Data Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative U24 Clinical Trial Required) | PAR 21 242

Frequently Asked Questions (FAQs) - NIH/NCCIH U24 Data Coordinating Center (PAR 21-242)

What is PAR 21-242?

PAR 21-242 is a National Institutes of Health (NIH) funding opportunity that uses a cooperative agreement (U24) to support a Data Coordinating Center (DCC) for an investigator-initiated, multi-site clinical trial focused on mind and body interventions aligned with the mission and priorities of the National Center for Complementary and Integrative Health (NCCIH).

What is being funded under this opportunity?

This opportunity funds a trial-specific Data Coordinating Center (DCC). The DCC is expected to provide the coordinating and analytic backbone for a particular, matched multi-site Phase III (and beyond) clinical trial being submitted at the same time under the corresponding Clinical Coordinating Center (CCC) funding pathway (referenced as TEMP-12554).

Can an organization apply for the DCC as a stand-alone coordinating center?

No. NCCIH is not seeking a generic or stand-alone coordinating center. The DCC application must be paired with, and tailored to, a specific multi-site Phase III (and beyond) clinical trial application submitted simultaneously under the CCC pathway. NCCIH will only consider the DCC if it is part of a matched set of applications designed to operate together as one integrated trial enterprise.

What is the relationship between the DCC application and the CCC application?

The DCC and CCC are intended to be submitted as a coordinated pair at the same time. The CCC application proposes the actual clinical trial operations, while the DCC application proposes the data coordination, infrastructure, and biostatistical leadership needed to support the trial. The two applications should be explicitly designed to work together.

What type of clinical trial is this opportunity tied to?

The DCC must support an investigator-initiated, multi-site clinical trial focused on mind and body interventions, at Phase III (and beyond), and aligned with NCCIH mission relevance and high program priority.

What does NCCIH mean by "mind and body interventions" in this context?

Based on the provided description, the trial must focus on mind and body interventions that align with NCCIH's mission and priorities. The opportunity emphasizes alignment with NCCIH strategic vision and research priorities, and applicants are directed to consult NCCIH materials and communicate with NCCIH before submission to confirm fit.

What are the main responsibilities of the Data Coordinating Center (DCC)?

The DCC is expected to provide a full, trial-specific plan for overall coordination and the technical infrastructure required to execute a complex, multi-site trial. This includes project coordination and administration across sites, robust data management systems and workflows, and biostatistical leadership appropriate for a late-phase, multi-site clinical trial.

What kinds of data management capabilities are expected from the DCC?

The description indicates NCCIH expects the DCC to be capable of managing trial-wide data standards and consistent procedures across sites, quality control, database build and maintenance, data cleaning, audit trails, secure handling of sensitive information, and cross-site workflows that support credibility and execution of a multi-site trial.

What kinds of biostatistical and analysis responsibilities are expected from the DCC?

The DCC is expected to provide biostatistical leadership supporting the trial's design and analytic approach, including randomization schemes as appropriate, interim and final analyses as applicable, monitoring of data quality and performance metrics, and the reporting and documentation needed for a rigorous multi-site effort.

Does the DCC need to address trial monitoring and performance metrics?

Yes. The description specifically notes expectations that the DCC will support monitoring of data quality and performance metrics and provide the types of reporting and documentation needed for a rigorous multi-site trial.

What does it mean that this is a cooperative agreement (U24)?

A cooperative agreement implies substantial NIH programmatic involvement compared with a standard research project grant. Applicants should anticipate active coordination expectations and ongoing interaction with NCCIH as the trial progresses.

How important is NCCIH mission fit and program priority?

It is central. The opportunity indicates that only trials that NCCIH deems both relevant to its mission and a high program priority are intended to fall under this announcement. Applicants are directed to consult NCCIH strategic vision and research priorities and to contact the appropriate NCCIH Scientific/Research contact before submission.

Is pre-submission contact with NCCIH required or strongly encouraged?

The opportunity strongly steers applicants to reach out to the appropriate NCCIH Scientific/Research contact before submission. This is framed as an important step to confirm that the proposed trial is within scope and competitive, especially given the emphasis on fit and high program priority.

Who is eligible to apply?

Eligibility is broad across U.S.-based organizations and governmental entities. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other categories listed in the opportunity.

Are minority-serving institutions and community-based organizations eligible?

Yes. The opportunity highlights eligibility for institution types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), as well as faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.

Can a foreign institution apply as the applicant organization?

No. Non-U.S. entities (foreign institutions) cannot apply as applicants under this opportunity.

Can a non-U.S. component of a U.S. organization apply?

No. The opportunity states that non-U.S. components of U.S. organizations are not eligible to apply.

Are foreign components allowed in any form?

Yes. Foreign components (as defined under the NIH Grants Policy Statement) are allowed. This generally means the applicant organization must be U.S.-based, but certain foreign activities or collaborations may be included if they meet NIH policy requirements and are well-justified.

What is the funding instrument and activity category?

The funding instrument is a cooperative agreement, and the activity category is health.

Is this opportunity discretionary?

Yes. The listing identifies this as a discretionary funding opportunity.

What is the CFDA number associated with this opportunity?

The CFDA number provided is 93.213.

When was this opportunity created and what is the listed closing date?

The opportunity was created on 2021-06-14, and the listed original closing date is 2024-03-11.

Is the award ceiling provided? How many awards are expected?

The provided listing does not specify an award ceiling or the expected number of awards. The description suggests applicants may need to consult the full FOA text and NCCIH guidance for budget expectations and the likely scale of support.

What is the overall intent of this NCCIH two-part submission structure?

The announcement is framed as NCCIH building a structured, two-part submission pathway for high-priority, late-phase, multi-site mind and body intervention trials: one application to run the trial (CCC) and a second, tightly linked application to ensure coordination, data systems, and statistics are strong enough to support definitive, practice-informing conclusions.