HT942526OCRPOCCTAECI_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

Ovarian Cancer Research Program Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award

Funding Opportunity Number: HT942526OCRPOCCTAECI

Pre-Application Due: September 15, 2026

Application Due: October 1, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Ovarian Cancer Clinical Trial Academy – Early-Career Investigator 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 Ovarian Cancer Clinical Trial Academy – Early-Career Investigator 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 Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award 3

Before You Begin

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

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

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

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

Who to Contact for Support

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

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

eBRAP Help Desk

301-682-5507 help@eBRAP.org

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

Grants.gov Support Center

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

Questions regarding Grants.gov registration and Workspace.

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

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

FY26 Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award 4

1. Basic Information About the Funding Opportunity

Summary: Created in FY23, the Ovarian Cancer Clinical Trial Academy (OCCTA) supports the next generation of Early-Career Investigators (ECIs) in clinical trial research to produce effective treatments and cures for ovarian cancer. The OCCTA, through its Leadership, provides for professional and leadership development of the ECIs to include skills and competencies needed to execute clinical trials, providing intensive mentoring, national networking, collaborations, and a peer group for junior clinical trialists. The OCCTA will bring together established investigators (the Academy Dean and Assistant Dean), established Career Guides (mentors), and a group of ECIs/Scholars to conduct successful, highly productive clinical trials in ovarian cancer.

Distinctive Features: Research funded under this FY26 funding opportunity will support translational research and small-scale, early-phase clinical trials in ovarian cancer. Preliminary data are required, however, these data do not necessarily need to be derived from the ovarian cancer research field. The ECI must be within 12 years of their last postdoctoral research position (Ph.D.), clinical fellowship (M.D.), or equivalent at the time of full application submission deadline. The ECI must commit no less than 25% effort to this award and/or OCCTA activities for the first two years. The Designated Mentor must be a clinical trialist with a strong record of mentoring and training early-career investigators.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $4.2M to fund approximately three Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award applications with total cost caps of $1.4M per award. 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 (Letter of Intent) Submission Deadline: 5:00 p.m. Eastern Time (ET), September 15, 2026

• Application Submission Deadline: 11:59 p.m. ET, October 1, 2026

• End of Application Verification Period: 5:00 p.m. ET, October 6, 2026

• Peer Review: November 2026

• Programmatic Review: January 2027 Announcement Type: Initial Funding Opportunity Number: HT942526OCRPOCCTAECI Assistance Listing Number: 12.420

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

FY26 Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award 5

2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

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

2.1.2. Principal Investigator

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

• Early-Career Investigator

Must have completed their last postdoctoral research position (Ph.D.), clinical fellowship (M.D.) or equivalent within 12 years of the full application submission deadline.

Individuals in a postdoctoral research position (Ph.D.), clinical fellowship (M.D.) or equivalent at the time of full application submission are not eligible.

A Statement of Eligibility is required with the submission of the full application.

For industry, investigators at or above an independent scientist level may be named by the company as the PI on the application, provided they meet the criteria listed above.

Must commit no less than 25% effort to this award and/or OCCTA activities for the first two years.

• Designated Mentor Must be an independent, established clinical trialist and have a balanced portfolio of successful clinical trial experience.

Must have an active clinical trial at the time of application.

May be at the same institution as the ECI. If not at the same institution, another mentor

(“Other Mentor,” see below) at the ECI’s institution must also be included in the application submission.

Must have experience in ovarian cancer research if the ECI’s experience is not in ovarian cancer research.

Must demonstrate a commitment to develop and sustain the ECI’s independent career in ovarian cancer research; it is recommended that the Designated Mentor demonstrate a 5% effort for mentoring and participating in OCCTA activities such as offsite meetings and webinars. Mentor responsibilities include mentoring the ECI (i.e., the PI of this award) and an additional ECI within the OCCTA. Offsite OCCTA activities include annual in-person workshops and monthly web-based meetings.

A current OCCTA Designated Mentor can only be a Designated Mentor to one Ovarian Cancer Academy – Early-Career Investigator at a time; thus, current OCCTA Designated Mentors cannot be named as a Designated Mentor in an FY26 application unless the period of performance of the current Ovarian Cancer Clinical Trial Academy – Early-https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:%7E:text=pre%2Dapplication%20submission.-,Extramural%20Organization%3A,-A%20foreign%20or https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=Intramural%20DOW%20Organization%3A%20A%20subset%20of%20intragovernmental%20organizations%3B%20refers%20specifically%20to%20DOW%20organizations%2C%20including%20DOW%20laboratories%2C%20DOW%20military%20treatment%20facilities%2C%20and/or%20DOW%20activities%20embedded%20within%20a%20civilian%20medical%20center

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

FY26 Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award 6

Career Investigator Award mechanism ends no later than July 2027. The current OCCTA Dean and/or Assistant Dean cannot be listed as a Designated Mentor.

