HT942526ORPCRA_GG.pdf

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

Program Announcement for the Defense Health Agency

Orthopaedic Research Program

Clinical Research Award

Funding Opportunity Number: HT942526ORPCRA

Pre-Application Due: August 19, 2026

Application Due: November 18, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Orthopaedic 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 Orthopaedic 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/#:~:text=Frequently%20Asked%20Questions%20%C2%BB https://cdmrp.health.mil/#:~:text=Guide%20for%20Intragovernmental%20%26%20Intramural%20Applicants https://ebrap.org/eBRAP/public/Program.htm#:~: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 Orthopaedic Clinical Research Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Orthopaedic Research Program (ORP) Clinical Research Award (CRA) seeks clinical research that evaluates orthopaedic-specific factors and interventions. The ORP intends for research supported by this mechanism to generate clinically useful evidence with potential to optimize patient outcomes and inform clinical care or policy.

Applications must address how the proposed research will impact patient care and reduce the burden of orthopaedic injury and sequela. The ORP expects that research findings benefit Service Members, their families, Veterans and the general public. To meet the intent of the award mechanism, applications must specifically address at least one of the FY26 ORP CRA Focus Areas.

Distinctive Features:

• The CRA offers two research levels.

Research Level 1 (RL1) supports clinical research in the following FY26 ORP focus areas:

Research Level 2 (RL2) supports clinical trials in the following FY26 ORP focus areas:

• Ligamentous Trauma

• Osseointegration Outcomes

• Return-to-Duty Strategies

• Military Women’s Health

• Ligamentous Trauma

• Limb Stabilization and Protection

• Return-to-Duty Strategies

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $4.0M to fund approximately two CRA-RL1 applications with total cost caps of $2.0M per award; and allot roughly $9.6M to fund approximately three CRA-RL2 applications with total cost caps of $3.2M per award. The maximum period of performance is 4 years for both 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), August 19, 2026

• Invitation to Submit an Application: September 25, 2026

• Application Submission Deadline: 11:59 p.m. ET, November 18, 2026

• End of Application Verification Period: 5:00 p.m. ET, November 23, 2026

• Peer Review: January 2027

• Programmatic Review: March 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526ORPCRA

Assistance Listing Number: 12.420

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

There is no limitation on the number of applications for which an investigator may be named PI.

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:~:text=pre%2Dapplication%20submission.-,Extramural%20Organization%3A,-A%20foreign%20or https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~: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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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 Orthopaedic Research Program (ORP). 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 ORP in 2009 to provide support for research of high potential impact and exceptional scientific merit focused on optimizing recovery and restoration of function for military personnel with orthopaedic injuries sustained in combat or service-related duties. Appropriations for the ORP from FY09 through FY24 totaled $548.5 million (M). The FY26 appropriation is $20.0M.

The FY26 ORP challenges the scientific community to address the most significant gaps in care for the leading burden of injury and for facilitating return to duty. The program intends to support high-impact and clinically relevant research to advance treatment and rehabilitation from orthopaedic injuries (excluding spinal cord injuries) sustained during combat and service-related activities to maximize return to duty. It is expected that research findings would also benefit the general population. Applications involving interdisciplinary collaborations among academia, industry, the military services, the U.S. Department of Veterans Affairs (VA) and/or other federal agencies are highly encouraged.

FY26 congressional language for the Arthritis Research Program directed that arthritis research shall not be considered by other CDMRP peer reviewed programs such as ORP. The FY26 ORP will consider research that addresses conditions or health abnormalities related to arthritis.

3.1. Award History

The ORP previously offered a Clinical Translational Research Award and a Clinical Trial Award.

The ORP Clinical Research Award mechanism replaces these previous award mechanisms and is being offered for the first time in FY26.

3.2. Intent of the Clinical Research Award

The FY26 ORP CRA seeks clinical research that evaluates orthopaedic-specific factors and interventions. The ORP intends for research supported by this mechanism to generate clinically useful evidence with potential to optimize patient outcomes and inform clinical care or policy.

