Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

This Notice of Funding Opportunity (NOFO) is one of three NOFOs for the National Cancer Institute (NCI) Community Oncology Research Program (NCORP). NCORP is designed to enhance generalizability and dissemination of clinical trial and other human research study results through accrual in a variety of community settings. The purpose of NCORP is to engage cancer patient populations, those at risk of cancer, and organizations in rigorous studies focused on cancer control, prevention, treatment and care delivery.

NCORP will support the following components that will be individually awarded through the respective Request for Applications (RFAs) indicated below:

• RFA-CA-27-006 (This NOFO): NCORP Research Bases (UG1 Clinical Trials Required);
• RFA-CA-27-007: NCORP Community Sites (UG1 Clinical Trials Not Allowed); and
• RFA-CA-27-008: NCORP Academic Community Sites (UG1 Clinical Trials Not Allowed)

NCORP Research Bases will serve as the program's research hubs and are expected to:

• Provide an established organizational structure, with scientific and statistical leadership for developing, implementing, and analyzing multi-institutional cancer control, prevention, and care delivery (CCP&CD) clinical research, as well as quality-of-life studies embedded in treatment and imaging studies.
• Assume responsibility for study operations and data management, including efficient protocol development; compliance with Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulatory and participant protection requirements; auditing; training; quality assurance; and support to Community Sites and Academic Community Sites.
• Be based at institutions with comprehensive cancer clinical research expertise (e.g., NCI-designated Cancer Center, or healthcare research organization – including NCI's National Clinical Trials Network (NCTN) Group Operations Centers, or a cancer foundation associated with a NCTN Group ).

NCORP Community Sites is a healthcare system, a consortium of healthcare systems, or a consortia of community hospitals and/or oncology practices, public hospitals, and/or health care centers that can enhance the representativeness of participants accrued to cancer control, prevention, treatment and care delivery clinical trials and other human subjects research conducted through NCORP and NCTN.

NCORP Academic Community Sites are a consortium led by an academic center with a network of community hospitals and/or oncology practices, public hospitals, and/ or other healthcare centers that serve a patient population that can enhance the representativeness of participants accrued to cancer control, prevention, treatment and care delivery clinical trials and other human subjects research. The academic medical center should have a robust infrastructure to support the accrual of participants across their affiliate organizations.

Key Definitions for the context of this NOFO:

The terms “Clinical Research” and “Clinical Trials” in this NOFO follow the NIH definitions (https://grants.nih.gov/policy/clinical-trials/glossary-ct.htm#ClinicalResearch).

The terms “Human Subject” and “Human Subjects Research” in this NOFO follow the NIH definitions (https://grants.nih.gov/grants/glossary.htm#HumanSubject)

NCI Central Institutional Review Board (Central IRB): is a centralized approach to human subject protection through a process that streamlines local IRB review of selected NCI-sponsored trials for institutions across the country by relying on national experts to ensure trials are reviewed efficiently and with the highest ethical and quality standards (https://www.ncicirb.org/about-cirb/).

Community Site Primary Affiliate: In the context of NCORP community-based structure, a "primary affiliate" refers to a hospital, cancer center, physician practice, or other institution where patients/participants are enrolled on a regular and ongoing basis to the menu of NCI-approved clinical trials and other human subjects research available to the NCORP Community Site or Academic Community Site.

Community Site Sub-Affiliate: In the context of NCORP community-based structure, a "sub-affiliate" refers to a practice or organization that contributes to the overall accrual of a primary affiliate site but is located in a separate geographic location(s), is part of the primary affiliate’s business entity, and is managed by the primary affiliate under the primary Affiliate Site’s Federal Wide Assurance (FWA).

Research Base Member Sites: Members sites affiliated with a given Research Base may include NCORP Community and Academic Community Sites, Main members, affiliates, and Lead Academic Participating sites.

Background

The NCORP Research Bases support rigorous studies focused on cancer prevention and screening, cancer symptom management, quality of life studies embedded within treatment trials, and cancer care delivery. The integration of cancer prevention, symptom management, QoL, and cancer care delivery research within NCORP creates a comprehensive framework for improving outcomes across the cancer continuum. This synergy enables NCORP to optimize care delivery, and inform national guidelines through evidence generated in representative populations. By leveraging community partnerships and multidisciplinary expertise, NCORP advances science that is both rigorous and relevant. These efforts not only enhance patient experiences but also strengthen the healthcare system’s capacity to deliver high-quality cancer care nationwide.

Cancer prevention research is a cornerstone of NCORP’s mission because it addresses the root causes of cancer before they manifest clinically. By focusing on strategies such as risk reduction, optimal screening and surveillance, and cancer prevention, NCORP helps reduce cancer incidence. This proactive approach not only saves lives but also alleviates the economic and emotional burden of cancer treatment. NCORP’s community-based model ensures these preventive interventions reach patients where they live, making research findings broadly applicable.

