Spinal Cord Injury Research Program (SCIRP) Discovery Award

Spinal Cord Injury Research Program (SCIRP) Discovery Award is sponsored by Department of Defense (DoD). Encourages new ideas and approaches to spinal cord injury research.

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

# Program Announcement for the Defense Health Agency # Spinal Cord Injury Research Program # Funding Opportunity Number: HT942526SCIRPCTA # Pre-Application Due: August 03, 2026 # Application Due: November 12, 2026 FY26 Spinal Cord Injury Clinical Trial Award 2 Summarizes the funding opportunity , funding details , submission deadlines and review Details eligibility factors for the applicant organization and Principal Investigator Describes the program mission and intent of the Clinical Trial Award ; provides key award information and considerations ; and outlines funding details Presents the two-step application process and instructions for preparing a pre-application 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 Outlines what a successful applicant can expect if recommended for funding References policy requirements for funded research; outlines reporting requirements and restrictions related to Principal Investigator changes and institutional award transfers Outlines criteria for administrative actions including application rejection , modification , Includes a checklist for all full application components to facilitate application submission 40 FY26 Spinal Cord Injury Clinical Trial Award 3 • 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).

Questions regarding funding opportunity submission requirements, as well as technical assistance related to pre-application or intramural application submission. Grants. gov Support Center International: 1-606-545-5035 FY26 Spinal Cord Injury Clinical Trial Award 4 # 1.

Basic Information About the Funding Opportunity Summary: The fiscal year 2026 (FY26) Spinal Cord Injury Research Program (SCIRP) Clinical Trial Award (CTA) supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of spinal cord injury (SCI).

Distinctive Features: This funding opportunity contains an Early-Career Partnership Option ,which allows for two Principal Investigators (PIs). If this option is selected, at least one of the named PIs must be an early-career investigator. Only the Initiating PI will submit a pre-application, but all PIs will need to submit full applications.

The Partnering PI’s application is an abbreviated package specific to their distinct portion of the research project. If recommended for funding, each PI will be named on a separate award to the recipient organization(s). Be advised, all associated applications for a research project may be withdrawn if the initiating or partnering application is rejected or administratively withdrawn.

Applications to this funding opportunity must name at least two spinal cord injury (SCI) community partners (e.g., SCI Lived-Experience Consultants, representatives of community-based organizations) who will provide advice and consultation throughout the planning and implementation of the research project. **NEW for FY26** An investigator may be named on only one FY26 SCIRP Clinical Trial Award application as a PI.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $9. 76M to fund approximately 2 Clinical Trial Award applications with total cost caps of $4. 8M for a Single PI, or $4.

96M for the Early-Career Partnership Option, per award. The maximum period of performance is 4 years. 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 03, 2026 Invitation to Submit an Application: September 18, 2026 Application Submission Deadline: 11:59 p. m. ET, November 12, 2026 End of Application Verification Period: 5:00 p.

m. ET, November 16, 2026 Peer Review: January 2027 Programmatic Review: March 2027 Announcement Type: Initial Funding Opportunity Number: HT942526SCIRPCTA Assistance Listing Number: 12. 420 Section Shortcuts FY26 Spinal Cord Injury Clinical Trial Award 5 # 2.

Eligibility Information 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 Investigators affiliated with an eligible organization are eligible to be named as Principal Investigator (PI) on the application, regardless of ethnicity, nationality or citizenship status. An investigator may be named on only one fiscal year 2026 (FY26) Spinal Cord Injury Research Program (SCIRP) Clinical Trial Award (CTA) application as a PI.

Single PI Option: Independent investigators at all career levels may be named by the organization as the PI on the application.

Early-Career Partnership Option: If this option is selected, at least one of the named PIs (Initiating or Partnering) must be an investigator with at least three years' research experience (independent or non-independent) beyond a terminal degree but no more than seven years within their first faculty appointment, or equivalent independent research position (excluding time spent on family medical leave).

Lapses in research time or appointments as denoted in the biographical sketch should be explained in the application. The other PI (Initiating or Partnering) may be an independent investigator at any career level. Cost sharing is not an eligibility requirement.

Awards are made to eligible organizations , not to individuals. Refer to the GAI for additional recipient qualification requirements . Section Shortcuts FY26 Spinal Cord Injury Clinical Trial Award 6 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 Spinal Cord Injury Research Program (SCIRP). 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 SCIRP in 2009 to provide support for traumatic spinal cord injury (SCI)-related research of exceptional scientific merit that has the potential to make a significant impact on improving the health and well-being of military Service Members, Veterans, and other individuals living with SCI. Appropriations for the SCIRP from FY09 through FY25 totaled $477. 85 million (M).

