{"id":17587,"date":"2023-09-19T15:14:19","date_gmt":"2023-09-19T19:14:19","guid":{"rendered":"https:\/\/www.med.unc.edu\/neurology\/?page_id=17587"},"modified":"2026-02-26T13:15:40","modified_gmt":"2026-02-26T18:15:40","slug":"neurosciences-clinical-trials-unit","status":"publish","type":"page","link":"https:\/\/www.med.unc.edu\/neurology\/research-main\/neurosciences-clinical-trials-unit\/","title":{"rendered":"Neurosciences Clinical Trials Unit"},"content":{"rendered":"<p>&nbsp;<\/p>\n<p>The Neurosciences Clinical Trials Unit (NCTU) plays a central role in designing, activating, and managing clinical research within UNC Neurology. We partner with investigators across all divisions to ensure that studies are feasible, compliant, financially sustainable, and supported by trained clinical research staff.<\/p>\n<p>NCTU provides structured, transparent processes that enhance productivity and streamline communication between investigators, coordinators, departmental leadership, and central offices such as FiRST, OSP, and NC TraCS.<\/p>\n<div class=\"row  oscitas-bootstrap-container\">\n<div class=\"col-lg-4 col-md-4 col-xs-12 col-sm-12 oscitas-bootstrap-container\">\n<a class=\"btn btn-default btn-lg btn-block  oscitas-bootstrap-container\" target=\"_self\" href=\"#nctu-investigators\">Investigators<\/a>\n<\/div>\n<div class=\"col-lg-4 col-md-4 col-xs-12 col-sm-12 oscitas-bootstrap-container\">\n<a class=\"btn btn-default btn-lg btn-block  oscitas-bootstrap-container\" target=\"_self\" href=\"#nctu-operations\">Structure<\/a>\n<\/div>\n<div class=\"col-lg-4 col-md-4 col-xs-12 col-sm-12 oscitas-bootstrap-container\">\n<a class=\"btn btn-default btn-lg btn-block  oscitas-bootstrap-container\" target=\"_self\" href=\"#nctu-contact\">Contact<\/a>\n<\/div>\n<\/div>\n<hr \/>\n<h2>Our Mission<\/h2>\n<p>To advance neurological science by supporting efficient, safe, and high\u2011quality clinical trials that improve patient outcomes and strengthen the research portfolio of UNC Neurology.<\/p>\n<p>We accomplish this through:<\/p>\n<ul>\n<li>Dedicated and well\u2011trained research coordinators<\/li>\n<li>Rigorous financial and regulatory oversight<\/li>\n<li>Clear communication and shared expectations<\/li>\n<li>A collaborative partnership with investigators<\/li>\n<\/ul>\n<div class=\"row  oscitas-bootstrap-container\">\n<div class=\"col-lg-6 col-md-6 col-xs-12 col-sm-12 oscitas-bootstrap-container\">\n<a class=\"btn btn-primary btn-lg btn-block  oscitas-bootstrap-container\" target=\"_self\" href=\"https:\/\/www.med.unc.edu\/neurology\/research-main\/neurosciences-clinical-trials-unit\/neuroscience-clinical-trials-unit-staff\/\">NCTU Team<\/a>\n<\/div>\n<div class=\"col-lg-6 col-md-6 col-xs-12 col-sm-12 oscitas-bootstrap-container\">\n<a class=\"btn btn-primary btn-lg btn-block  oscitas-bootstrap-container\" target=\"_self\" href=\"https:\/\/www.med.unc.edu\/neurology\/research-main\/neurosciences-clinical-trials-unit\/dr-susan-wilson-award\/\">Dr. Susan Wilson Award<\/a>\n<\/div>\n<\/div>\n<hr \/>\n<h2 id=\"nctu-investigators\">How We Support Investigators<\/h2>\n<div role=\"tablist\" class=\"panel-group yourcustomclass oscitas-bootstrap-container\" id=\"unc-accordion-0\">\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-0-0\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h3 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-0-0\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-0\"    \n                aria-controls=\"#details-0-0\"  \n                aria-expanded=\"false\" \n                href=\"#details-0-0\">\n                Study Feasibility &amp; Start-Up            <\/button>\n\n        <\/h3>\n\n    <\/div>\n\n    <div id=\"details-0-0\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">NCTU conducts an internal feasibility review for every new study to ensure adequate staffing, resources, space, and financial viability. This evaluation begins after receipt of study documents and runs parallel to sponsor and regulatory processes.