Symptom management research within NCORP is vital because cancer patients often experience multiple distressing symptoms—such as cognitive impairment, neuropathy, pain, fatigue, and nausea—that significantly impair daily functioning and emotional well-being. NCORP trials evaluate interventions to prevent or alleviate these symptoms during and after treatment, improving tolerability and adherence to therapy. This includes examining interventions that enhance these dimensions, from behavioral strategies to mitigate treatment side effects to psychosocial support for patients and caregivers. This work is particularly important in community settings, where access to specialized palliative care may be limited. By including symptom management studies, NCORP ensures that advances in supportive care are integrated into routine oncology practice.

Quality of life (QoL) research is central to NCORP’s vision of patient-centered care. Beyond survival, patients value physical comfort, emotional stability, and social functioning. NCORP’s QoL studies embedded with treatment trials help us understand if the advances made with new therapies are accompanied by improved or worse QoL. These efforts recognize that cancer care extends beyond tumor control—it encompasses holistic well-being. By conducting QoL research in community settings, NCORP ensures findings reflect real-world challenges and solutions, ultimately guiding policies and practices that prioritize patient dignity and resilience.

Cancer care delivery research (CCDR) within NCORP focuses on understanding and improving how cancer care is organized, coordinated, and provided in real-world settings. This research examines factors such as access to care, patient-provider communication, and the implementation of evidence-based practices across representative communities. By embedding CCDR studies into community oncology practices, NCORP identifies barriers and facilitators to optimal care, evaluates innovative models like telehealth and team-based approaches, and informs policy changes that enhance efficiency and quality. Ultimately, CCDR ensures that advances in diagnosis, treatment, and supportive care translate into patient-centered outcomes nationwide.

NCORP has streamlined its scientific and operational processes and expanded its review structure with three NCI Coordinating Center for Clinical Trials (CCCT) dedicated scientific Steering Committees, (Symptom Management & Quality of Life, Cancer Care Delivery, and Cancer Prevention) that provide peer-review for scientific concepts. Access to the Clinical Trials Support Unit (CTSU) allows sites access to all current study materials and the Central Investigational Review Board (CIRB) provides human subjects review, all of which increase efficiency and reduces redundancy.  In addition, an infrastructure for cancer care delivery research studies has been built in which both interventional and observational care delivery research studies are being conducted.

Overall Goals of NCORP and Scope of this NOFO

The overall goal of NCORP is to bring cancer clinical research studies to individuals in their own communities, thereby generating a broadly applicable evidence base that contributes to improved patient outcomes.  

The roles of NCORP Community Sites and Academic Community Sites are to provide access to clinical trials close to where patients live in the community..

The role of NCORP Research Bases is to serve as a main research infrastructure and awardees will be expected to contribute to and focus on the following activities:

• Interacting with NCORP Community Sites and Academic Community Sites in the development and conduct of cancer prevention and screening, cancer symptom management, and cancer care delivery (if applicable) clinical trials and other human subject studies as well as quality of life studies embedded within treatment trials.
• Providing oversight of the conduct of clinical trials in NCORP, including the responsibility for data management, reporting, and required regulatory compliance.
• Spurring clinical trial innovation, with technical assistance on innovative designs as applicable. 
• Integrating into the cancer research agenda, the expertise of primary healthcare providers, other non-oncology specialists, health services and behavioral studies, and patient advocates.
• Accelerating the translation of knowledge gained from cancer research into clinical practice.
• Using NCORP biospecimen banks as a scientific resource to inform future research directions.

Scope of Activities for Research Bases

The scope of research activities for the proposed NCORP Research Bases encompasses three major areas delineated below:

Area 1: Cancer Control Research; and/or

Area 2: Cancer Prevention Research; and

Area 3: Cancer Care Delivery Research.

Research Bases must cover Area 1. Areas 2 and 3 are optional. 

Additional details and examples of research appropriate for Areas 1-3 are provided below.

Area 1: Cancer Control Research. Efforts in this area should be aimed to reduce the morbidities associated with cancer and its treatment, as well as improve the quality of life of individuals undergoing cancer treatment or with a history of cancer.  Studies can include, but are not limited to:

• Elucidating the mechanisms of cancer symptoms and treatment-related toxicities.
• Testing molecularly targeted agents to prevent or reduce toxicities.
• Identifying and testing biomarkers to identify predictors of risks and response to interventions in symptom management.
• Testing interventions to improve the quality of life of patients with advanced disease and at the end of life.

Area 2: Cancer Prevention Research. Efforts in this area should be aimed at reducing cancer risk, incidence and mortality. Studies can include but are not limited to:

• Testing risk reducing agents.
• Modifying lifestyle behaviors.
• Testing new screening technologies.
• Identifying and testing biomarkers to identify predictors of cancer risk.
• Examining different approaches to managing precancerous lesions.

