Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)

Q: How much funding does Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required) provide?

Funding amounts vary. Check the grant details for specifics.

Q: When is the deadline for Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)?

The deadline is November 2, 2028.

National Institutes of Health

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Funding Amount

Varies

Deadline

November 2, 2028

939 days left

Grant Type

federal

Overview

Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)

This Notice of Funding Opportunity (NOFO) supports applications for a collaborating Data Coordinating Center (DCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website.This NOFO will utilize a milestone-driven cooperative agreement mechanism of award and runs in parallel with a companion NOFO (PAR-27-012) for a collaborating Clinical Coordinating Center (CCC). The objective of the DCC application is to present a comprehensive plan to provide overall project coordination, administration, data management, and biostatistical support for the clinical trial proposed in the collaborating CCC application. The application should also describe its approaches to collaborate with the CCC on implementation of the clinical trial community engagement plan. Both a DCC application and a collaborating CCC application must be submitted on the same application due date for consideration by NHLBI. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application.

Details

Agency: National Institutes of Health
Department: Department of Health and Human Services
Opportunity #: PAR-27-013
Instrument: cooperative_agreement

Eligibility

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/Foreign CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting

Eligibility

Eligible Applicant Types

nonprofits_non_higher_education_without_501c3private_institutions_of_higher_educationcounty_governmentsfederally_recognized_native_american_tribal_governmentspublic_and_state_institutions_of_higher_educationspecial_district_governmentsstate_governmentsnonprofits_non_higher_education_with_501c3othercity_or_township_governmentsother_native_american_tribal_organizationspublic_and_indian_housing_authoritiessmall_businessesindependent_school_districtsfor_profit_organizations_other_than_small_businesses

How to Apply

PAR-27-013-Full-Announcement.html

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<title>PAR-27-013: Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)</title>

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<div id="page-title" class="heading1" tabindex="0">Department of Health and Human Services</div>

<div>

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<a id='_bookmark261373' tabindex='-1' aria-hidden='true'></a><a name="_Part 1. Overview Information"></a><h1>Part 1. Overview Information</h1>
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<a id='_bookmark261374' tabindex='-1' aria-hidden='true'></a>Participating Organization(s)
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<p>National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)</p>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261376" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261376' tabindex='-1' aria-hidden='true'></a>Components of Participating Organizations
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<p>National Heart, Lung, and Blood Institute (<a href="https://www.nhlbi.nih.gov/" target="_blank" rel="noreferrer">NHLBI</a>)
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<a id='_bookmark261378' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Title
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<div class=" col-md-8 datacolumn">
<span class="title">Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)</span>
</div>
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<a id='_bookmark261379' tabindex='-1' aria-hidden='true'></a>Activity Code
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<p><a href="http://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=u24&Search.x=0&Search.y=0&sort=ac&Search_Type=Activity&text_prev=">U24</a> Resource-Related Research Projects – Cooperative Agreements</p>
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<a id='_bookmark261380' tabindex='-1' aria-hidden='true'></a>Announcement Type
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Reissue of

PAR-22-193

<br/>
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<a id='_bookmark261381' tabindex='-1' aria-hidden='true'></a>Related Notices
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<div class=" col-md-8 datacolumn">
<ul><li>Check for any recent <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=11163">Notices of NIH Policy Changes</a> that may impact application requirements.</li></ul>
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<a id='_bookmark261382' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Number (FON)
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<div class=" col-md-8 datacolumn">
<span class="noticenum">PAR-27-013</span>
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<div class="row" data-index="11">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261383" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261383' tabindex='-1' aria-hidden='true'></a>Companion Funding Opportunity
</div>
<div class=" col-md-8 datacolumn">
<a href="https://www.grants.gov/search-results-detail/358851" target="_blank" rel="noreferrer">PAR-27-012</a>