Applications must address how the proposed research will impact patient care and reduce the burden of orthopaedic injury and sequela. The ORP expects that research findings benefit Service Members, their families, Veterans and the general public. To meet the intent of the award mechanism, applications must specifically address at least one of the FY26 ORP CRA focus areas.

Applications to the FY26 ORP CRA mechanism must support clinical research and may not be used for preclinical research studies. Applicants seeking support for preclinical research projects should consider the FY26 ORP Applied Research Award (Funding Opportunity Number HT942526ORPARA).

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3.2.1. Focus Areas for the CRA

Applications submitted to the FY26 ORP must address one or more of the following focus areas:

Focus Areas for Research Level 1

• Ligamentous Trauma: Musculoskeletal extremity soft tissue trauma treatments for shoulder, knee or chronic ankle instability and sequelae only to optimize return to duty, work or reintegration.

• Osseointegration Outcomes: Identification of best practices to optimize outcomes of patients who have percutaneous osseointegrated prosthetic limbs (e.g., infection, rejection, adapters and fail-safe devices, clinical outcomes).

• Return to Duty Strategies: Optimization and/or validation of decision-support tools, interventions and/or rehabilitation strategies that can retain a Service Member on duty, enable them to return to duty within one year of injury, or avoid reinjury for common combat-related musculoskeletal injuries. Treatment strategies that can be utilized along the continuum of care are encouraged. Biomarker studies are excluded. The current standard of care must be noted. The rehabilitation strategy to be used in the proposed study must be specified, as applicable. Capabilities for diagnosis of underlying pathology and efficacy of interventions measurements are encouraged.

• Military Women’s Health: Studies that assess the impact of novel or established orthopaedic injury care interventions on military women’s health. Application must describe how outcomes of the proposed research will address areas and conditions that affect women uniquely, disproportionately or differently from men. Areas of interest include preservation of function and physical ability, quality of life, symptom management and resilience in military women, as well as sex-specific considerations following orthopaedic injury and treatment.

Focus Areas for Research Level 2

• Ligamentous Trauma: Musculoskeletal extremity soft tissue trauma treatments for shoulder, knee or chronic ankle instability and sequelae only to optimize return to duty, work or reintegration.

• Limb Stabilization and Protection: Development and/or clinical evaluation of rapid limb stabilization and novel wound protectants for severely or critically wounded limbs to enable prolonged care and eventual transport to the point of definitive treatment. Interventions that solely address infection will not be considered.

• Return to Duty Strategies: Optimization and/or validation of decision-support tools, interventions and/or rehabilitation strategies that can retain a Service Member on duty, enable them to return to duty within one year of injury or avoid reinjury for common combat-related musculoskeletal injuries. Treatment strategies that can be utilized along the continuum of care are encouraged. Biomarker studies are excluded. The current standard of care must be noted. The rehabilitation strategy to be used in the proposed study must be specified, as applicable. Capabilities for diagnosis of underlying pathology and efficacy of interventions measurements are encouraged.

3.2.2. Key Elements for the CRA

The FY26 ORP CRA requires inclusion of preliminary and/or published data relevant to the proposed research. Applications must demonstrate logical reasoning for the proposed work. To be competitive, the application must include a sound scientific rationale and a well-

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

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FY26 Orthopaedic Clinical Research Award 8 formulated, testable hypothesis established through a critical review and analysis of the literature.

The FY26 ORP CRA offers two research levels based on the scope of research proposed. The applicant must select the research level that is most appropriate for the research proposed.

• RL1 supports clinical research.

○ Projects with potential to impact the standard of care, both immediate and long-term, as well as contribute to evidence-based guidelines for the evaluation and care of military, Veterans and all patients with orthopaedic injuries.

• RL2 supports clinical trials.

○ Clinical trials with potential to have a significant impact on the treatment or management of military combat or service-related orthopaedic injuries that significantly impact unit readiness and return-to-duty/work rates.