Area 3: Cancer Care Delivery Research. Efforts in this area should seek to improve clinical outcomes and patient well-being by intervening on patient, clinician, and organizational factors that influence care delivery with an emphasis on diagnosis, treatment, survivorship, and end-of-life care.   The most desirable studies will be those that undertake one or more of the following:

• Identify modifiable factors, particularly at the clinician and organization level, that can be the target of interventions to improve care delivery.
• Conduct pragmatic trials to assess the efficacy of interventions aimed at improving evidence-based clinical practice.
• Test the effectiveness in community settings of interventions shown to be efficacious in academic settings.
• Assess facilitators of and barriers to implementation and de-implementation of effective interventions in community settings.

NCORP Trans-network Interactions

All NCORP participants will be expected to work jointly towards the NCORP network goals by using the following general strategies:

• A coordinated and collaborative process involving broad representation of community oncology stakeholders, including academic and community clinical investigators, responsible for generating cancer clinical research concepts.
• Incorporation of innovative science into cancer clinical research through collaboration with institutions and investigators conducting research relevant to cancer control, prevention, and care delivery.
• Evaluation of research concepts for scientific merit by nationally-recognized experts serving on NCI-managed Steering Committees.
• Efficient and timely activation, conduct, and completion of studies, through the effective integration of scientific expertise with operational management capabilities.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions - Includes all types

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

Nonprofits Other Than 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)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• 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)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• 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

The following additional provisos apply:

• New Applications: An application must be submitted by an NCI Clinical Trials Network (NCTN) Group, a cancer foundation affiliated with an NCTN Group, or NCI-designated Cancer Center with comprehensive expertise in cancer clinical research.
• Renewal Applications: NCORP Research Base awardees seeking renewal must submit information from an applicant institution that plays a substantial role in the current award. A substantial role may be defined as employing one or more of the existing multiple PD/PIs, receiving a substantial (25% or more) amount of the current award or employing a significant number of the staff required to support the existing infrastructure.

Foreign Organizations/Foreign Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. 

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

Facilities & Other Resources:  In addition to standard items for this attachment, the applicants should provide the following information/documentation.

Summary of Collective Bodies/Committees for Research Base Core Functions (use filename: 1-Core Functions).

For a new application, do not contact or name potential members in the application. For a renewal application provide the names only of current members of the established committees in the application. Provide information on committee memberships held by key investigators that will contribute to the core functions of the proposed Research Base.  Memberships may include committees such as Executive and Oversight Committees (all members should be listed); Data Safety and Monitoring Board (all members should be listed); Scientific Committees (list only Chair and Vice-Chair positions - do not include subcommittee heads); Community investigators for each Scientific Committee should be listed; and Administrative Committees (list only Chair and Vice-Chair positions - do not include subcommittee heads). Please Note: A table can be used to show this information with column headings for the Staffing Category for the Research Base (i.e., type of committee), Member status (i.e., Chair, Vice-Chair, Member) general category of Research Base or Network Group/NCI Steering Committee/NCI Initiative, specific category or activity; Member Name, Member Title, Member Institution, and Length of Service in the Position.  The date the table was prepared should be provided as a sub-heading (e.g., Information Current as of MM, DD, YY).

Constitution and By-Laws for Site & Investigator Membership in the proposed Research Base (use filename: 2-Membership Constitution By-Laws).

Provide a summary of the Constitution & By-Laws for the proposed Research Base related to both site and investigator membership to illustrate how both sites and investigators are recruited and evaluated.

Performance Site Locations including NCORP Sites (use filename: 3-Member sites)

List all performance sites that conduct clinical trials and human subjects studies

Other Attachments:  Applicants must provide the following additional material specified below.  Each attachment should be uploaded as a separate PDF using the indicated filenames (which will serve as application bookmarks).Attachment number continues from the previous section.

Attachment 1.  Summary of Important Primary Scientific Achievements (use filename: 4-Primary Achievements)

• For Renewal applications: In this attachment, document important primary scientific achievements of the Research Base that were accomplished during the current funding period. "Important primary scientific achievements" refer to the Primary Endpoint(s) for an NCORP clinical study (or legacy NCORP study from the prior NCI-sponsored Community Clinical Oncology Program Program) specified in the protocol document.  A table can be used to show this information with column headings for the study category, i.e., CPC&CCDR, study design (i.e., clinical trial phase, longitudinal/cohort), year of publication of study primary outcome or other significant impact, NCORP Research Base or Network Group protocol number and brief title, experimental agent/regimen, primary endpoint result/indication, manuscript or abstract reference, brief description of the importance of the primary scientific achievement (incorporated into practice guideline), date trial activated, date trial closed to accrual, total number of patients enrolled on the trial. The timeframe for the table should be provided as a sub-heading (provide the date range encompassed).
• For New applications: In this attachment document "important primary scientific achievements" in terms of clinical studies designed and conducted by the applicant group over the past 5 years.  Include details and formats analogous to those requested above for Renewal applications.

Attachment 2:  Summary of Other Important Achievements (use filename: 5-Other Achievements).

