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

Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required) is sponsored by National Heart, Lung, and Blood Institute (NHLBI). Seeks applications for a Data Coordinating Center to support multi-site investigator-initiated clinical trials in HLBS disorders.

Expired PAR-22-193: Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Heart, Lung, and Blood Institute ( NHLBI ) Funding Opportunity Title Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required) U24 Resource-Related Research Projects – Cooperative Agreements May 21, 2025 - Notice of Extension to PAR-22-193 "Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)".

See Notice NOT-HL-25-014 . March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity UG3 / UH3 Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II See Section III.

3. Additional Information on Eligibility . Assistance Listing Number(s) 93.

837, 93. 838, 93. 839, 93.

840, 93. 233 Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) 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 FOA 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 FOA will utilize a milestone-driven cooperative agreement mechanism of award and runs in parallel with a companion FOA PAR-22-192 () that encourages applications 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 plans.

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. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date Dates in bold and italics reflect changes per NOT-HL-25-014 .

Application Due Dates Review and Award Cycles New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date October 11, 2022 November 10, 2022 January 11, 2023 March 2023 May 2023 July 2023 February 10, 2023 March 10, 2023 May 11, 2023 July 2023 October 2023 December 2023 June 13, 2023 July 11, 2023 September 11, 2023 November 2023 January 2024 April 2024 October 11, 2023 November 13, 2023 January 11, 2024 March 2024 May 2024 July 2024 February 13, 2024 March 11, 2024 May 10, 2024 July 2024 October 2024 December 2024 June 11, 2024 July 11, 2024 September 11, 2024 November 2024 January 2025 April 2025 October 11, 2024 November 12, 2024 January 10, 2025 March 2025 May 2025 July 2025 February 11, 2025 March 11, 2025 May 12, 2025 July 2025 October 2025 December 2025 June 11, 2025 July 11, 2025 September 11, 2025 November 2025 January 2026 April 2026 October 10, 2025 November 10, 2025 January 12, 2026 March 2026 May 2026 July 2026 All applications are due by 5:00 PM local time of applicant organization.

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. New Date January 12, 2026 per NOT-HL-25-014 (Prior Date September 12, 2025).

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description This FOA supports applications to develop and implement a Data Coordinating Center (DCC) for investigator-initiated multi-site clinical trials submitted to the collaborating Clinical Coordinating Center FOA ( PAR-22-192 ) . Clinical trials supported by this FOA 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 FOA. This FOA 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 holds 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.

Clinical trials require the recruitment of human participants, so it is of foremost importance that participant safety and inclusion of individuals from a variety of backgrounds, for example, men, women, and individuals of all ages, including children and older adults be considered .

Recruitment should include populations affected by health disparities, for example, Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, and underserved rural populations.

Proposed research may utilize a design anywhere along the continuum of efficacy, effectiveness, pragmatic and/or implementation research clinical trials. For this FOA, 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. Innovative trial designs such as adaptive designs will be considered. The trial design should be appropriate for the study question.

Trials for which this FOA applies are expected to contribute to the evidence base for important health matters of relevance to the research mission of NHLBI, including approaches to increase variety of participants in the research and reduce health disparities. For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website .

A key characteristic of this FOA is 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.

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 subsequent approval of Data and Safety Monitoring Board; and Single Institutional Review Board (see NOT-OD-16-094 ) approvals of the trial protocol; and informed consent(s)/assent(s); manual of operations; data management systems and randomization procedures; and finalized integrated project management plans.

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 FOAs, 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.

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.

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 eConnect , an NHLBI platform that facilitates transfer of electronic information to NHLBI.

NHLBI policies regarding milestones and relevant clinical research/studies policies are described in the following: NHLBI Accrual of Human Subjects (Milestones) Policy , NHLBI Policy for Inclusion of Women and Minorities in Clinical Research , NHLBI Policy for Data and Safety Monitoring of Extramural Clinical Studies, NIH Single IRB Policy and NHLBI Data Sharing Policy .

Note: This DCC FOA runs in parallel with a companion FOA ( PAR-22-192 ) 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 will not proceed to review.

Applicants are encouraged to use the Compendium of Best Practices for Data Coordinating Centers as a reference tool. Applicants are strongly encouraged to consult with the Scientific/Research contacts for the area of science for which they are planning to develop an application prior to submission to confirm the NHLBI-specific clinical trial FOA 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, and to provide information and guidance to potential applicants. Additionally, a staff consultation is required when direct costs (DCs) are $500,000 or higher (see NHLBI policy regarding direct costs of $500,000 or more).

