><i class="far fa-clock" aria-hidden="true"> </i></em><strong>Hours:</strong> 8:30 a.m. – 5 p.m. ET, M-F</p></div><div class="col-xl-6 col-lg-6 col-md-6 col-sm-6 col-xs-12"><p><strong>Mail: </strong> National Institute of Mental Health <br>Office of Science Policy, Planning, and Communications <br>6001 Executive Boulevard, MSC 9663 <br>Bethesda, MD 20892-9663</p></div></div></div> </div> <div id="block-nimhtheme-linkdisclaimer" class="block block-block-content block-block-content43e6eaa7-a06a-4a06-9eff-b06d3dded90d"> <div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><div id="footer-disclaimer"><h2>Disclaimer</h2><p>We link to external websites for informational purposes only, but we do not endorse or guarantee their accuracy. Once you leave our site, you will be subject to the new website’s privacy policy. Read NIMH’s <a href="/site-info/policies#part_2717"><u>full external linking policy</u></a> for more information.</p></div></div> </div> </div> </div> </footer> <footer id="footer-social"> <div class="footer-container container"> <div> <div id="block-followusfooter" class="block block-block-content block-block-contentcafb1a66-d0fb-4772-b5c2-5c7d0773f849"> <div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="row"><div class="col-lg-8 col-md-7 col-sm-12 followus"><h3>Follow Us</h3><p><a class="external-disclaimer" href="https://www.instagram.com/nimhgov/" title="NIMH Instagram" rel="external"><span class="hidden">Instagram</span><em><i class="fab fa-instagram" style="background:#005395;" aria-hidden="true"> </i></em></a> <a class="external-disclaimer" href="https://www.facebook.com/nimhgov" title="NIMH Facebook" rel="external"><span class="hidden">Facebook</span><em><i class="fab fa-facebook-f" style="background:#005395;" aria-hidden="true"> </i></em></a> <a class="external-disclaimer" href="https://www.linkedin.com/company/national-institute-of-mental-health-nimh" title="NIMH LinkedIn" rel="external"><span class="hidden">Linkedin</span><em><i class="fab fa-linkedin-in" style="background:#005395;" aria-hidden="true"> </i></em></a><a class="external-disclaimer" href="https://twitter.com/nimhgov" title="NIMH Twitter" rel="external"><span class="hidden">Twitter</span><em><i class="fab fa-x-twitter" style="background:#005395;" aria-hidden="true"> </i></em></a> <a class="external-disclaimer" href="https://www.youtube.com/nimhgov" title="NIMH YouTube" rel="external"><span class="hidden">YouTube</span><em><i class="fab fa-youtube" style="background:#005395;" aria-hidden="true"> </i></em></a><a href="/news/email-updates" title="NIMH Newsletters" data-entity-type="node" data-entity-uuid="72c6d25b-a844-48b0-be68-5c85cf5df771" data-entity-substitution="canonical"> <em><i class="far fa-file-alt" style="background:#005395;" aria-hidden="true"> </i></em></a><a href="/news/web-channels" title="NIMH News Feeds" data-entity-type="node" data-entity-uuid="26a1cafd-738b-443d-920f-c491f872d6d9" data-entity-substitution="canonical"> <em><i class="fas fa-rss" style="background:#005395;" aria-hidden="true"> </i></em></a></p></div><div class="col-lg-4 col-md-5 col-sm-12"><h3 class="mb-0">Subscribe to NIMH Email Updates</h3><form class="subscribe-in-banner" accept-charset="UTF-8" action="https://public.govdelivery.com/accounts/USNIMH/subscribers/qualify" method="get" name="Subscribe"><p><label><span class="hidden">Type email address...