<span class="separator" style="position:relative;left:-3px">,</span>
<a href="https://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=UG3&&Search.x=0&&Search.y=0&&Search_Type=Activity" target="_blank" rel="noreferrer">UG3</a>/
<a href="https://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=UH3&&Search.x=0&&Search.y=0&&Search_Type=Activity" target="_blank" rel="noreferrer">UH3</a>
Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II

<br/>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261384" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
<a id='_bookmark261384' tabindex='-1' aria-hidden='true'></a>Number of Applications
</div>
<div class=" col-md-8 datacolumn">
<p>See Section III. 3. Additional Information on Eligibility.</p>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261385" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261385' tabindex='-1' aria-hidden='true'></a>Assistance Listing Number(s)
</div>
<div class=" col-md-8 datacolumn">
93.837, 93.840, 93.233, 93.838, 93.839
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</div>

<div class="row" data-index="14">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261386" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
<a id='_bookmark261386' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Purpose
</div>
<div class=" col-md-8 datacolumn">
<p>This Notice of Funding Opportunity (NOFO) supports applications for a collaborating Data Coordinating Center (DCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html">NOT-OD-15-015</a>). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the <a href="http://www.nhlbi.nih.gov/">NHLBI website</a>. </p><p>This NOFO will utilize a milestone-driven cooperative agreement mechanism of award and runs in parallel with a companion NOFO (<a href="https://grants.nih.gov/grants/guide/pa-files/PAR-26-023.html">PAR-27-012</a>) for a collaborating Clinical Coordinating Center (CCC). The objective of the DCC application is to present a comprehensive plan to provide overall project coordination, administration, data management, and biostatistical support for the clinical trial proposed in the collaborating CCC application. The application should also describe its approaches to collaborate with the CCC on implementation of the clinical trial community engagement plan.  </p><p>Both a DCC application and a collaborating CCC application must be submitted on the same application due date for consideration by NHLBI. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application. </p>
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<a id='_bookmark261388' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Goal(s)
</div>
<div class=" col-md-8 datacolumn">
<p>The Division of Cardiovascular Sciences supports research and training to foster heart and vascular research in the basic, translational, clinical and population sciences, and to foster training to build talented young investigators in these areas, funded through competitive research training grants.</p><p>The Division of Lung Diseases supports research and research training on the causes, diagnosis, prevention, and treatment of lung diseases and sleep disorders.</p><p>The Division of Blood Diseases and Resources supports and research and training to foster research and research training on the pathophysiology, diagnosis, treatment, and prevention of non-neoplastic blood diseases, including anemias, sickle cell disease, thalassemia; biology of red blood cells, white blood cells, and platelets, hematopoietic stem cells and the bone marrow niche, hemophilia and other abnormalities of hemostasis and thrombosis.</p><p>The Center for Translation Research and Implementation Science (CTRIS) plans, fosters, and supports late-stage research to identify promising approaches for ensuring successful integration of evidence and evidence-based interventions within clinical and public health settings, such as health centers, worksites, schools, and communities in the United States and abroad.</p><p>The National Center on Sleep Disorders Research (NCSDR) supports research and research training related to sleep disordered breathing, and the fundamental functions of sleep and circadian rhythms.</p>
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<a id='_bookmark261389' tabindex='-1' aria-hidden='true'></a><a name="_Key Dates"></a><h2>Key Dates</h2>
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<a id='_bookmark261390' tabindex='-1' aria-hidden='true'></a>Posted Date
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March 18, 2026
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<a id='_bookmark261391' tabindex='-1' aria-hidden='true'></a>Open Date (Earliest Submission Date)
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<div class=" col-md-8 datacolumn">
May 02, 2026
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<thead>
<tr>
<th scope="col" colspan="3" style="border:2px solid #bcbcbc;" class="text-center">Application Due Dates</th>
<th scope="col" colspan="3" style="border:2px solid #bcbcbc;" class="text-center">Review and Award Cycles</th>
</tr>
<tr>
<th scope="col" style="width:16.66%;border-left:2px solid #bcbcbc;" class="text-center">New</th>
<th scope="col" style="width:16.66%" class="text-center">Renewal / Resubmission / Revision (as allowed)</th>
<th scope="col" style="width:16.66%;border-right:2px solid #bcbcbc;" class="text-center">AIDS - New/Renewal/Resubmission/Revision, as allowed</th>
<th scope="col" style="width:16.66%" class="text-center">Scientific Merit Review</th>
<th scope="col" style="width:16.66%" class="text-center">Advisory Council Review</th>
<th scope="col" style="width:16.66%;border-right:2px solid #bcbcbc;" class="text-center">Earliest Start Date</th>
</tr>
</thead>
<tbody>
<tr>
<td>
June 02, 2026
</td>
<td>
July 02, 2026
</td>
<td>
Not Applicable
</td>
<td>November 2026</td>
<td> January 2027