• Renewal applications:  Provide information on other important achievements associated with studies that were reported out for the last five (5) years.  Other important achievements refer to important information from secondary endpoints of NCORP clinical studies (or legacy NCORP clinical studies from the prior NCI-sponsored Community Clinical Oncology Program) specified in the protocol such as validation of an integrated biomarker or other important analyses (e.g., meta-analyses; special population analyses).  If applicable, Health Related Quality of Life (HRQOL) sub-studies in NCTN trials funded by DCP NCORP Research Base grants should be included in this table.  A table can be used to show the information such as the general cancer site category (i.e. CCP&CCDR), trial phase, year of publication of study primary outcome or other significant impact,  Research Base or Network Group Protocol number and brief title, experimental agent/regimen, description of secondary endpoint or sub-study result, manuscript or abstract reference, brief description of the importance of the secondary endpoint or sub-study result, date trial activated, date trial closed to accrual, and total accrual (i.e., total number of patients enrolled on the trial). The timeframe for the table should be provided (provide the date range encompassed).
• New Applicants:  Provide information on other important achievements on clinical studies designed and conducted by the applicant group over the past 5 years.  Provide details as requested above for Renewal applications in terms of the information to include in a table format.

Attachment 3:  Summary Accrual for All Clinical Trials and Related Studies by CCP&CCDR Category of the Research Base to Research Base Trials(use filename:  6-Member Accruals).

• For Renewal applications:  Provide documentation of patient accrual on NCORP clinical studies during the current funding period by members of the Research Base to Research Base trials. Accrual figures should include the unique number of patients enrolled on each NCORP study. Separate accrual numbers should be reported for quality of life accruals.  Include the following information: major CPC&CCDR categories (cancer control, prevention, care delivery) all clinical trial phases, as well as longitudinal/cohort/descriptive studies and total column summing accrual across study designs. The timeframe for the period of accrual should be provided as a sub-heading for each table.
• For New applications:  Provide documentation of patient accrual to clinical studies designed and conducted by the applicant group over the past 5 years. Accrual figures should include the unique number of patients enrolled on each study.   Using preferably tabular format, summarize this information for major CPC&CCDR categories (cancer control, prevention, care delivery), all clinical trial phases, as well as longitudinal/cohort/descriptive studies.  Include appropriate total values reflecting summing accrual across study designs.

Attachment 4:  Conflict of Interest Policy (use filename: 7-COI).

Provide documentation of the Conflict of Interest Policy used by the proposed Research Base to ensure that staff and investigators working on the design, monitoring, and analysis of specific studies do not have any conflicts of interest with respect to the studies. Include policies to maintain study blinding.

Attachment 5:  Model Statistical Analysis Template (use filename: 8-Statistical Template).

Provide documentation/example of the proposed Research Base’s standard template used for generating statistical analysis plans for clinical studies as well as the proposed Research Base’s standard "Report of Studies" template for providing information related to ongoing and recently closed studies to its members.

Attachment 6:  Audit Policy and On-Site Auditing Summary (use filename:  9-Audit Policy and Auditing Summary).

• For Renewal applications:  Provide documentation of the auditing policy for the Research Base for NCORP studies, including how patient cases are selected for auditing and how data are validated at site and in associated study databases.  Provide information on the number of audits performed by the Research Base for its member institutions since during the current funding period. In general, the NCI Clinical Trials Monitoring Branch (CTMB) Guidelines for Auditing NCTN and NCORP clinical studies require all participating sites to be audited at least once every 36 months. On-site auditing information for Research Base members should be provided in a table by member site category only (not by individual sites).
• Include major site categories (e.g., main members, affiliates of main members, NCORP Sites),
• Number of active sites during reporting period,
• Number of sites terminated during reporting period, number of sites withdrawn during reporting period,
• Number of routine audits performed and percent of those audits with specific ratings (acceptable, acceptable with follow-up, unacceptable) by audit category (Institutional Review Board/Informed Consent Content, Pharmacy, and Patient Cases) during the reporting period), and
• Number of re-audits and off-cycle audits performed and percent of those audits with specific ratings (acceptable, acceptable with follow-up, unacceptable) by audit category (Institutional Review Board/Informed Consent Content, Pharmacy, and Patient Cases) during the reporting period).
• Note:  Sites that are terminated or withdrawn within the reporting period and later re-activated should still be counted in the columns of the report if they were audited.
• New Applicants:  Provide documentation of the auditing policy for the proposed Research Base for clinical studies, including how patient cases will be selected for auditing and how data will be validated at site and in associated study databases.

Attachment 7:  Operational Timelines for Development of Clinical Trials and Related Studies (use filename: 10-Study Timelines).

• For Renewal applications: Provide information on the timeline for the development and activation/opening of NCORP studies. This information should be provided only for NCORP studies that were activated during the current funding period. This information should be provided in a series of tables so that the data can be provided separately by scientific area (cancer control, prevention, and care delivery) and study design (clinical trial, longitudinal/cohort, observational, descriptive).
• For New applications:   Provide information on the timeline for the development and activation/opening of clinical studies designed and conducted by the applicant group. This information should be provided only for clinical studies activated in the past 5 years. This information should be provided in a series of tables so that the data can be provided separately by scientific area (cancer control, prevention, and care delivery) and study design (clinical trial, longitudinal/cohort, observational, descriptive).

