Single Source: Cardiothoracic Surgical Trials Network (CTSN) Data Coordinating Center (U01 Clinical Trial Required) | RFA HL 27 002

Frequently Asked Questions (FAQs)

1) What is this funding opportunity?

This is an NIH Notice of Funding Opportunity (NOFO) from the National Heart, Lung, and Blood Institute (NHLBI) to support the Data Coordinating Center (DCC) for the Cardiothoracic Surgical Trials Network (CTSN). The opportunity is published as RFA-HL-27-002.

2) What funding mechanism is being used?

The NOFO uses the U01 mechanism, which is a cooperative agreement. Under a cooperative agreement, NHLBI is expected to have substantial programmatic involvement in the supported activities, rather than acting only as a pass-through funder.

3) Is this a single-source opportunity?

Yes. This is a single-source cooperative agreement, meaning eligibility is restricted to a single applicant organization identified in the NOFO.

4) Who is eligible to apply?

Eligibility is extremely limited. Only the Icahn School of Medicine at Mount Sinai is eligible to apply under this single-source NOFO.

5) Are foreign organizations eligible to apply?

No. Foreign organizations are not eligible to apply.

6) Are non-U.S. components of U.S. organizations eligible?

No. Non-U.S. components of U.S. organizations are not eligible to apply.

7) Are foreign components allowed at all?

Yes. Foreign components (as NIH defines them in its Grants Policy Statement) are allowed. This means certain international elements may be able to participate under defined arrangements, while the applicant organization remains U.S.-based and eligible.

8) Does single-source mean the award is guaranteed?

No. Even though it is single-source, the application will still go through standard NIH peer review, and funding is not guaranteed unless the submission is judged scientifically and operationally strong.

9) What is the main purpose of the award?

The purpose is to provide the centralized infrastructure needed to run multiple randomized clinical trials within the CTSN. The DCC is intended to serve as the operational hub that keeps complex, multi-site cardiothoracic surgery trials moving consistently, safely, and on schedule.

10) What kinds of trials will this DCC support?

The DCC is expected to support multiple randomized clinical trials in cardiothoracic surgery conducted through the Cardiothoracic Surgical Trials Network (CTSN).

11) What are the DCC's core responsibilities?

Core responsibilities include: overseeing trial conduct across participating clinical sites; ensuring regulatory and administrative requirements are met; building and maintaining systems for high-quality data collection and management; and providing statistical analysis and timely reporting of trial results.

12) Why is the DCC considered central to trial quality?

Because the DCC is accountable for the behind-the-scenes operational work that determines whether trials are executed rigorously, whether data are reliable and auditable, and whether findings can be reported credibly and quickly enough to influence clinical practice.

13) How does NHLBI expect the DCC to be structured?

NHLBI expects the DCC to function as two closely collaborating components: a Data Management and Analytics Center (DMAC) and a Clinical Coordination Center (CCC).

14) What does the Data Management and Analytics Center (DMAC) typically do?

The DMAC side typically focuses on trial databases and data pipelines, data quality control, statistical design and monitoring, interim and final analyses, and reporting.

15) What does the Clinical Coordination Center (CCC) typically do?

The CCC side typically focuses on clinical operations such as protocol implementation support, site coordination, participant tracking, training, communications, and other day-to-day trial execution tasks.

16) Does NHLBI encourage a multi-PD/PI leadership model?

Yes. NHLBI strongly encourages a multi-PD/PI model with two leaders: one primarily responsible for the DMAC and one for the CCC. This reflects the common need for distinct leadership across analytics and clinical operations within large trial networks.

17) What does "substantial programmatic involvement" mean in this context?

In this NOFO, "substantial programmatic involvement" indicates that NHLBI will be actively involved in the program as a cooperative partner, rather than serving only as a funding source without ongoing involvement.

18) What additional collaboration expectations are included beyond standard coordinating center tasks?

The DCC is expected to strengthen collaboration across the CTSN and connect the network to the broader research ecosystem. This includes promoting communication among CTSN investigators and coordinating outreach that may involve foundations, other research entities, and small businesses when interests align with public health priorities in cardiothoracic surgical care.

19) What types of partners or collaborators might the DCC need to integrate?

The DCC is responsible for integrating efforts across clinical sites, core laboratories, and other collaborators. The description notes that surgical trials may rely on imaging cores, adjudication committees, biorepositories, device-related partners, or specialized labs to standardize endpoints and ensure consistent interpretation of outcomes.

20) Is long-term follow-up required, and how must it be done?

Yes. A notable operational requirement is that the DCC will centrally conduct long-term follow-up by telephone.

21) Why does the NOFO emphasize centralized telephone follow-up?

Centralized follow-up can reduce burden on enrolling sites, improve consistency in follow-up procedures, and help maintain retention over long time horizons. This is especially relevant when cardiothoracic outcomes may occur months or years after surgery.

22) What operational capabilities are implied by centralized telephone follow-up?

The NOFO implies the DCC must have appropriate staffing, standardized scripts and procedures, tracking systems, and compliance safeguards to support systematic participant contact and documentation.

23) Does the DCC have responsibilities related to training or workforce development?

Yes. NHLBI anticipates the DCC will centrally manage a Clinical and Implementation Research Skills Program.

24) What is the goal of the Clinical and Implementation Research Skills Program?

The intent is to build capacity that blends practical clinical research skills with dissemination and implementation science, helping ensure CTSN discoveries are not only generated but are also more likely to be adopted effectively in real-world settings.

25) How is the scholars or skills program described in terms of outcomes?

It is envisioned as a pipeline that helps generate additional research questions within CTSN and develops a cohort of investigators who can carry these methods into leadership roles in academic and clinical programs.

26) What is the application due date listed for this opportunity?

The listing provides an original application due date of July 7, 2026.

27) How many awards does NHLBI expect to make?

NHLBI expects to make a single award.

28) What is the annual award ceiling?

The annual award ceiling listed is $8,000,000.

29) How is this opportunity categorized in terms of funding type?

The opportunity is categorized as discretionary funding and is within NIH health-related activity areas, with multiple CFDA listings associated with NHLBI programs.

30) What does success look like for this DCC, based on the NOFO description?

Based on the description, success means the CTSN has a robust, centralized coordinating structure capable of running several rigorous randomized trials at once, maintaining compliance and data integrity, supporting long-term follow-up, fostering external collaboration, and building implementation-oriented research talent that helps translate evidence into routine cardiothoracic surgical care.