• Other Mentor (if applicable) Must be at the same institution as the ECI if the Designated Mentor is not from the same institution as the ECI.

Must be an independent cancer clinical trialist or an independent researcher in ovarian cancer. The Designated Mentor or Other Mentor must have experience in ovarian cancer research if the ECI’s experience is not in ovarian cancer research.

Must have research funding (past and present).

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#_Recipient_Qualification_Restriction_Info:%7E:text=APPENDIX%201-,RECIPIENT%20QUALIFICATION%20AND%20RESTRICTION%20INFORMATION,-A.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0

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

FY26 Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award 7

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 Ovarian Cancer Research Program (OCRP). 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 OCRP in FY97 to provide support for research of high potential impact and exceptional scientific merit. Appropriations for the OCRP from FY97 through FY25 totaled $556.45 million (M). The FY26 appropriation is $50M.

The mission of the OCRP is to support research to prevent, detect, treat, cure, and optimally survive ovarian cancer to enhance the well-being of Service Members, Veterans, retirees, their Family members, and all women impacted by this disease.

3.1. Award History

The OCRP Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award mechanism was first offered in FY24. Since then, 10 Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award applications were received, and three were recommended for funding.

3.2. Intent of the Ovarian Cancer Clinical Trial Academy – Early-Career Investigator

The intent of the Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award (OCCTA-ECI) is to enhance knowledge within next generation of ECIs in clinical trial research and to produce effective treatments and cures for ovarian cancer. The OCCTA enables the ECI (the investigator named as the PI on the application) to pursue funding for ovarian cancer clinical trial research under the guidance of a Designated Mentor. Because of the early-career nature of the PI, clinical trials initiated or collaborated with during the award period of performance are anticipated to be led by the Designated Mentors. Beyond research, OCCTA ECIs will be expected to participate in monthly webinars and annual workshops; and to communicate and collaborate with other members of the OCCTA (other ECIs, Mentors, Dean, Assistant Dean) as well as with the advocacy community.

This award provides the ECI with funding, networking, and collaborative opportunities, as well as the research experience necessary to develop and sustain a successful, independent career at the forefront of ovarian cancer clinical research. This award also provides support and protected time for the ECI for four years of intensive research under the guidance of the Designated Mentor. Although the OCCTA will serve as a conduit to share knowledge and research experience among all OCCTA members, the ECI and Designated Mentor will be responsible for designing and executing the proposed research and for developing the ECI’s career development plan.

3.2.1. Key Elements for the OCCTA-ECI

The ECI must clearly articulate their commitment to a career as an ovarian cancer clinical trialist and to participating in and contributing to the growth of the OCCTA.

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

FY26 Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award 8

The OCRP encourages applications from ECIs whose ability to commit to conducting ovarian cancer research is limited by minimal resources or a lack of resources, such as a qualified Designated Mentor at their institution; access to ovarian cancer research tools, resources and opportunities for establishing collaborations; or other obstacles.

The Designated Mentor must be a clinical trialist with a strong record of mentoring and training ECIs. The Designated Mentor will serve as a resource to the ECI in designing and executing ovarian cancer clinical trial research to fit the research landscape. With the goal to establish and enrich the mentorship capabilities of the OCCTA, current Ovarian Cancer Clinical Trial Academy (OCCTA) Designated Mentors cannot be named as a Designated Mentor in an FY26 application unless the period of performance of the current Ovarian Cancer Academy – Early-Career Investigator Award ends no later than July 2027. In the same manner, the Dean and Assistant Dean of the OCCTA cannot be listed as Designated Mentors.

Research funded under this FY26 program announcement must support a clinical trial, including small-scale, early-phase clinical trials in ovarian cancer. Examples of encouraged projects include, but are not limited to, diagnostic or prevention-focused studies, dietary or lifestyle interventions, therapeutic or surgical interventions, studies on quality of life, and repurposed drug trials.

Preliminary Data Are Required: Inclusion of preliminary data relevant to the proposed clinical trial is required. Preliminary data to support the feasibility of the research hypotheses and research approaches are required; however, these data do not necessarily need to be derived from the ovarian cancer research field.

