Single Source for Chronic Pancreatitis Clinical Research Consortium (CPCRC) Data Coordinating Center (CPCRC-DCC) (U01 Clinical Trial Optional) | RFA DK 25 020

Opportunity Information: Apply for RFA DK 25 020

The funding opportunity titled "Single Source for Chronic Pancreatitis Clinical Research Consortium (CPCRC) Data Coordinating Center (CPCRC-DCC) (U01 Clinical Trial Optional)" is a National Institutes of Health (NIH) cooperative agreement that seeks a single awardee to serve as the consortiums Coordination and Data Management Center, also referred to as the Coordination and Data Management Center (CDMC). The purpose is to continue and support the ongoing work of the broader Chronic Pancreatitis, Diabetes and Pancreatic Cancer (CPDPC) Consortium, which is structured around multiple Clinical Centers (CCs) working with one centralized data and coordination hub. In practical terms, the award is meant to keep the existing, multi-site research enterprise running smoothly so it can complete active studies and continue generating high-quality, comparable data across all participating sites.

Scientifically, the consortium focuses on chronic pancreatitis (CP) and related conditions and outcomes, with a strong emphasis on understanding factors that elevate pancreatic cancer risk. The studies include both children and adults with chronic pancreatitis, people with pancreatogenic (type 3c) diabetes (T3cDM), and individuals with newly diagnosed diabetes who may be at higher risk for pancreatic cancer. The NOFO highlights that, since the consortium began in Fall 2015, it has built a robust longitudinal clinical research program that combines epidemiological data with biological characterization. This includes enrolling and following patients with chronic pancreatitis and those with acute recurrent pancreatitis (ARP) to better understand disease mechanisms and downstream complications such as chronic pain, pancreatic exocrine insufficiency, development of T3cDM, and the observed association between diabetes and pancreatic cancer. In addition to pancreatitis-centered cohorts, the consortium has also undertaken studies specifically examining pancreatic cancer development among people with newly diagnosed diabetes, reflecting the growing interest in diabetes as a potential early warning context for pancreatic malignancy.

The central deliverable of this announcement is the establishment or continuation of a single, high-functioning coordinating and data management operation that can support these complex, multi-site longitudinal studies. While the NOFO language is brief in the excerpt provided, a CDMC in a U01 consortium setting typically carries responsibility for cross-site harmonization of protocols and data standards, development and maintenance of shared data systems, data quality control, secure data transfer and storage, coordination of reporting and monitoring, support for statistical and analytic needs, and ensuring that consortium-wide activities stay aligned with agreed milestones. Because this is a cooperative agreement, NIH is expected to have substantial involvement, and the CDMC will likely operate in close partnership with NIH program staff and the participating Clinical Centers on governance, prioritization, and operational decision-making. The "Clinical Trial Optional" designation indicates that the award mechanism permits clinical trial activities if they are proposed and justified, but does not require that the application include a clinical trial.

This opportunity is explicitly tied to the companion solicitation for the consortiums Clinical Centers, which is being solicited separately under RFA-DK-25-019 (the continuation of the CPDPC Clinical Centers). The CDMC funded under this NOFO is expected to work hand-in-glove with whichever Clinical Centers are funded under that companion announcement. Another key expectation is a strong culture of collaboration and data sharing: the CDMC and the Clinical Centers are expected to share results freely within the consortium and to continue trans-consortium collaborative projects that leverage the combined expertise, tools, and technologies available across members. The NOFO points applicants to the consortiums studies webpage (https://cpdpc.mdanderson.org/clinicalstudies.html) as a reference for the kinds of ongoing projects and collaborative scope involved, signaling that applicants should be prepared to support active, real-world studies rather than designing a brand-new network from scratch.

From an administrative standpoint, this is a discretionary NIH award using the cooperative agreement funding instrument (U01). The opportunity number is RFA-DK-25-020, and it is associated with CFDA (now Assistance Listing) number 93.847. The listed application due date (original closing date) is October 18, 2024. The posted award ceiling is $1,000,000, indicating the maximum amount expected per award under this announcement, and the NOFO is framed as a single source application for one CDMC, meaning NIH anticipates making one award to one coordinating center to serve the consortium.

Eligibility details in the excerpt emphasize restrictions on non-U.S. participation. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. At the same time, foreign components, as defined in the NIH Grants Policy Statement, are allowed, which typically means a U.S. applicant organization may include certain foreign activities or collaborations as components of the project if they meet NIH policy requirements and are well-justified. The excerpt also lists "Small businesses" under eligible applicants, though applicants would still need to align with the NOFOs full eligibility language and the practical expectations of running a consortium-level data coordinating center. As always with NIH NOFOs, the full notice contains the definitive requirements for eligibility, scope, and review criteria, and applicants would need to use that full document to shape a compliant and competitive application.

Overall, this NOFO is aimed at sustaining the operational backbone of a mature NIH consortium that has been running since 2015 and is now positioned to finish and extend high-value longitudinal studies on chronic pancreatitis, pancreatitis-related diabetes, and pancreatic cancer risk. The CDMC role is central: it is the infrastructure that allows multiple clinical sites to function like one coherent study platform, producing consistent datasets, reliable analyses, and consortium-wide outputs that can advance understanding of disease mechanisms and cancer risk in these clinically complex patient populations.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Single Source for Chronic Pancreatitis Clinical Research Consortium (CPCRC) Data Coordinating Center (CPCRC-DCC) (U01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2024-07-31.
• Applicants must submit their applications by 2024-10-18. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
• Eligible applicants include: Small businesses.

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