</td>
<td>April 2027</td>
</tr>
<tr>
<td>
October 02, 2026
</td>
<td>
November 02, 2026
</td>
<td>
Not Applicable
</td>
<td>March 2027</td>
<td> May 2027

</td>
<td>July 2027</td>
</tr>
<tr>
<td>
February 01, 2027
</td>
<td>
March 01, 2027
</td>
<td>
Not Applicable
</td>
<td>July 2027</td>
<td> October 2027

</td>
<td>December 2027</td>
</tr>
<tr>
<td>
June 02, 2027
</td>
<td>
July 02, 2027
</td>
<td>
Not Applicable
</td>
<td>November 2027</td>
<td> January 2028

</td>
<td>April 2028</td>
</tr>
<tr>
<td>
October 01, 2027
</td>
<td>
November 01, 2027
</td>
<td>
Not Applicable
</td>
<td>March 2028</td>
<td> May 2028

</td>
<td>July 2028</td>
</tr>
<tr>
<td>
February 01, 2028
</td>
<td>
March 01, 2028
</td>
<td>
Not Applicable
</td>
<td>July 2028</td>
<td> October 2028

</td>
<td>December 2028</td>
</tr>
<tr>
<td>
June 01, 2028
</td>
<td>
June 30, 2028
</td>
<td>
Not Applicable
</td>
<td>November 2028</td>
<td> January 2029

</td>
<td>April 2029</td>
</tr>
<tr>
<td>
October 02, 2028
</td>
<td>
November 02, 2028
</td>
<td>
Not Applicable
</td>
<td>March 2029</td>
<td> May 2029

</td>
<td>July 2029</td>
</tr>
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<a id='_bookmark261395' tabindex='-1' aria-hidden='true'></a><p>All applications are due by 5:00 PM local time of applicant organization. </p>

<p>Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.</p>
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<a id='_bookmark261401' tabindex='-1' aria-hidden='true'></a>Expiration Date
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November 03, 2028
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<a id='_bookmark261402' tabindex='-1' aria-hidden='true'></a>Due Dates for E.O. 12372
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<p>Not Applicable</p>
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<a id='_bookmark262221' tabindex='-1' aria-hidden='true'></a>Required Application Instructions
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<p>It is critical that applicants follow the instructions in the Research (R) Instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a>, except where instructed to do otherwise (in this NOFO or in a Notice from <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11164">NIH Guide for Grants and Contracts</a>).</p><p>Conformance to all requirements (both in the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a> and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a> as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a>, follow the program-specific instructions.</p><p><strong>Applications that do not comply with these instructions may be delayed or not accepted for review.</strong></p>
</div>

