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

Program Announcement for the Defense Health Agency

Traumatic Brain Injury and Psychological Health Research Program

Clinical Trial Award

Funding Opportunity Number: HT942526TBIPHRPCTA

Pre-Application Due: July 13, 2026

Application Due: October 15, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Traumatic Brain Injury and Psychological Health Clinical Trial 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 Trial 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

Appendix 3 Additional Focus Area Information

Appendix 4 Optimizing Research Impact Through Community Collaboration

FY26 Traumatic Brain Injury and Psychological Health Clinical Trial 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.

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

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1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Traumatic Brain Injury and Psychological Health Research Program (TBIPHRP) Clinical Trial Award (CTA) intends to support clinical trials with the potential to have a significant impact on psychological health conditions and/or traumatic brain injury (TBI) through clinical applications, including health care products, technologies and/or practice guidelines.

Distinctive Features: Funding from this award mechanism must support a clinical trial.

• Clinical trials may be designed to evaluate a wide range of interventions, including new drugs, biologics, medical devices, diagnostics, therapies and behavioral health strategies.

• Preliminary data are required.

• The inclusion of community-based participatory research (CBPR) approaches is required.

• The CTA offers funding for two Research Levels. The applicant is responsible for selecting the Research Level based on the scope of the research.

○ Research Level 1: Supports proof-of-principle pilot studies, as well as phase 1 and phase 2 clinical trials.

○ Research Level 2: Supports larger-scale and advanced clinical trials that evaluate effectiveness in relevant patient populations.

• Early-Career Investigator Partnering Option (available for both Research Levels): This option accommodates two Principal Investigators (PIs), one of which is an Early-Career Investigator. If recommended for funding, each PI will receive a separate award.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $18.6M to fund approximately three Research Level 1 and three Research Level 2 applications with total cost caps of $2.1M (Research Level 1) and $4.1M (Research Level 2).

The maximum period of performance is 4 years. It is anticipated that awards made from this fiscal year 2026 (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 13, 2026

• Invitation to Submit an Application: August 27, 2026

• Application Submission Deadline: 11:59 p.m. ET, October 15, 2026

• End of Application Verification Period: 5:00 p.m. ET, October 20, 2026

• Peer Review: December 2026

• Programmatic Review: March 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526TBIPHRP

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 affiliated with an eligible organization are eligible to be named as PI, Initiating PI or Partnering PI on the application, regardless of ethnicity, nationality or citizenship status. Individuals in mentored positions (e.g., postdoctoral fellows, clinical fellows) are not considered independent investigators.

Early-Career Investigator Partnering Option (ECIPO):

For applications that select the Early-Career Investigator Partnering Option, both PIs must be independent investigators, and the Early-Career Investigator must be within 10 years after completion of their terminal degree by the time of the application submission deadline (excluding time spent in residency or on family medical leave). Time spent as a postdoctoral fellow is included. Lapses in research time or appointments as denoted in the biographical sketch should be explained in the application. For Early-Career Investigator Partnering Option applications, at least one of the named PIs must be an Early-Career Investigator.

Application limit: The same independent investigator may not be named as a PI, Initiating PI, or Partnering PI on more than four CTA applications.

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 General Application Instructions (GAI) for additional recipient qualification requirements.

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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 Traumatic Brain Injury and Psychological Health Research Program (TBIPHRP). 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 TBIPHRP in FY07 in response to the traumatic brain injuries (TBIs) sustained and psychological health issues experienced by our deployed forces in Iraq and Afghanistan. The TBIPHRP complements ongoing DOW efforts toward promoting a better standard of care for TBI and psychological health in the areas of prevention, detection, diagnosis, treatment and rehabilitation. Appropriations for the TBIPHRP from FY07 through FY24 totaled $2.6 billion. The FY26 appropriation is $40.5 million (M).

The vision of the TBIPHRP is to optimize the prevention, assessment and treatment of psychological health conditions and/or TBIs. The program seeks to fund research that understands, prevents and treats psychological health conditions and/or traumatic brain injuries that accelerates solutions to improve the health, well-being and health care of Service Members, DOW beneficiaries, Veterans and the American Public.

3.1. Award History

The TBIPHRP first offered the Clinical Trial Award mechanism in FY21. Since then, 289 Clinical Trial Award applications/proposals were received, and 83 were recommended for funding.