Study Population: The application should demonstrate the availability of and access to a suitable patient population that will support a meaningful outcome for the study. The application should include a discussion of how accrual goals will be achieved, as well as the strategy for inclusion of diverse populations in the clinical trial appropriate to the objectives of the study.

Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, ethnicity, or race (typically classified as exempt from Institutional Review Board [IRB] review) are exempt from this requirement.

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

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, knowledge of U.S. Food and Drug Administration (FDA) processes (if applicable), and data management. The application should identify coordinator(s) who will guide the clinical protocol through the local 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 FDA regulatory sponsor, ensuring all sponsor responsibilities described in Code of Federal Regulations, Title 21, Part 312 (21 CFR 312), Subpart D, are fulfilled.

Consumer Advocates: Applications are encouraged to include consumer advocate involvement. The consumer advocate is encouraged to be involved in the development of the research question, project design, oversight, recruitment, and evaluation, as well as other significant aspects of the proposed project. As a lay representative, the consumer advocate must be an individual who has been diagnosed with ovarian cancer and should be active in an ovarian cancer advocacy organization. Their role in the project should be independent of their

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

FY26 Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award 9 employment, and they cannot be employees of any of the organizations participating in the application. Their role should be focused on providing objective input on the research and its potential impact for individuals with, or at risk for, ovarian cancer. The consumer advocate should have a high level of knowledge of current ovarian cancer issues and the appropriate background and/or training in ovarian cancer research to contribute to the project.

Statistical Analysis and Data Management Plans: The application should include a clearly articulated statistical analysis plan, a power analysis reflecting sample size projections that will answer the objectives of the study, and a data management plan that includes use of an appropriate database to safeguard and maintain the integrity of the data. If required by a Regulatory Agency, the trial must use a 21 CFR 11-compliant database and appropriate data standards.

3.2.2. Other Important Considerations for the OCCTA-ECI

Funding from this award mechanism must support a clinical trial. Applicants seeking funding for research that does not meet this definition should consider one of the other FY26 OCRP program announcements being offered.

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

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.

The proposed research must be relevant to Service Members, Veterans, military beneficiaries and/or the American public. 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.

A congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, CDMRP encourages applicants to review the recommendations and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY26 OCRP priorities.

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.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:%7E:text=SPIRIT%20and%20CONSORT%20are%20evidence,relevant%20empirical%20evidence%20where%20possible https://www.nature.com/articles/s41591-025-03668-w?fromPaywallRec=false https://arriveguidelines.org/arrive-guidelines https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=Period%20of%20Performance%3A%20The%20time%20interval%20between%20the%20start%20of%20a%20federal%20award%20and%20the%20planned%20end%20date.

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

FY26 Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award 10

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $1.4M. 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:

• Annual OCCTA workshop travel costs: Travel costs for the ECI and Designated Mentor (and

Other Mentor, if applicable) to attend an OCRP OCCTA Workshop with the OCCTA Leadership and other OCCTA members every year.

May be requested for (not all-inclusive):

Funding for the Designated Mentor(s)’s salary support (it is recommended that the requested salary amount to 5% of the Designated Mentor(s)’s annual salary to match efforts related to mentorship and participation in OCCTA activities).

If applicable and well justified, salary support for the Other Mentor.

Travel costs between collaborating organizations.

• Travel in support of multi-institutional collaborations.

• Costs associated with participating in the virtual OCCTA (e.g., hardware and/or software for the audio- or video-teleconferencing or web-based communications).

• Costs for one investigator to travel to two scientific/technical meetings per year in addition to the required OCCTA meeting described above. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the OCRP Ovarian Cancer Clinical Trial Academy– Early-Career Investigator Award.

Must not be requested for:

• Tuition.

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

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=in%20project%20activities.-,Cost%20Cap%3A,-The%20maximum%20cost

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

FY26 Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award 11

4. Application Contents and Format

4.1. Application Overview

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

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

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

4.2. Pre-Application Components

Letter of Intent (one-page limit): Provide a brief description of the research to be conducted.

LOIs are used for program planning purposes only (e.g., reviewer recruitment) and will not be reviewed during either the peer or programmatic review. An invitation to submit a full application is NOT provided after LOI submission. Applicants are encouraged to develop pre-application and full application components concurrently and submit a full application AFTER successful submission of the pre-application.

4.3. Full Application Components

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

Describe the proposed project in detail using the outline below.