The FY26 appropriation is $33M.

Mission of the SCIRP: To fund research and encourage interdisciplinary collaborations for the development and translation of more effective strategies to improve the health and well-being of Service Members, Veterans, and other individuals with spinal cord injury Vision of the SCIRP: Advance the treatment and management of spinal cord injury and ameliorate its consequences Innovative research that investigates new directions or addresses neglected issues in the field of traumatic SCI is supported, although studies focused exclusively on identifying intervention targets are discouraged.

Mechanism-focused studies must be specific to SCI and demonstrate a clear path from increased understanding to advancing treatments. Applications proposing interventions must demonstrate a clinically feasible window for treatment and more than incremental improvement over existing therapies.

Studies addressing critical questions essential for advancing research toward clinical use, such as study population selection, dosing and safety are allowable. 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 significant to Service Members, Veterans, their Families and the American public. 3. 1.

Program Priority Areas With Programmatic Goals For FY26, the SCIRP identified near-term and long-term programmatic goals for program-supported research outcomes and products, which align to four key priority areas within the SCI field. Research supported by the FY26 SCIRP must address at least one of the program priority areas and undertake an associated near-team programmatic goal listed below.

Section Shortcuts FY26 Spinal Cord Injury Clinical Trial Award 7 Additionally, applicants will be asked to describe the steps the research team will take to further advance the project’s outcome(s)/product(s) in accordance with the long-term programmatic goal of the same priority area.

Priority Area: Acute Injury Intervention Near-Term Goal: Develop and/or test interventions, e.g., surgical, device, pharmacologic, that protect spinal cord tissue from further damage shortly after injury and can be administered on a timeline suitable for acute trauma care in both battlefield and civilian settings.

Long-Term Goal: Adoption of management/stabilization practices into the standard of care for acute spinal cord injury, leading to meaningfully improved outcomes within the prehospital, hospital or deployed environments. Priority Area: Secondary Health Effects Near-Term Goal: Develop and/or test interventions to prevent or manage the secondary health effects of spinal cord injury that impact injury survivors throughout their lifespan.

Long-Term Goal: Adoption of interventions into the standard of care that significantly reduce the burden of secondary health effects and improve the lifelong health of SCI survivors. Priority Area: Psychosocial Well-Being Near-Term Goal: Develop and/or test psychosocial interventions that are specifically tailored to the unique needs of individuals with SCI, their families and/or care partners.

Long-Term Goal: Adoption of interventions into the standard of care that promote psychosocial well-being for people with SCI, their families and/or care partners. Priority Area: Rehabilitation and Regeneration Near-Term Goal: Develop and/or test rehabilitation, regenerative or neuroplastic interventions for individuals with spinal cord injury that can be implemented at any stage of life post-injury.

Long-Term Goal: Adoption of validated rehabilitation and regenerative therapies into the standard of care that meaningfully improve function, independence and quality of life after SCI. The SCIRP Clinical Trial Award mechanism was first offered in FY09. Since then, 306 Clinical Trial Award applications were received, and 62 were recommended for funding.

3. 3. Intent of the Clinical Trial Award The SCIRP Clinical Trial Award mechanism supports the rapid execution and analysis of clinical trials with the potential to have a significant impact on the treatment or management of SCI.

Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs, biologics or medical devices), clinical guidance, and/or emerging approaches and technologies.

Proposed projects may range from small proof-of-concept trials (i.e., pilot, first-in-human, phase 0) to demonstrate the feasibility or inform the design of more advanced trials through large-scale trials to determine efficacy in relevant patient populations.

Section Shortcuts FY26 Spinal Cord Injury Clinical Trial Award 8 Alternative trial designs to traditional randomized clinical trials are allowed but should be appropriate to the objective of the trial. Utilization of decentralized clinical trial strategies that leverage virtual elements/tools for participant enrollment, communication, and data collection is especially encouraged. 3.

3. 1. Key Elements for the CTA Impact: Applications must articulate how the proposed research will advance at least one of the FY26 SCIRP priority areas and help achieve its associated near-term programmatic goal identified in Section 3.

1 . Early-Career Partnership Option: To promote enhanced research capacity within the SCI field, the FY26 CTA includes an option specifically for partnership with or among early-career investigators. The Partnership Option is structured to accommodate two PIs who will work together on a single research project.

