Peer Reviewed Alzheimer's Transforming Care Award (TrCA)

Peer Reviewed Alzheimer's Transforming Care Award (TrCA) is sponsored by Department of Defense, Defense Health Agency Contracting Activity - DHACA. The intent of the FY24 Transforming Care Award (TrCA) is to support research that provides answers and solutions in critical areas to improve quality of life, reduce caregiver burden and stress, reduce health disparities, and increase support for individuals with a diagnosis of …

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

# Program Announcement for the Defense Health Agency # Alzheimer’s Research Program # Transforming Care Award # Funding Opportunity Number: HT94252 6AZ RP TrCA # Pre -Application Due: June 2 2, 2026 # Application Due: September 24, 2026 FY2 6 Alzheimer’s Transforming Care 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 Transforming Care 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 38 FY2 6 Alzheimer’s Transforming Care 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 registration s are active and up to date prior to application • Read th is 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 th is 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 key s (Windows) or command + left arrow key s (Mac intosh ) on your keyboard . Click to be taken to additional guidance and instruction s within the General Application Instructions ( GAI ).

funding opportunity submission as well as technical assistance related to pre -application or intramural application submission . Grants. gov Support Center International: 1 -606 -545 -5035 and Workspace .

Section Shortcuts FY2 6 Alzheimer’s Transforming Care Award 4 # 1.

Basic Information About the Funding Opportunity Summary: The fiscal year 2026 (FY26) Alzheimer’s Research Program (AZRP) Transforming Care Award (TrCA ) supports clinical research or clinical trials evaluating interventions, innovations, and solutions in critical areas for dementia care for individuals with Alzheimer’s disease and Alzheimer’s disease related dementia (AD/ADRD) and their care partner(s).

Clinical research and clinical trials are allowed; however, clinical trials solely testing or evaluating pharmacological interventions do not meet the intent of this funding opportunity. Studies utilizing animal models do not meet the intent of the mechanism and are not Preliminary data are required. Community collaboration is required for research prospectively enrolling human subjects.

The AZRP encourages studies to leverage existing cohorts/datasets. Cohorts consisting of individuals 65 years or younger are also encouraged. Career Initiation or Transition (CIT) Partnership Option : The TrCA includes an option for more than one PI and supports both new and existing collaborative partnerships.

If recommended for funding, each PI will be named on separate awards to the recipient organization(s). If utilizing this option, at least one independent investigator must meet the CIT Partnership Option eligibility requirements at the time of application submission. Funding Details: The Congressionally Directed Medical Research Programs ( CDMRP ) expects to allot roughly $5.

4 M to fund approximately three TrCA applications with total cost cap s of $1. 6 M per award for the single PI option and $1. 9M combined for the CIT Partnership Option .

The maximum period of performance is 4 years. It is anticipated that awards made from this FY2 6 funding opportunity will be funded with FY2 6 funds, which will expire for use on September 30, 203 2. Awards supported with FY2 6 funds will be made no later than September Submission and Review Dates and Times Pre -Application (Preproposal ) Submission Deadline: 5:00 p.

m. Eastern Time (ET), Invitation to Submit an Application : August 10, 20 26 Application Submission Deadline: 11:59 p. m.

ET, September 24 , 20 26 End of Application Verification Period: 5:00 p. m. ET, September 29 , 20 26 Peer Review: December 20 26 Programmatic Review: February 20 27 Announcement Type: Initial Funding Opportunity Number: HT94252 6AZR PTrCA Assistance Listing Number: 12.

420 Section Shortcuts FY2 6 Alzheimer’s Transforming Care Award 5 # 2. Eligibility Information 2. 1.

Eligible Applicants 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 Principal Investigator (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.

At least one independent investigator must meet the CIT Partnership Option eligibility Career Initiation investigators must have at least three years of research experience beyond a terminal degree but no more than seven years within their first independent research position with only nominal, if any, research support or publications in the field.

Lapses in research time or appointments as denoted in the biographical sketch should be explained in Career Transition investigators may be any level, but new to military health, traumatic brain injury, and/or AD/ADRD fields, with nominal, if any, publications and/or research support for Application Limit: The same independent investigator may not be named as a PI, Initiating PI, or Partnering PI on more than four (4) TrCA applications.

Cost sharing is not an eligibility requirement . Awards are made to eligible organizations , not to individuals. Refer to the G AI for additional recipient qualification requirements .

Section Shortcuts FY2 6 Alzheimer’s Transforming Care 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 Alzheimer’s Research Program (AZRP).