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<a id='_bookmark261403' tabindex='-1' aria-hidden='true'></a><p style="margin-left:0in;">There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You <strong>must</strong> use one of these submission options to access the application forms for this opportunity.</p><ol><li>Use the <a href="https://public.era.nih.gov/assist/landing.era?tabId=0819b5fc-46b7-4f02-b6b7-127e5a4e19fa">NIH ASSIST system</a> to prepare, submit and track your application online.</li><li>Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and <a href="https://public.era.nih.gov/commons/">eRA Commons</a> to track your application. Check with your institutional officials regarding availability.</li><li>Use <a href="https://grants.gov/search-grants?oppStatuses=closed|archived|posted|forecasted&fon=PA-25-301">Grants.gov</a> Workspace to prepare and submit your application and <a href="http://public.era.nih.gov/commons/">eRA Commons</a> to track your application.</li></ol>
</div>

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<div class="heading1" tabindex="0">Table of Contents</div>
<div class="toc-link"><a href="#_Part%201.%20Overview%20Information">Part 1. Overview Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Key%20Dates">Key Dates</a></div><div class="toc-link"><a href="#_Part%202.%20Full%20Text%20of%20Announcement">Part 2. Full Text of Announcement</a></div><div class="toc-link P_SingleIndent"><a href="#_Section%20I.%20Notice%20of%20Funding%20Opportunity%20Description">Section I. Notice of Funding Opportunity Description</a></div><div class="toc-link P_SingleIndent"><a href="#_Section%20II.%20Award%20Information">Section II. Award Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section%20III.%20Eligibility%20Information">Section III. Eligibility Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section%20IV.%20Application%20and%20Submission%20Information">Section IV. Application and Submission Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section%20V.%20Application%20Review%20Information">Section V. Application Review Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section%20VI.%20Award%20Administration%20Information">Section VI. Award Administration Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section%20VII.%20Agency%20Contacts">Section VII. Agency Contacts</a></div><div class="toc-link P_SingleIndent"><a href="#_Section%20VIII.%20Other%20Information">Section VIII. Other Information</a></div>
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<a id='_bookmark261405' tabindex='-1' aria-hidden='true'></a><a name="_Part 2. Full Text of Announcement"></a><h1>Part 2. Full Text of Announcement</h1>
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<a id='_bookmark261406' tabindex='-1' aria-hidden='true'></a><a name="_Section I. Notice of Funding Opportunity Description"></a><h2>Section I. Notice of Funding Opportunity Description</h2>
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<a id='_bookmark261407' tabindex='-1' aria-hidden='true'></a><p><strong>NOFO Research Objectives</strong></p><p>This NOFO supports applications to develop and conduct a Data Coordinating Center (DCC) for investigator-initiated multi-site clinical trials submitted to the collaborating Clinical Coordinating Center NOFO (<a href="https://grants.nih.gov/grants/guide/pa-files/PAR-26-023.html">PAR-27-012</a>). Clinical trials supported by this NOFO include Phase II and above clinical trials that will enroll participants from two or more recruitment sites. Applications that propose to leverage resources and infrastructure of active clinical trial networks are also supported by this NOFO. This NOFO will utilize a cooperative agreement mechanism (U24) and will be milestone-driven and performance-based to achieve completion of the clinical trial on time and on budget. The DCC is integral to the proficient operation of a clinical trial. The DCC contributes critically to the study design, ensures appropriate adverse event monitoring and reporting, manages data, conducts statistical analyses, and helps with the dissemination of results. The data are often randomized and blinded and the DCC statistician(s) hold the key to the codes. Thus, an independent DCC is a necessary component of any multi-site clinical trial in order to ensure data integrity.  </p><p>Proposed research may utilize a design anywhere along the continuum of efficacy, effectiveness, pragmatic and/or implementation research clinical trials. For this NOFO, pragmatic trials are considered those that test an intervention under the usual clinical conditions in which it will be applied, while efficacy trials do so under more idealized circumstances. Implementation trials test strategies to adopt and integrate evidence-based health interventions and change practice patterns within specific settings. These implementation trials can include hybrid implementation/effectiveness studies. Innovative trial designs such as adaptive designs will be considered. The trial design should be appropriate for the study question. Trials for which this NOFO applies are expected to contribute to the evidence base for important health matters of relevance to the research mission of NHLBI, close gaps in health outcomes within the US population and increase health for all. For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the <a href="https://www.nhlbi.nih.gov/">NHLBI website</a>. </p><p>A key characteristic of this NOFO is the completion of core milestones. A core milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must be performance-based to achieve completion of the trial on time and on budget, and must be established to align with the bi-phasic mechanism of the CCC award. Milestones must be established for both the first year (coinciding with the UG3 phase of the CCC award) and subsequent years (coinciding with the UH3 phase of the CCC award) of the project. These clinical trials are expected to be conducted with a high degree of efficiency, with streamlined administrative procedures wherever possible. Applicants are strongly encouraged to employ project management principles as appropriate. Applications that address contingency plans to proactively confront potential delays or disturbances in meeting the milestones are strongly encouraged. </p><p><strong>Phases of Award</strong></p><p>The first year of the DCC will correspond to the UG3 phase of the collaborative CCC application and is intended to support the development of case report forms and other resources necessary to the performance of the clinical trial; further development of study partnerships; finalization of the protocol and approval by a Data and Safety Monitoring Board (DSMB); Single Institutional Review Board (see <a href="https://grants.nih.gov/grants/guide/notice-files/not-od-16-094.html">NOT-OD-16-094</a>) approvals of the trial protocol; informed consent(s)/assent(s); development of the manual of operations; data management systems and randomization procedures; finalized integrated project management plans; training and activation of clinical sites; and initiation of enrollment of trial participants by the end of the first year. </p><p>The second year of the DCC award is contingent on the successful completion of the UG3 phase of the collaborative CCC application, and corresponds to the first year of the UH3 phase of the CCC. The decision to proceed beyond the first year of the DCC award will be made after administrative reviews of the progress made by both the DCC and the CCC are conducted approximately 9 months into award (i.e., progress report will be due), with particular attention paid to the extent to which agreed-upon milestones have been met and are subject to the availability of funds. Due to the collaborative and parallel nature of these NOFOs, NHLBI will enter into negotiation with the DCC to achieve early phase-out of the award if CCC or DCC progress is deemed inadequate upon administrative review. </p><p>For trials using an FDA regulated product and requiring an IND or IDE application to administer the product to humans, investigators must (1) secure IND authorization or IDE approval and (2) provide documentation of this authorization or approval to NHLBI before a funding decision will be made. Necessary drugs, devices, or other resources must be obtained by the end of the first year of the award to allow for the full execution of the proposed clinical trial. In addition, proposed clinical trials are expected to be able to begin enrollment by the end of the first year of the DCC award.</p><p>U24 milestones must address timing of overall recruitment/enrollment and retention goals, including accrual goals for women, minorities, and individuals of all ages including children and older adults. It is expected that, if funded, both the CCC and DCC will be responsible for milestone completion but that only one party, the CCC or the DCC, will be responsible for recording the completion of both CCC and DCC milestones through <a href="http://econnect.nhlbi.nih.gov/econnect/">eConnect</a>, an NHLBI platform that facilitates transfer of electronic information to NHLBI. </p><p>NHLBI policies regarding milestones and relevant clinical research/studies policies are described in the following: <a href="https://www.nhlbi.nih.gov/research/funding/human-subjects/accrual-guidelines">NHLBI Accrual of Human Subjects (Milestones) Policy</a>, <a href="http://www.nhlbi.nih.gov/research/funding/human-subjects/women-minority-policy">NHLBI Policy for Inclusion of Women and Minorities in Clinical Research</a>, <a href="http://www.nhlbi.nih.gov/research/funding/human-subjects/data-safety-monitoring-policy">NHLBI Policy for Data and Safety Monitoring of Extramural Clinical Studies,</a> <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html">NIH Single IRB Policy</a> and <a href="https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-for-data-sharing">NHLBI Supplement to the NIH Policy for Data Management and Sharing</a></p><p><strong>Note: </strong>This DCC NOFO runs in parallel with a companion NOFO (<a href="https://grants.nih.gov/grants/guide/pa-files/PAR-26-023.html">PAR-27-012</a>) for a collaborating Clinical Coordinating Center (CCC). Both a DCC application and a collaborating CCC application must be submitted on the same due date for consideration by NHLBI. DCC applications submitted without a collaborative CCC (UG3/UH3) application will be deemed incomplete and <strong>will not</strong> proceed to review. Applicants are encouraged to use the <a href="https://www.nhlbi.nih.gov/events/2011/compendium-best-practices-data-coordinating-centers">Compendium of Best Practices for Data Coordinating Centers</a> as a reference tool.<strong> </strong></p><p><strong>Prior to Submission</strong></p><p>Applicants are <strong>strongly</strong> encouraged to consult with the Scientific/Research contacts for the area of science for which they are planning to develop an application <strong>prior to submission</strong> to confirm the NHLBI-specific clinical trial NOFO to which the application should be submitted. Early contact (at least 12 weeks prior to submission) is encouraged. This period of time provides an opportunity for NHLBI staff to discuss the scope and goals of the applications, and to provide information and guidance to potential applicants. </p>