</span> <input class="subscribe_box" aria-label="Type email address..." name="email" placeholder="Type email address..." size="30" type="text"> </label><input type="submit" value="Subscribe"> </p></form></div></div><style> .followus p a { margin: .1rem; } .followus i.fab:hover, .followus i.far:hover, .followus i.fas:hover{ background-color: #00335e !important; } </style></div> </div> </div> </div> </footer> <footer id="footer-siteInfo"> <div class="footer-container container"> <div> <div id="block-siteinfofooter" class="block block-block-content block-block-content7adf2027-35bd-4389-9dd4-330dcc3d17c4"> <div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="row" id="block-footer"><div class="col-xl-4 col-lg-4 col-md-4 col-sm-4 col-xs-12"><h5>NIMH Resources</h5><p><a href="/topics" data-entity-type="node" data-entity-uuid="add12a7e-af7c-46c1-b846-9fadb595b4f9" data-entity-substitution="canonical">Topic Finder</a> <br><a href="/health/publications" data-entity-type="node" data-entity-uuid="3a6321c0-9c96-45b6-8d5c-5f4eab17632b" data-entity-substitution="canonical">Brochures and Fact Sheets</a> <br><a href="/site-info/contact-nimh" data-entity-type="node" data-entity-uuid="3b82dd34-6040-4763-a9ff-db0c3d5b6a38" data-entity-substitution="canonical">Contact Us</a> <br><a href="/health/topics/espanol" data-entity-type="node" data-entity-uuid="d6df42f3-6876-496e-918c-cc34cc7681f7" data-entity-substitution="canonical">Información en español</a></p></div><div class="col-xl-4 col-lg-4 col-md-4 col-sm-4 col-xs-12"><h5>Policies and Notices</h5><p><a href="/site-info/privacy-policy" data-entity-type="node" data-entity-uuid="f9084068-f15e-4322-b69b-eb250f301bf4" data-entity-substitution="canonical">Privacy Policy</a> <br><a href="/site-info/policies" data-entity-type="node" data-entity-uuid="e7a9f3b0-b458-4dcd-84aa-2c373b217d3f" data-entity-substitution="canonical">Website Policies</a> <br><a href="http://www.nih.gov/icd/od/foia/index.htm" rel="external">FOIA <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon" aria-hidden="true"></i></a> <br><a href="/site-info/accessibility" data-entity-type="node" data-entity-uuid="35acaa5a-b4a3-4061-b0b9-018d0e02b011" data-entity-substitution="canonical">Accessibility</a> <br><a href="https://www.hhs.gov/vulnerability-disclosure-policy/index.html" rel="external">HHS Vulnerability Disclosure <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon" aria-hidden="true"></i></a></p></div><div class="col-xl-4 col-lg-4 col-md-4 col-sm-4 col-xs-12"><h5>Federal Resources</h5><p><a href="http://www.nih.gov/" rel="external">National Institutes of Health (NIH) <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon" aria-hidden="true"></i></a> <br><a href="https://www.nih.gov/virtual-tour/" rel="external">NIH Virtual Tour <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon" aria-hidden="true"></i></a> <br><a href="https://www.hhs.gov" rel="external">U.S. Department of Health and Human Services <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon" aria-hidden="true"></i></a> <br><a href="http://www.usa.gov/" rel="external">USA.gov <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon" aria-hidden="true"></i></a></p></div></div><p class="institute_boilerplate">The National Institute of Mental Health (NIMH) is part of NIH, a component of the U.S. Department of Health and Human Services.</p></div> </div> <div id="block-backtotop" class="block block-block-content block-block-content2fd64a46-6d78-4c08-8260-bf3aad9aa46d"> <div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><p class="hidden-sm hidden-xs" id="backtotop"><a href="#skipnav"><span class="bt-img"> </span><span>Top</span></a> </p></div> </div> </div> </div> </footer> </div> </div> <script src="/sites/default/files/js/js_B19ttubucDC00CWvfEil2yCK-_TGbiAWhwGcrbwiD4Y.js?scope=footer&delta=0&language=en&theme=nimhtheme&include=eJzLy8zNKMlIzU3VT8_JT0rM0S1OLsosKCnWyYNLpOXnlSSWpxbn56bGmwEA0b0S7A"></script> <script src="//kit.fontawesome.com/1ea3372bd6.js" crossorigin="anonymous"></script> </body> </html>