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 D epartment of War, DOW . Congress initiated the AZRP in 2011 to provide support for Alzheimer’s disease research of high potential impact and exceptional scientific merit. Appropriations for the AZRP from FY 11 through FY 25 totaled $ 213 million (M).

The FY 26 appropriation is $ 15 M. AZRP Vision Statement: Mitigate the impact of Alzheimer’s and related dementias associated with traumatic brain injury (TBI ), military and diverse risks. AZRP Mission Statement: Fund impactful, solution -oriented research to address critical needs and improve quality of life for Service Members, Veterans, their Families, and the public who are living with Alzheimer’s disease and related dementias.

The AZRP Transforming Care Award (TrCA ) mechanism was first offered in FY 23 . Since then, 68 TrCA applications were received, and 5 were recommended for funding. 3.

2 . Intent of the Transforming Care Award The FY26 TrCA intend s to support well -designed non -incremental clinical research /trials in dementia care that provide significant impact and solutions for the AD/ADRD field, Community, and military health. Funded research will support the evaluation of interventions, innovations, and solutions in critical areas in dementia care .

Applications may address knowledge gaps, interventions, strategies, technologies and/or tools. Research should lead to improved quality of life, reduced caregiver burden and stress, and increased support for those living with dementia diagnoses. Applications ar e encouraged to prioritize both the individual living with an AD/ADRD diagnosis and their care partner(s).

In addition, the FY26 AZRP TrCA encourages applications that address health disparities in Alzheimer’s Disease (AD) and Alzheimer’s Disease Related Dementias (ADRD) research .

Research responsive to the FY26 AZRP TrCA includes, but is not limited to , studies that : • Inform improvements and solutions in long -term care, quality of life , and psychosocial • Provide evidence supporting quality of life improvements for aging in place, belonging, and community living for individuals, care partners, and families living with a dementia diagnosis • Address dementia care considerations specific to Service Members , and/or Veterans , and their Families, such as navigating the AD/ADRD diagnosis and care path and overcoming care partner/caregiver stress • Evaluate the impact of interventions, innovations, and solutions for individuals living with AD/ADRD and their caregiver sSection Shortcuts FY2 6 Alzheimer’s Transforming Care Award 7 For the purposes of this funding opportunity, the following terms are defined: • Care is used comprehensively to indicate the broad spectrum of dementia care, beyond that of medical care/pharmacological intervention administered by clinicians.

• Community encompasses the network of individuals living with an AD/ADRD diagnosis, their care partner(s), families, advocates and/or other close connections. The CDMRP refers to these individuals as consumers. • Military or military health refers to not only members of all components of the U.S. Armed Forces, but Veterans, their Families, and other DOW beneficiaries.

Note that these could be individuals living with AD/ADRD but also their caregivers. 3. 2.

1. Key Elements for the TrCA Research Should Be Robust: Characteristics of robust research include transparency, adequate sample size, strong methodology, replicability, and control for biases. Preliminary data are required.

Applicants must provide sufficient preliminary data to support the rationale for the proposed research and associated endpoints. Solution -Oriented: All applications to the FY26 AZRP TrCA should involve research that prioritizes solutions for people living with a dementia diagnosis. Research projects should align to a clear pathway to implementation.

Clinical research and clinical trials are allowed. Clinical trials solely testing or evaluating pharmacological interventions do not meet the intent of this funding opportunity. Research Manual: The FY26 AZRP TrCA requires manualization of the proposed research to enable consistency and replicability.

Applicants should include a draft research manual that outlines methodology, procedures, and considerations as part of Attachment 2 . This manual should be revised and expanded upon throughout the lifetime of the award. 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.

This is a high priority for the program as it provides critical context to enhance the quality and impact of research. The AZRP encourages studies to leverage existing cohorts or datasets. Cohorts consisting of individuals 65 years or younger are encouraged.

There is no requirement for any specific research population, such as Service Members or Veterans. Instead, the AZRP encourages investigators to consider how their research from a civilian cohort might apply to such populations , and vice versa .

Pathway to Clinical Application: Applicants must provide a plan to transition research outcomes to clinical application through engagement of both the scientific and the lived experience community(ies). This information will be captured in Attachment 7 : Post -Award Community -Informed Research: Research funded by the FY26 AZRP should be responsive to and informed by the needs of people living with AD/ADRD and their Communities.

Applicants should leverage patient and/or caregiver perspectives research to inform the proposed research question, study design, and actions to lower the burden of participating in research. For the FY26 AZRP TrCA, Community collaboration is required for studies prospectively enrolling human subjects .

