Single Source: Post-Stroke Vascular Contributions to Cognitive Impairment and Dementia (VCID) in the United States

Single Source: Post-Stroke Vascular Contributions to Cognitive Impairment and Dementia (VCID) in the United States is sponsored by NIH. Funds research on vascular contributions to cognitive impairment, which may intersect with tau pathology studies.

Expired RFA-NS-19-012: Post-Stroke Vascular Contributions to Cognitive Impairment and Dementia (VCID) in the United States Including in Health Disparities Populations (U19 Clinical Trial not Allowed) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Institute of Neurological Disorders and Stroke ( NINDS ) National Institute on Aging ( NIA ) Funding Opportunity Title Post-Stroke Vascular Contributions to Cognitive Impairment and Dementia (VCID) in the United States Including in Health Disparities Populations (U19 Clinical Trial Not Allowed) U19 Research Program Cooperative Agreements Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose With one in three people having a clinical stroke during their lifetime and dementia occurring in an estimated 30% of post-stroke patients, the public health impact is enormous .

The purpose of this FOA is to determine the specific subsets of stroke events that cause (and do not cause) cognitive impairment and dementia in post-stroke populations in the United States, including in health disparities populations, and what additional clinical factors, as well as comorbidities including those along the AD/ADRD spectrum, may causally synergize with stroke to result in cognitive impairment and dementia outcomes.

Applicants are encouraged to leverage existing resources for VCID, stroke and other dementia research. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) April 17, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s) October 2019 Council, which is meeting on September 5, It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of the Announcement I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Full Text of Announcement Section I. Funding Opportunity Description and Alzheimer’s pathologies are the most frequent pathologies in the brains of individuals with dementia.

Moreover, it is increasingly reported that mixed pathology dementias account for half or more of all dementia cases, with beta-amyloid and vascular disease constituting the most frequent combination of pathologies. Atherosclerosis, arteriosclerosis, microinfarcts, silent stroke, and diffuse white matter disease are also associated with increased risk of dementia.

Therefore, the National Plan to Address Alzheimer’s Disease (AD) recognizes the significance of vascular contributions to cognitive impairment and dementia (VCID) in Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias (AD/ADRD).

To establish National Plan research priorities for VCID and other ADRD disorders the National Institute of Neurological Disorders and Stroke (NINDS), with input from multiple stakeholders including the National Institute on Aging (NIA), holds triennial ADRD Summits that result in ADRD research milestones for the National Plan to Address Alzheimer s Disease .

Among the highest priorities identified in the ADRD Summits to date ( 2013 , 2016 ) is the need to understand the relationships between cerebrovascular disease and AD/ADRD in order to target underlying mechanisms and reduce the burden of cognitive impairment and dementia.

This is because - despite the established relationships among stroke, AD, and dementia - the specific types (e.g. ischemic versus hemorrhagic, vessel types and sizes, and anatomical locations) and magnitudes of stroke events that cause post-stroke VCID are almost entirely unknown, as are the specifics of comorbid clinical factors, including other AD/ADRD disorders that may synergize with stroke to cause cognitive decline.

If successful, results from this study will support development of future clinical trials that test interventions designed to reduce the burden of VCID following stroke. From a clinical practice standpoint, knowledge gained through this program will increase understanding of personalized post-stroke medical management and planning needed by post-stroke patients.

Applications are requested for one large prospective clinical research study to determine associations between stroke subtypes, the clinical context in which they occur, and subsequent development of cognitive impairment, including dementia.

The overarching goal of this research program is to determine the specific subsets of stroke events that cause (and do not cause) cognitive impairment and dementia in post-stroke populations in the United States and what additional clinical factors and comorbidities may causally synergize with stroke to result in or prevent cognitive impairment and dementia outcomes.

The study must be sufficiently powered to answer these questions in typical US populations, including in at least two health disparities populations proposed in the application, that are representative of gender, racial, and ethnic diversity in the United States.

Specifically, the responsive applications must incorporate: A collaborative network of sites with the expertise, capacity, and access to target populations needed to achieve the overarching purpose of this RFA.