For RL2 Applications Only:

• Study Population: Evidence of availability and access to a suitable patient population that will support a meaningful outcome for the study is required. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, gender, ethnicity or race (typically classified as exempt from Institutional Review Board [IRB] review) are exempt from this requirement.

• Intervention Availability: Evidence of documented availability and access to the drug/compound, device and/or other materials needed, as appropriate, for the proposed duration of the study is required.

• Study Team: Evidence of the study team’s expertise and experience in all aspects of conducting clinical trials, including appropriate statistical analysis, knowledge of U.S. Food and Drug Administration (FDA) processes (if applicable) and data management is required.

3.2.3. Other Important Considerations for the CRA

Funding from this award mechanism must support clinical research (CRA-RL1) or a clinical trial (CRA-RL2).

A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. An intervention includes both physical procedures by which information or biospecimens are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.

Studies that do not seek to measure safety, effectiveness and/or efficacy outcome(s) of an intervention are not considered clinical trials.

For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research encompasses research with human data, human specimens and/or interaction with human subjects. Clinical research is observational in nature and includes:

• Research conducted with human subjects and/or material of human origin such as data, specimens, and cognitive phenomena for which an investigator (or co-investigator) does not seek to assess the safety, effectiveness and/or efficacy outcomes of an intervention.

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Research meeting this definition may include but is not limited to: (a) mechanisms of human disease; (b) diagnostic or detection studies (e.g., biomarker or imaging); (c) health disparity studies; and (d) development of new technologies.

• Epidemiologic and behavioral studies that do not seek to assess the safety, effectiveness and/or efficacy outcomes of an intervention.

• Outcomes research and health services research that do not fit under the definition of clinical trial.

Excluded from the definition of clinical research are in vitro studies that utilize human data or specimens that cannot be linked to a living individual and meet the requirements for exemption under §46.104(d)(4) of the Common Rule.

Proposed clinical trials submitted to CRA-RL2 are expected to begin no later than six months after the award date. Unless otherwise noted, for the purposes of this funding opportunity, Regulatory Agency refers to the FDA or any equivalent international regulatory agency.

If an Investigational New Drug (IND) application, Investigational Device Exemption (IDE) or equivalent, is required, a regulatory application must be submitted to the relevant regulatory agency prior to the CRA submission deadline. The regulatory application should be specific for the product and indication to be tested in the proposed clinical trial.

Animal research is not allowed under the CRA mechanism.

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 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 $2.0M for Research Level 1 or $3.2M for Research Level 2. 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.

https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.104 https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:~: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:~: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 Orthopaedic Clinical Research Award 10

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:

Must be requested for:

• Travel costs for up to two investigators to present project information or disseminate project results at one DOW-sponsored meeting (e.g., the Military Health System Research Symposium) during Year 3 or 4 of the project’s period of performance. For planning purposes, it should be assumed that the meeting will be held in the National Capital or Central Florida areas. These travel costs are in addition to those allowed for annual scientific/technical meetings.

May be requested for (not all-inclusive):

• Research subject compensation and reimbursement for study-related out-of-pocket costs (e.g., travel, lodging, parking, costs associated with caregiving and resources/equipment to enable participation).

• Travel in support of multi-institutional collaborations.

• Costs for one investigator to travel to one scientific/technical meeting per year in addition to the required meeting described above. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the FY26 ORP

CRA.

Must not be requested for:

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

• Animal research costs.

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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.

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

• Preproposal Narrative (two-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/Research Problem/Rationale: Describe the research problem to be addressed by the proposed study and the rationale on which it is based. State how the proposed research addresses the intent of the award mechanism. Clearly identify whether the proposed study is clinical research or a clinical trial.

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

○ Specific Aims and Study Design: Concisely state the specific aims of the study and describe the scientific approach and how it will accomplish the study aims. Include a description of controls, as appropriate.