To maximize the impact and implementation of Section Shortcuts FY2 6 Alzheimer’s Transforming Care Award 8 the proposed research, teams are expected to form effective and equitable partnerships with members of the AD/ADRD lived experience Community. CIT Partnership Option: The TrCA includes an option for more than one PI. The TrCA supports both new and existing collaborative partnerships .

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. 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 .

2.

Other Important Considerations for the TrCA Community collaboration in research is defined by the AZRP as research that incorporates shared responsibility and ownership of a research project between the scientific investigators Community collaboration supports strengths -based approaches where scientific researchers and Community members work in partnership on all aspects of the project, which may include needs assessment, planning, research intervention design, implementation, ev aluation and dissemination.

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 augment the potential impact of a research program on people living with dementia, their families and/or their care partners.

These collaborative relationships are often established through integrating Community members and/or organizations into research teams as co -researchers, advisory board members and consultants. It is up to each applicant to choose the appropriate approach that is best suited for the unique needs of the research project. Clinical trials are allowed within th is funding opportunity.

Clinical trials solely testing or evaluating pharmacological interventions do not meet the intent of this funding opportunity. Clinical research is also allowed within this funding opportunity.

All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research, such as those described in the STROBE , CONSORT , SPIRIT and ARRIVE 2. 0 guidelines .

Applications from investigators within the DOW and applications involving multidisciplinary collaborations among academia, industry, the DOW , the U.S. Department of Veterans Affairs (VA) and other federal government agencies are highly encouraged.

These relationships can leverage knowledge, infrastructure and access to unique clinical populations that the collaborators bring to the research ef fort, ultimately advancing research that is of significance to Service Members, Veterans, their Families and the Ame rican 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 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 Section Shortcuts FY2 6 Alzheimer’s Transforming Care Award 9 and VA areas of research interest or potential opportunities for collaboration can be found in The funding instrument for awards made under the program announcement will be grants Period of Performance : The maximum period of performance is 4 years . 3. 4.

1. Application Submission With a Single PI Cost Cap : The application’s total costs budgeted for the entire period of performance should not 3. 4.

2. Application Submission With the CIT 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 $1. 9M .

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. 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 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 Direct Cost Restrictions: For this award mechanism, direct costs: May be requested for (not all -inclusive): Travel in support of multi -institutional collaborations. Costs for one investigator 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 AZRP TrCA . Costs associated with data and resource sharing. Costs associated with the Community collaborative research approach (e.g., consultant costs, capacity -building exercises).

Section Shortcuts FY2 6 Alzheimer’s Transforming Care Award 10 • Research subject compensation and reimbursement for study -related out -of -pocket costs (e.g., travel, lodging, parking, costs associated with caregiving, and resources/equipment to Must not be requested for: • Costs for travel to scientific/technical meeting(s) beyond the limits stated above . • Animal costs.

Section Shortcuts FY2 6 Alzheimer’s Transforming Care Award 11 # 4. Application Contents and Format 4. 1.

Application Overview Application s ubmission 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 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 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 and Rationale : Briefly describe the critical area to be addressed by the research.

State the scientific rationale on which the proposed research project is based. Describe the scientific rationale on which the proposed work is based; include relevant preliminary data and literature citations. Specific Aims and Study Design: Concisely state the hypothesis and specific aims and provide a brief overview of the study design.

If prospective human subjects research is proposed, indicate how the research or study design is informed by the lived experience Community and/or patient p erspectives research. Adherence to the Intent of the Funding Opportunity: Describe how the proposed research is responsive to the intent of the FY2 6 TrCA. Impact: Describe the potential impact to people living with AD/ADRD , their families, or care partners using lay language.

Guidelines for writing in lay language, also known as plain language, can be found online . Partnership : For preapplications submitted under the CIT Partnership Option , briefly describe the qualifications of the two PIs and how their collaborative efforts will better address the research question.

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: Section Shortcuts FY2 6 Alzheimer’s Transforming Care Award 12 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 TrCA 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 o f how each pre -application's research List of Abbreviations, Acronyms, and Symbols: Provide a list of abbreviations, acronyms, and symbols used in the Preproposal Narrative. Key Personnel Biographical Sketches : All biographical sketches should be uploaded as a single combined file.

Biographical sketches should be used to demonstrate background and expertise through education, positions, publications, and previous work accomplished. 4. 3.

