Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required) | PAR 18 410

Opportunity Information: Apply for PAR 18 410

The opportunity titled "Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)" (Funding Opportunity Number PAR-18-410) is a National Institutes of Health (NIH) funding announcement designed to support the Data Coordinating Center (DCC) for an investigator-initiated, multi-site clinical trial. It is specifically geared toward Phase II and later-stage trials, and the proposed study must align with the mission and research priorities of the National Heart, Lung, and Blood Institute (NHLBI). In practical terms, this means the clinical trial needs to fall within NHLBI-relevant areas such as heart and vascular disease, lung disease, blood disorders, and sleep-related conditions, and it must meet the NIH definition of a clinical trial as described in NIH guidance (referenced in the announcement as NOT-OD-15-015). The program emphasizes that applicants should review NHLBI strategy and priorities and are encouraged to talk with the relevant NHLBI scientific/research contact before submitting, which signals that fit with NHLBI priorities and readiness for cooperative-trial operations are important.

This FOA uses a cooperative agreement mechanism (U24), which generally means NIH staff will have substantial involvement during the conduct of the award compared with a standard grant. The DCC is not being funded in isolation; it is intended to operate in tandem with a separately submitted, companion application for a Clinical Coordinating Center (CCC). The key structural requirement is that the DCC application must be explicitly tied to, and written for, the same specific clinical trial proposed in the collaborating CCC application. Both applications must be submitted by the same due date to be considered together by NHLBI. This paired-center approach reflects a common model for large, multi-site trials: the CCC typically focuses on clinical operations (site management, participant recruitment and retention, regulatory coordination across sites, intervention delivery, and clinical monitoring), while the DCC is responsible for the trial-wide data and statistical backbone plus overall coordination across moving parts.

The core purpose of the DCC component is to present a thorough, trial-specific plan for overall project coordination and administration, data management, and biostatistical support. A competitive application would therefore be expected to lay out how the DCC will manage the end-to-end data lifecycle and trial oversight functions that keep a complex, multi-site study consistent, compliant, and analytically sound. That typically includes building and maintaining robust data capture systems; developing case report forms and data dictionaries; establishing data quality control procedures; performing real-time data cleaning and query resolution; supporting randomization and allocation procedures; maintaining databases with appropriate privacy and security protections; and ensuring standardized reporting across sites. On the biostatistics side, the DCC is commonly expected to support study design finalization, power and sample size justification, interim monitoring approaches where applicable, prespecified analysis plans, generation of reports for oversight bodies, and final statistical analyses. Because this FOA is for multi-site Phase II and beyond trials, the DCC role is also usually central to producing consistent performance metrics, helping troubleshoot site-level data issues, and supporting the reporting needs associated with safety and trial governance.

From an applicant eligibility standpoint, the announcement is broad and inclusive. Eligible applicants include many types of U.S. governmental entities (state, county, city/township, special districts), educational institutions (public/state-controlled and private institutions of higher education, including independent school districts in the eligibility list), tribal governments and tribal organizations, public housing authorities/Indian housing authorities, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), and small businesses. The FOA also explicitly calls out additional eligible organization types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This wide eligibility reflects the reality that DCC expertise can reside in academic, nonprofit, government, or private-sector settings, and that multi-site trials may benefit from specialized coordinating centers with established clinical data infrastructure.

Administratively, the FOA is categorized as a discretionary health funding opportunity and is associated with multiple CFDA numbers (93.233, 93.837, 93.838, 93.839, 93.840), reflecting NHLBI’s range of program authorities across heart, lung, blood, and sleep research areas. The announcement record lists an original closing date of 2019-08-05 (with a creation date of 2017-10-25), which is important for planning purposes because it indicates the specific posting is not current unless reissued or updated in a newer cycle. While the summary information provided does not list an award ceiling or expected number of awards, the cooperative agreement format and the requirement to submit paired DCC and CCC applications strongly suggest the institute is looking for well-developed, trial-ready proposals with clear division of responsibilities, strong communication plans, and credible operational and statistical infrastructure capable of supporting a rigorous, multi-site Phase II-plus clinical trial.

Overall, this FOA is best understood as NHLBI support for the specialized coordinating functions that make a complex, investigator-initiated, multi-site clinical trial workable and credible. The DCC is expected to be the hub for data integrity, statistical rigor, and cross-site coordination, operating collaboratively with a separately funded CCC that manages clinical execution. The most critical compliance point is that the DCC application must be specific to the partnered clinical trial and must be submitted in parallel with the CCC application on the same due date, making the combined DCC-CCC team and their integrated trial plan the true unit of review and consideration.

• 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 2017-10-25.
• Applicants must submit their applications by 2019-08-05. (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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