The network should include clinical and non-clinical scientists with expertise in stroke, VCID, imaging and other relevant biomarkers, clinical data collection and management, cognitive impairment including dementia, statistical approaches, population-based clinical research, health disparities, relevant anatomy, relevant comorbidities, and vascular biology.

Stratification and hypotheses regarding not only cardio- and cerebrovascular risk and disease, but also regarding common sporadic clinical comorbidities, as well as AD/ADRD comorbidities. Inclusion criteria and stratification based on severity of the index stroke event, stroke type, and stroke location.

Tracking cognitive trajectories including whether the following occur: cognitive decline at the time of and following the index stroke; recovery or non-recovery following cognitive decline; resistance to cognitive decline at the time of and/or following the index stroke.

Identification of factors associated with cognitive recovery versus non-recovery and/or progressive cognitive decline following the index A study design that considers acceptable timing of enrollment in relation to the index stroke as well as the proposed optimum follow-up period to establish incidence and progression of cognitive impairment including Use of relevant biomarkers including VCID diagnostic and progression biomarkers that have been or currently are being validated in systematic multi-site studies; further development and validation of these VCID biomarkers in this high throughput clinical research study; inclusion of amyloid-beta and tau biomarkers of Alzheimer’s pathology during life.

Collection, managing and analysis of clinical data (including imaging) and biospecimens needed to meet the overarching goals of this RFA using methods that are standardized, rigorous and follow or improve upon best Approaches to address mechanisms when possible, including by determining interrelationships (cross-sectional and longitudinal) among the stroke event, overall cerebrovascular and cardiovascular disease and risk factors (including sex and other demographic differences), dementia-relevant genetic variants (including ApoE) and mutations including those known to cause VCID (e.g. in Notch 3) and cause or be a risk for clinical Alzheimer's disease (e.g. APP, PS1, PS2, PICALM, CLU, TREM2).

Applicants are encouraged to leverage existing resources for VCID and stroke research, including MarkVCID ( https://markvcid. partners. org/ ), StrokeNet ( https://www.

nihstrokenet. org/ ), and other dementia centers and resources, as well as established prospective cohorts. Applicants are encouraged to follow or build upon standards for VCID clinical data and best practices for biospecimens established by MarkVCID.

Applicants are strongly encouraged to consult with NINDS Scientific/Research Staff early on during the planning stage of their application (see Agency contacts, Section VIII). See also Applicant Webinar information under Section IV. 7 below ("Other Submission Requirements and Information").

Information for award authorities and regulations. Section II. Award Information Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement.

Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI. 2 for additional information about the substantial involvement Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on Not Allowed: Only accepting applications that do not help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards NIH intends to commit $9,750,000 Total Costs in FY 2019 to Budgets are limited to $39,000,000 in Direct Cost over the The scope of the proposed project should determine the project period. The maximum project period is 6 years. described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible Foreign components, as defined in the NIH Grants Policy Statement , are not allowed.

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted.

Registration can take 6 weeks or more, so applicants should begin the registration process as soon as Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.

After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually .

The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration, but all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. must have an active DUNS number and SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

This means that the NIH will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ). Section IV. Application and Submission Information The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution.

A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions (R&R) Application Guide , except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants. gov downloadable forms currently used with most NIH opportunities.

Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: Roderick A. Corriveau, Ph. D.

Strategy/Program Plan Page Limits Core (Use for: Administrative Core; Statistics Core; Recruitment and Retention Core; and Repository Core) Additional page limits described in the SF424 Application Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components: Overall: required, maximum 1 Administrative Core: required, maximum 1 Statistics Core: required, maximum 1 Recruitment and Retention Core: required, maximum 1 Repository Core: required, maximum 1 When preparing your application, use Component Type All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall) PHS 398 Cover Page Supplement (Overall) Project Information (Overall) Follow standard instructions.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon Senior/Key Person Profile (Overall) Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

The PD(s)/PI(s) of the study must have experience and demonstrated excellence in the dementia and stroke research fields, in communication, in large-scale geographically dispersed clinical research projects, in neurological clinical data, in sharing data (collecting, banking, receiving, curating, distributing de-identified clinical data), and in informed consent in order to ensure successful leadership of this project.