<\/p>\n<p>Our team partners with PIs to:<\/p>\n<ul>\n<li>Estimate coordinator effort and enrollment expectations<\/li>\n<li>Develop staffing plans, including hiring when needed<\/li>\n<li>Assess bandwidth and prevent direct competition between similar studies<\/li>\n<li>Provide guidance for investigator\u2011initiated or non\u2011industry projects<\/li>\n<li>Coordinate contract execution with OSP and FiRST<\/li>\n<\/ul>\n<p>Studies that are low\u2011risk and underfunded may be eligible for an NCTU involvement waiver, while others may be referred to the Research Coordination &amp; Management Unit (RCMU).<\/div>\n\n    <\/div>\n        \n<\/div>\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-0-1\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h3 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-0-1\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-0\"    \n                aria-controls=\"#details-0-1\"  \n                aria-expanded=\"false\" \n                href=\"#details-0-1\">\n                Coordinator Support            <\/button>\n\n        <\/h3>\n\n    <\/div>\n\n    <div id=\"details-0-1\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">Every study supported by NCTU includes professional clinical research coordination services. Coordinators are trained to manage every aspect of the study lifecycle, including:<\/p>\n<ul>\n<li>Screening, consenting, and study visits<\/li>\n<li>OnCore data entry, participant tracking, and invoiceable items<\/li>\n<li>Regulatory submissions in Veeva (IRB, amendments, protocols, DUAs, MTAs)<\/li>\n<li>Biospecimen handling and documentation<\/li>\n<li>Study\u2011specific communication and project detail tracking<\/li>\n<\/ul>\n<p>NCTU ensures appropriate backup coverage within pods to maintain continuity when staff are out of office.<\/div>\n\n    <\/div>\n        \n<\/div>\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-0-2\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h3 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-0-2\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-0\"    \n                aria-controls=\"#details-0-2\"  \n                aria-expanded=\"false\" \n                href=\"#details-0-2\">\n                Transparent Financial Management            <\/button>\n\n        <\/h3>\n\n    <\/div>\n\n    <div id=\"details-0-2\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">NCTU works closely with FiRST to ensure clear, sustainable budgeting for every clinical trial.<\/p>\n<p>Our commitments include:<\/p>\n<ul>\n<li>Itemized, transparent budgets (no lump sums accepted)<\/li>\n<li>Realistic effort projections for faculty and coordinators<\/li>\n<li>Monthly financial reviews to monitor study health<\/li>\n<li>Early intervention if a study approaches a deficit<\/li>\n<li>Support for PI\u2011funded continuation of otherwise unsustainable studies<\/li>\n<\/ul>\n<p>Residuals are reinvested in research activities, bridging funds, and professional development.<\/div>\n\n    <\/div>\n        \n<\/div>\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-0-3\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h3 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-0-3\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-0\"    \n                aria-controls=\"#details-0-3\"  \n                aria-expanded=\"false\" \n                href=\"#details-0-3\">\n                Expectations for Investigators            <\/button>\n\n        <\/h3>\n\n    <\/div>\n\n    <div id=\"details-0-3\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">Successful trial execution depends on partnership. NCTU asks investigators to:<\/p>\n<ul>\n<li>Provide and regularly update availability and preferred contact methods<\/li>\n<li>Maintain an up\u2011to\u2011date CV<\/li>\n<li>Notify