See Section VIII. Other Information for award authorities and regulations. Section II.

Award Information Cooperative Agreement: A support 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 FOA. Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Required: Only accepting applications that propose clinical trial(s). Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Application budgets are not limited but need to reflect the actual needs of the proposed project. The combined budgets of the CCC and DCC will be used to determine whether the policy regarding direct costs of $500,000 or more in any year will be applied. The scope of the proposed project should determine the requested project award period.

The period of award is expected to be 5 years. Up to 7 years may be requested if strongly justified. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) Non-domestic (non-U.S.) Entities (Foreign Institutions) 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. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. 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.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM. gov registration process.

SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.

eRA Commons - Once the unique organization identifier () is established, organizations can register with eRA Commons in tandem with completing their full SAM and 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 (PD/PI) account in order to submit an application.

Grants. gov – Applicants must have an active SAM registration in order to complete the Grants. gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role.

Obtaining an eRA Commons account can take up to 2 weeks. Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. Multiple PDs/PIs are allowed on any single application.

Because the FOA already supports a team approach between groups of experts across sites and collaborating applications, the designation of multiple PDs/PIs on a single application may be less likely to apply. PD(s)/PI(s) from each linked application should not be designated as multiple PDs/PIs on each application of a collaborative set.

ESI applicants can be the PI/PD of an application providing they can show support of investigators with appropriate clinical trial data coordinating experience (as part of a multiple PI team). ESIs are encouraged to be part of the study team and they should be budgeted for support at a level appropriate for the role on the project. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.

3. 7. 4 Submission of Resubmission Application .

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ) This FOA only accepts applications that are part of a collaborative pair of applications. The pair must include one DCC U24 application to this FOA plus one application to the companion CCC UG3/UH3 FOA. Section IV.

Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution.

Links to apply using ASSIST or Grants. gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: Director, Office of Scientific Review National Heart, Lung, and Blood Institute Email: [email protected] All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages.

For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. All instructions in the SF424 (R&R) Application Guide must be followed.

Descriptive Title of Applicant's Project: To allow NIH to identify a related set of collaborative applications, the title of each application in the set must have the following format: a “1/N” indicator + Identical Title (e.g., “1/3”, where the 1/3 means this is site 1 of 3 sites in the set.

The other sites will be labeled 2/3, etc.) Titles may not exceed 200 characters in length, including the tag, e.g., 1/3, at the beginning of the title. Cover Letter Attachment: The Cover Letter is one PDF file only.

The following collaborative information is required in the Cover Letter: a listing of all the applications that are a part of the set of collaborative applications being submitted, including for each: 1) the PD/PI(s) name(s), 2) the Title (including the tag, e.g., “1/3”), and 3) the Applicant Institution. Each site should submit an identical listing.

If the direct costs of the combined CCC and DCC budgets equal or exceed $500,000 in any given year, a copy of the NHLBI approval letter must be attached. SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed.

Facilities and Other Resources: Describe the facilities and resources available for the coordination of a multi-site clinical trial, including project management tools that will be used. Describe how the infrastructure at the DCC and performance sites will facilitate the efficient operation of the proposed multi-site clinical trial.

If applicable, discuss any community participatory agreements and/or stakeholder agreements to support the protocol. Other Attachments: The attachments listed below that are marked as "Required" must be provided or the application will not be peer reviewed. 1.

Trial Management Plan (Required): A description of how the proposed trial will be managed must be provided as an attachment using the filename "Trial Management Plan. pdf" and may not exceed 5 pages .

Describe the strategy that will be used throughout the project to ensure that management activities of the clinical trial are performed including directly supporting the needs of scientific study leadership to identify barriers, make timely responses, and optimize the allocation of limited resources to meet pre-defined study objectives. This description should include: Description of the project management team and levels of effort.

Description of how the CCC and DCC project management teams will integrate with one another. A risk management plan that addresses contingencies in the event that there is inadequate progress toward achieving the U24 core milestones. The plan should identify a range of contingencies that could threaten study progress or feasibility, and propose solutions using study resources.

Key methodology and standard operating procedures governing resource management, study deployment, operations/execution, and study closure. How the clinical trial management team, in collaboration with the CCC, will resolve fiscal and logistical issues in a timely manner including plans to pro-actively evaluate and prioritize study risks and issue corrective responses.

Processes required for orderly project closure including how the study will comply with the NIH Data Sharing Policy, and biorepository plans if specimens will be stored after planned study testing and analyses are complete. In summary, the trial management plan should provide sufficient detail to demonstrate the ability to achieve the goals of the clinical trial on-budget and on-time and to successfully manage and mitigate risks. 2.

Clinical Trial Research Experience (CTE) (Required): Applicants must provide a table listing the characteristics of trials that demonstrate experience from key personnel in trial coordination in the last 5 years. The table must be provided as an attachment called "Clinical Trial Research Experience. pdf" and may not exceed 3 pages .

The table columns should include: Column A: clinical study title Column B: applicant's role in the study Column C: a brief description of the study design Column D: planned enrollment Column E: actual enrollment Column F: number of sites Column G: whether the studies were completed on schedule or not Column H: publication reference(s) 3.

Network Description (Optional): A Network Description Plan is optional and should only be provided as an attachment using the filename "Network Description. pdf" if the proposed clinical trial is to be conducted using the infrastructure of an existing Network.

This attachment may not exceed 6 pages and should include the following description: Number of years and funding remaining to support the Network infrastructure and any information on the continuance of the Network Plans to replace sites that are under-performing or that are removed through the Network re-competition process.

These plans should include contingencies for funding, data recovery, and the follow-up of enrolled trial participants.

Infrastructure capacity and availability of patient populations considering current ongoing trials within the Network Plans to incorporate the current Network infrastructure into the proposed trial, including participant recruitment, trial implementation, and central coordination through the CCC and data management, data analysis, or statistical analysis through the DCC Plans to utilize master clinical trial agreements and a single IRB Describe the part of the Network that will be leveraged by the CCC and the DCC, respectively.

If both the CCC and the DCC applications intend to leverage the infrastructure of an existing network, the CCC application must also include this information. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed.

The PD/PI (or Multi-PDs/PIs) of the DCC must be experienced in the coordination and management of multi-center clinical trials, including success in meeting milestones and timelines. The experience of each PD/PI and all Key Personnel must be carefully documented and roles and responsibilities must be well-defined.

DCCs require a multidisciplinary team and the application should reflect the team's hands-on involvement in DCC functions, including coordination, tracking, logistics and administration, communications, data management (including quality control), data security and IT infrastructure (including development of public and secure study websites), regulatory support, and biostatistical/analytical support.

Applicants must include personnel and corresponding biographical sketches for the DCC only. All Key Personnel who are major scientific contributors to the study must provide an NIH Biosketch whether or not they are budgeted. The PD/PI (or Multi-PDs/PIs) for the DCC cannot be Key Personnel on the CCC application.

All instructions in the SF424 (R&R) Application Guide must be followed. The application must include only its own budget, including any subcontract budgets associated with it. Separate itemized budgets must be prepared for each subcontract.

The application must provide detailed annual budgets that will enable the DCC to meet its milestones. Any cores (e.g., economics/quality of life) must be a subcontract to either the DCC or CCC. Separate itemized budgets must be prepared for each subcontract and/or for each collaborating center or core.

All costs requested and all changes in budgets after the first year should be clearly identified and justified. The DCC budget must be synchronized with the CCC budget. Include costs associated with community engagement activities (e.g., community advisory board(s), infrastructure needs), as applicable.

If parts of the costs of the trial are to be provided by sources other than NHLBI, these contributions must be presented in detail in the budget justification. Third Party support of the proposed research activity (if approved) will be incorporated as a Special Award Condition.

Applicants are reminded that although Cost Share is not required, if these types of costs are included in the research application and peer reviewed, it is expected that these costs will not be covered by NHLBI. The DCC should include in their budget all costs associated with DSMB activities. This includes the costs for preparing reports for the DSMB and meeting reimbursement for the DSMB members.

The DCC should assess the need for liability insurance for DSMB members and provide a plan commensurate with the risk of the trial. The budget should include provision for executing the plan proposed. The DCC should also include a plan for assessing DSMB member conflict of interest, and put associated costs in the budget.

Additionally, if the DSMB is convened by NHLBI, the DCC should include in their budget coordination of support for at least one DSMB meeting per year in Bethesda, MD and coordinate regular DSMB calls as needed (by teleconference or videoconference). Include budget support for steering committee meetings whether in person or as a hybrid video conference. Include budget support for publication, dissemination of results, and data sharing.

The DCC budget should request only the costs