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. At least one of the PIs (Initiating or Partnering) must be an early-career investigator .

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 a separate award 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 PIs, refer to Section 5. 3, Submission Instructions . Community-Informed Research: Research funded by the FY26 SCIRP CTA must be responsive to the needs of people with SCI, their families and/or their care partners.

To this end, applicants are encouraged to leverage patient perspectives research to inform the research question or study design of the proposed trial. Furthermore, research teams are also required to establish and utilize effective and equitable partnerships with SCI lived-experience community members to maximize the translation and impact potential of the proposed research.

Applications to the FY26 SCIRP CTA are expected to name at least two community partners (e.g., SCI Lived-Experience Consultants, representatives of community-based organizations) who will provide advice and consultation throughout the planning and implementation of the research project. For additional resources, see Community Collaboration below. 3.

3. 2. Other Important Considerations for the CTA Allowable Research: Funding from this award mechanism must support a clinical trial .

Preclinical research is not supported in this funding opportunity. Applicants seeking funding for research that does not meet the definition of a clinical trial should consider other 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.

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.

Section Shortcuts FY26 Spinal Cord Injury Clinical Trial Award 9 An informational resource for preparing an application, the Human Subject Research Resource , is available on the CDMRP website. Project Timeline: 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 U.S. Food and Drug Administration (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 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.

Use of Common Data Elements (CDEs): Use of the National Institute of Neurological Disorders and Stroke SCI CDEs is strongly encouraged for all human subject research. Relevance to Military Health: To help elucidate the realities of treating and managing SCIs while in a deployed environment, a resource document is now available that outlines Spinal Cord Injury Management within the Military Health System (MHS) .

Applicants are encouraged to read and consider this document before preparing applications. Furthermore, applicants 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 Community Collaboration: Collaborative research approaches, such as community-based participatory research, participatory action research, and integrated knowledge transition create partnerships between scientific researchers and community members to create knowledge useable by both sets of stakeholders.

Recognizing the strengths of each partner, scientific researchers and community members collaborate and contribute equitably on all aspects of the project, which may include needs assessment, planning, research intervention design, implementation, evaluation and dissemination.

Collaborative research approaches feature shared responsibility and ownership for the research project to ensure non-tokenistic involvement of community members within the research team. Research results are jointly interpreted, disseminated, fed back to affected communities, and may be translated into interventions or policy.

These methods are critically important for community-level interventions and can also have important impacts on translational research and prototype development to identify and augment the potential impact of a research program on people living with SCI, their families and/or their care partners.

Collaborative relationships with consumers and the lived-experience community are often established through integrating community members into research teams as co-researchers, advisors and/or consultants.

Some examples for implementing collaborative research approaches include: Lived-Experience Consultation: The research team includes at least one project advisor with lived SCI experience who will provide advice and consultation throughout the planning and implementation of the research project. Lived-Experience Consultants may include individuals with SCI, their family members and/or their care partners.

Partnership With a Community-Based Organization: The research team establishes partnerships with at least one community-based organization that provides advice and Section Shortcuts FY26 Spinal Cord Injury Clinical Trial Award 10 consultation throughout the planning and implementation of the research project.

Community-based organizations may include advocacy groups, service providers, policymakers or other formal organizational stakeholders. Community Advisory Board Utilization: A community advisory board is composed of multiple community stakeholders and can take many forms, from a board of Lived-Experience Consultants to a coalition of community-based organizations or any combination thereof.

As with Lived-Experience Consultants and organizational partners, the community advisory board provides advice and consultation throughout planning and implementation of the research project. Additional information on collaborative research approaches can be found here: Wallerstein, N. and Duran B.

2010. Community-based participatory research contributions to intervention research: The intersection of science and practice to improve health equity . American Journal of Public Health 100(S1):S40-S46.

doi: 10. 2105/AJPH. 2009.

184036. Gainforth, H. L.

, F. Hoekstra, R. McKay, et al.

2021. Integrated knowledge translation guiding principles for conducting and disseminating spinal cord injury research in partnership . Archives of Physical Medicine and Rehabilitation 102(4):656-663.

doi: 10. 1016/j. apmr.

2020. 09. 393.

The funding instrument for awards made under the program announcement will be grants (31 USC 6304). Period of Performance : The maximum period of performance is 4 years. 3.

5. 1. Application Submissions With a Single PI Cost Cap : The application’s total costs budgeted for the entire period of performance should not 3.

