Clinical Coordination Center for Common Fund Acute to Chronic Pain Signatures (A2CPS) Program (U24 Clinical Trial Optional) | RFA RM 18 035

Frequently Asked Questions (FAQs)

What is the funding opportunity being described?

This opportunity is NIH Funding Opportunity Announcement (FOA) RFA-RM-18-035. It supports the establishment of a Clinical Coordination Center (CCC) for the Common Fund Acute to Chronic Pain Signatures (A2CPS) Program.

What is the A2CPS Program trying to accomplish?

The A2CPS Program focuses on understanding how acute pain transitions into chronic pain and on identifying measurable "signatures" associated with that transition. The CCC is intended to help the overall program generate consistent, comparable, high-quality evidence across multiple clinical sites.

What is being funded under this FOA?

NIH is funding a Clinical Coordination Center (CCC) that serves as the central operational and scientific hub for a multisite consortium of clinical centers participating in A2CPS.

What award mechanism is used for this FOA?

The mechanism is a U24 cooperative agreement.

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

A U24 cooperative agreement indicates that the funded CCC is expected to work in close partnership with NIH staff and with the rest of the A2CPS consortium. It is not intended to operate as a fully independent, investigator-directed project; instead, it functions as a coordinated, collaborative effort with substantial NIH involvement.

What role does the Clinical Coordination Center (CCC) play in the consortium?

The CCC is intended to be the coordinating backbone of the program. It supports alignment across multiple participating clinical sites by improving consistency, speed, and quality of research implementation, and by enabling data generated at different sites to be combined and compared with fewer avoidable inconsistencies.

What are the CCC's key operational responsibilities across clinical sites?

Based on the FOA description, the CCC is responsible for coordinating and aligning study implementation across sites, tracking and supporting recruitment and retention, monitoring progress and performance, troubleshooting barriers to implementation, and keeping the overall multisite effort running efficiently.

How does the FOA emphasize standardization across sites?

Standardization is a major emphasis. The CCC is expected to lead the consortium in developing and implementing standardized research and operational protocols that all sites follow so that clinical and operational activities are comparable across institutions.

What types of standardized protocols is the CCC expected to develop and implement?

The FOA highlights standardized protocols and procedures such as common safety standards, harmonized staff training procedures, and shared approaches to patient phenotyping and testing. It also references ensuring comparable clinical assessments and biospecimen collection (where relevant), along with other measurements performed across institutions.

What is the CCC expected to do related to recruitment and retention?

The CCC is expected to track and support recruitment and retention efforts across participating sites, helping the consortium maintain progress toward study enrollment and continued participation.

What does "monitoring progress and performance across locations" mean in this context?

It refers to the CCC overseeing how participating sites are performing against operational and research expectations, identifying issues that slow or compromise implementation, and helping resolve barriers so the program remains on track and produces reliable, consistent outputs.

What regulatory responsibilities does the CCC have?

The CCC is expected to coordinate regulatory processes, including harmonizing human subjects protections requirements, supporting IRB-related documentation and workflows, and helping sites maintain compliance with applicable NIH policies and Good Clinical Practice (GCP) expectations.

Is human subjects oversight (such as IRB coordination) part of the CCC scope?

Yes. The FOA specifically notes coordination of regulatory processes, which typically includes harmonizing human subjects protections and supporting IRB-related documentation and workflows across sites.

What is the CCC expected to do regarding data coordination?

Data coordination is described as a core responsibility. The CCC is expected to lead development of data standards, with particular emphasis on electronic health record (EHR) integration and EHR data standards to support pooled analyses and cross-site comparisons.

Why does the FOA focus on EHR data standards?

Because multisite studies often capture clinical information differently at each location, which makes pooling and comparing data difficult. The CCC is expected to reduce those gaps by defining shared EHR-related standards so data can be extracted, cleaned, validated, combined, and compared more reliably.

What kinds of EHR standardization activities are mentioned?

The FOA points to defining common data elements, consistent coding and formatting rules, and procedures for extracting, cleaning, and validating EHR-derived variables.

What is the broader goal of having a CCC in a multisite program like A2CPS?

The goal is to create a central operational and scientific hub that improves consistency, speed, and quality across sites, enabling high-quality pooled analyses and minimizing site-to-site variability caused by differences in implementation or data capture.

What CFDA number and category are associated with this FOA?

The FOA is categorized under health and is associated with CFDA 93.310. It is listed as a discretionary funding opportunity.

What was the application due date shown in the provided information?

The source information reflects an original closing date of October 24, 2018, indicating a time-limited competition tied to the launch and operation of the A2CPS program.

Does the provided information specify an award ceiling or the number of awards?

No. The provided text does not specify an award ceiling or the number of expected awards.

Does the opportunity appear to support one CCC or multiple CCCs?

The description strongly implies a single coordinating center award that supports and oversees activities distributed across multiple clinical research sites.

Who is eligible to apply?

Eligibility is broad and includes many types of U.S.-based organizations and governmental units. 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 Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses.

Are minority-serving institutions and other specific groups called out as eligible?

Yes. The FOA explicitly identifies additional eligible applicant groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and faith-based or community-based organizations, among others.

Are federal agencies eligible to apply?

Yes. The FOA includes eligible federal agencies among the eligible applicant types described.

Are U.S. territories or possessions eligible to apply?

Yes. The FOA explicitly includes U.S. territories or possessions among eligible applicant groups.

Can a non-U.S. (foreign) organization apply as the prime applicant?

No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply directly as applicant organizations under the information provided.

Are foreign components allowed in some form?

Yes. The FOA indicates that non-domestic components of U.S. organizations are eligible, and that "foreign components" (as defined in the NIH Grants Policy Statement) are allowed. In practice, this means the prime recipient must be a domestic eligible entity, but certain internationally based activities or collaborations may be included if they meet NIH definitions and requirements.

What does the CCC do to ensure high-quality, uniform study implementation?

The CCC is expected to align study design decisions across sites, implement standardized operational and research protocols, harmonize training and safety standards, coordinate regulatory workflows, monitor performance, and troubleshoot barriers so the research is conducted uniformly and produces comparable data.

How does the CCC help ensure data from different sites can be combined?

By leading standardization efforts (including EHR data standards, common data elements, and consistent coding/formatting rules), and by supporting uniform implementation across sites so site-specific differences do not undermine pooled analyses and cross-site comparisons.