PAR-27-013: Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (U24)

PAR-27-013: Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (U24)

What this opportunity is and what makes it different

This is a cooperative agreement (U24) for building or operating a Data Coordinating Center that supports investigator-initiated, multi-site clinical trials. It is distinct from traditional research grants because it is explicitly structured as a paired mechanism with a companion CCC mechanism (PAR-27-012, UG3/UH3 Clinical Coordinating Center). The NOFO is not a standalone trial application: it is the operations half of a larger trial stack.

The NOFO’s language is explicit that the DCC is not optional support for your own internal project; it is a mechanism expected to serve a companion clinical trial package. That means the DCC must be able to coordinate protocol operations, data systems, accrual monitoring, randomization and analysis infrastructure, and execution timelines for a trial submitted to the paired CCC NOFO.

This opportunity is practical for teams that already have a credible investigator-initiated clinical trial concept but need a robust, independent coordinating infrastructure. The phrase used by the NOFO is important: it is milestone-driven and performance-based. If your team sees DCC operations as a background administrative function, this mechanism is likely too demanding. If your team understands this as a program leadership role with measurable milestones, it can be a strong fit.

What the program is designed to fund

Core funding target

The NOFO covers the development and operation of a DCC for multi-site clinical trials with two to more than two recruitment sites, including trials that may be efficacy, comparative effectiveness, pragmatic, or implementation-focused. Innovative designs including adaptive and Bayesian methods are explicitly encouraged, which means a trial that has already moved beyond simple parallel-arm thinking can be considered when the method aligns with NHLBI goals.

The DCC role includes:

• Clinical trial coordination architecture across sites
• Data collection, curation, quality control, and analysis systems
• Randomization support and operational execution
• Adverse-event monitoring workflows and regulatory interfaces
• Community engagement support as required by the companion CCC application
• Milestone planning across UG3/UH3 phases

The NOFO emphasizes that the first year is expected to align with the UG3 phase, including final protocol development, DSMB engagement, protocol approval flow, data-management systems, randomization plans, and trial-start activities. The second year is contingent on successful first-year progress and aligns with the UH3 phase. The publication repeatedly says the award is performance-based and tied to milestones, not just scientific concept quality.

Where the money and timeline fit

The NOFO does not state a fixed total program amount in the public lines, so you should treat it as a proposal-budget-negotiated mechanism with no hard cap disclosed in that section. This is common for infrastructure-linked U24s and clinical-coordination programs, but it does increase compliance risk because scoring reviewers and NSF/NIH-style peer frameworks are often less forgiving of under-defined budgets in this domain.

Key dates are strong planning anchors:

• Posted: March 18, 2026
• First open date: May 2, 2026
• First full deadline: June 2, 2026 (5:00 PM local)
• Subsequent cycles for 2026-2027 include 2026-10-02, 2027-02-01, 2027-06-02, 2027-10-01
• Expiration: November 3, 2028

Because cycles are explicitly repeated and structured, this should be treated as a 2026/2027 recurring pathway, not a one-off opportunity.

Who this is for and who should likely skip it

Good fit profiles

This mechanism fits organizations and investigators who:

• Can operate at trial-coordination and trial-governance depth
• Can show prior NIH-style clinical trial experience, especially in multi-site operations
• Can provide cross-functional DCC personnel: management, biostatistics, data systems, quality control, protocol operations
• Can submit in sync with a CCC concept to PAR-27-012 and keep both applications synchronized
• Can document contingency plans for recruitment, retention, and operational delays

Teams with a strong clinical trial operational lead, data platform lead, and governance model for multi-site trial logistics generally perform better than teams with only a science lead.

Not a fit for

Avoid this if your application is:

• A single-site observational study
• A purely observational grant proposal without protocolized trial mechanics
• A non-clinical trial grant
• A DCC-only concept without a matched and complete companion CCC plan
• A team unable to support strict milestone delivery and compliance checks

The NOFO explicitly states that applications submitted as DCC without the companion CCC on the same due date are incomplete and will not be reviewed.

Eligibility and hard gates (from the rulebook)

Applicant organizations

Eligibility is broad but constrained by operational and policy context. The NOFO allows multiple organizational types, including higher education institutions, nonprofits, small and larger for-profits, state and local governments, federal agencies, school districts, tribal governments, and some faith/community organizations.

Foreign components can be eligible in specific contexts, but there is a strict policy warning in the NOFO: domestic or foreign entities with foreign subawards/subcontracts are not eligible unless submitted under collaboration-specific NOFOs. This is now the high-risk compliance point that often causes silent failure.