Attachment 8: Data Management and Monitoring Policies & Procedures for Clinical Studies (use filename: 11-Data Management and Monitoring).

• Provide documentation of key procedures for data management and monitoring policies for clinical studies, including risk-based central monitoring.

Attachment 9: Key Procedures to Ensure Security and Confidentiality of Patient Data (use filename: 12-Securing Patient Confidentiality).

• Provide documentation of key procedures for ensuring the security and confidentiality of patient data, including protected health information.

Attachment 10: Summary Accrual for All Clinical Trials and Related Studies by CCP&CCDR Category of the Research Base to Other Research Base Trials(use filename:  13-Cross Network Member Accruals).

• For Renewal applications:  Provide documentation of patient accrual on NCORP clinical studies during the current funding period to trials sponsored by other network research bases. Accrual figures should include the unique number of patients enrolled on each NCORP study. Separate accrual numbers should be reported for quality of life accruals.  Include the following information: major CPC&CCDR categories (cancer control, prevention, care delivery) all clinical trial phases, as well as longitudinal/cohort/descriptive studies and total column summing accrual across study designs. The timeframe for the period of accrual should be provided as a sub-heading for each table.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

Budget forms appropriate for the specific component should be included in the application package. Restricted budgets should be included for Study specific budget (if applicable), CCDR (if applicable), Auditing costs, per-case management not managed through a study budget, Biospecimen core (Cancer Center applicants only).

a) PD/PI Effort Commitment. The minimal effort commitment for the Contact PD/PI must be 1.2 person-months per year. The effort commitment for the other PDs/PIs (if multiple) must be a minimum of 1.2 person-months per year. These effort commitments cannot be reduced in later years of the award. A minimal effort level of 1.2 person-months is required for each PD/PI regardless of whether that individual is designated as contact PD/PI or not.  (This commitment cannot be reduced below that level during the projects period).

b) Travel Expenses. Applicants must budget travel funds for four persons (two PDs/PIs or one PD/PI and additional senior investigators and two operations staff members) to attend one NCORP Annual Meeting in-person meeting per year in addition to other travel expenses. 

c) Other Expenses. Applicants must include in the budget appropriate expenses to cover development and conduct of trials and human subjects studies across each included scientific area as well as support for the Data Safety Monitoring Board activities and auditing activities. Biobanking costs can be included for Cancer Center applicants.

d) General determination of level of "per-case management" funding (aka capitation funding) for Member Sites other than NCORP Sites. The NCORP provides general total cost support for different types of accrual for member sites depending on the accrual type category. Total cost funding for "per case management" for treatment intervention trials is expected to be provided in following estimated amounts by accrual category per enrolled patient listed below:

• IND-Exempt Intervention Trial: $3,000
• IND Intervention Trial: $3,300 
• Primary Imaging Base Intervention Trial: $1,300
• Screening Only: $650 (patient does not go onto intervention of trial)
• One Biospecimen Collection “Package” per Patient: $500 
• Cohort study or Centralized NCORP Intervention Trial(range depending on workload): $1,200-$2,500
• Special entry credit: $50-$250

Please Note: "Per-case management" funding may be provided out of the Research Base capitation budget for collections of radiologic images (not costs of the actual imaging) but only for NCI/NCORP approved integral and/or integrated imaging studies embedded in NCORP trials and the collection must be coordinated through the Network Radiotherapy and Imaging Core Services Center. Quality assurance/control for significant radiotherapy interventions in NCORP trials is performed by the Network Radiotherapy and Imaging Core Services Centers. "Per-case management" funding may be provided for biospecimens collected for NCI/NCORP approved integral and/or integrated studies in embedded NCTN trials as well as for optional biospecimen collections for future unspecified research if approved by NCI/NCORP.

To justify the budget, the applicant needs to describe using an "Accrual InputTable or Narrative" in the budget narrative detailing the number of patients expected to be accrued in the "screen only" category for intervention trials, intervention category for trials, cohort study or centralized intervention category, and 1 patient biospecimen collection for each enrollment by category site type. The applicant should use the prior funding period as a guide for reasonable estimates of future patient enrollments by accrual type with appropriate justification for any significant changes in anticipated levels of patient enrollments. Cross research base accruals should also be estimated.

The following costs are not supported under this NOFO;

• Costs associated with routine patient care.
• Funds for tumor banks, correlative science research and/or reference laboratories unless otherwise noted.
• Funds for integral and/or integrated laboratory and/or biomarker studies unless selected for BIQSFP funding.
• Costs for alterations and renovations.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims:  Describe the overall Specific Aims for the proposed Research Base addressing the development and conduct of cancer prevention, control, and care delivery (CPC&CCD) trials and human subjects studies in the applicable areas.  The study design, methods, and/or interventions for these areas of research may not by themselves be innovative but address important questions or unmet needs.  Explain how the completion of these Aims is expected to advance oncology care and enhance cancer care and outcomes through a solutions-oriented approach.