3.2. Intent of the Clinical Trial Award

The TBIPHRP Clinical Trial Award mechanism supports the rapid execution of clinical trials with the potential to have a significant impact on the treatment or management of psychological health conditions and/or traumatic brain injuries.

Clinical trials may be designed to evaluate a wide range of interventions, including new drugs, biologics, medical devices, diagnostics, therapies and behavioral health strategies. Proposed research may range from proof-of-concept trials (i.e., pilot, first-in-human, phase 0) that establish feasibility to larger scale and advanced trials that evaluate effectiveness in relevant patient populations.

3.2.1. Focus Areas for the CTA

To meet the intent of the funding opportunity, applications must address at least one sub-area (e.g., 1a, 1b, 2a, 2b) within one of the two FY26 TBIPHRP CTA focus areas listed below.

Bulleted items are provided in Appendix 3 to indicate additional context regarding programmatic intent but are not required to be specifically addressed by applications. Selection of the appropriate FY26 TBIPHRP CTA focus area is the responsibility of the applicant.

1. Prevent and Assess: Research will address the prevention, screening, diagnosis or prognosis of psychological health conditions and/or TBI.

a. Identification and validation of biomarkers or other objective methods for assessment, diagnosis, prognosis or real-time monitoring of psychological health conditions and/or TBI, including subclinical presentations, and associated sequelae of these conditions.

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Development of decision-making frameworks or tools that incorporate objective assessments and may consider long-term outcomes to inform return-to-activity/duty decisions are within scope.

b. Development and evaluation of approaches or tools to prevent or reduce risk of psychological health conditions and/or TBI.

c. Development and evaluation of crosscutting prevention approaches to address multiple adverse outcomes such as suicide, interpersonal violence including intimate partner and family violence, sexual assault, psychological health issues and/or TBI.

Crosscutting prevention approaches refer to strategies that enhance protective factors and reduce risk factors at multiple socio-ecological levels (e.g., individual, relationship and community).

d. Development and evaluation of solutions to support military and Family readiness and increase psychological resilience in individuals to the potential negative impacts of specific military and life stressors.

Military readiness refers to the ability of military forces to fight and meet the demands of national military strategy; Family readiness is the state of preparedness to effectively navigate the challenges of daily living experienced in the unique context of military service.

2. Treat: Research will address novel and repurposed interventions to improve the outcomes of psychological health conditions and/or TBI. Efforts that address treatment, rehabilitation and health services research are within scope.

a. Interventions that promote sustained functional recovery, including interventions administered acutely, during the post-acute phase or chronic phase of injury.

b. Development of postvention strategies to support individuals in workplace or community environments following a sexual assault, suicide event or other trauma.

Postvention refers to response activities that should be undertaken in the immediate aftermath of a suicide that has impacted the unit. Postvention has two purposes: to help suicide attempt survivors cope with their grief, and to prevent additional suicide.

c. Health services research to improve the adoption of evidence-based practices, access to care, or reduce barriers to care. Individual and systemic factors that influence access to or barriers to care as well as other factors that influence treatment engagement, follow-up care and improvement of long-term outcomes are applicable.

3.2.2. Key Elements for the CTA

Proposed research can be aligned with TBI, psychological health, or in combination.

Preliminary Data: Inclusion of preliminary data relevant to the proposed clinical trial is required.

Study Population: The proposed research solution(s) should be representative of the characteristics and priorities of the population(s) intended to benefit from the research.

Intervention Availability: The application should demonstrate the documented availability of and access to the drug/compound, device and/or other materials needed, as appropriate, for the proposed duration of the study.

https://www.prevention.mil/Portals/130/Documents/PPoA_2.0.pdf https://apps.dtic.mil/sti/pdfs/ADA439918.pdf https://www.esd.whs.mil/Portals/54/documents/DD/issuances/dodi/134222p.pdf https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/649016p.pdf?ver=2020-06-15-112615-427

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Precision Medicine Approaches: When appropriate, the TBIPHRP encourages the use of precision medicine approaches. These tailored treatments deliver the right treatment at the right time while considering an individual’s unique characteristics.