NCTU early about new studies or anticipated hires<\/li>\n<li>Review adverse events in real time or within 5 business days<\/li>\n<li>Complete required CITI and COI training<\/li>\n<li>Attend or review NC TraCS Clinical Trialist Bootcamp if research effort \u226510%<\/li>\n<li>Offer constructive, timely feedback for coordinators<\/div>\n\n    <\/div>\n        \n<\/div>\n<\/div><\/li>\n<\/ul>\n<hr \/>\n<h2 id=\"nctu-operations\">How We Operate<\/h2>\n<div role=\"tablist\" class=\"panel-group yourcustomclass oscitas-bootstrap-container\" id=\"unc-accordion-1\">\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-1-0\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h3 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-1-0\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-1\"    \n                aria-controls=\"#details-1-0\"  \n                aria-expanded=\"false\" \n                href=\"#details-1-0\">\n                Pod Structure            <\/button>\n\n        <\/h3>\n\n    <\/div>\n\n    <div id=\"details-1-0\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">NCTU is organized into pods \u2014 small teams of 3\u20138 coordinators led by a pod manager. Pod managers:<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Oversee study operations<\/li>\n<li>Serve as the primary point of contact for investigators<\/li>\n<li>Provide onboarding and mentorship<\/li>\n<li>Coordinate their own study portfolios<\/li>\n<li>Assist with performance reviews and staffing decisions<\/div>\n\n    <\/div>\n        \n<\/div><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-1-1\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h3 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-1-1\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-1\"    \n                aria-controls=\"#details-1-1\"  \n                aria-expanded=\"false\" \n                href=\"#details-1-1\">\n                Communication &amp; Documentation            <\/button>\n\n        <\/h3>\n\n    <\/div>\n\n    <div id=\"details-1-1\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">To ensure clarity and accountability:<\/p>\n<ul>\n<li>Written communication is preferred whenever possible<\/li>\n<li>Meeting agendas should be provided in advance<\/li>\n<li>Updates on enrollment, activation status, and study issues are sent periodically to division chiefs and investigators<\/li>\n<\/ul>\n<p>Concerns should be routed to pod managers first, with escalation to NCTU leadership as needed.<\/div>\n\n    <\/div>\n        \n<\/div>\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-1-2\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h3 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-1-2\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-1\"    \n                aria-controls=\"#details-1-2\"  \n                aria-expanded=\"false\" \n                href=\"#details-1-2\">\n                Our Commitment to Quality            <\/button>\n\n        <\/h3>\n\n    <\/div>\n\n    <div id=\"details-1-2\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">Mistakes are expected in a learning environment. NCTU promotes:<\/p>\n<ul>\n<li>A just culture where errors are reported without fear<\/li>\n<li>Structured processes for feedback and remediation<\/li>\n<li>Training and credential maintenance for all coordinators<\/li>\n<li>Transparent documentation in OnCore and Veeva<\/li>\n<li>High efficiency in meetings and study workflows<\/div>\n\n    <\/div>\n        \n<\/div>\n<\/div><\/li>\n<\/ul>\n<hr \/>\n<h2 id=\"nctu-contact\">Contact &amp; Collaboration<\/h2>\n<p>NCTU leadership welcomes open dialogue and values investigator feedback. We are committed to continuous improvement and to supporting innovative, impactful clinical research across every neurology division.<\/p>\n<p>Please reach out to NCTU Director, Chris Hilliard for further information.