Research Strategy:  Organize the Research Strategy section with sub-sections in the specified order and follow the instructions provided below. Start each subsection with the appropriate subsection heading.

Overview

Outline the overall strategy and approaches that the applicant team will use to develop and implement its research agenda.

• For new applications:  Identify the specific areas of research that the applicant team plans to pursue from the three (3) Areas referenced under the "Scope of Activities for Research Base" and explain how the proposed research agenda will benefit the NCORP Program.
• For renewal applications:  Identify the specific areas of research that the Research Base will continue to pursue from the three (3) Areas referenced under the "Scope of Activities for Research Base" and/or any new directions planned. Explain how the research priorities will benefit the NCORP Program.
• For new and renewal applications:  Explain how the proposed research agenda will improve scientific knowledge and/or clinical practice.

Progress Report for Renewal applicants:

• Highlight the most significant achievements in terms of clinical studies designed, activated, and analyzed during the recent project period as well as patient enrollment by its Research Base Members to studies (led by the applicant Research Base and other Network Groups).  Provide this information by scientific area, i.e., cancer control, prevention, care delivery.
• Describe how the applicant has integrated and centralized functions to form an efficient operational organization for its Research Base Members that participate in NCORP research.
• Highlight the Research Base's major contributions to the overall infrastructure of the NCORP Network and significant collaborations with other NCI-sponsored programs.

For New applicants:

• Provide the highlights of major contributions to cancer-related clinical research, including NCI-supported clinical trials through the venues in which the applicant organization has had access over the last 5 years.

Subsection A. Organizational Leadership, Structure and Operational Management - Address the following areas:

Administrative Leadership

• Describe the senior administrative leadership team and the organizational structure of the proposed Research Base and its key governance policies. The applicant should also provide a diagram illustrating the organizational structure of the proposed Research Base.
• Describe the chain of responsibility for decision-making and conflict resolution at the proposed Research Base as well as succession planning for senior leadership positions.
• Describe the communication process within the organizational structure, e.g., to Committees and to community investigators.
• Describe how administrative functions are centralized for efficiency.

Operational Capacity/Oversight

• Describe the proposed Research Base’s capability to develop, activate, conduct, and monitor clinical studies in a timely manner.
• Describe how the proposed Research Base provides oversight and coordination of study development, patient accrual, study conduct (e.g., at community sites enrolling both children and adults), and on-site auditing for NCORP studies. 
• The applicant should describe the data management systems employed and how the proposed Research Base will use standard NCI tools including the Common Data Management System (CDMS), the Regulatory Support System (RSS), the Oncology Patient Enrollment Network (OPEN), the  Clinical Data Update Systems (CDUS/CDS) or the new CTEP AERS System, the NCI Common Terminology Criteria for Adverse Events (CTCAE) for data management, and trial registration in the NCI National Clinical Trials Reporting Program (CTRP) and in the U.S. National Library of Medicine (NLM) (www.clinicaltrials.gov) along with results reporting, as applicable.
• Describe how the information technology (IT) support for central storage, security, analysis and retrieval of clinical data for the Data Safety and Monitoring Committees will adequately support clinical trials and other human subjects research.
• Describe the applicant's methods and procedures for biospecimen collection tracking; assessing case eligibility and evaluability; and, ensuring timely medical review and assessment of patient data.
• Explain the proposed Research Base’s guidelines for data submission, including a summary of data quality and questionnaire completeness.

Scientific Leadership

• Define lines of responsibilities in terms of pursuing the goals and research agenda of the proposed Research Base.
• Describe the applicant’s senior research teams (e.g., scientific research committees and administrative committees) and the processes these teams follow to develop the research agenda of the proposed Research Base.
• Summarize the collective capabilities and experience of the proposed Research Base’s development team in successfully developing, organizing, and coordinating research studies within the NCORP scope as well as experience in leveraging resources from multiple funding sources for the conduct of ancillary studies (e.g., correlative science studies) associated with clinical studies.
• Describe how the proposed Research Base will provide appropriate orientation for:
• Scientific Committee Chairs;
• Research Base member sites [e.g., for protocol chairs, institutional site PD(s)/PI(s), and clinical research associates (CRAs)].
• Outline the general strategies anticipated by the team leadership for other relevant research-enhancing activities.

Subsection B. Scientific Agenda - Address the following areas for the development of clinical trials for cancer prevention, control, and care delivery (CPC&CCD) as indicated in the specific aims:

Research Priorities

• Explain the strategies that will set or sets priorities and timelines for development of clinical studies for the NCORP network.
• Describe any novel (or refinements/improvements) concepts, approaches, or methods that are being developed or used and any advantage that they may have over existing methods with respect to the development, design, and conduct of clinical studies.
• Explain how the applicant will incorporate translational science (including integral and integrated biomarkers) into its clinical trials.
• Describe how the applicant will use the NCORP biospecimen banks as a scientific resource to inform future research studies.
• Describe how the applicant will use the NCORP Imaging and Radiation Oncology Core resources, if applicable, to integrate advanced technology into research studies.