Individual eligibility and operational gates

Even though individual PI eligibility is broad (“any individual with the required skills and resources”), this is a collaborative and procedural program, not a solo concept competition. Practical eligibility is controlled by whether the organization and PI can satisfy:

• eRA Commons and Grants.gov/SAM registration readiness
• complete institutional registration and PI account setup (PD/PI account, and potentially separate AOR and SO roles)
• timely submission mechanics via ASSIST, institutional S2S, or Grants.gov Workspace
• inclusion of required milestone and management documentation in the application package
• explicit scientific rationale linking clinical trial operations to the companion application

In short, if you can submit a simple NIH grant, this may still be too operationally demanding; if you already run collaborative trial infrastructure, this is likely a closer fit.

Collaboration rule that is easy to miss

The most important hard gate is simple and strict: PAR-27-013 and PAR-27-012 must be a pair. The NOFO states this clearly, and every one of the major review and administrative points assumes this as true.

Application process and required materials

Submission route

Use one of the official NIH submission systems:

• NIH ASSIST
• institutional S2S route
• Grants.gov Workspace

All routes require pre-completion of registrations and electronic systems before the due date.

Critical formatting and compliance points

Your DCC cover page title must include a synchronized marker that identifies linked applications (for example, 1/3 style labeling in collaborative sets). This is not cosmetic; the NOFO says this is required to identify the related set for review.

Required major components from the NOFO include, at minimum:

• SF424(R&R) cover and narrative sections per NIH rules
• Trial Management Plan (PDF, ≤5 pages)
• Clinical Trial Research Experience table (PDF, ≤3 pages)
• Detailed Budget with synchronization to the companion CCC budget, including milestone-linked spending
• Research Plan with Significance, Innovation, Approach, milestones, and a strategy for enrollment and retention
• PHS clinical trial elements (human subjects forms and related fields)
• Timeline with measurable milestones and Gantt-style sequencing
• Strong evidence of trial management team readiness and governance model

The NOFO emphasizes required attachments and page limits; missing required attachments or format mistakes can make the package noncompliant. For this mechanism, compliance quality is effectively review leverage.

Collaboration mechanics with PAR-27-012

The DCC and CCC are expected to operate as an integrated system. In practical terms:

• The DCC should coordinate with CCC on recruitment assumptions
• Milestone timing should align between UG3/UH3 phases
• Data-sharing and analysis systems should map directly to CCC workflow
• Community engagement and dissemination statements should be aligned with the CCC narrative

Many teams lose points on narrative mismatch across the two applications rather than scientific weakness. This often comes from writing two independent applications with incompatible acronyms, timelines, and assumptions.

Where to check official support before submission

The NOFO provides explicit support points: eRA Service Desk for ASSIST/eRA Commons issues and Grants.gov Support Center for Grants.gov. For clinical research administration, the program contacts in the NOFO are the proper route for NHLBI content questions.

Deadlines, review logic, and what reviewers will prioritize

Milestone-centered design

For this NOFO, milestones are not just reporting requirements; they are the program architecture. Proposals are expected to define measurable, timed outcomes tied to recruitment, data integrity, and operational efficiency.

The review sections repeatedly check:

• Feasibility of completing the DCC mission
• Trial design adequacy and ability to support statistical power and analysis goals
• Data management governance, quality procedures, and dissemination logic
• Management quality and team capacity
• Alignment between DCC operations and trial protocol scope
• The ability to run adaptive or pragmatic trials at pace without protocol drift

Review is then mapped into NIH standard peer-review logic (overall impact, significance, investigators, innovation, approach, environment), but with NOFO-specific criteria layered on top.

What reviewer focus looks like in practice

From review language in the NOFO:

• Can your DCC design answer the science question within the trial architecture in time?
• Are investigators capable of running coordinated multi-site operations and data oversight?
• Is the data management plan credible and reproducible?
• Is the study timeline realistic and resilient to enrollment variability?
• Do roles and responsibilities avoid overlap and ambiguity?
• Are milestone definitions measurable and achievable?

In a U24 clinical coordination mechanism, the “good idea + weak execution plan” equation is often enough to fail at review. Strong execution planning can partially offset novelty limitations; weak execution will often override very strong science.

Cost, budget strategy, and spending logic

Because there is no fixed cap in the extracted NOFO section, applicant teams should build budgets that are:

• justified at activity level,
• coherent with trial milestones,
• synchronized to the companion CCC, and
• explicit about DSMB, steering, community engagement, and dissemination costs.