– Background: The background section should 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 trial. 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 (as applicable). The research project must be focused on ovarian cancer.

https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E: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:%7E:text=%C2%B7-,Project%20Narrative%3A,-Attach%20as%20%E2%80%9CProjectNarrative https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:%7E:text=IV.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20GRANTS.GOV https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_eBRAP:%7E:text=V.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20eBRAP

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

FY26 Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award 12

– Objectives/Specific Aims/Hypotheses: Provide a description of the purpose of the study with detailed objectives, specific aims, and/or study questions/hypotheses.

Study Design: Describe the type of clinical trial research to be performed (e.g., prospective, randomized, controlled) and outline the proposed methodology in sufficient detail to show a clear course of action. This clinical trial research can be a part of designated mentor’s current/future clinical trial but needs to be focused on ovarian cancer and should be developed towards the ECI’s own independent project.

If a small-scale clinical trial requiring FDA approval is proposed, the application must include documentation of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application submission or approval (i.e., the file number of the application or the IND/IDE approval number).

Describe the experimental design, methods, and analyses (including appropriate randomization, blinding, sample-size estimation, and controls) in sufficient detail for analysis.

Describe how data will be collected, handled, and analyzed in a manner that is consistent with the study objectives.

Describe the statistical plan including a power analysis to demonstrate that the sample size is appropriate to meet the objectives of the study.

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

Describe the study population and include a detailed plan for the recruitment of human subjects or the acquisition of samples.

If applicable, describe the strategy for the inclusion of diverse populations appropriate to the objectives of the study, including a description of the composition of the proposed study population in terms of racial and/or ethnic group and an accompanying rationale for the selection of subjects. It is not expected that every study will include all racial and/or ethnic groups. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, ethnicity, or race are exempt from this requirement.

Identify the intervention to be tested and describe the projected outcomes. Describe how the intervention addresses current clinical needs and how it compares with currently available interventions and/or standards of care. Describe the plan; and demonstrate the availability of and access to the drug/compound, device, and/or other materials needed, as appropriate, for the proposed study.

Define the study variables and describe how they will be measured. Include a description of appropriate controls and the endpoints to be tested.

Describe the methods that will be used to recruit a sample of human subjects from the accessible population (e.g., convenience, simple random, stratified random).

Provide information on the availability of, and access to, the appropriate patient population(s), as well as the ability to accrue sufficient subjects for the clinical trial.

Provide readiness and/or anticipated first-patient-in date and a brief timeline for accrual and endpoints readout.

Describe the human subject-to-group assignment process (e.g., randomization, block randomization, stratified randomization, age-matched controls, alternating group, or

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

FY26 Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award 13 other procedures), if applicable. Explain the specific actions to accomplish the group assignment (e.g., computer assignment, use of table of random numbers).

ECI Career Goals: Discuss the ECI’s record of accomplishments, demonstrating the potential for becoming an independent investigator and ovarian cancer clinical trialist.

Describe the ECI’s career goals and plans in ovarian cancer clinical trials and how the proposed research and career development experience will promote an independent, sustainable career.

Integration of Career Development and Research: Describe how the individualized career development plan and research project are integrated and how they will contribute to preparing the ECI for an independent, sustainable career in ovarian cancer clinical trials.

Commitment to the OCCTA: Describe why participation in the OCCTA is important in developing the ECI’s career. Describe the ECI’s motivation and commitment to participating in the OCCTA, to include networking and collaborating with other ECI/Designated Mentor pairs (and, if applicable, an Other Mentor) and the OCCTA Leadership.

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 GAI, Appendix 4, for additional considerations.

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 (one-page limit per letter is recommended): Provide individual letters signed by collaborating individuals and/or organizational officials demonstrating that the PI has the support and resources necessary for the proposed https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource:%7E:text=eBRAP.org.-,APPENDIX%204.,-USE%20OF%20DOW https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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

FY26 Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award 14 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 Collaboration: Provide a signed letter from each collaborating individual and/or organization demonstrating that the PI has the support and resources necessary for the proposed work. If an investigator at an intramural DOW organization is named as a collaborator on a full application submitted through an extramural organization, the application must include a letter from the collaborator’s Commander or Commanding Officer at the intramural DOW organization authorizing the collaborator’s involvement.

Intellectual Property: Information can be found in the 2 CFR 200.315, “Intangible Property.”

Intellectual and Material Property Plan (if applicable): Provide a plan for resolving intellectual and material property issues among participating organizations.

