RFA-CA-27-006-Full-Announcement.html
HTML file 173 KB Posted
- Attached to
- NCI Community Oncology Research Program (NCORP) Research Bases (UG1 Clinical Trial Required)
- Opportunity number
- RFA-CA-27-006
About this file
This is a Request for Application (RFA) for the National Cancer Institute's (NCI) Community Oncology Research Program (NCORP) Research Bases, announcing a cooperative agreement funding opportunity for cancer clinical research infrastructure. The NCI, a component of the National Institutes of Health within the Department of Health and Human Services, intends to commit $74.5 million in FY 2027 to fund up to seven Research Base awards with a 6-year project period. Research Bases must serve as research hubs providing organizational structure, scientific and statistical leadership, and operational oversight for multi-institutional cancer control, prevention, and care delivery (CCP&CD) clinical trials and human subjects research. Eligible applicants are limited to NCI Clinical Trials Network (NCTN) Groups, cancer foundations affiliated with NCTN Groups, or NCI-designated Cancer Centers with comprehensive cancer clinical research expertise. The RFA requires that applications propose clinical trials and include a minimum 1.2 person-months per year effort commitment from each PD/PI.
The application deadline is August 18, 2026, with peer review and advisory council review occurring by March 2027 and earliest start date of September 18, 2027. Applications must address one or more of three research areas: Area 1 (Cancer Control Research—required), Area 2 (Cancer Prevention Research—optional), and Area 3 (Cancer Care Delivery Research—optional). Required attachments include organizational structure documentation, constitutions and by-laws, member site lists, primary and secondary scientific achievements, accrual summaries, conflict of interest policies, statistical analysis templates, audit policies, study timelines, and data management procedures. Budget requirements include travel funds for four persons to attend one annual NCORP meeting yearly and per-case management funding for member sites ranging from $650 to $3,300 per patient depending on trial type. Applications are evaluated on significance, investigator qualifications, innovation, approach, and environment, with emphasis on how proposals address critical gaps in cancer prevention and control, capability to conduct multi-institutional trials, and engagement of community sites and patient populations. The funding opportunity relates to CFDA programs 93.393 (Cancer Cause and Prevention Research) and 93.399 (Cancer Control).
RFA-CA-27-006-Full-Announcement.html
Text of this file
Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)
National Institutes of Health (NIH)
Components of Participating Organizations
National Cancer Institute (NCI)
Funding Opportunity Title
NCI Community Oncology Research Program (NCORP) Research Bases (UG1 Clinical Trial Required)
Activity Code
UG1 Clinical Research Cooperative Agreements - Single Project
Announcement Type
Reissue of
RFA-CA-18-015
Related Notices
Check for any recent Notices of NIH Policy Changes that may impact application requirements.
Funding Opportunity Number (FON)
RFA-CA-27-006
Companion Funding Opportunity
RFA-CA-27-007
, UG1
Clinical Research Cooperative Agreements - Single Project
RFA-CA-27-008
, UG1
Clinical Research Cooperative Agreements - Single Project
Number of Applications
See Section III. 3. Additional Information on Eligibility.
Assistance Listing Number(s)
93.393, 93.399
Funding Opportunity Purpose
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 subject 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 is a community-based research network that:
| Designs and conducts clinical trials and other human subject studies for adults and children in cancer control, prevention, screening, and care delivery, as well as quality-of-life studies embedded within treatment trials; |
| Enhances patient and provider access to treatment and imaging trials conducted under the National Clinical Trials Network (NCTN); |
NCORP will support the following components that will be individually awarded through the respective Request for Applications (RFAs) indicated below:
| NCORP Research Bases (UG1 Clinical Trials Required)(covered by this NOFO); |
| NCORP Community Sites (UG1 Clinical Trials Not Allowed); and |
| 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). |
Funding Opportunity Goal(s)
To identify cancer risks and risk reduction strategies, to identify factors that cause cancer in humans, and to discover and develop mechanisms for cancer prevention and preventive interventions in humans and to reduce cancer risk, incidence, morbidity, and mortality and enhance quality of life in cancer survivors through an orderly sequence from research on interventions and their impact in defined populations to the broad, systematic application of the research results through dissemination and diffusion strategies.
Key Dates
Posted Date
May 21, 2026
Open Date (Earliest Submission Date)
August 18, 2026
| Application Due Dates |
| Review and Award Cycles |
| New |
| Renewal / Resubmission / Revision (as allowed) |
| AIDS - New/Renewal/Resubmission/Revision, as allowed |
| Scientific Merit Review |
| Advisory Council Review |
| Earliest Start Date |
September 18, 2026
September 18, 2026
Not Applicable
| March 2027 | |
| May 2027 |
July 2027
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.
Expiration Date
September 19, 2026
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
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. | |
| Use the NIH ASSIST system to prepare, submit and track your application online. | |
| 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. | |
| Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application. |
Table of Contents
Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information
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
Funding Instrument
Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.
Application Types Allowed
New
Renewal - Renewal (but only for the awards supported under RFA-CA-18-015)
The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Clinical Trial?
Required: Only accepting applications that propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
Funds Available and Anticipated Number of Awards
The National Cancer Institute intends to commit $74.5 million in FY 2027 for up to seven awards.
Award Budget
Application budgets are not limited but need to reflect the actual needs of the proposed project.
Award Project Period
All applicants should request a 6-year project period.
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
Eligible Organizations
| 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.
Required Registrations
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.
Eligible Individuals (Program Director/Principal Investigator)
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.
Instructions for Application Submission
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
SF424(R&R) Other Project Information
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
R&R Budget
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
PHS 398 Cover Page Supplement
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
This is the start of the file's text. The full file is on GovTribe.
Other files
| File | Type | Posted |
|---|---|---|
| PKG00292876.pdf |
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
File details come from the government source that posted it. Updated .