Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required) | PAR 19 330

Opportunity Information: Apply for PAR 19 330

This grant opportunity (PAR-19-330) from the National Institutes of Health supports the creation and operation of 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 targeted under this announcement can include efficacy studies, comparative effectiveness trials, pragmatic trials, and implementation research trials, as long as they meet the NIH definition of a clinical trial (as referenced in NOT-OD-15-015). The overall intent is to fund the specialized infrastructure and expertise needed to coordinate complex, multi-site studies by centralizing data operations and statistical leadership in a dedicated coordinating center.

A key feature of this opportunity is that it uses a cooperative agreement mechanism (U24), which generally means NHLBI expects to have substantial programmatic involvement during the life of the award compared with a standard grant. The DCC application is not meant to stand alone; it must be tied directly to a specific clinical trial being proposed through a separate, companion application for a collaborating Clinical Coordinating Center (CCC) under a parallel FOA (referenced as PAR-19-NNN in the text). In practice, applicants need to develop two tightly linked applications: one describing the CCC and the scientific/clinical conduct of the trial, and the other describing the DCC and how data, statistics, and overall coordination will be handled. Both applications must be submitted by the same due date to be considered together by NHLBI, so the DCC and CCC teams need to be integrated early and present a coherent, unified operational plan.

The DCC is expected to provide comprehensive trial-wide coordination and technical leadership that typically includes overall project management and administration, data management systems and workflows, biostatistical support, and cross-site operational harmonization. This generally covers responsibilities such as developing and maintaining the data capture platform, setting data standards and definitions, designing data quality control processes, overseeing database lock procedures, producing regular reports for study leadership and NHLBI, and ensuring consistent implementation of the protocol across all sites from a data and analytics standpoint. On the statistical side, the DCC would normally be responsible for supporting the analysis plan, overseeing randomization procedures when applicable, guiding interim monitoring and reporting, contributing to Data and Safety Monitoring Board materials as needed, and ensuring that final analyses and dissemination are conducted rigorously and reproducibly. The emphasis is on presenting a full, trial-specific operational blueprint showing that the DCC can manage the scope, complexity, and compliance demands of a modern multi-site NIH clinical trial.

The announcement highlights that the proposed trial must be relevant to NHLBI priorities, and applicants are encouraged to consult NHLBI strategic vision and research priorities to ensure alignment. It also strongly encourages prospective applicants to contact the appropriate NHLBI scientific or research contact before submission, which is often important for confirming fit, clarifying expectations for cooperative agreements, and reducing the risk of proposing a trial structure that does not match NHLBI program needs. This kind of pre-submission communication can also help applicants understand how NHLBI views the division of responsibilities between the CCC and DCC, expectations around governance, and any NHLBI-specific operational requirements.

Eligibility is broad and includes many types of domestic entities such as state, county, city, township, and special district governments; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses) and small businesses; independent school districts; public housing authorities/Indian housing authorities; and Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments). The opportunity also explicitly includes a wide range of additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This broad eligibility signals NHLBI interest in encouraging diverse institutional participation and potentially expanding trial capabilities across different settings and populations.

From an administrative standpoint, the opportunity is categorized as discretionary funding, with the activity area in health. It lists CFDA numbers 93.233, 93.837, 93.838, 93.839, and 93.840, reflecting NHLBI-related program areas. The original closing date shown in the provided source is September 8, 2022, and no award ceiling or expected number of awards is specified in the excerpt. The FOA was created on August 5, 2019. Applicants planning to pursue this mechanism would typically need to verify the current status of the announcement (since dates and availability can change), but the central structure remains: a collaborative, paired CCC and DCC submission designed to support a specific NHLBI-relevant, investigator-initiated, multi-site NIH clinical trial, with the DCC focused on coordination, data systems, and biostatistics under a cooperative agreement model.

• 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 2019-08-05.
• Applicants must submit their applications by 2022-09-08. (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.

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