<\/p>\n<som-cell cell-info=\"{&quot;ID&quot;:22493,&quot;post_author&quot;:&quot;68462&quot;,&quot;post_date&quot;:&quot;2026-02-03 14:59:45&quot;,&quot;post_date_gmt&quot;:&quot;2026-02-03 19:59:45&quot;,&quot;post_content&quot;:&quot;&quot;,&quot;post_title&quot;:&quot;NCTU - quote&quot;,&quot;post_excerpt&quot;:&quot;&quot;,&quot;post_status&quot;:&quot;publish&quot;,&quot;comment_status&quot;:&quot;closed&quot;,&quot;ping_status&quot;:&quot;closed&quot;,&quot;post_password&quot;:&quot;&quot;,&quot;post_name&quot;:&quot;nctu-quote&quot;,&quot;to_ping&quot;:&quot;&quot;,&quot;pinged&quot;:&quot;&quot;,&quot;post_modified&quot;:&quot;2026-02-03 14:59:45&quot;,&quot;post_modified_gmt&quot;:&quot;2026-02-03 19:59:45&quot;,&quot;post_content_filtered&quot;:&quot;&quot;,&quot;post_parent&quot;:0,&quot;guid&quot;:&quot;https:\\\/\\\/www.med.unc.edu\\\/neurology\\\/cell\\\/nctu-quote\\\/&quot;,&quot;menu_order&quot;:0,&quot;post_type&quot;:&quot;somcell&quot;,&quot;post_mime_type&quot;:&quot;&quot;,&quot;comment_count&quot;:&quot;0&quot;,&quot;filter&quot;:&quot;raw&quot;}\" cell-meta=\"{&quot;_wpv_contains_gutenberg_views&quot;:[&quot;&quot;],&quot;_upd_sortorder&quot;:[&quot;1&quot;],&quot;layout&quot;:[&quot;SingleCellBlocks&quot;],&quot;cellInformation&quot;:[&quot;{\\&quot;singleCellBlocks\\&quot;:{\\&quot;quoteText\\&quot;:\\&quot;The NCTU is made up of passionate professionals, dedicated to the ideals of outstanding research and compassionate care for our study participants. Partnering with our faculty, we strive to open cutting-edge clinical trials that meet the needs of the people of North Carolina. We are looking out for you!\\&quot;,\\&quot;linkText\\&quot;:\\&quot;Chris Hilliard, CCRC, Director of the UNC Neuroscience Clinical Trials Unit\\&quot;,\\&quot;linkURL\\&quot;:\\&quot;https:\\\/\\\/www.med.unc.edu\\\/neurology\\\/people\\\/chris-e-hilliard-bs-ccrc\\\/\\&quot;,\\&quot;backgroundColor\\&quot;:\\&quot;mediumBlue\\&quot;},\\&quot;repeatableBoxes\\&quot;:[],\\&quot;blockType\\&quot;:\\&quot;textBlocks\\&quot;,\\&quot;blockStyle\\&quot;:\\&quot;cleanQuote\\&quot;}&quot;],&quot;apiCallInformation&quot;:[&quot;{}&quot;]}\"><\/som-cell>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; The Neurosciences Clinical Trials Unit (NCTU) plays a central role in designing, activating, and managing clinical research within UNC Neurology. We partner with investigators across all divisions to ensure that studies are feasible, compliant, financially sustainable, and supported by trained clinical research staff. NCTU provides structured, transparent processes that enhance productivity and streamline communication &hellip; <a href=\"https:\/\/www.med.unc.edu\/neurology\/research-main\/neurosciences-clinical-trials-unit\/\" aria-label=\"Read more about Neurosciences Clinical Trials Unit\">Read more<\/a><\/p>\n","protected":false},"author":68462,"featured_media":0,"parent":18111,"menu_order":5,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"layout":"","cellInformation":"","apiCallInformation":"","footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-17587","page","type-page","status-publish","hentry","odd"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Neurosciences Clinical Trials Unit | Department of Neurology<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.med.unc.edu\/neurology\/research-main\/neurosciences-clinical-trials-unit\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Neurosciences Clinical Trials Unit | Department of Neurology\" \/>\n<meta property=\"og:description\" content=\"&nbsp; The Neurosciences Clinical Trials Unit (NCTU) plays a central role in designing, activating, and managing clinical research within UNC Neurology. We partner with investigators across all divisions to ensure that studies are feasible, compliant, financially sustainable, and supported by trained clinical research staff. 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