RFA-CA-27-021-Revised-Full-Announcement.html

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

Sustained Support for Informatics Technologies for Cancer Research and Management (U24 Clinical Trial Optional)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

Reissue of

RFA-CA-24-019

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

RFA-CA-27-021

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.393, 93.396, 93.395, 93.399, 93.394

Funding Opportunity Purpose

This Notice of Funding Opportunity (NOFO) solicits applications for the continued development and sustainment of high value informatics research resources to improve the acquisition, management, analysis, and dissemination of data and knowledge across the cancer research continuum including cancer biology, cancer treatment and diagnosis, early cancer detection, risk assessment and prevention, cancer control and epidemiology. As a component of the NCI's Informatics Technology for Cancer Research (ITCR) Program, this NOFO is focused on sustaining operations and maintaining and evolving the scientific relevance of existing, widely-adopted informatics tools and resources. This is in contrast to early-stage and advanced development efforts to generate these tools and resources that will be supported by companion ITCR NOFOs. The central mission of ITCR is to promote research-driven informatics technology across the development lifecycle to address priority needs in cancer research. In order to be successful, the application must provide clear justification for why the research resource should be maintained and how it has benefited and will continue to benefit the cancer research field. In addition, mechanisms for assessing and maximizing the value of the resource to researchers and supporting close engagement between the resource and the targeted research community should be described.

This NOFO invites applications to support the sustained operations of informatics technology resources that support a wide range of cancer research, including discovery biology, population studies, as well as clinical and translational research. The emphasis is on sustaining resources that have had a demonstrated impact on cancer research. In addition, all projects proposed in response to this NOFO must involve the following general attributes:

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. Research programs include: (1) chemical, physical and molecular carcinogenesis; (2) screening, early detection and risk assessment, including biomarker discovery, development and validation; (3) epidemiology; (4) nutrition and bioactive food components; (5) immunology and vaccines; (6) field studies and statistics; (7) cancer chemoprevention and interception; (8) pre-clinical and clinical agent development; (9) organ site studies and clinical trials; (10) health-related quality of life and patient-centered outcomes; and (11) supportive care and management of symptoms and toxicities.

Key Dates

Posted Date

May 21, 2026

Open Date (Earliest Submission Date)

June 01, 2026

July 01, 2026

July 01, 2026

Not Applicable

April 2027

October 19, 2026

October 19, 2026

Not Applicable

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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Expiration Date

October 20, 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.

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

Purpose The ITCR Program The central mission of ITCR is to promote research-driven informatics technology across the development lifecycle to address priority needs in cancer research. The program supports the development of critical tools and resources to improve the acquisition, analysis, visualization, and interpretation of data across the cancer research continuum including cancer biology, cancer treatment and diagnosis, early cancer detection, risk assessment and prevention, cancer control, and epidemiology.

ITCR provides support for informatics technology development through NOFOs aimed at distinct phases of the technology development lifecycle:

Specific Research Objectives and Scope of this NOFO This NOFO invites applications to support the sustained operations of informatics technology resources that support a wide range of cancer research, including discovery biology, population studies, as well as clinical and translational research. The emphasis will be on sustaining resources that have had a demonstrated impact on cancer research. In addition, all projects proposed in response to this NOFO must involve the following general attributes:

Awardees will be expected to participate in additional collaborative research activities, identified post-award, to enhance the utility and/or interoperability of the informatics technology being supported through the award. These expansion activities are intended to further the impact of the technology that is the subject of the award. Collaborations with investigators outside the current ITCR network are welcome. Proposals for these expanded collaborative activities will be evaluated by processes established by the ITCR Steering Committee.

Examples of post-award collaborative research activities include, but are not limited to:

For details on addressing these requirements, see Section IV. Application and Submission Information Responsive Technologies and Scientific Scope of this NOFO Informatics technologies applicable to any aspect of the cancer research continuum are appropriate for this NOFO. General areas of interest include, but are not limited to, the following:

Examples of activities appropriate to the sustained operations of informatics technology in support of research include:

Applications in support of computational methods that address under-represented areas in the program portfolio are of particular interest to NCI. Applicants are encouraged to review the list of funded projects for information about research areas already supported by the program. https://www.cancer.gov/about-nci/organization/cssi/research/itcr/funded-projects.

Applications Not Responsive to This NOFO The following types of studies are not responsive to this NOFO and will not be reviewed.

Alternative Opportunities

Potential applicants are strongly encouraged to consult with the Scientific/Research contact listed in Section VII for the appropriateness of submission to this NOFO.

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

Resubmission

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?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NCI intends to commit $1,800,000 in FY 2027 to fund 2 awards.

Award Budget

Budgets are limited to $600,000 Direct Costs (excluding consortium F&A) per year.

Award Project Period

The maximum project period is five years.

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

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

Non-domestic (non-U.S.) Entities (Foreign Organizations)

Foreign Organizations/Foreign Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are 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.

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:

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

SF424(R&R) Senior/Key Person Profile

R&R Budget

Principal Investigator Level of Effort: For single PI projects, the PI is required to commit a minimum of 1.8 person months/year (15% effort) to the project. For multi-PI (MPI) projects, each PI (MPI) is required to commit 1.2 person months/year (10% effort) to the project.

Collaborative Activities: Applicants must set aside 10 percent of their annual budget (Direct Costs) in Budget Period 2 and beyond to support collaborative activities with any appropriately qualified research group within or beyond ITCR. The amount should be presented in the Other Expenses category under the heading "Collaborative Funds". Final decisions for the release of set-aside funds will be contingent upon assessment of the collaborative project's value for advancement of the developed technology by the ITCR Steering Committee.

Travel: Applicants are required to include travel support for an investigator from their research team to attend the annual meeting. In the budget, a travel budget for one trip per year to these meetings must be included. The meeting location varies each year and is held at an ITCR investigator institution site in the US or at the NCI's facilities in Rockville, MD.

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:

For this funding opportunity, URLs of publicly available websites may be cited for the purpose of referencing the existing software or code that is the subject of the proposed research, or for the purpose of demonstrating dissemination and outreach activities.

The application must provide evidence of the development status of the existing software that is to be sustained through this project. This could include the following: a pointer to a running hosted instance of the software; a mechanism to install and evaluate the software locally, such as binary files, a Docker container, or source code with appropriate instructions; a pointer to a comprehensive description of the current software package and its functionality, including user instructions; one or more peer-reviewed publication(s) showing significant results obtained with the proposed software.

Collaborative Activities Awardees will be expected to participate in additional collaborative research activities identified post-award, in alignment with the goal of the ITCR program to enhance the utility and interoperability of informatics technologies. In the 'Research Strategy', a separate section titled 'Collaborative Activities' should be devoted to briefly describing abilities and potential opportunities for collaborative activities that could enhance the utility and/or interoperability of the informatics technology that is developed in response to this NOFO, through the use of funds restricted for this purpose. Collaborations with investigators outside the current ITCR network are welcome. Collaborative projects supported through the set-aside funds must be scientifically focused.

Letters of Support: Applicants are encouraged to provide letters of support (no more than 10) from the cancer research community. These letters should describe how the technology has benefited their research and why the resource should be sustained. The letters should provide supporting evidence for the need to sustain the resource for the targeted cancer research community.

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.

Software and Model Sharing Plan:

A plan and timeline for sharing software developed through the award must be provided that addresses the following requirements:

NCI is committed to maximizing the transparency and utility of machine learning models for cancer research (machine learning models are defined as computational algorithms that learn patterns from data and make predictions and/or generate content based on these patterns). In support of these goals, projects that propose the development or enhancement of machine learning models must include a plan and timeline for disseminating the model including the named repository where the model will be stored and versioned together with detailed "model card"annotations that include the following:

A draft model card with known values and parameters must be included in the Software and Model Sharing Plan for projects proposing the development or enhancement of machine learning models.

Standards for machine learning model annotations are quickly evolving and NIH may refine these requirements during the award period, taking into consideration community input in developing the standards.

Prior to funding, program staff may negotiate modifications to the Software and Model Sharing Plan with the applicant. The Software and Model Sharing Plan represents a commitment by the institution (and its subcontractors, as applicable), to support and abide by the plan. The final version of the accepted Software and Model Sharing Plan will become a condition of the award.

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

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.

PHS Assignment Request Form

Foreign Organizations Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply Application Guide.

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.

Mandatory Disclosure

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

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.

Overall Impact

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).

Scored Review Criteria

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.

Significance

Does the proposed project address needs of the cancer research community? Is the scope of activities proposed for the project appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the targeted research area?

In addition, for applications involving clinical trials Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Specific to this NOFO:

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the project? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing research that has advanced their field(s)? Do the investigators demonstrate significant experience with coordinating collaborative cancer research? If the project is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, and organizational structure appropriate for the project? Does the applicant have experience overseeing selection and management of subawards, if needed?

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Specific to this NOFO:

How successful have the PD(s)/PI(s) been in disseminating and implementing informatics resources and supporting community engagement activities?

Innovation

Does the application propose novel strategies to support and advance cancer research?

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Specific to this NOFO:

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research project? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the project, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Does the application adequately address the following, if applicable Study Design Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, sex, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Specific to this NOFO:

Environment

Will the institutional environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

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.

Study Timeline

Specific to applications involving clinical trials Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in…