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

Frequently Asked Questions (FAQs)

1) What is this funding opportunity?

This is an NIH funding opportunity from the National Heart, Lung, and Blood Institute (NHLBI) to support a Data Coordinating Center (DCC) for an investigator-initiated, multi-site clinical trial. The award mechanism is a cooperative agreement (U24), which is designed for projects with substantial NIH involvement and active oversight.

2) What is the funding opportunity number?

The funding opportunity number is PAR-27-013.

3) Which NIH Institute is sponsoring this opportunity?

The opportunity is through NIH, specifically the National Heart, Lung, and Blood Institute (NHLBI).

4) What type of award mechanism is used?

The mechanism is a U24 cooperative agreement. This is a milestone-driven structure with expected NIH involvement and progress tied to predefined milestones.

5) What is the DCC expected to do?

The DCC is expected to provide the data and statistical infrastructure and centralized coordination needed to run a complex multi-site clinical trial. This includes overall project coordination and administration, robust data management, and biostatistical leadership and support.

6) What does "milestone-driven cooperative agreement" mean in this context?

It means the award is expected to involve substantial NIH involvement and active oversight, with the project accountable to predefined milestones that guide progress and performance.

7) What kinds of clinical trials can be supported under this opportunity?

The trials can include efficacy studies, comparative effectiveness research, pragmatic trials, and implementation research trials, as long as they align with NHLBI program priorities and meet the NIH definition of a clinical trial.

8) Are innovative trial designs allowed or encouraged?

Yes. The announcement explicitly encourages modern and innovative trial designs, including platform trials, adaptive designs, and Bayesian approaches.

9) What types of interventions or strategies can be evaluated?

The opportunity allows trials evaluating a wide range of strategies, including therapeutic interventions, behavioral interventions, and prevention approaches, provided they align with NHLBI priorities and meet NIH's clinical trial definition.

10) Is this DCC award meant to operate alone?

No. The DCC solicitation is designed to operate in tandem with a companion funding opportunity for a Clinical Coordinating Center (CCC) (PAR-27-012). Together, the DCC and CCC form the coordinating backbone for a single proposed multi-site clinical trial.

11) What is the CCC and how does it differ from the DCC?

In practice, the CCC typically leads clinical operations and site management, while the DCC provides the data and statistical infrastructure and centralized coordination required to support the trial across multiple locations.

12) Do applicants need to submit both a DCC and a CCC application?

Yes. A central requirement is that applicants must submit both a DCC application and a collaborating CCC application for the same trial.

13) Do the DCC and CCC applications need to be submitted by the same deadline?

Yes. Both applications must be submitted by the same due date to be considered by NHLBI.

14) What happens if only the DCC application is submitted without the CCC application (or vice versa)?

Based on the stated requirement, both a DCC and a collaborating CCC application for the same trial must be submitted by the same due date in order to be considered by NHLBI.

15) What must the DCC application include for coordination and administration?

The DCC application is expected to include a complete plan for overall project coordination and administration, including governance structures, operational workflows, timelines, communication practices, and how the DCC will work day-to-day with the CCC and participating clinical sites.

16) What data management capabilities are expected from the DCC?

Expected capabilities include building and maintaining data capture systems, ensuring data quality control, establishing data standards and documentation, supporting secure data handling, and preparing data for monitoring, interim analyses, and final reporting.

17) What biostatistical responsibilities are expected from the DCC?

The DCC is expected to provide biostatistical leadership and support, which typically includes protocol-level statistical design input, randomization procedures, sample size and power considerations, statistical analysis plans, interim monitoring and stopping rules where appropriate, and final analysis and interpretation support consistent with the proposed trial design (including adaptive or Bayesian methods when used).

18) Does the NOFO expect the DCC to help with community engagement?

Yes. The NOFO emphasizes collaboration on community engagement. The DCC application should describe how it will work with the CCC to implement the trial's community engagement plan.

19) What might be included in the community engagement plan the DCC supports?

Examples described include strategies to support recruitment and retention, build trust and bidirectional communication with participant communities, improve representation of populations relevant to the disease burden, and incorporate stakeholder input into trial conduct and dissemination.

20) Is the DCC viewed as only a data management group?

No. The expectation is that the DCC is not just a back-end data shop, but an active partner in ensuring the trial is feasible, participant-centered, and executed to high quality standards.

21) Who is eligible to apply?

Eligibility is broad and includes many U.S. organization types such as federal-recognized tribal governments and organizations, state and local governments, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses, among others.

22) Are foreign organizations eligible to apply?

Yes. Foreign organizations are eligible to apply, and foreign components of U.S. organizations are allowed as defined in NIH policy.

23) Are foreign subawards or foreign subcontracts allowed under this opportunity?

No. NIH policy effective May 1, 2025 states that NIH will not issue awards that involve foreign subawards or foreign subcontracts unless the application is submitted under a NOFO specifically designated for funded international collaborations. Under this NOFO, applications that include foreign subawards/subcontracts will be considered noncompliant and will not be reviewed for funding.

24) If foreign subawards/subcontracts are prohibited, is any international involvement still possible?

Yes. The information provided indicates that the policy restriction does not eliminate all forms of international involvement. It still allows unfunded international collaborations, foreign components where consistent with NIH policy, paying foreign consultants, and purchasing unique equipment or supplies from foreign vendors. What is prohibited under this announcement is sending NIH award funds to foreign entities through subawards or subcontracts.

25) What is the consequence if an application includes a foreign subaward or subcontract?

Applications that include foreign subawards or foreign subcontracts under this NOFO will be considered noncompliant and will not be reviewed for funding.

26) What is the companion CCC funding opportunity number?

The companion funding opportunity for the Clinical Coordinating Center (CCC) is PAR-27-012.

27) What is the activity category listed for this opportunity?

The listing identifies the activity category as health-related.

28) What is the original closing date listed for this opportunity?

The opportunity is listed with an original closing date of November 2, 2028.

29) Is NHLBI expecting applicants to reach out before applying?

Yes. Applicants are strongly encouraged to contact the relevant NHLBI scientific/research program contact before submitting to discuss fit, the trial concept, and the planned DCC-CCC partnership structure.

30) How should the DCC describe working relationships with the CCC and clinical sites?

The DCC application is expected to explain day-to-day collaboration with the CCC and participating clinical sites, including communication practices, operational workflows, governance structures, and timelines to support consistent execution across multiple locations.