Ideally, leadership for the application will have proven success and a strong plan for facilitating interactions, e.g. data and sample collection, harmonization, transfer, sharing, etc., with other databases such as dbGAP , PDBP , LONI , NACC , NINDS Repositories, MarkVCID and NCRAD . The experience of each PD/PI must be carefully documented, and roles and responsibilities must be well defined.

In addition, the responsibilities and authority of each PD/PI must be specified. The application must ensure that a multidisciplinary team of appropriate personnel are proposed at the participating sites to facilitate the implementation of all aspects of the project.

Commensurate with the scale of this program, the Contact PD/PI will be expected to also be the Administrative Core Lead and to commit at least 3 calendar months per year to the project over its entire course. A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon PHS 398 Research Plan (Overall) Specific Aims: Describe the overall scientific objective of the proposed study; the individual aims of the proposed study; how the individual components contribute to these aims; and the overall research objective that must align with the purpose of this RFA: to determine the specific subsets of stroke events that cause (and do not cause) cognitive impairment and dementia in post-stroke populations in the United States, including in health disparities populations, and what additional clinical factors, as well as comorbidities including those along the AD/ADRD spectrum, may causally synergize with stroke to result in cognitive impairment Research Strategy states the theme, vision and rationale for the proposed study, and provides an overview of planned activities, with rationale including preliminary data, to achieve the specific aims.

Organize the Research Strategy Section into sections on Significance, Innovation, and Approach.

The scientific rationale and need for a study to understand post-stroke VCID by determining subsets of stroke events that cause (and do not cause) cognitive impairment including dementia, and the role of comorbidities including other AD/ADRD, should be well supported by preliminary data, clinical and/or preclinical studies, information in the literature and/or knowledge of biological mechanisms.

Focus the project as a whole on how the science of post-stroke VCID will be advanced by this research (including via increased understanding of mechanisms, targets, and risk, as well as advancing VCID biomarkers), and how the results of this study will affect clinical practice in the future. Describe the preliminary data on which the study is based.

Describe how novel approaches, investigator expertise, and collaborative activities that are synergistic will advance the goals of this RFA, including unique contributions with strong potential to advance scientific knowledge, technical capacity, and, in the future, clinical practice, treatments and service, including preventative interventions.

The applicants should clearly define and justify selection of the target populations including with clearly defined questions and rigorous approaches as outlined by the NIH that provide assurance of the durability of the results.

The study should propose and justify selection of broad inclusion criteria and discuss strategies to enroll a geographically diverse population with a high proportion of women and minorities, including identification of clinical sites that cover a representative population of the United States.

Applications must address post-stroke VCID in typical U.S. populations and be sufficiently powered to address all major questions in at least two health disparities populations, for example racial and ethnic minority groups, socioeconomically disadvantaged populations, underserved rural populations, and sexual or gender Include both a description and a table or graph of the overall project timeline and key milestones.

The overall study timeline should include a description of key milestones that need to be met throughout the life of the study to ensure its success. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must be relevant, measurable, results-focused and time-bound.

Milestones may include, for example, timelines for IRB approval of the study consent; adoption of standardized clinical data (including imaging) and biospecimen collection, storage, and sharing; enrollment of first subject; enrollment of 500th subject; enrollment of 8000th subject; completion of first analysis (specify) for publication.

Letters of Support: A strong commitment to the proposed study by the leadership of the participating clinical sites should be demonstrated by including letters of support from the participating site signed by individuals with financial authority within the Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Separate Data Sharing Plans for the individual Cores and Repository are not expected. For this FOA, the following criteria apply: It is required that all biospecimens and clinical data collected (including imaging) and/or used for research under funding from this FOA have appropriate informed consent per NIH policy and as mandated by law.

Applications are expected to include plans for appropriately collecting, storing, and sharing de-identified clinical data.

When new biospecimens and/or clinical data (including imaging) are collected, consent must allow all enrolled individuals the opportunity to consent to share, including via NINDS repositories, their de-identified samples and data to researchers in academics, not for profits, and industry (for internal research only, for profit use is not allowed).

