Cancer Prevention Clinical Trials Network (CP-CTNet): Data Management, Auditing, and Coordinating Center (DMACC) (U24 Clinical Trials Required) | RFA CA 18 030

Opportunity Information: Apply for RFA CA 18 030

The Cancer Prevention Clinical Trials Network (CP-CTNet): Data Management, Auditing, and Coordinating Center (DMACC) funding opportunity (RFA-CA-18-030) is a National Cancer Institute (NCI), NIH cooperative agreement that supports the infrastructure needed to run a national network focused on early phase cancer prevention clinical trials. The larger CP-CTNet program is built to move promising prevention agents and interventions through phase 0 (microdosing), phase I (dose finding), and phase II (preliminary efficacy) studies, with a strong emphasis on understanding how these approaches affect carcinogenesis-related molecular pathways and biological processes. In practice, the network is meant to test safety and tolerability while also generating mechanistic evidence, such as changes in target engagement, cell proliferation, apoptosis, growth factor signaling, oncogene expression, and immune response, and then connecting those findings to clinical endpoints. Another key scientific aim is to deepen understanding of prevention mechanisms and to help develop and refine biomarkers or other markers that can predict or measure response.

CP-CTNet is structured around two complementary components: five CP-CTNet clinical trial Sites (solicited under a companion FOA, RFA-CA-18-029) and one centralized DMACC (solicited under this FOA). The Sites are positioned as the scientific engines of the network, responsible for proposing, developing, and conducting early phase prevention trials and for managing and analyzing trial data. The DMACC, by contrast, is the backbone that keeps the entire network operating as a coordinated system rather than a set of loosely connected projects. This FOA specifically calls for a U24 award mechanism with clinical trials required, reflecting that the DMACC is expected to directly support the execution and oversight of clinical trials activities across the network under a cooperative agreement structure, where NIH/NCI program staff typically have substantial involvement in steering and coordination.

The DMACC has three central responsibilities. First, it provides centralized data management and data reporting for CP-CTNet studies. That generally means building and maintaining systems and processes for consistent data collection, cleaning, quality control, database management, and standardized reporting across multiple trials and institutions so that results are reliable and comparable. Second, it conducts clinical trials auditing. This function focuses on ensuring that participating sites follow protocols and regulatory requirements, that source documentation and case report data align, and that participant safety and data integrity are protected through routine and for-cause audits. Third, it performs administrative and logistical coordination across CP-CTNet, which commonly includes organizing network communications, meetings, timelines, cross-site operational alignment, and other trans-network activities needed to keep trials moving efficiently and consistently across all participating sites.

Eligibility for this opportunity is broad across U.S.-based organizations and includes many types of government entities (state, county, city/township, special district), public and private institutions of higher education, independent school districts, federally recognized tribal governments and other tribal organizations, public housing authorities/Indian housing authorities, nonprofits with or without 501(c)(3) status, for-profit organizations (other than small businesses), small businesses, and other eligible applicants. The FOA explicitly highlights additional eligible applicant categories such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, AANAPISIs, Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply; however, foreign components as defined by NIH policy are allowed, meaning a U.S. applicant can include certain foreign elements in the project when justified and compliant with NIH rules.

Administratively, this is listed as a discretionary funding opportunity using a cooperative agreement funding instrument, within education and health activity categories, and associated with CFDA numbers 93.393 and 93.399. The opportunity was created on September 14, 2018, with an original closing date of November 15, 2018. The award ceiling and expected number of awards are not specified in the provided source text. Overall, the FOA is essentially seeking a capable, experienced coordinating center that can standardize and safeguard data and operations across multiple early phase cancer prevention trials, while also providing the auditing and network-level coordination needed to ensure high-quality, compliant, and interpretable results.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Cancer Prevention Clinical Trials Network (CP-CTNet): Data Management, Auditing, and Coordinating Center (DMACC) (U24 Clinical Trials Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393, 93.399.
• This funding opportunity was created on 2018-09-14.
• Applicants must submit their applications by 2018-11-15. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA CA 18 030

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: