This program announcement must be read in conjunction with the General Application Instructions, version CD26_01.

Program Announcement for the Defense Health Agency

Arthritis Research Program Clinical Research Award

Funding Opportunity Number: HT942526ATRPCRA

Pre-Application Due: July 22, 2026

Application Due: October 22, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Arthritis Clinical Research Award 2

Content Before You Begin 3

Basic Information Summarizes the funding opportunity, funding details, submission deadlines and review dates

Eligibility Details eligibility factors for the applicant organization and Principal Investigator

Program Description Describes the program mission and intent of the Clinical Research Award; provides key award information and considerations; and outlines funding details

Application Contents Presents the two-step application process and instructions for preparing a pre-application and full application

Submission Requirements Provides locations for application packages, instructions for submitting pre-applications and full applications, and describes application verification

Application Review Information Outlines the processes for application compliance review, pre-application and full application selection/notification, and risk assessment. Also, details the review criteria for pre-application screening and both tiers of the CDMRP application review process – Peer Review and Programmatic Review

Federal Award Notices Outlines what a successful applicant can expect if recommended for funding

Post-Award Requirements References policy requirements for funded research; outlines reporting requirements and restrictions related to Principal Investigator changes and institutional award transfers

Other Information Outlines criteria for administrative actions including application rejection, modification, withdrawal and withhold

Appendix 1 Includes a checklist for all full application components to facilitate application submission

Appendix 2 Acronym List

FY26 Arthritis Clinical Research Award 3

Before You Begin

• Active SAM.gov, eBRAP.org and Grants.gov registrations are required for application submission. User registration for each of these websites can take several weeks or longer.

Each applicant must ensure their registrations are active and up to date prior to application preparation.

• Read this funding opportunity announcement in the order it is written before beginning to prepare application materials. It is the responsibility of the applicant to determine whether the proposed research meets the intent of this funding opportunity and that all parties meet eligibility requirements.

• To support application preparation, additional resources are available including an application process FAQ, a Guide for Intragovernmental & Intramural Applicants and a CDMRP Video Series detailing the application process.

Who to Contact for Support

This document uses internal links; you can go back to where you were by pressing the Alt + left arrow keys (Windows) or command + left arrow keys (Macintosh) on your keyboard.

Click to be taken to additional guidance and instructions within the General Application Instructions (GAI).

eBRAP Help Desk

301-682-5507 help@eBRAP.org

Questions regarding funding opportunity submission requirements, as well as technical assistance related to pre-application or intramural application submission.

Grants.gov Support Center

800-518-4726 International: 1-606-545-5035 support@grants.gov

Questions regarding Grants.gov registration and Workspace.

https://sam.gov/ https://ebrap.org/eBRAP/public/index.htm https://grants.gov/register https://cdmrp.health.mil/#:%7E:text=Frequently%20Asked%20Questions%20%C2%BB https://cdmrp.health.mil/#:%7E:text=Guide%20for%20Intragovernmental%20%26%20Intramural%20Applicants https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Journey%20of%20an,Tier%20Review%20Process mailto:help@eBRAP.org mailto:support@grants.gov https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

Section Shortcuts Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Arthritis Clinical Research Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Arthritis Research Program (ATRP) Clinical Research Award (CRA) supports clinical research that evaluates disease-specific factors and interventions. Research is intended to generate clinically useful evidence with potential to optimize patient outcomes and inform clinical care or policy. Research addressing any and all types of arthritis is encouraged.

Applications must address one of two FY26 ATRP CRA Focus Areas: Prevention and Early Diagnosis, or Treatment and Mitigation of Disease Progression/Burden.

Distinctive Features: The FY26 ATRP CRA offers funding for two research levels. It is the responsibility of the applicant to select the level that aligns with the scope of the proposed research.

• Research Level 1: Applications proposing clinical research or early-phase/pilot clinical trials, to include new or emerging research that is not ready for a full-scale randomized controlled clinical trial.

• Research Level 2: Applications proposing a full-scale clinical trial.

Applications should include a community collaborator (e.g., patient/care partner, community-based organization consultant) who will provide advice and consultation during study design and throughout study planning and implementation. The ATRP encourages a community collaborator for Research Level 1 applications and requires a community collaborator for Research Level 2 applications.

Preliminary and/or published data are required.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $7.15M to fund approximately three Clinical Research Award – Research Level 1 applications and one Clinical Research Award – Research Level 2 application with total cost caps of $1.30M for Research Level 1 and $3.25M for Research Level 2. The maximum period of performance is 4 years for both research levels. It is anticipated that awards made from this FY26 funding opportunity will be funded with FY26 funds, which will expire for use on September 30, 2032. Awards supported with FY26 funds will be made no later than September 30, 2027.

Submission and Review Dates and Times

• Pre-Application (Preproposal) Submission Deadline: 5:00 p.m. Eastern Time (ET), July 22, 2026

• Invitation to Submit an Application: August 27, 2026

• Application Submission Deadline: 11:59 p.m. ET, October 22, 2026

• End of Application Verification Period: 5:00 p.m. ET, October 27, 2026

• Peer Review: December 2026

• Programmatic Review: February 2027 Announcement Type: Initial Funding Opportunity Number: HT942526ATRPCRA Assistance Listing Number: 12.420

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Arthritis Clinical Research Award 5

2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

Extramural and intramural U.S. Department of War (DOW) organizations are eligible to apply, including foreign and domestic organizations, for-profit and nonprofit organizations, and public or private entities.

2.1.2. Principal Investigator

Independent investigators affiliated with an eligible organization are eligible to be named Principal Investigator (PI) on the application, regardless of ethnicity, nationality or citizenship status.

An investigator may be named PI on no more than two FY26 ATRP applications across both award mechanisms, in any combination.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement.

2.3. Other

Awards are made to eligible organizations, not to individuals. Refer to the GAI for additional recipient qualification requirements.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:%7E:text=pre%2Dapplication%20submission.-,Extramural%20Organization%3A,-A%20foreign%20or https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=Intramural%20DOW%20Organization%3A%20A%20subset%20of%20intragovernmental%20organizations%3B%20refers%20specifically%20to%20DOW%20organizations%2C%20including%20DOW%20laboratories%2C%20DOW%20military%20treatment%20facilities%2C%20and/or%20DOW%20activities%20embedded%20within%20a%20civilian%20medical%20center.

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Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

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3. Program Description

The Defense Health Agency Contracting Activity (DHACA) is soliciting applications to this funding opportunity using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The CDMRP is the program office managing this FY26 funding opportunity as part of the Arthritis Research Program (ATRP). The CDMRP is located within the Defense Health Agency Research and Development (DHA R&D), which is a part of the Department of Defense, DOD, herein referred to using the secondary title Department of War, DOW. Congress initiated the ATRP in 2024 to provide support for research of high potential impact and exceptional scientific merit focused on reducing the detrimental impact of arthritis on Service Members and their retention. The appropriation for the ATRP for FY24 was $10 million (M). The FY26 appropriation is $10M.

The vision of the ATRP is to lessen the burden of, and ultimately cure, arthritis. The mission is to fund high-impact research to optimize the health and well-being of all people affected by arthritis, and to improve Service Member readiness and retention. It is expected that research findings from awards funded by the ATRP will also benefit those who receive care through the Military Health System and those within the general population. As mandated by Congress, the ATRP will support high-impact research on any type of arthritis, including but not limited to osteoarthritis, post-traumatic arthritis, inflammatory arthritis, juvenile arthritis and rheumatoid arthritis. The ATRP encourages applications that provide solutions for and also examine the impact of arthritis in understudied populations such as women, minorities, or less prevalent arthritis types.

3.1. Intent of the Clinical Research Award

The FY26 ATRP Clinical Research Award (CRA) is intended to support clinical research that evaluates disease-specific factors and interventions. Research supported by this mechanism is intended to generate clinically useful evidence with potential to optimize patient outcomes and inform clinical care or policy. Research addressing any and all types of arthritis is encouraged including but not limited to osteoarthritis, post-traumatic arthritis, inflammatory arthritis, juvenile arthritis or rheumatoid arthritis. The ATRP encourages applications that address sex as a biological variable and understudied arthritis types. The ATRP also encourages applicants to consider whether large datasets or existing studies/consortia can be leveraged to maximize the potential impact of the proposed research.

Applicants must address how the proposed research will impact patient care and reduce the burden of disease. It is expected that any research findings would benefit Service Members, Veterans, their Families and the general public.

3.1.1. Focus Areas for the CRA

To meet the intent of the funding opportunity, applications submitted to this program announcement must address one of the following FY26 ATRP CRA Focus Areas listed below.

• Prevention and Early Diagnosis: Identify factors capable of predicting the onset or progression of disease, and/or identify technologies, solutions, or knowledge products for the prevention of arthritis.

• Treatment and Mitigation of Disease Progression/Burden: Evaluate interventions or treatment strategies that address the multifactorial burden of arthritis. This may include

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Arthritis Clinical Research Award 7 solutions which address one or more of the following factors: pain or other symptoms, function, psychosocial factors, comorbidities, or the pathologic burden of disease.

Disease Subtype: Applicants must select the primary arthritis type that the study seeks to address.

• Osteoarthritis

• Post-traumatic arthritis

• Rheumatoid arthritis

• Juvenile arthritis

• Inflammatory arthritis

• Other arthritis type not listed

• Non-specific/general arthritis Selection of the appropriate focus area and disease subtype are the responsibility of the applicant.

3.1.2. Key Elements for the CRA

Important aspects of this award mechanism include:

• Impact: The application should explicitly state how outcomes of the proposed research will have a significant impact on arthritis disease management, patient care, and quality of life.

• Relevance to Military Health: The application should clearly describe how the research addresses the impact of arthritis in the military, which may include its effect on Service Member recruitment, retention and recovery. Applicants may also choose to include impacts to the Military Health System, which provides health care support to Service Members and their Families (Eligibility | TRICARE).

• Post-Award Transition Plan: The application should include the plan by which knowledge gained after successful completion of the award will be implemented in guidelines, communicated to relevant stakeholders, or moved to the next phase of development.

• Employing Community Collaborations: Research funded by the FY26 ATRP CRA should be responsive to the needs of lived experience/consumer, family, and care provider communities. Research teams are therefore encouraged (Research Level 1) or required (Research Level 2) to establish and utilize effective and equitable collaborations and partnerships with community members to maximize impact potential of the proposed research. Pre-applications and applications to the FY26 ATRP Clinical Research Award – Research Level 2 must incorporate a Community Collaboration to provide advice and consultation throughout the planning and implementation of the research project.

The Community Collaboration requires scientific researchers and community members to work together to address the critical challenges faced by persons affected by arthritis, particularly those in understudied populations such as women, minorities, or less prevalent arthritis types. Recognizing the strength of each partner, scientific researchers and community members collaborate and contribute equitably their expertise on all aspects of the project, which may include needs assessment, planning, research intervention design, implementation, evaluation and dissemination. Researchers and community collaborators share responsibility for and ownership of the research project; and the https://www.tricare.mil/eligibility

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FY26 Arthritis Clinical Research Award 8 research results are jointly interpreted, disseminated, and fed back to affected communities and may be translated into interventions or policy. This engagement is critically important for community-level interventions and disproportionally affected populations. These interactions can accelerate “bench to bedside” translation and augment the potential impact of research on people living with arthritis. Interactions between team members should be well integrated and ongoing, not limited to attending seminars and semi-annual meetings.

Collaborative relationships with the lived experience community are often established through integrating community members into research teams as co-researchers, advisors and/or consultants. Examples of Community Collaborations include:

○ Lived Experience Consultation: The research team includes at least one project advisor impacted by arthritis who will provide advice and consultation throughout the planning and implementation of the research project. Lived Experience Consultants may include individuals with arthritis, their family members, and/or their care partners.

○ Partnership With a Community-Based Organization: The research team establishes a partnership with at least one community-based organization that provides advice and consultation throughout the planning and implementation of the research project.

Community-based organizations may include advocacy groups, service providers, policymakers or other formal organizational stakeholders.

○ Community Advisory Board Utilization: A community advisory board is composed of multiple community stakeholders and can take many forms, from a board of Lived Experience Consultants to a coalition of community-based organizations, or any combination thereof. As with Lived Experience Consultants and organizational partners, the community advisory board provides advice and consultation throughout planning and implementation of the research project.

Additional information on collaborative research approaches can be found here:

• Nina Wallerstein and Bonnie Duran, Community-based participatory research contributions to intervention research: The intersection of science and practice to improve health equity, American Journal of Public Health 100, no. S1 (2010): S40- S46, doi: 10.2105/AJPH.2009.184036.

When developing applications for the ATRP CRA mechanism, the ATRP strongly encourages applicants to provide sufficient evidence to demonstrate the following key considerations:

• The availability of, and access to, the study population is sufficient.

• The availability of, and access to, the intervention.

• The study team composition is appropriate for the proposed research.

• The statistical considerations, data management and analysis plans are appropriate for the proposed research.

3.1.3. Other Important Considerations for the CRA

In accordance with the National Defense Authorization Act for Fiscal Year 2026, Section 732, CDMRP does not support the conduct of painful research (U.S. Department of Agriculture pain category D or E) involving domestic cats or dogs, except for studies relating to military or service animals.

Clinical research and clinical trials are allowed within this funding opportunity.

Preclinical research, such as those involving cell lines or animals, is not supported in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2837458/pdf/S40.pdf https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2837458/pdf/S40.pdf https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2837458/pdf/S40.pdf https://doi.org/10.2105/ajph.2009.184036 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#:%7E:text=considered%20clinical%20trials.-,Clinical%20Research,-%3A%20For%20the https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in

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FY26 Arthritis Clinical Research Award 9 this funding opportunity. Applicants seeking funding for preclinical or animal research should consider the FY26 ATRP Translational Research Award mechanism (Funding Opportunity Number: HT942526ATRPTRA).

All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research, such as those described in the STROBE, CONSORT, SPIRIT and ARRIVE 2.0 guidelines.

Applications from investigators within the DOW and applications involving multidisciplinary collaborations among academia, industry, the DOW, the U.S. Department of Veterans Affairs (VA) and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, their Families and the American Public. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

3.3. Funding Instrument

The funding instrument for awards made under the program announcement will be grants

(31 USC 6304).

3.4. Funding Details

Period of Performance: The maximum period of performance is 4 years.

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $1.3M for Research Level 1 or $3.25M for Research Level 2.

Research Level 1: Applications proposing clinical research or early-phase/pilot clinical trials, to include new or emerging research that is not ready for a full-scale randomized controlled clinical trial.

Research Level 2: Applications proposing a full-scale clinical trial.

The requested funding level should align with the scope of the research proposed and the research level description.

If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

All direct and indirect costs of any subaward or contract must be included in the direct costs of the primary award.

The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 4 years.

The appropriateness of the budget for the proposed research will be assessed during peer review.

Direct Cost Restrictions: For this award mechanism, direct costs:

May be requested for (not all-inclusive):

• Travel in support of multi-institutional collaborations.

https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:%7E:text=SPIRIT%20and%20CONSORT%20are%20evidence,relevant%20empirical%20evidence%20where%20possible https://www.nature.com/articles/s41591-025-03668-w?fromPaywallRec=false https://arriveguidelines.org/arrive-guidelines https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=Period%20of%20Performance%3A%20The%20time%20interval%20between%20the%20start%20of%20a%20federal%20award%20and%20the%20planned%20end%20date.

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FY26 Arthritis Clinical Research Award 10

• Costs for one investigator to travel to two scientific/technical meetings per year. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the ATRP Clinical Research Award.

Must not be requested for:

• Preclinical research costs.

• Animal research costs.

• Costs for travel to scientific/technical meeting(s) beyond the limits stated above.

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FY26 Arthritis Clinical Research Award 11

4. Application Contents and Format

4.1. Application Overview

Application submission is a two-step process requiring both a pre-application submitted via the Electronic Biomedical Research Application Portal (eBRAP) and a full application submitted through eBRAP or Grants.gov. Depending on the submission portal, certain aspects of the application will differ.

Intramural DOW organizations submitting a full application should follow instructions for submission through eBRAP.

Extramural organizations submitting a full application must follow instructions for submission through Grants.gov.

4.2. Pre-Application Components

Pre-application submissions must include the following components.

• When starting the pre-application, applicants will be asked to select the primary arthritis type addressed by the proposed research: osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, juvenile arthritis, inflammatory arthritis, other arthritis type not listed, or non-specific/general arthritis.

Upload documents as individual PDF files unless otherwise noted. Files must comply with the formatting guidelines listed in the GAI.

• Preproposal Narrative (one-page limit): The Preproposal Narrative page limit applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project. Inclusion of URLs that provide additional information to expand the Preproposal Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the pre-application.

The Preproposal Narrative should include the following:

○ Background: State the FY26 ATRP CRA Focus Area addressed by the proposed research. Briefly present the rationale behind the proposed clinical study.

○ Hypothesis/Objective(s): State the hypothesis to be tested and/or objective(s) to be reached.

○ Specific Aims: State the specific aims of the study.

○ Study Design: Briefly describe the study design, including appropriate controls. If the study involves a clinical trial, specify the clinical trial phase.

○ Impact: Briefly describe how the proposed clinical project will impact patient care and reduce the burden of arthritis disease. Briefly describe how the research outcomes will be relevant to the military.

• Pre-Application Supporting Documentation: The items to be included as supporting documentation for the pre-application must be uploaded as individual files and are limited to the following:

○ References Cited (one-page limit): List the references cited (including URLs if available) in the Preproposal Narrative using a standard reference format that includes https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#Appendix2:%7E:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:%7E:text=IV.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20GRANTS.GOV https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_eBRAP:%7E:text=V.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20eBRAP

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FY26 Arthritis Clinical Research Award 12 the full citation (i.e., author[s], year published, reference title, and reference source, including volume, chapter, page numbers, and publisher, as appropriate).

○ List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms and symbols used in the Preproposal Narrative.

4.3. Full Application Components

Applicants must receive an invitation to submit a full application. Uninvited full application submissions will be rejected.

Each application submission must include the completed full application package for this program announcement. See Appendix 1 for a checklist of the full application components.

(a) SF424 Research & Related Application for Federal Assistance Form (Grants.gov submissions only):

IMPORTANT: When completing the SF424 R&R, enter the eBRAP log number assigned during pre-application submission into Block 4a – Federal Identifier.

(b) Attachments:

Each attachment of the full application components must be uploaded as an individual file in the format specified and in accordance with the formatting guidelines in the GAI.

○ Attachment 1: Project Narrative (12-page limit): Upload as

“ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

– Background: Describe in detail the scientific rationale for the study. Clearly state how the proposed research addresses the selected FY26 ATRP CRA Focus Area(s), and how research findings will generate clinically useful evidence with potential to optimize patient outcomes and inform clinical care or policy. Provide a review and analysis of the available literature and completed/ongoing studies relevant to the proposed clinical study.

Describe the preliminary studies and/or preclinical data that support the proposed clinical study.

Provide a summary of other relevant ongoing, planned or completed clinical research efforts, and describe how the proposed study differs.

If applicable, summarize key preclinical pharmacological findings, dosage studies and other clinical studies that examine the safety and stability (as appropriate) of the intervention.

If the proposed clinical study was initiated using other funding prior to this application, explain the history and background of the clinical research and declare the source(s) of prior funding. Identify the specific portions of the study that will be supported with funds from this award.

– Intervention:

If an intervention will not be utilized for the clinical effort, describe how the proposed study meets the definition of clinical research.

If an intervention will be utilized for the clinical effort, identify the intervention to be tested. Include the following components, as applicable:

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FY26 Arthritis Clinical Research Award 13

Intervention type (drug, device, behavioral, surgical, etc.), complete name and composition, source, general concept of design, administration route.

Indicate who holds the intellectual property rights to the intervention, if applicable, and how the PI has obtained access to those rights, along with access to the intervention itself, for conduct of the clinical study.

As applicable, appropriate letters of commitment should be provided in Attachment 2: Supporting Documentation, demonstrating the study team’s access to the intervention(s) for the duration of the clinical study.

Describe how the intervention addresses current clinical needs and how it compares with or improves currently available interventions and/or standards of care.

– Objectives, Specific Aims and Hypotheses: Describe the purpose of the proposed study with detailed objectives. State the hypothesis/research question to be tested in the proposed clinical research and detail the specific aims that will address the hypothesis/research question. Indicate whether the research addresses health areas and conditions that affect women uniquely, disproportionately or differently from men.

– Study Design: Describe the proposed clinical research study in sufficient detail to evaluate its appropriateness and feasibility, relating to both the scientific success of the study and setting reasonable expectations of what study participants will experience. Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported.

Describe the type of study to be performed. Outline the proposed clinical research methodology and study variables in sufficient detail to demonstrate a clear course of action and justification. Describe the interaction with the human subject, including the study intervention (if applicable) that they will experience, and include the dose and administration route. Provide sufficient detail in chronological order for a person not involved in the study to understand what the study participant will experience.

Provide a schedule (e.g., flowchart or diagram) of study intervention(s), evaluation(s), and follow-up procedures, including, if applicable, the biospecimen that will be collected, the collection schedule and amount. Describe measures to ensure consistency of dosing (e.g., active ingredients for nutritional supplements, rehabilitation interventions). Specify the standard of care. Define each arm/study group of the proposed study, if applicable, and describe how group assignment will occur. Include a description of controls, as appropriate. Specify the approximate number of study participants to be enrolled. Indicate whether subjects, clinicians, data analysts and/or others will be blinded during the study.

Describe any other measures to be taken to reduce bias.

Define all endpoints/outcome measures relevant to the objectives of the study;

explain why they were chosen, and describe how, when and where they will be measured. Include all evaluations that will be made for study purposes. If questionnaires or other research data collection instruments will be used, include a copy of them in Attachment 2: Supporting Documentation. Describe the reliability and validity of the selected endpoints/outcome measures and evaluations, along with the applicable quality standards. Explain how the results of evaluations and/or data collection instruments will be used to meet the objectives of the study (or to monitor safety of human subjects).

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FY26 Arthritis Clinical Research Award 14

Briefly describe the study population and the inclusion and exclusion criteria that will be used to meet the needs of the proposed clinical study. Additional details should be provided in Attachment 7: Study Population Recruitment and Safety Plan.

– Statistical Plan and Data Analysis: Describe the statistical model and data analysis plan with respect to the study objectives. Ensure sufficient information is provided to allow for a thorough evaluation of statistical calculations during review of the application.

Include a complete power analysis to demonstrate that the proposed clinical study’s anticipated sample size is appropriate to meet the objectives of the study.

Describe all clinical and statistical justifications and assumptions that support the sample size calculations. Explain any anticipated subgroup analyses and demonstrate that such analyses will be appropriately powered.

Describe the strategy for how sex will be considered as a biological variable. This strategy should include a brief discussion of what is currently known regarding sex differences in the applicable research area. Clearly articulate how sex as a biological variable will be factored into the data analysis plan and how data will be collected and disaggregated by sex. Refer to the CDMRP Directive on Sex as a Biological Variable in Research for additional information.

For phase 3 clinical trials, describe plans for the valid and sufficiently powered analysis of group differences on the basis on sex, race and/or ethnicity as appropriate for the scientific goals of the study. Refer to the CDMRP Directive on the Inclusion of Women and Minorities as Subjects in Clinical Research for additional information on the requirements for phase 3 studies.

Pitfalls and Mitigation Strategy: Describe potential challenges and discuss alternative methods/approaches that may be employed to overcome them.

○ Attachment 2: Supporting Documentation: Combine and upload as a single file named “Support.pdf”.

There are no page limits for these components unless otherwise noted. Include only components described below; inclusion of items not requested or viewed as an extension of the Project Narrative will result in the removal of those items or may result in administrative withdrawal of the application.

References Cited: List the references cited in the Project Narrative using a standard reference format (include URLs, if available).

List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms and symbols.

Facilities, Existing Equipment and Other Resources: Describe the facilities and equipment available for performance of the proposed project; include any additional facilities or equipment proposed for acquisition at no cost to the award. Indicate whether government-furnished facilities or equipment are proposed for use. If so, reference the original or present government award under which the facilities or equipment items are now accountable. There is not a standardized form for this information.

Publications and/or Patents: Include a list of relevant publication URLs and/or patent abstracts. If articles are not publicly available, then copies of up to five https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Directive%20on%20Inclusion%20of%20Women%20and%20Minorities%20as%20Subjects%20in%20Clinical%20Research https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Directive%20on%20Inclusion%20of%20Women%20and%20Minorities%20as%20Subjects%20in%20Clinical%20Research https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Arthritis Clinical Research Award 15 published manuscripts may be included in Attachment 2. Extra items will not be reviewed.

Letters of Support (two-page limit per letter is recommended): Provide individual letters signed by collaborating individuals and/or organizational officials demonstrating that the PI has the support and resources necessary for the proposed work. Letters from the PI’s Department Chair, or appropriate organization official, should also confirm that the PI(s) meet eligibility criteria. If applicable, provide a letter of support, signed by the lowest-ranking person with approval authority, confirming participation of intramural DOW collaborator(s) and/or access to military populations, databases or DOW resources. If applicable, provide a letter of support signed by the VA Facility Director(s), or an individual designated by the VA Facility Director(s), confirming access to VA patients, resources and/or VA research space.

Commercial Entity Letters of Commitment (if applicable; one-page limit per letter is recommended): If the proposed study involves use of a commercially produced investigational drug, device, or biologic, provide a letter of commitment from the commercial entity indicating the availability of the product for the duration of the proposed clinical study, support for the proposed phase of research, and support for the indication to be tested.

Sex as a Biological Variable Strategy (two-page limit is recommended):

Describe the strategy for how sex will be considered as a biological variable. This strategy should include a brief discussion of what is currently known regarding sex differences in the applicable research area. Clearly articulate how sex as a biological variable will be factored into the data analysis plan and how data will be collected and disaggregated by sex. If needed, provide a strong rationale for proposing a single-sex study, based on justification from scientific literature, preliminary data or other relevant considerations. Refer to the CDMRP Directive on Sex as a Biological Variable in Research for additional information.

Research Sharing Plan: Describe the type of data or research resources (e.g., bio-specimen, analysis tool/software, training material) to be made publicly available as a result of the proposed work. Describe the mechanism (e.g., direct sharing, repository, mixed mode) by which data and resources generated during the period of performance will be shared with the research community and other affected communities, including clinical research participants. Include the name of the repository(ies) where scientific data and resources arising from the proposed study will be archived, if applicable. Identify and provide the rationale for any data or resources that will not be shared (e.g. for intellectual property, feasibility, cost, or other considerations). The plan should also protect participant privacy, confidential and proprietary data, and performer/third-party intellectual property. Provide a milestone plan for disseminating data/results including when data and resources will be made available to other users. In cases where the study participant could potentially derive medical or other benefit from the information, explain whether the results of screening and/or study participation will be shared with the participant or their primary care provider, including results from any screening or diagnostic tests performed as part of the study.

Do not submit a copy of the National Institutes of Health Data Management and Sharing Plan or duplicate the Data Management Plan which will be requested only after a recommendation for funding is made.

https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Arthritis Clinical Research Award 16

Refer to the CDMRP Directive on Sharing Data and Research Resources for more information about the CDMRP’s expectations for making data and research resources publicly available.

Questionnaires and Other Research Data Collection Instruments: Include a copy of the most recent version of questionnaires, data collection forms, rating scales, interview guides or other instruments. This should include any drafts that are currently in use or under development.

○ Attachment 3: Technical Abstract (one-page limit): Upload as “TechAbs.pdf”.

Write the technical abstract using the outline below. Clarity and completeness within the space limits are highly important.

Background: Present the scientific rationale behind the proposed research project.

Briefly describe how the proposed research aligns with the selected FY26 ATRP CRA Focus Area.

Hypothesis/Objective(s): State the hypothesis to be tested and/or objective(s) to be reached.

Specific Aims: State the specific aims of the study.

Study Design: Describe the study design, including appropriate controls.

Clinical Impact: Briefly describe how the proposed clinical trial will have a significant impact on the health and well-being of persons impacted by arthritis. Describe how the study is relevant to the military/military health.

○ Attachment 4: Lay Abstract (one-page limit): Upload as “LayAbs.pdf”.

The lay abstract should address the points outlined below in a manner that is readily understood by readers without a background in science or medicine. Avoid overuse of scientific jargon, acronyms and abbreviations. Do not duplicate the technical abstract.

– Summarize the objectives and rationale for the proposed research.

– What population will the research help, and how will it help them?

– What are the expected clinical applications and potential risks of the anticipated outcomes?

– Describe the ultimate applicability and impact of the proposed study and the anticipated outcomes to advancing research, patient care and/or quality of life?

– Describe the potential benefit of the proposed study and the anticipated outcomes to

Service Members, Veterans and/or their Families.

○ Attachment 5: Statement of Work (five-page limit): Upload as “SOW.pdf”.

Refer to eBRAP for the Suggested SOW Format.

For guidance on preparing the SOW, refer to the Example: Assembling a Clinical Research and/or Clinical Trial Statement of Work. Include milestones for data or research resource(s) sharing.

o Attachment 6: Impact Statement (three-page limit): Upload as “Impact.pdf”. The impact statement summarizes the potential short- and long-term impact of the proposed clinical research study. The statement should address the points outlined below written https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Lay%20Abstract%3A,-Attach%20as%20%E2%80%9CLayAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Arthritis Clinical Research Award 17 in a manner that is readily understood by readers without a background in science or medicine. Overly technical jargon should be avoided and technical terms, if any, should be defined.

– Summarize the potential benefit(s) and anticipated outcomes of the intervention of the proposed clinical study as it relates to the FY26 ATRP CRA Focus Area(s)

– Detail the anticipated research outcome(s) that will be directly attributed to the results of the proposed clinical study and describe the anticipated benefits of these outcomes for individuals impacted by arthritis and the research field. Describe any relevant controversies, treatment issues or health disparities that will be addressed by the proposed study.

Explain the long-range vision for how implementation/dissemination of the intervention and/or research outcome(s) will improve patient care and/or quality of life for the target population. Describe how the intervention, if applicable, represents an improvement over currently available interventions and/or standards of care.

Describe any potential challenges that might limit the impact of the proposed clinical trial, including barriers to implementation or acceptance by users. Provide approaches to overcome those challenges

– Demonstrate how the proposed research project is relevant to military health and/or the health care needs and quality of life of Service Members, Veterans, or military Family member population(s) impacted by arthritis.

– Explicitly state how outcomes of the proposed research may lessen the impact of arthritis in the military, which may include its effect on Service Member recruitment, retention and recovery.

If applicable, describe how the anticipated outcomes of the proposed study will make an impact in understanding health differences between sexes.

If applicable, indicate to what extent the project findings are anticipated to lead to improvements in women’s health outcomes and/or advancements in knowledge for women’s health.

○ Attachment 7: Study Population Recruitment and Safety Plan (no page limit):

Upload as “StudyPopPlan.pdf”. Include the components listed below as applicable to the proposed study type.

Enrollment Distribution: Provide anticipated enrollment table(s) with the proposed enrollment distributed on the basis of sex, race and ethnicity using the Public Health Service (PHS) Inclusion Enrollment Report. The enrollment table(s) should be appropriate to the objectives of the study.

Inclusion/Exclusion Criteria: List the inclusion and exclusion criteria for the proposed clinical study. If limiting inclusion by age, race, ethnicity or sex, provide strong rationale based on justification from scientific literature, preliminary data or other relevant considerations.