Statistics and Data Management

• Describe the role of the statisticians and community representatives and at what point in the process their input is incorporated into trial development.
• Describe how the statistician interacts with the study chair.
• From the statistics perspective, describe the general strategy and approaches to study design and analysis plans for multi-institutional clinical studies, including guidelines for interim monitoring and general procedures for sample size estimation and choice of testing and estimation procedures.
• Describe how the senior statisticians of the proposed Research Base provide leadership in study design and analysis
• Describe what policies the applicant has in place to ensure that final study analyses are performed in a manner to provide timely publication of study results, results reporting, and data sharing per NIH/NCI, NCORP, and federal regulations.

Investigator Participation throughout the NCORP Network

• Characterize the extent to which individuals playing distinct roles (such as investigators, patient advocates, and other members of the oncology and non-oncology community) participate in the design, conduct, and monitoring of clinical studies. Describe the engagement of early career investigator and community investigators in trial development.
• Outline how the affiliated NCORP Community Sites, NCORP Academic Community Sites and other institutional members will be involved in Research Base activities (e.g., committee memberships, study chair roles, training programs, anticipated scientific collaborations, etc.).
• Explain how the proposed Research Base and its committee structure will promote interdisciplinary exchange in the development and conduct of CPC&CCDR studies.
• Explain how the proposed Research Base will contribute to the overall infrastructure of the NCORP Program through examples of participation in the Scientific Steering Committees under the NCI Coordinating Center for Clinical Trials (https://www.cancer.gov/about-nci/organization/ccct/about )and associated Task Forces and Working Groups, the NCI Central IRB, and other NCI/NCORP initiatives.
• For renewal applications:  Describe the Research Base’s current collaborations and plans for new collaborations with other NCORP Research Bases on clinical studies as well as other aspects of study design and conduct.
• For new applications:  Describe the applicants past and proposed collaborations and other future plans for research activities with other NCORP Research Bases on clinical studies.

Subsection C. Member Site Accrual and Performance -Address the following areas:

Accruals

• Describe the requirements for Research Bases membership.
• Explain how the proposed Research Base will engage with NCORP Community and Academic Community Sites as well as other member sites to ensure the appropriate enrollment of patients across the cancer trajectory and in representative populations.
• Describe what resources and tools (NCI or others) will inform plans to ensure enrollment, e.g., screening log, administrative and PI webinars.
• Describe how the proposed Research Base will strategically engage NCORP sites to create recruitment plans to achieve proposed accrual goals.
• Describe how the Research Base will collaborate with other Research Bases to enhance accrual across the network.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan

Other Plan(s): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format should not exceed two (2) pages. Where the DMS Plan Format Page requires a “Yes or No” response, no additional narrative is allowed.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

All active human subjects research for renewal applications should have a record.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

Both Renewal and New Applications must add and complete the Delayed Onset Study record and must check box "Anticipated Clinical Trial?".

Study Title-- use:  "Multiple Delayed Onset Studies"

Justification Attachment:  Clinical trials will be designed and conducted by the NCORP Research Base during the Project Period. Each clinical trial protocol developed will be subject to approval through the standard NCI procedure that involves an initial concept submission and subsequent review.  

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. 

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO. 

