All USA USA Territories: American Samoa (USA); Guam (USA); Puerto Rico (USA); Virgin Islands (USA); Northern Mariana Islands (USA);
Important Dates
LOI Date: 01/28/23 Deadline: 02/28/23 5:00 PM Applicant's Local Time
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Grant Description
Cooperative agreement to a USA or territories entity that provides healthcare, including an IHE, agency, nonprofit or for-profit organization, or Tribe to provide statistical expertise and data management to a multidisciplinary team of cancer researchers. Applicants are advised that required registrations may take several weeks to complete.
The primary goal of the Cancer Screening Research Network (CSRN) is the conduct of multi-center cancer screening trials and studies. This Network is designed to take advantage of large and diverse populations receiving routine care in a variety of healthcare settings. The CSRN will engage these populations in rigorous studies focused on cancer screening to improve early cancer detection and evaluate emerging cancer screening modalities with the ultimate goal of reducing cancer incidence, and cancer-related morbidity and mortality.
CSRN Statistics and Data Management Center (SDMC) will provide statistical expertise and centralized data management, quality control, and reporting in support of CSRN clinical trials and other cancer screening studies.
To support the CSRN goal, the SDMC will be expected to have the expertise and capacity to contribute the following:
Provide the statistical leadership and expertise required to assure the effective scientific design and conduct of clinical trials and other cancer screening studies.
Ensure the integrity of clinical trials including randomization and establishment of interim analyses and early stopping rules for safety and futility.
Provide high-quality data management support (collection and monitoring) and procedures to ensure appropriate trial and study conduct, reporting of adverse events, and timely trial completion and publication.
Collect, store, and provide quality control for all participant data for cancer screening trials and studies. This includes, but is not limited to the data management, the design of all trial forms and questionnaires, and the design and operation of systems for secure and timely receipt of trial data from the ACCESS Hubs.
Support processes to promote the collection of long-term follow-up data for both screen positive and screen negative participants.
Produce interim trial reports for the Data Safety Monitoring Board.
Develop and implement a plan for sharing trial data with the research community.
Collaborate with the NCI program staff including statisticians to develop and execute plans for analysis and quality control of trial data, and assist with trial publications. This will involve data sharing with the NCI statisticians and program staff at pre-specified time points for the Vanguard study.
Coordinate auditing and trial conduct in a collaborative and integrated manner with the CCC.
Ensure compliance with all federal and international standards for clinical research.
For profit organizations other than small businesses
Independent school districts
Native American tribal governments (Federally recognized)
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
Public and State controlled institutions of higher education
Public housing authorities/Indian housing authorities
Others (see text field entitled "Additional Eligibility Criteria" for clarification)
Small businesses
Special district governments
State governments
Additional Eligibility Criteria
Eligible Organizations:
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
An eligible institution/organization for the purposes of this application is defined as a healthcare providing entity including, but not limited to, a consortium of academic and community institutions, a healthcare system, practice-based research network, or other institution providing direct medical care to patients that are considered one integral organizational entity under a single financial management system and governance structure.
Applicants that contain multiple types of eligible institutions are welcome to apply.
Only one application per institution is allowed.
Ineligible
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
The following types of activities remain outside the scope of this FOA, and applications proposing them are non-responsive to this FOA and will not be reviewed:
- Evaluating technology for the purpose of detecting the recurrence of previously treated cancers.
- Applications that do not address NCI’s scientific mission.
Pre-Application Information
Timeline:
- Letter of Intent Due Date: January 28, 2023
- Application Due Date: February 28, 2023
- Scientific Merit Review: July 2023
- Advisory Council Review: October 2023
All applications are due by 5:00 PM local time of applicant organization.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Applicants may submit applications via the NIH ASSIST system or via Grants.gov Workspace.
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.
- System for Award Management (SAM)
- eRA Commons
- Grants.gov
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Scientific/Research Contact(s):
Paul Pinsky, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7014
Email: CSRN@nih.gov
Elyse LeeVan, M.D.
National Cancer Institute (NCI)
Telephone: 240-276-7314
Email: CSRN@nih.gov