Considerations that investigators should include in consent forms for samples and data collected include the following: sample and de-identified clinical data (including imaging) may be submitted to an NINDS (or other NIH) repository or database, research resources supported by the National Institutes of Health/National Institute of Neurological Disorders de-identified samples and clinical data will be securely stored at the personal identifiers will be sent with samples and data samples may be used for preparation of DNA, plasma, serum, and cells that may be used for cell culture, including stem cells, from which DNA can be prepared; other biological samples may be collected as applicable, for example cerebrospinal de-identified samples (and their derivatives) and clinical data can be distributed to scientists for use in research and teaching only, and as such the Repository does not return results to donors de-identified samples and clinical data could be used for research in any type of disease or genetic factors, not just vascular contributions to cognitive de-identified samples and clinical data will be available for research and teaching purposes to hospitals, universities, not for profit research organizations, and commercial organizations de-identified samples and clinical data will be used for research only, and will never be distributed for profit is a risk that someone could use information from the sample submitted, via DNA, to identify the person from which it came if it were matched with another DNA sample provided by that person.

However, any user of this sample must agree not to use it for that purpose, and the risk, while real, is small. have the right to withdraw from this research project at any time. If possible, any samples contributed will be discarded if requested; however, because of the sample masking, NINDS may not always be able to identify which samples were donated by a specific person.

Withdrawal from the study will in no way affect access to medical care for which the subject is eligible. Embargo time for sharing with researchers that are not part of the funded application will be 2 years maximum for both de-identified clinical data (including images) and biospecimens from the date of collection; it is a requirement that all relevant agreements, including informed consent, recognize and comply with this requirement.

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall) When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered Yes to the question Are Human Subjects Involved?

on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components.

To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed with the following additional For this FOA, follow the instructions for the PHS Human Subjects and Clinical Trials Information for the Overall component only.

Section 2 - Study Population Recruitment and Retention Plan This section should refer to the Research Strategy section of the Recruitment and Retention Core. 3 - Protection and Monitoring Plans Protection of Human Subjects Address all ethical issues and issues related to human subject safety oversight for the study including developing informed consent documents or opt-out consents (if applicable).

Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site? Applicants should propose a consolidated or centralized IRB approach for study oversight to facilitate the appropriate and timely implementation of the study. onset studies are not permitted.

All instructions in the SF424 (R&R) Application Guide must be followed PHS Assignment Request Form (Overall) All instructions in the SF424 (R&R) Application Guide must be followed. When preparing your application, use Component Type Administrative All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Complete only the following fields: Title of Applicant’s Project Project Start/Ending Dates PHS 398 Cover Page Supplement (Administrative Project Information (Administrative Core Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted Project /Performance Site Location(s) (Administrative Core) List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for Senior/Key Person Profile (Administrative Core) Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component. than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Lead (Study Director) should be the Contact PD/PI for the entire application and must be experienced in multi-center clinical research coordination and management, including success in meeting milestones and timelines.

The Study Director's experience must be documented, and his or her role and responsibilities must be well defined Budget (Administrative Core) Budget for the Administrative core should reflect actual expenses related to study administration and management.

The applicants should budget for expenses related to one in-person meeting of the Observational Study Monitoring Board (OSMB) during the Protocol Refinement and Study Start-up Phase, and one in-person meeting and one OSMB teleconference in years 2 through 6 of the study.

NINDS will be responsible for appointing the members of the OSMB, as well as for direct support of the meeting and expenses for OSMB members; the Administrative Core budget should only reflect costs related to preparation of reports and other OSMB-related materials and expenses for key personnel to travel and attend in-person meetings. All in-person meetings of the OSMB will be held in the Washington, DC area.

The budget should also include all expenses for a year-one Kickoff Meeting and an annual Investigator Meeting, to be held at sites proposed by the applicant; and meetings of the steering committee and subcommittees as needed (generally by teleconference or in conjunction with a planned in-person OSMB or annual The budget for the Administrative Core should also include all costs related to implementation of the study in the large network of participating clinical sites.

Such activities may include but are not limited to screening, verifying participant eligibility, enrollment, performing baseline and follow-up measurements, ascertainment and adjudication of outcomes, data and biospecimen collection, and submission of data/specimens to Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries.

All other SF424 (R&R) instructions apply. PHS 398 Research Plan (Administrative Specific Aims: Aims for this core should define key aspects of administration and management of the study. Research Strategy: The Administrative Core is responsible for implementing the overall project management strategy in accordance with the