Mind and Body Intervention Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 - Clinical Trial Required) | PAR 18 663

Frequently Asked Questions (FAQs)

What is PAR-18-663?

PAR-18-663 is an NIH cooperative agreement funding opportunity for a Mind and Body Intervention Multi-Site Clinical Trial Data Coordinating Center (DCC). The award mechanism is a collaborative U24, and a clinical trial is required.

What is the main purpose of this grant?

The purpose is to support a dedicated Data Coordinating Center (DCC) that serves as the operational and data/statistical backbone for a large, multi-site clinical trial of mind and body interventions. The DCC is expected to keep the study consistent, reliable, and compliant across participating sites, while partnering closely with a separately proposed Clinical Coordinating Center (CCC).

Which NIH institute/center is sponsoring this opportunity?

This opportunity is associated with the National Institutes of Health (NIH) and is run through the National Center for Complementary and Integrative Health (NCCIH).

What does "cooperative agreement (U24)" mean in this context?

A cooperative agreement indicates that NIH/NCCIH staff are expected to have substantial programmatic involvement compared with a standard research grant. The DCC should be prepared to work closely with NCCIH on governance, reporting, and trial oversight structures.

Is a clinical trial required?

Yes. The opportunity is explicitly described as "Clinical Trial Required" and is designed to support the coordinating infrastructure for a Phase III (and beyond) multi-site clinical trial.

What kind of clinical trial is this DCC expected to support?

The DCC is expected to support a large, multi-site clinical trial focused on mind and body interventions, aligned with NCCIH's mission and considered a high priority by the Center.

Do applicants submit a standalone DCC proposal, or must it be connected to a specific trial?

The DCC application cannot be generic. It must be tailored to a specific companion trial application submitted by a Clinical Coordinating Center (CCC). The DCC plan must match the companion trial's design, endpoints, recruitment plan, sites, intervention, and operational workflow.

Is there a companion funding opportunity announcement (FOA) for the Clinical Coordinating Center (CCC)?

Yes. The DCC application under PAR-18-663 must be submitted at the same time as a corresponding CCC application submitted under PAR-18-117.

How will NCCIH review the DCC and CCC applications?

NCCIH will consider the DCC and CCC together as a coordinated package, since the intent is to ensure the trial has both clinical leadership (CCC) and centralized data/quality/statistical infrastructure (DCC).

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

The DCC is responsible for comprehensive project coordination and day-to-day execution support spanning administration, data management, and biostatistics. Typical responsibilities include building and maintaining data systems, standardizing data collection and management across sites, implementing case report forms and databases, overseeing data quality assurance/validation/monitoring, managing randomization when applicable, and providing statistical leadership for interim and final analyses.

What specific operational functions might the DCC handle?

Based on the synopsis, DCC functions can include centralized trial operations such as data system development and maintenance, standardized procedures across sites, data quality processes, validation and monitoring, randomization management (if applicable), and statistical planning and analysis support.

Is this opportunity limited to Phase III trials only?

The synopsis emphasizes support for a Phase III (and beyond) multi-site trial, indicating the DCC is intended for large, later-stage trials rather than small early-stage studies.

How important is alignment with NCCIH priorities?

Alignment is central. The clinical trials supported must fit NCCIH's mission and be a high priority for the Center. The synopsis encourages applicants to review NCCIH strategic materials and contact NIH scientific/research staff before applying to confirm fit and expectations.

Should applicants contact NCCIH staff before applying?

Yes. The synopsis explicitly encourages prospective applicants to contact relevant NIH scientific/research staff before applying, suggesting that early discussion of fit, priority, and expectations may affect whether the project is appropriate and competitive for this mechanism.

Who is eligible to apply?

Eligibility is broad and includes many domestic organization types that can function as a coordinating center. Examples include state/county/local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); small businesses; and other qualified entities.

Are specific institution types explicitly highlighted as eligible?

Yes. The announcement highlights inclusion of organizations such as HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

Can a foreign institution apply as the applicant organization?

No. Foreign institutions are not eligible to apply as applicants for this opportunity.

Are non-U.S. components of U.S. organizations eligible to apply?

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

Are foreign components allowed at all?

The synopsis indicates that foreign components (as NIH defines them in the NIH Grants Policy Statement) may be allowed, meaning a primarily U.S.-based award could potentially include certain justified foreign elements under NIH rules.

What is the CFDA number associated with this opportunity?

The opportunity is associated with CFDA number 93.213.

What type of funding opportunity is this (administratively)?

It is described as a discretionary health funding opportunity under a cooperative agreement (U24).

When was this opportunity created and when was it originally set to close?

The opportunity was created on 2018-02-14, and the listed original closing date is 2020-06-29.

Does the synopsis provide an award ceiling or the expected number of awards?

No. The excerpt provided does not specify an award ceiling or the expected number of awards. Applicants would typically look to the full FOA and NIH/NCCIH communications for budget expectations and likely award levels.

What makes this FOA "collaborative"?

It is collaborative because the DCC application must be paired with and submitted concurrently with a companion CCC application, and the two are considered together as a coordinated package. The DCC is expected to integrate tightly with the CCC's clinical leadership and the specific trial design.

Why does NIH/NCCIH require a paired DCC and CCC structure?

The paired structure is intended to ensure the trial has both strong clinical leadership (through the CCC) and a robust centralized engine for data management, quality control, and statistical rigor (through the DCC), which is especially important for complex, multi-site trials.