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director’s Statement of Priorities, entitled “Advancing NIH’s Mission Through a Unified Strategy.” 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Development of research strategy for clinical trial development across the funded scientific areas and appropriate conduct, monitoring, and results reporting of NCI-approved trials.
• Recruitment of permanent member sites for patient enrollment to NCORP trials and oversight of member sites for the conduct of trials they participate in across the NCORP, including evaluation of member site performance and auditing of member sites per CTMB Guidelines.
• Mentoring of new/junior investigators as well as patient advocates in clinical trials research/activities.
• Development of an overall strategy to provide statistical expertise for effective scientific design, conduct, and data management of NCORP trials..
• Provision of standard operating procedures covering all aspects of clinical trial design, trial conduct (including compliance with Good Clinical Practice (GCP) guidelines and risk-based central monitoring for applicable NCTN IND trials), development and compliance with data safety/monitoring plans and Data Safety Monitoring Board policy for applicable trials, and training for Clinical Research Associates (CRAs) at member participating sites and Study Chairs/Teams about their responsibilities for study monitoring.
• Responsibilities as a drug sponsor for investigational agent or device development for Canadian Clinical Trials Applications (CTAs) and/or Investigational Testing Applications (ITAs) clinical trials when the Research Base holds the CTA and/or ITA for an NCTN trial.
• Participation in the collective management of the NCORP, including participation in appropriate NCORP Program activities and initiatives (e.g., NCI Scientific Steering Committees).
• Compliance with NCORP Program/NCI/NIH timelines and policies for registration of trials in clinicaltrials.gov and NCI's Clinical Trials Reporting Program (CTRP), publication, and trial data deposit in the NCTN/NCORP Data Archive.
• Use of NCTN Program's common data management system including use of NCTN reporting tools for adverse event reporting and risk-based central monitoring.
• Compliance with NCTN Network Operating Principles to ensure member sites have the opportunity to participate in any network-wide adult or adolescent and young adult (AYA) NCTN trial (both trials led by the Network Group Operations Center as well as trials led by other NCTN Network Groups) and receive funding for per case management per NCI/DCTD designated allocations.
• Compliance with NCORP Program Guidelines/Handbook published at the time of award and any subsequent updated versions of the Guidelines/Handbook.
• Recipients will comply with the Handbook for Clinical Investigators Conducting Therapeutic Clinical Trials Supported by the Cancer Therapy Evaluation Program (CTEP), DCTD, NCI at (https://ctep.cancer.gov/investigatorResources/investigators_handbook.htm), the NCI Guidelines for Auditing Clinical Trials for the National Clinical Trials Network (NCTN) Program including NCI Community Oncology Research Program (NCORP) and Research Bases at (https://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm), NCI/DCTD CRADA agreements, and the Intellectual Property Option to Collaborators at (https://ctep.cancer.gov/branches/rab/intellectual_property_option_to_collaborators.htm) for NCTN trials.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies and within the limits of any accepted binding NCI/NIH collaborative agreements with biotechnology and as governed by NCI-approved Data Management and Sharing Plans and NCI-approved review for use of biospecimens collected in association with NCORP trials.

NCI program staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The substantially involved NCI program staff member(s), acting as Project Scientist(s), will coordinate in a centralized fashion the various activities of the recipients. Specific responsibilities of the NCI Project Scientist(s) will include but will not be limited to.

• Responsibility for ensuring trials proposed are within the research scope of the NCORP Program.
• Set priorities for prevention, control and care delivery research trials/studies based on the state of the science, Research Base resources and availability of funding.
• Final review and approval of trial Concepts after evaluation by NCI Scientific Steering Committees as well as review and approval of final protocols and subsequent amendments for all NCORP trials.
• Approval of non-U.S. member sites for the Research Base roster for the NCORP.
• Evaluation and approval of clinical trial collaborations with non-NCORP, non-U.S. trial sites and organizations including review of any agreements/MOUs for compliance with NIH/NCI, federal, and NCORP policies. Review and approval of agreements/MOUs between the U.S. Groups and other entities related to NCORP trials for compliance with NCI/NIH, federal, and NCTN policies.
• Serving as scientific liaisons to recipients of this key component of the NCORP Program and participation in scientific meetings of this key component as well as informing Network investigators of scientific opportunities resulting from NCI-supported clinical research programs.
• Oversight of data and safety monitoring plans and boards for NCORP clinical trials.
• Oversight of data management and monitoring programs for NCORP trials as well as onsite auditing programs and quality assurance programs for the NCORP Program, including oversight of core services for radiotherapy and imaging support in NCORP trials.
• Facilitating coordination of the clinical trial activities and collaborations between the Network and other NCI-sponsored programs and investigators.
• Designation of "per case management" funding amounts for all NCORP trial components.
• Final review and approval of requests for use of any biospecimens collected in association with NCORP trials.
• Ensuring compliance with FDA for investigational agents and ensuring compliance with OHRP and other federal regulations for research involving human research subjects including compliance with Good Clinical Practice (GCP) guidelines: http://www.fda.gov/oc/gcp/default.htm and https://ctep.cancer.gov/branches/ctmb/clinicalTrials/docs/good_clinical_practices.pdf for applicable NCORP trials.
• Participate in on-site audits of conducted by Research Bases, when appropriate.
• Monitoring the progress and performance of this key component of the NCORP Program.
• The NCI will have access to all data (including imaging data) collected and/or generated under this Cooperative Agreement and may periodically review the data.
• Additionally, an agency program official or IC program officer (other than the NCI Project Scientist) will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• General aspects of collaboration on study development and conduct especially with respect to compliance with federal regulations for clinical trial research, conduct of Data and Safety Monitoring Boards (DSMBs) for phase 3 trials and randomized phase 2 trials.
• Review of recommendations from the NCI Clinical Trials and Translational Research Advisory Committee (CTAC) on strategic directions for the NCORP Program.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format should not exceed two (2) pages. Where the DMS Plan Format Page requires a “Yes or No” response, no additional narrative is allowed. 

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk - Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

NCORP Director
National Cancer Institute (NCI)
Telephone: 240-276-7048
Email: NCORP@mail.nih.gov

Center for Scientific Review (CSR)
Email: NOFOReviewContact@csr.nih.gov

Office of Grants Administration
National Cancer Institute (NCI)
Email: NCIFinancialContact@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.