Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required) | PAR 22 193

Opportunity Information: Apply for PAR 22 193

This NIH funding opportunity (PAR-22-193) invites applications to serve as a Data Coordinating Center (DCC) for an investigator-initiated, multi-site clinical trial that aligns with the mission of the National Heart, Lung, and Blood Institute (NHLBI). The trials supported under this announcement can span a wide range of designs and purposes, including efficacy trials, comparative effectiveness research, pragmatic trials, and implementation research trials. The interventions being tested may be therapeutic, behavioral, and/or preventive in nature. A key requirement is that the proposed study must meet the NIH definition of a clinical trial (as referenced in NIH guidance such as NOT-OD-15-015) and must be clearly relevant to NHLBI priorities, meaning applicants should be prepared to show how the trial addresses important questions in heart, lung, blood, or sleep-related health.

The award mechanism is a cooperative agreement (U24), which signals a more collaborative relationship with NIH than a standard grant. In practice, this typically means NIH staff are expected to have substantial programmatic involvement during planning and execution, and the DCC will need to be ready to operate in a coordinated, milestone-driven environment with regular reporting, shared decision-making structures, and active oversight. The core purpose of the DCC application is to lay out a complete, credible plan for centralized coordination and technical leadership in data and statistics for the clinical trial being proposed by a partnering Clinical Coordinating Center (CCC).

A central feature of this FOA is that it runs in parallel with a companion announcement for the Clinical Coordinating Center (listed as PAR-22-NNN in the materials you provided). The DCC and CCC applications are meant to function as a matched pair: the CCC typically leads clinical operations (site management, recruitment, intervention delivery, clinical oversight), while the DCC provides the infrastructure and expertise that make a complex, multi-site trial run smoothly from a data, analytics, and overall coordination standpoint. Importantly, NHLBI will only consider the DCC application if a collaborating CCC application is submitted at the same time, by the same due date. In other words, applicants need a committed partnership and a tightly integrated plan across the two centers, with roles and responsibilities clearly divided but operationally seamless.

Within the DCC scope, applicants are expected to propose robust capabilities for overall project coordination and administration, data management, and biostatistical support. This generally includes building and maintaining systems for high-quality data capture and cleaning; developing data standards, dictionaries, and documentation; supporting randomization and masking procedures when relevant; producing interim and final statistical analyses; ensuring data quality assurance across multiple sites; managing secure data flow and storage; supporting trial monitoring and reporting; and helping drive consistent implementation of the protocol through centralized tools, training, and communication. Because these are multi-site trials, the DCC is also typically responsible for harmonizing procedures across sites and providing centralized support that reduces variability and improves trial integrity. While the FOA text in your excerpt emphasizes coordination, data, and statistics, applicants should also anticipate expectations common to NIH clinical trials, such as adherence to good clinical practice principles, reproducible analysis practices, and careful planning for data sharing and archiving consistent with NIH policies.

Eligibility is broad and includes many types of domestic organizations and governments, such as public and private institutions of higher education, state and local governments, federally recognized tribal governments, tribal organizations, public housing authorities, nonprofits (including both 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), and small businesses. The FOA also explicitly highlights additional eligible applicant categories that reflect NIH interest in broad participation, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, historically Black colleges and universities (HBCUs), tribally controlled colleges and universities (TCCUs), faith-based or community-based organizations, U.S. territories or possessions, and even non-U.S. (foreign) organizations and regional organizations. This wide eligibility suggests NHLBI is open to a range of institutional homes for a DCC, as long as the applicant can demonstrate the operational maturity, technical expertise, and governance structures needed to support a rigorous, multi-site clinical trial.

Administratively, the opportunity is listed as discretionary funding, in the health activity category, under multiple CFDA numbers (93.233, 93.837, 93.838, 93.839, 93.840), reflecting NHLBI’s broad portfolio. The sponsoring agency is the National Institutes of Health, with the opportunity originally created on 2022-07-12 and an original closing date shown as 2025-09-11 in the provided record. The award ceiling and expected number of awards are not specified in the excerpt, which usually means applicants need to rely on the full FOA text (and often NHLBI guidance) to understand typical budget ranges, project periods, and any institute-specific constraints.

Overall, this FOA is best understood as support for the specialized “engine room” of a multi-site NHLBI-relevant clinical trial: the DCC that ensures the study is well-coordinated, the data are reliable and secure, the statistical design and analyses are sound, and the overall effort stays organized and compliant from start to finish. The strongest applications will usually be those that show a well-matched partnership with a CCC, present a detailed and realistic operational plan, and demonstrate prior experience running or supporting complex, multi-site clinical trials with the level of rigor expected in NHLBI-funded research.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839, 93.840.
• This funding opportunity was created on 2022-07-12.
• Applicants must submit their applications by 2025-09-11. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 22 193

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