Personnel and Environment: The application should demonstrate the study team’s expertise and experience in all aspects of conducting clinical trials, including appropriate statistical analysis and knowledge of Regulatory Agency processes (if applicable). The application should include a study coordinator(s) who will guide the clinical protocol through the local Institutional Review Board (IRB) of record and other federal agency regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual.

The application should show strong institutional support and, if applicable, a commitment to serve as the regulatory sponsor, ensuring all sponsor responsibilities described in the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312), Subpart D, for U.S. Food and Drug Administration (FDA)-regulated studies.

Research Levels: The TBIPHRP CTA offers funding for two Research Levels (refer to Section 3.4, Funding Details). Applicants may choose only one Research Level per application. The applicant is responsible for selecting the Research Level that aligns with the scope of the proposed research. The Research Level selected should be based on the research scope and not on the amount of the budget. The following are generalized descriptions of the scope of the research appropriate for each Research Level.

• Research Level 1: Supports proof-of-principle pilot studies, as well as phase 1 and phase 2 clinical trials.

• Research Level 2: Supports larger-scale and advanced clinical trials that evaluate effectiveness in relevant patient populations.

Early-Career Investigator Partnering Option (available for both research levels): Both Research Levels include an option for more than one PI. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. The intent is not to create a mentor-mentee arrangement. Both PIs should contribute significantly to the development and execution of the proposed research project. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory and administrative requirements. For individual submission requirements for the Initiating and Partnering PI(s), refer to Section 5.3, Submission Instructions.

3.2.3. Other Important Considerations for the CTA

Clinical Trial Start Date: The proposed clinical trial is expected to begin no later than 12 months after the award date or 18 months after the award date for studies regulated by the Regulatory Agency. Unless otherwise noted, for the purposes of this funding opportunity, Regulatory Agency refers to the FDA or any equivalent international regulatory agency.

Hypothesis-Driven Research: Applications consisting solely or primarily of planning, engineering, manufacturing, or formulation activities, without a core, scientific hypothesis and testing, may be administratively withdrawn.

Research requiring an exception from informed consent (EFIC) is prohibited.

Funding from this award mechanism must support a clinical trial. Preclinical research is not supported in this funding opportunity.

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An informational resource for preparing an application, the Human Subject Research Resource, is available on the CDMRP website.

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 by the Clinical Trial Award application submission deadline. The regulatory application should be specific to the product and indication to be tested in the proposed clinical trial.

Regulatory Strategy (if applicable): All interventions, even if they are not FDA-regulated (or international equivalent), are within scope but the regulatory status must be documented in Attachment 7, Regulatory Strategy.

Community-Based Participatory Research: Applicants should propose research that directly addresses the psychological health conditions and TBI needs of people with lived experience, their families and care providers. These partnerships are key to maximizing the translational potential and impact of research. CBPR approaches can be documented in Attachment 12, CBPR Documentation. Additional information can be found in Appendix 4.

Data Sharing Requirements for Traumatic Brain Injury or Psychological Health Human Subjects Research: The CDMRP intends that information, data and research resources generated under this funding opportunity will be made available to the research community and the public at large. The information below outlines the mandatory data and sharing requirements for all prospective human-subjects research:

• Informed consent: Consent forms must allow for the submission of de-identified data to a repository. It is also strongly encouraged to include language for optional passive follow-up via electronic health records (EHR).

• Common Data Elements (CDEs): Use of CDEs relevant to the field of study (e.g., National Institute of Neurological Disorders and Stroke (NINDS) TBI CDEs, PhenX collections) is mandatory. Justification is required if CDEs are not used.

• Secondary Outcomes: Applicants are strongly encouraged to include secondary outcomes to address potential crosscutting impacts

• For studies prospectively enrolling 50 or more subjects, applications must share data in an appropriate repository based on the application’s research area. Recommended repositories are below:

○ National Institute of Mental Health Data Archive (NDA): The NDA houses, harmonizes and shares all human-subjects data collected as part of NIMH-funded projects, with the goal of accelerating progress in mental health research. Applicants should use the NDA cost estimation tool to budget for manpower and associated costs.

○ Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System:

FITBIR is a central repository to promote collaboration, accelerate research and advance knowledge on the characterization, prevention, diagnosis and treatment of TBI.

Applicants should use the FITBIR cost estimation tool to budget for manpower and associated costs.

○ Additional National Institutes of Health (NIH)-supported Data Repositories can be found at https://www.nlm.nih.gov/NIHbmic/domain_specific_repositories.html

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.

https://cdmrp.health.mil/#:~:text=Human%20Subject%20Research%20Resource https://www.commondataelements.ninds.nih.gov/ https://www.commondataelements.ninds.nih.gov/ https://www.phenxtoolkit.org/index.php https://nda.nih.gov/ https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fs3.amazonaws.com%2Fnda.nih.gov%2FDocuments%2FNDA_Data_Submission_Cost_Estimation_Tool.xlsx&wdOrigin=BROWSELINK https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fs3.amazonaws.com%2Fnda.nih.gov%2FDocuments%2FNDA_Data_Submission_Cost_Estimation_Tool.xlsx&wdOrigin=BROWSELINK https://fitbir.nih.gov/ https://fitbir.nih.gov/jsp/contribute/fitbir-costs.jsp https://www.nlm.nih.gov/NIHbmic/domain_specific_repositories.html 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

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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.

PIs are encouraged to integrate and/or align their research projects with DOW and/or VA research laboratories and programs. Collaboration with the DOW and/or VA is also encouraged. A list of websites that may be useful in identifying additional information about ongoing DOW and VA areas of research interest or potential opportunities for collaboration can be found in Appendix 10 of the GAI.

Classified research is prohibited. This includes classified research data within the application and/or proposing research of which the anticipated outcomes may be classified or deemed sensitive to national security concerns may result in application withdrawal. This includes, but is not limited to, research involving directed energy (e.g., photonic, radio frequency, acoustic energy, other non-kinetic sources), anomalous health incidents, Havana syndrome and associated neurological syndromes/injuries. Refer to the GAI, Appendix 7, Section C.

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.

3.4.1. Application Submission With a Single PI

• For Research Level 1

○ Cost Cap: The application’s/proposal’s total costs budgeted for the entire period of performance should not exceed $2.1M.

• For Research Level 2

○ Cost Cap: The application’s/proposal’s total costs budgeted for the entire period of performance should not exceed $4.1M.

3.4.2. Application Submission With the Early-Career Investigator Partnering Option

• For Research Level 1

○ Cost Cap: The combined total costs budgeted for the entire period of performance in the applications of the Initiating PI and the Partnering PI should not exceed $2.1M.

• For Research Level 2

○ Cost Cap: The combined total costs budgeted for the entire period of performance in the applications of the Initiating PI and the Partnering PI should not exceed $4.1M.

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A separate award will be made to each PI’s organization.

The PIs are expected to be partners in the research, and total cost funding should be divided accordingly unless otherwise warranted and clearly justified.

3.4.3. For Both Options Within This Award Mechanism

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:

Must be requested for:

• In Years 3 and 4, travel costs for the PI or Initiating PI and Partnering PI to present project information or disseminate project results at a DOW-sponsored meeting (e.g., Military Health System Research Symposium). For planning purposes, it should be assumed that the meeting will be held in the Central Florida Area.

May be requested for (not all-inclusive):

• Travel in support of multi-institutional collaborations.

• Starting in Year 2, travel costs for the PI or Initiating PI and Partnering PI to present project information or disseminate project results at one scientific/technical meeting per year in addition to the required meetings described above. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the FY26 TBIPHRP CTA .

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

• Costs associated with data and research resource sharing (i.e., making a large dataset available to the public or developing an important resource for the scientific community). If recommended for funding, the government reserves the right to reduce the data/resource sharing budget request during negotiations in order to maximize funding available for research. The TBIPHRP will not provide future TBIPHRP funds to preserve or share data/resources indefinitely.

Must not be requested for:

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

• Tuition.

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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

The Initiating PI must submit the following pre-application 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:

○ Focus Area: Describe how the proposed project is relevant to the selected sub-area(s) within one of the two FY26 TBIPHRP CTA Focus Areas.

○ Background and Rationale: Describe the scientific rationale on which the proposed work is based; include relevant preliminary data and literature citations. Identify the phase of the clinical trial proposed.

○ Specific Aims and Study Design: Concisely state the hypothesis and specific aims.

Provide a brief overview of the study design. Briefly describe the intended subject population(s). As applicable, identify the availability of and accessibility to the intervention. As applicable, provide the regulatory status (including device classification) and identify the regulatory sponsor. Indicate how the study design is informed by the CBPR approach. Identify and justify the requested Research Level.

○ Research Team: Briefly state the qualifications and expected contributions of the PI(s), CBPR approach and key personnel to perform the clinical trial. Note any DOW or VA collaborations. Explain how the project incorporates CBPR.

○ Impact and Relevance to Military Health: Describe how the clinical trial will improve the prevention, assessment and treatment of psychological health conditions and/or traumatic brain injuries. Describe how the research is relevant to the health care needs of Service Members.

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

FY26 Traumatic Brain Injury and Psychological Health Clinical Trial Award 13

• Pre-Application Supporting Documentation: The items to be included as supporting documentation for the pre-application/pre-proposal 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).

○ Other Pre-Applications (two-page limit): If applicable, provide a list of all FY26 CTA pre-applications where the PI is also named as a PI, Initiating PI, Partnering PI, or collaborator. Each entry must include the CDMRP log number, the PI's role, the project title, the specific aims and a brief explanation of how each pre-application's research questions are distinct.

○ 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. Biographical sketches, or equivalent document, should also be included for lived-experience consultants (LECs) or community-based partners to demonstrate background and experience related to their role in the proposed research project. Letters of support are not appropriate and will be removed. (For administrative purposes, please use the label “Consumer” when assigning the community partners’ roles in eBRAP).

4.3. Full Application Components

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

Early-Career Investigator Partnering Option: The CDMRP requires separate full application package submissions for the Initiating PI and each Partnering PI, even if the PIs are located within the same organization. The application submission process for the Partnering PI uses an abbreviated full application package.

4.3.1. Full Application Components for the PI or Initiating PI

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

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Formatting_Guidelines:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:~:text=SF424%20(R%26R)%20%E2%80%93%20Application%20for%20Federal%20Assistance%20Form https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Formatting_Guidelines:~:text=%C2%B7-,Project%20Narrative%3A,-Attach%20as%20%E2%80%9CProjectNarrative https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:~:text=eBRAP%20User%20Name-,Biographical%20Sketch,-%3A%20This%20file

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

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

FY26 Traumatic Brain Injury and Psychological Health Clinical Trial Award 14

Describe the proposed project in detail using the outline below. It should be evident that the proposed study meets the definition of a clinical trial.

– Background: Describe in detail the scientific rationale for the study. Provide a review and analysis of relevant literature, unpublished data, preliminary studies/data and/or preclinical data relevant to the proposed clinical trial.

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

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

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

▪ Describe any CBPR/stakeholder engagement that was performed and how it helped to formulate the hypothesis/objective and research strategy. Full details of the CBPR approach should be provided in Attachment 12.

If the proposed clinical trial was initiated using other funding prior to this application, explain the history and background of the clinical trial 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: 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 intervention itself, for conduct of the clinical trial. As applicable, appropriate letters of support/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.

– 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 trial and detail the specific aims that will address the hypothesis/research question. The aims should align with the associated tasks described in the Statement of Work (SOW) (Attachment 5).

– Study Design: Describe the proposed clinical trial 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.

Describe how the proposed research aligns with at least one of the sub-area(s) within one of the three FY26 TBIPHRP CTA Focus Areas and is appropriate for the requested Research Level. 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 trial methodology and study variables in sufficient detail to demonstrate a clear course of action and justification. Describe the interaction with the human https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in

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

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

FY26 Traumatic Brain Injury and Psychological Health Clinical Trial Award 15 subject, including the study intervention 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). Define each arm/study group of the proposed trial, 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).

▪ Briefly describe the study population and the inclusion and exclusion criteria that will be used to meet the needs of the proposed clinical trial. Additional details should be provided in Attachment 9: Study Population Recruitment and Safety Plan.

▪ 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. Note that CDMRP will not serve as the government sponsor or signatory on any access applications or agreements for DOW or VA patient populations, resources or databases. 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 GAI, Appendix 4, for additional considerations.

– 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 trial’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.

▪ 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 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource:~:text=APPENDIX%204.%0AUSE%20OF%20DOW%20OR%20U.S.%20DEPARTMENT%20OF%20VETERANS%20AFFAIRS%20RESOURCES

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

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

FY26 Traumatic Brain Injury and Psychological Health Clinical Trial Award 16 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 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…