Avoid generic budget requests. The NOFO calls for a trial-management budget that reflects required operations and not just science costs. Include:

• core project staff with percent effort tied to phases
• DCC systems and data platforms
• governance and monitoring costs
• dissemination and publication costs
• realistic quality-control and protocol-monitoring overhead

Because the mechanism is performance-based and subject to progress reviews around month 9 in year one, reviewers and post-award monitors expect a budget-to-milestone linkage.

Practical preparation strategy (recommended 16-week playbook)

Month 1–2: Fit and architecture alignment

• Select and lock in the companion PAR-27-012 intent so that trial design, data scope, and timeline are matched.
• Appoint a single team lead who owns DCC/CCC integration.
• Create a shared milestone map with UG3/UH3 and DCC milestones in the same units (enrollment windows, data lock windows, interim analyses, dissemination milestones).

Month 3–4: Documentation spine

• Build the Trial Management Plan first because it is a required attachment with detailed scope.
• Draft a clinical trial research experience table with recent, relevant entries and outcomes.
• Prepare facilities and resource narrative to demonstrate capacity across study management, data systems, and reporting workflows.

Month 5: Compliance freeze

• Confirm registration completion (eRA Commons, SAM, UEI, CAGE/NCAGE where needed).
• Reconcile titles with collaboration tags (e.g., 1/N style naming for each linked submission) and validate character limits.
• Convert all attachments into the exact required format and naming.

Final 2–3 weeks: pre-submission quality pass

• Run an internal compliance checklist against NIH R&R instructions and NOFO-specific requirements.
• Verify all required pages and forms are present and within size limits.
• Simulate late-day edits by using an internal submission date buffer.
• Confirm both PAR-27-013 and PAR-27-012 are submitted by the same timestamp.

This sequence is not optional; it is the only way to avoid late-system issues and pre-review rejection.

Common mistakes and how to prevent them

Mistake 1: Submitting DCC application without an aligned CCC package

The NOFO will return this as incomplete if not aligned. Prevent it with a joint planning matrix across both NOFO sections before writing final narrative.

Mistake 2: Missing Trial Management Plan depth

The required plan is not a placeholder. Include staffing, risk register, fallback plans, communication cadence, and data-release/compliance sequencing.

Mistake 3: Weak timeline feasibility

Many applicants underestimate site activation, IRB cycles, enrollment delays, and data lock readiness. Include conservative buffer assumptions and explicit mitigation for under-enrollment.

Mistake 4: Late-compliance errors in NIH systems

Common errors: invalid titles, missing required credentials, incomplete registrations, and mis-tagged attachments. Because deadlines apply system-wide and late corrected submissions are considered late, fix errors early.

Mistake 5: Misalignment in trial design and data architecture

If the trial analytics, data model, and DCC role are described differently from companion CCC assumptions, score drops. Keep one architecture document and reuse across applications.

FAQ

Is this an early-stage grant or an implementation grant?

It is not a seed pilot mechanism. It is for coordinating and supporting investigator-initiated multi-site clinical trials, including implementation-oriented design elements across the clinical pipeline.

Can non-clinical institutions apply?

Institutions across sectors can apply if they can meet all administrative and technical requirements, but clinical-trial relevance and registration compliance remain mandatory.

Is there a fixed budget cap?

The NOFO section reviewed does not list a fixed dollar amount for each application. Budget is determined by project needs and must be fully justified.

Is prior trial experience required?

The NOFO strongly favors teams with proven trial coordination and clinical trial management experience. The CTE attachment is required for a reason: reviewer confidence is tied to execution history as much as science.

What is the difference between UG3 and UH3 in this mechanism?

The DCC first-year phase is tied to UG3-style development goals. Continuation into UH3-like execution years is contingent on milestone achievement and progress evaluation.

Official links and immediate next steps

• Opportunity page (NOFO): https://files.simpler.grants.gov/opportunities/9eef95f7-4437-45bc-810a-2514c89f8019/attachments/7b08124a-50f5-4660-a324-42157aa41ad9/PAR-27-013-Full-Announcement.html
• Companion NOFO reference: PAR-27-012 UG3/UH3 Clinical Coordinating Center (same NHLBI pathway; check linked companion in the NOFO)
• Program contacts listed in NOFO: Division of Blood Diseases and Resources, Division of Cardiovascular Sciences, Division of Lung Diseases, Center for Translational Research and Implementation Science (NHLBI)

For 2026/2027 planning, the practical next step is to decide whether your team can commit to a paired submission rhythm and whether you can execute a fully synced submission with PAR-27-012. If the answer is yes, build the trial operations architecture first, then write scientific details around it. If the answer is no, this mechanism will likely consume more review capital than it returns.