Commercialization Strategy (if applicable): Describe the commercialization plan. The plan should include intellectual property, market size, financial analysis, strengths and weaknesses, barriers to the market, competitors, and management team. Discuss the significance of this development effort, when it can be anticipated, and the potential commercial use for the technology being developed.

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

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

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

FY26 Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award 15

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.

Inclusion Enrollment Report: Provide an anticipated enrollment table(s) for the inclusion of women and minorities using the Public Health Service (PHS) Inclusion Enrollment Report, a three-page fillable PDF form, that can be downloaded from eBRAP. The enrollment table(s) should be appropriate to the objectives of the study with the proposed enrollment distributed on the basis of sex, race, and ethnicity.

Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, ethnicity, or race (typically classified as exempt from IRB review) are exempt from this requirement.

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

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

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

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

Specific Aims: State the specific aims of the study.

Study Design: Describe the study design, including appropriate controls. Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported.

Impact: Briefly describe how the proposed project will have an impact on research, patient care, and survivorship in ovarian cancer. Describe how the proposed research will make an important contribution toward the goal of eliminating ovarian cancer.

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

Career Development Sustainment Plan:

Summarize how the proposed research and Career Development and

Sustainment Plan will facilitate and sustain the ECI’s independent career at the forefront of ovarian cancer research.

Describe how the proposed research project will allow the PI to make valuable contributions to ovarian cancer.

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

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

– Summarize the objectives and rationale for the proposed research.

– Describe the PI’s career goals in ovarian cancer research.

How do the research and career development plans support the PI in attaining these goals?

https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Statement%20of%20Work-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report,-n/a https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Statement%20of%20Work-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report,-n/a https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Lay%20Abstract%3A,-Attach%20as%20%E2%80%9CLayAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs

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

FY26 Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award 16

– Describe how the PI will participate in and contribute to the growth of the OCCTA.

Describe the ultimate applicability of the research.

– What are the potential applications, benefits and risks of the anticipated outcomes?

– What are the likely contributions of the proposed research project to advancing research, patient care and/or quality of life?

– What is the potential benefit of the proposed study and the anticipated outcomes to

Service Members, Veterans and/or their Families.

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

Refer to eBRAP for the Suggested SOW Format.

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

○ Attachment 6: Career Development and Sustainment Plan (two-page limit): Upload as “CareerSustain.pdf”.

– Describe the individualized career and professional development plan, which may include workshops, conferences, seminars, journal clubs, teaching responsibilities, and/or clinical responsibilities. Explain how this development plan will enable the ECI to obtain independent ovarian cancer research funding and publish in peer-reviewed journals.

– Discuss how the Designated Mentor and Other Mentor, if applicable, will assist the ECI in not only developing, but also sustaining, a career as an independent ovarian cancer researcher. Explain how the Career Development and Sustainment Plan is supported by the environment; include a description of resources available to the ECI at their institution, and, if different, at the Designated Mentor’s institution.

– Outline how the ECI and Designated Mentor (and Other Mentor, if applicable) will evaluate the ECI’s progress of achieving and, more importantly, sustaining a productive and independent career in ovarian cancer research.

○ Attachment 7: Impact Statement (one-page limit): Upload as “Impact.pdf”.

Identify the sample population(s) that will participate in the proposed intervention, inclusive of diverse populations if applicable; describe how they represent the target population that would benefit from the intervention; and describe the potential impact and anticipated outcomes of the proposed clinical trial on the lives and health of the target population. Describe how the proposed research will make a contribution toward the OCRP mission and will impact ovarian cancer research and/or patient care/or survivorship.

Describe any relevant controversies or treatment issues that will be addressed by the proposed clinical trial.

Describe any potential issues that might limit the impact of the proposed clinical trial.

Describe how the intervention represents an improvement over currently available interventions and/or standards of care.

https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW

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

FY26 Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award 17

Explain how the proposed research and Career Development and Sustainment Plan will facilitate professional development and sustain the ECI’s independent career at the forefront of ovarian cancer research.

Explain how the proposed research will have an impact on the health and well-being of Service Members, Veterans and their Family members.

○ Attachment 8: Designated Mentor’s Letter (three-page limit): Upload as “MentorLetter.pdf”.

– Describe the ECI’s background and potential to become an independent ovarian cancer researcher. Explain how this award will enhance the ECI’s capabilities to sustain a career in ovarian cancer clinical research.

– Describe the Designated Mentor’s background and experience in clinical trial research, success in acquiring funding in clinical trial research, and their record of mentoring and training ECIs.