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<a id='_bookmark261409' tabindex='-1' aria-hidden='true'></a><p>Investigators proposing NIH-defined clinical trials may refer to the <a href="https://researchmethodsresources.nih.gov/">Research Methods Resources</a> website for information about developing statistical methods and study designs.</p>
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<a id='_bookmark261410' tabindex='-1' aria-hidden='true'></a><p>See Section VIII. Other Information for award authorities and regulations.</p>
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<a id='_bookmark261411' tabindex='-1' aria-hidden='true'></a><a name="_Section II. Award Information"></a><h2>Section II. Award Information</h2>
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<a id='_bookmark261412' tabindex='-1' aria-hidden='true'></a>Funding Instrument
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<div class=" col-md-8 datacolumn">
<p>Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.</p>
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<a id='_bookmark261413' tabindex='-1' aria-hidden='true'></a> Application Types Allowed
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<div class=" col-md-8 datacolumn">
New
<br>
Resubmission
<br>
Revision
<br>
</div>
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<div class="col-md-push-4 col-md-8 datacolumn">
<a id='_bookmark261415' tabindex='-1' aria-hidden='true'></a><p>The <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11116">OER Glossary</a> and the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a> provide details on these application types. Only those application types listed here are allowed for this NOFO.</p>
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<a id='_bookmark261416' tabindex='-1' aria-hidden='true'></a>Clinical Trial?
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<p>Required: Only accepting applications that propose clinical trial(s).</p>
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<div class="col-md-push-4 col-md-8 datacolumn">
<a id='_bookmark261417' tabindex='-1' aria-hidden='true'></a><p><a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82370">Need help determining whether you are doing a clinical trial?</a></p>
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<a id='_bookmark261418' tabindex='-1' aria-hidden='true'></a>Funds Available and Anticipated Number of Awards
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<p class="Normal">The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. </p>
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<a id='_bookmark261419' tabindex='-1' aria-hidden='true'></a>Award Budget
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<div class=" col-md-8 datacolumn">
<p>Application budgets are not limited but need to reflect the actual needs of the proposed project. </p>
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<a id='_bookmark261420' tabindex='-1' aria-hidden='true'></a>Award Project Period
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<div class=" col-md-8 datacolumn">
<p class="Normal" paraeid="{2f33597b-32ce-4873-b80d-f5c97ee5b7d2}{237}" paraid="298960245">The scope of the proposed project should determine the requested project award period. </p><p class="Normal" paraeid="{2f33597b-32ce-4873-b80d-f5c97ee5b7d2}{241}" paraid="298960246">The period of award is expected to be 5 years. Up to 7 years may be requested if strongly justified. </p>
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<a id='_bookmark261421' tabindex='-1' aria-hidden='true'></a><p>NIH grants policies as described in the <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11120">NIH Grants Policy Statement</a> will apply to the applications submitted and awards made from this NOFO.</p>
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<a id='_bookmark261422' tabindex='-1' aria-hidden='true'></a><a name="_Section III. Eligibility Information"></a><h2>Section III. Eligibility Information</h2>
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<a id='_bookmark261423' tabindex='-1' aria-hidden='true'></a><h4>1. Eligible Applicants</p>
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<a id='_bookmark261424' tabindex='-1' aria-hidden='true'></a>Eligible Organizations
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<p>Higher Education Institutions - Includes all types</p><ul><li>Public/State Controlled Institutions of Higher Education</li><li>Private Institutions of Higher Education</li></ul><p>Nonprofits Other Than Institutions of Higher Education</p><ul><li>Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)</li><li>Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)</li></ul><p>For-Profit Organizations</p><ul><li>Small Businesses</li><li>For-Profit Organizations (Other than Small Businesses)</li></ul><p>Local Governments</p><ul><li>State Governments</li><li>County Governments</li><li>City or Township Governments</li><li>Special District Governments</li><li>Indian/Native American Tribal Governments (Federally Recognized)</li><li>Indian/Native American Tribal Governments (Other than Federally Recognized)</li></ul>
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<a id='_bookmark261425' tabindex='-1' aria-hidden='true'></a><p>Federal Governments</p>

<ul>
<li>Eligible Agencies of the Federal Government</li>
<li>U.S. Territory or Possession</li>
</ul>
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<a id='_bookmark261426' tabindex='-1' aria-hidden='true'></a><p>Other</p>

<ul>
<li>Independent School Districts</li>
<li>Public Housing Authorities/Indian Housing Authorities</li>
<li>Native American Tribal Organizations (other than Federally recognized tribal governments)</li>
<li>Faith-based or Community-based Organizations</li>
<li>Regional Organizations</li>
<li>Non-domestic (non-U.S.) Entities (Foreign Organizations)</li>
</ul>
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<a id='_bookmark261428' tabindex='-1' aria-hidden='true'></a><h4>Foreign Organizations/Foreign Collaborations</h4>
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<a id='_bookmark261429' tabindex='-1' aria-hidden='true'></a><p class="Normal">Non-domestic (non-U.S.) Entities (Foreign Organizations) <strong>are </strong>eligible to apply.</p>
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<a id='_bookmark261430' tabindex='-1' aria-hidden='true'></a><p>Non-domestic (non-U.S.) components of U.S. Organizations <strong>are </strong>eligible to apply.</p>
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<a id='_bookmark261431' tabindex='-1' aria-hidden='true'></a><p>Foreign components, as <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11118">defined in the <em>NIH Grants Policy Statement</em></a>, <strong>are </strong>allowed. </p>
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<a id='_bookmark262151' tabindex='-1' aria-hidden='true'></a><p>NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.</p><p>Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_1/1.2_definition_of_terms.htm">foreign components</a>, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.</p>
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<a id='_bookmark261432' tabindex='-1' aria-hidden='true'></a>Required Registrations
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<p><strong>Applicant Organizations</strong></p>

<p>Applicant organizations must complete and maintain the following registrations as described in the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a> to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=82423">NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications</a> for additional information</p>

<ul>
<li><a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82390">System for Award Management (SAM) –</a> Applicants must complete and maintain an active registration, <strong>which requires renewal at least annually</strong>. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

<ul>
<li><a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11176">NATO Commercial and Government Entity (NCAGE) Code</a> – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.</li>
<li>Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.</li>
</ul>
</li>
<li><a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=11123">eRA Commons</a> - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator

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Focus Areas & Funding Uses

Fields of Work

$2,000,000 - $5,000,000

Deadline

April 13, 2026

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Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)

Overview

Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)

Details

Eligibility

Eligibility

Eligible Applicant Types

How to Apply

PAR-27-013-Full-Announcement.html

Focus Areas & Funding Uses

Fields of Work

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