○ Clinical Impact: State the FY26 ORP CRA Focus Area(s) addressed by the proposed research. Briefly describe how the proposed project will have an impact on patient care for those who have sustained traumatic orthopaedic injuries, service-related or otherwise.

• 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 the full citation (i.e., author[s], year published, reference title, and reference source, including volume, chapter, page numbers, and publisher, as appropriate).

https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#Appendix2:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:~: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:~: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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○ List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms and symbols used in the Preproposal Narrative.

○ Key Personnel Biographical Sketches: All biographical sketches should be uploaded as a single combined file. Biographical sketches should be used to demonstrate background and expertise through education, positions, publications and previous work accomplished.

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 (30-page limit): Upload as “ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

– Background: Establish the relevance of the study to an FY26 ORP CRA Focus Area. Describe in detail the rationale for the study questions and/or study hypotheses. Detail the scientific rationale for the study, establish the study’s relevance and clearly explain the basis for the study questions and/or study hypotheses.

Provide a literature review and analysis. Describe the preliminary studies and/or preclinical data that led to the development of the proposed clinical study. Provide a summary of other relevant ongoing, planned or completed clinical studies and describe how the proposed study differs. Include a discussion of any current clinical use of the intervention under investigation, and/or details of its study in clinical trials for other indications, if applicable.

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

– Intervention (if applicable):

▪ Identify the intervention to be tested. Include the following components, as applicable: 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 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=(a)%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20SF424%20(R%26R)%20%E2%80%93%20Application%20for%20Federal%20Assistance%20Form https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Project%20Narrative%3A,-Attach%20as%20%E2%80%9CProjectNarrative

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FY26 Orthopaedic Clinical Research Award 13 intervention itself, for conduct of the clinical trial. 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 trial.

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

▪ Clearly delineate research procedures from routine clinical procedures.

▪ Discuss any preclinical and/or clinical evidence that supports the safety and stability (as appropriate) of the intervention.

▪ Discuss the clinical monitoring plan and explain how it addresses the level of risk of the clinical trial.

▪ Describe measures to ensure consistency of dosing (e.g., active ingredients for nutritional supplements, rehabilitation interventions).

▪ Explain how the proposed intervention and its endpoints are feasible and rational for use in its intended environment. If proposing that an intervention has utility or is deployable on the battlefield or military setting, describe how the clinical setting of the study accurately represents that environment. Describe any limitation in the evaluative setting and any anticipated hurdles for translation to the final treatment environment.

– Objectives/Specific Aims/Hypotheses: Clearly identify the proposed study as clinical research or a clinical trial. Describe the purpose of the study with detailed objectives, specific aims and/or study questions/hypotheses.

– Study Design: Describe the proposed research in sufficient detail to evaluate its appropriateness and feasibility.

▪ Describe the type of study to be performed (e.g., treatment, prevention, diagnostic), the study phase or class (if applicable) and the study model (e.g., single group, parallel, crossover). Outline the proposed clinical research methodology and study variables in sufficient detail to demonstrate a clear course of action and justification.

▪ Provide a schedule (e.g., flowchart or diagram) of study intervention(s), evaluation(s) and follow-up procedures, if applicable, including any biospecimens to be acquired, the collection schedule and amount.

▪ Describe the interaction with the human subject and what they will experience.

Provide sufficient detail in chronological order for a person not involved in the study to understand what the study participant will experience.

▪ Briefly describe and justify the study population and the inclusion and exclusion criteria that will be used to meet the objectives of the proposed clinical research.

Summarize the methods that will be used to recruit a sample of human subjects from the accessible population (e.g., convenience, simple random, stratified random). Additional details should be provided in Attachment 6: Study Population Recruitment and Safety Plan.

▪ Define each arm/study group of the proposed clinical 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.

If multiple study sites are involved, state the approximate number to be enrolled

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Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Orthopaedic Clinical Research Award 14 at each site. 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.