5. 2. Application Submissions With the Early-Career Partnership Option 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.

96M . A separate award will be made to each PI’s organization. The PIs are expected to be partners in the research, and direct cost funding should be divided accordingly unless otherwise warranted and clearly justified.

Any application that requests the higher level of funding and that does not include an eligible early-career PI will have its budget reduced as appropriate. 3. 5.

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.

Section Shortcuts FY26 Spinal Cord Injury Clinical Trial Award 11 All direct and indirect costs of any subaward or contract must be included in the direct costs of the primary award. The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 4 years. The appropriateness of the budget for the proposed research will be assessed during peer review.

Direct Cost Restrictions: For this award mechanism, direct costs: May be requested for (not all-inclusive): • Costs for sharing data and research resources. • Costs associated with collaborative research approach (e.g., consultant costs, equitable participation training, capacity-building activities).

• 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). • Travel in support of multi-institutional collaborations. • Costs for one investigator, per award, to travel to one scientific/technical meeting per year.

The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the FY26 SCIRP CTA. Must not be requested for: • Preclinical research costs. • Costs for travel to scientific/technical meeting(s) beyond the limits stated above.

Section Shortcuts FY26 Spinal Cord Injury Clinical Trial Award 12 # 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 PI, or Initiating PI if selecting the Early-Career Partnership Option , 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: Background/Rationale: State the scientific rationale on which the proposed research project is based.

Clearly demonstrate that there is sufficient rationale, background data and readiness to support the initiation of the proposed clinical trial. Indicate how the research question or study design is informed by the lived-experience community and/or patient perspectives research. Specific Aims and Study Design: Concisely state the specific aims for the clinical trial and describe the scientific approach to address them.

Indicate whether alternative trial designs to traditional randomized clinical trials will be utilized and how the approach is appropriate to the objective of the trial. If applicable, describe the decentralized clinical trial strategies to be leveraged, including virtual elements/tools for participant enrollment, communication and data collection. It should be evident that the proposed study meets the definition of a clinical trial .

Impact: Describe the potential impact of the proposed research on at least one of the FY26 priority areas. Indicate how the proposed research will address a near-term programmatic goal identified in Section 3. 1 .

Relevance to Military Health: Describe whether/how the proposed research project is applicable to spinal cord-injured military Service Members, Veterans, and/or their Family members and care partners. Applicants are encouraged to review the Relevance to Military Health section of this program announcement prior to preparing this section.

Section Shortcuts FY26 Spinal Cord Injury Clinical Trial Award 13 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).

List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms, and symbols used in the Preproposal Narrative. 4. 3.

Full Application Components Applicants must receive an invitation to submit a full application. Uninvited full application submissions will be rejected. Early-Career Partnership Option: The CDMRP requires separate full application package submissions for the Initiating PI and Partnering PI, even if the PIs are located within the same organization.

The application submission process for the Partnering PI uses an abbreviated full 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 IMPORTANT: When completing the SF424 R&R, enter the eBRAP log number assigned during pre-application submission into Block 4a – Federal Identifier. 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”. 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 the available literature and completed/ongoing studies relevant to the proposed clinical trial.

This section should establish the relevance of the study and explain the applicability of the proposed findings to the SCI community and at least one of the FY26 SCIRP Program Priorities and associated near-term Describe the preliminary studies and/or preclinical data that support the proposed clinical trial. Include community/patient perspectives data to support the rationale and study design.

Section Shortcuts FY26 Spinal Cord Injury Clinical Trial Award 14 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.

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 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.

Objectives, Specific Aims and Hypotheses: Describe the purpose of the proposed study with detailed objectives. State the hypothesis/research question to be tested in the proposed clinical trial and detail the specific aims that will address the hypothesis/research question. Only describe aims that the SCIRP award would fund.

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

Describe the type of study to be performed. Alternatives to traditional randomized clinical trial designs are supported by this funding mechanism. 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 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.

If applicable, describe the decentralized clinical trial strategies to be leveraged, including virtual elements/tools for participant recruitment/enrollment, intervention administration/delivery and/or outcome data acquisition.

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 along with 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 Section Shortcuts FY26 Spinal Cord Injury Clinical Trial Award 15 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.

Where applicable, describe the SCI CDEs to be collected. 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 6: Study Population Recruitment and Safety Explain how the study design is appropriate to achieve the objectives of the trial.

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 thorough evaluation of all 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