Full Application Components Applicants must receive an invitation to submit a full application. Uninvited full application submissions will be rejected . CIT 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 application 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. 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 G AI . Attachment 1: Project Narrative (15 -page limit): Upload as Describe the proposed project in detail using the outline below. Background/Rationale: Present the ideas and scientific rationale behind the proposed research project.

Provide a review and analysis of relevant literature and completed/ongoing studies, including preliminary studies and preclinical dat a. If prospective human subjects research is proposed, describe how lived experience Section Shortcuts FY2 6 Alzheimer’s Transforming Care Award 13 Community and/or patient perspectives informed the research .

Describe how this proposed research represents a non -incremental advance upon the existing Specific Aims/Objectives: Clearly and concisely explain the project’s specific aims , objectives , and hypotheses . If the proposed research project is part of a larger study, present only tasks that this AZRP award would fund. Preliminary Data: Clearly demonstrate that there is sufficient evidence to support the proposed stage of research.

Provide preliminary data to support the proposed research and endpoints to be measured. Research Strategy: Describe the research strategy, study design, methods, and analys is of research outcomes , including appropriate controls, in sufficient detail for evaluation of their appropriateness and feasibility.

Detail how the research strategy provides a care -centered approach, and how the research builds capacity to transform care for individuals living with dementia. Consult the appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported. Identify and describe how the study design, methods, models, and analyses will meet the project’s goals and milestones.

If prospective human subjects research is proposed, describe how community/patient perspectives informed the study design. Details on prospective human subject recruitment will be required in the Study Population Recruitment and Safety Plan ( Attachment 10 ).

For studies proposing clinical trials , describe the intervention and expected Describe measures to ensure the research study is representative of the population(s) intended to benefit from the research. For studies performing deidentified human subjects research, describe the population(s) of interest and how access to the sample(s) , specimen(s), or dataset(s) will be achieved.

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 understand ing or other agreements required to access and publish data . Refer to the General Application Instructions, Appendix 4 , for additional considerations. Describe how the proposed project is feasible and will be completed within the proposed performance period.

Describe potential problem areas and provide alternative methods and Statistical Plan and Data Analysis: Describe the statistical model and data analysis plan with respect to the study objectives.

Ensure sufficient information is Section Shortcuts FY2 6 Alzheimer’s Transforming Care Award 14 provided to allow for a thorough evaluation of statistical calculations during review of Include a complete power analysis to demonstrate that the sample size is appropriate to meet the objectives of the study . Explain any anticipated subgroup analyses and demonstrate that such analyses will be appropriately powered.

Describe the strategy for how sex will be considered as a biological variable will be requested in Attachment 2 . 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 ad ministrative 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, 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 facilitie s or equipment items are now accountable. There is no t a standardized form for this 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 Letters of Support (two -page limit per letter is recommended): Provide individual letters signed by collaborating individual s and/or organization al officials demonstrating that the PI has the support and resources necessary for the proposed work . Letters from the PI ’s Department Chair , or appropriate organization official, should also confirm that the PI(s) meet eligibility criteria .

If applicable, p rovide a letter of support , signed by the lowest -ranking person with approval authority , confirming participation of intramural DOW collaborat or(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 . Sex as a Biological Variable Strategy (two -page limit is recommended ): Describe the strategy for how sex will be considered as a biological variable .

This stra tegy should include a brief discussion of what is currently known regarding sex differences in the applicable research area. Clearly articulate how sex as a biological variable will be factored into the data analysis plan and how data will be collected and disaggregated by sex.

If needed, provide a strong rationale for proposing a single -sex study, based on justification from scientific literature, preliminary data or Section Shortcuts FY2 6 Alzheimer’s Transforming Care Award 15 other relevant considerations . Refer to the CDMRP Directive on Sex as a Biological Variable in Research for additional information.

Draft Research Manual: Provide a stepwise, detailed plan that outlines the processes, procedures, evaluations, and considerations required to execute and assess the proposed research to ensure consistency and replicability .

This manual is meant to serve as a foundation where iterative revisions, edits, and additions during the period of performance evolve into a final research manual for use by the investigator team or to enable another party to adapt and expand the research with fidelity.

In addition to th e research methodology and timeline, the draft research Copies of the most recent versions of questionnaires, rating scales, interview guides or other data collection instruments. This should include any drafts that are currently in use or under development. Resources, operational practices, and training details necessary for effective data collection and analysis.

Considerations for participation, ethics, reporting and compliance. Critical elements to consider when expanding or scaling the research. 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 d ata 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) 1 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,