▪ Describe all evaluations and define all endpoints and 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 a description of controls, as appropriate. 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 evaluations, endpoints and outcome measures, 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 and/or to monitor safety of human subjects.

▪ Describe how data will be reported and how it will be assured that the documentation will support a regulatory filing with the FDA or any equivalent international regulatory agency, if applicable.

▪ Provide detailed plans for initiating the clinical study within six months of the award.

▪ Describe potential challenges and discuss alternative methods/approaches that may be employed to overcome them. Estimate the potential for human subject loss to follow-up and how such loss will be handled/mitigated.

– 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 sample size is appropriate to meet the objectives of the study and all proposed correlative studies. 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.

Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported.

If the proposed research involves access to military and/or VA patient populations and/or DOW or VA resources or databases, describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Also include a plan for obtaining any required data sharing, memorandum of understanding or other agreements required to access and publish data. Refer to the General Application Instructions, Appendix 4, for additional considerations.

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/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource:~:text=eBRAP.org.-,APPENDIX%204,-.%0AUSE%20OF

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Orthopaedic Clinical Research Award 15

○ 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 published manuscripts may be included in Attachment 2. Extra items will not be reviewed.

Letters of Support (1-page limit per letter 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.

Letters of Commitment (if applicable; one-page limit per letter recommended):

If the proposed study involves use of an investigational drug, device or biologic, provide a letter of commitment from the entity that holds the intellectual property rights indicating availability of the product for the duration of the 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 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.

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/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~: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 Orthopaedic Clinical Research Award 16

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 (NIH) Data Management and Sharing Plan or duplicate the Data Management Plan which will be requested only after a recommendation for funding is made.

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 (if applicable): 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 underdevelopment.

Informed Consent Documents (if applicable): Include a copy of the most recent version of the consent forms for the proposed clinical study. The following must appear in the consent form for human subject participation in a DOW-funded research study:

▪ A statement that the DOW is providing funding for the study.

▪ A statement that representatives of the DOW are authorized to review research records.

▪ In the event that Health Insurance Portability and Accountability Act authorization is required, the DOW must be listed as one of the parties to whom protected health information may be disclosed.

○ Attachment 3: Technical Abstract (1-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.

Hypothesis/Objective(s): Identify the proposed study as clinical research or a clinical trial. State the hypothesis to be tested and/or objective(s) to be reached.

Specific Aims: State the specific aims of the study.

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Orthopaedic Clinical Research Award 17

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

Clinical Impact: Briefly describe how the proposed project will have an impact on patient care and restoration of function for those who have sustained traumatic orthopaedic injuries, service-related or otherwise. Include the impact on at least one of the FY26 ORP CRA Focus Areas.

Military Relevance: Describe how the study is relevant to military health.

○ Attachment 4: Lay Abstract (1-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.

– Identify the FY26 ORP CRA Focus Area(s) to be addressed.

– Identify the population the research will help and explain how it will help them.

– Identify the potential applications, benefits and risks of the anticipated outcomes.

– Describe the likely contributions of the proposed research project to advancing research, patient care and/or quality of life for individuals who have sustained traumatic orthopaedic injuries, service-related or otherwise?

– Explain the potential benefit of the proposed study and the anticipated outcomes to Service Members, Veterans and/or their Families.

○ Attachment 5: Statement of Work (5-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.

○ Attachment 6: Study Population Recruitment and Safety Plan (no page limit):

Upload as “StudyPopPlan.pdf”. Include the components listed below.

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 trial. If limiting inclusion by age, race, ethnicity or sex, provide strong rationale based on justification from scientific literature, preliminary data or other relevant considerations. List and describe any evaluations (e.g., laboratory procedures, history or physical examination) that are required to determine eligibility/suitability for study participation and the diagnostic criteria for entry.

Describe how the study population represents the population anticipated to benefit from the intervention.

Study Population Availability: Demonstrate that the research team has access to the proposed study population at each site. Describe the approximate number, pertinent demographic information and other relevant characteristics of the study population at each enrollment site.