Expired RFA-AG-24-001: Alzheimer's Disea

Administrative Core

When preparing your application, use Component Type Admin Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

Applicant Information
Type of Applicant (optional)
Descriptive Title of Applicant’s Project
Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

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 in other components.

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 additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

In the 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 the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a 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.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
The Core Leader (CL) must have demonstrated leadership and administrative skills. Specifically, the CL must be able to organize and administer the resources created by the Center. Demonstrated leadership in mentoring junior investigators is desirable.
The PD(s)/PI(s)'of the proposed ADRC must also be the Administrative CL(s); sufficient time must be devoted to the core to ensure that the aims are met and required functions are carried out efficiently. For applications with multiple PIs, at least one PD/PI must be the Administrative CL. The PD(s)/PI(s)' biographical sketch must present evidence of scientific expertise relevant to the themes of the ADRC and demonstrate the capacity for the leadership of an ADRC.
The administrative requirements of the ADRC will necessitate the assistance of an administrator with business management expertise. It is important that such an individual be identified and be directly involved with the fiscal and administrative aspects of the ADRC application and grant. The administrator must be able to provide consultation in matters of fiscal administration and be familiar with NIH grant-related compliance policies.
An Associate Director may be named who will be involved in the administrative and scientific efforts of the Center.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

The CL of this component must commit, and sustain, a minimum of 2.4 person months of effort. For applications with multiple CLs, a minimum effort of 0.8 person-month is required per additional CL and the collective effort across the CLs must be at least 2.4 person months.
If large items of equipment are requested, the application must document what is already available and provide clear justification in terms of use by core staff and how it relates to research projects dependent on the component. General-purpose equipment needs must be included and justified only after surveying the availability of such items within the institution.
Domestic and foreign travel of personnel directly related to the component and scientific activities of the ADRC is allowable. Budgeting must include travel and lodging for representatives of the Center to attend the following:

1) The semi-annual meetings of the Center Directors;
2) Annual meetings of administrators, clinical CLs, education CLs, data managers, and neuropathology CLs;
3) Ad hoc meetings called by the ADRCs or NIA to discuss research findings, and plan cooperative projects, promulgate data sharing, and discuss standardization of procedures among the ADRCs; and
4) At least two ad hoc meetings on special topics, as well as for visits of Center investigators to other ADRCs for the exchange of scientific ideas, planning of multi Center research projects, and/or to learn specialized techniques.

Developmental projects must be budgeted in the Administrative Core budget. Detailed developmental project proposals including budgetary information will be requested as Just-in-Time (JIT) information through the eRA Commons shortly before the award of successful applications. Future-year developmental projects should be submitted with the annual Research Performance Progress Report (RPPR). Facilities & Administrative costs will be provided in accordance with these budgets. Developmental project costs should be in the range of $50,000-$100,000 in direct costs per year and may have a project term between 1 and 3 years. Developmental projects may be awarded to investigators outside of the home institution. Funds for the developmental projects should be included under the other expenses within the AC budget. These funds should not be listed as a separate line in the composite budget. Developmental projects are allowed for consortium arrangements.
Complete Magnetic Resonance Imaging, Amyloid positron emission topography (PET) Imaging, and Tau PET Imaging in at least 24 participants of the Clinical Core each year. All three imaging modalities must be completed for each participant. The Administrator is to ensure the minimum is met and distribute the funds appropriately to the relevant component(s) to accomplish the goals, including transmission of the data to SCAN.

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 Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly state how the Administrative Core will contribute to the goals of the ADRC, and outline interactions of the core with each of the other components of the Center.

Provide an overview of how the Administrative Core will set the overall direction of the Center and ensure optimal utilization of Center resources.

Research Strategy:

The Research Strategy should be organized into the following sections: Significance, Innovation, and Approach. Below is a description of what each section should entail:

Significance: Explain the role of the Administrative Core in the Center as a whole and as a resource for other ongoing activities in AD and other neurodegenerative diseases.

Approach and Innovation: Describe how the Center's administrative structure will facilitate the following:

Oversight of research and grants administrative processes, including preparation of annual RPPR;
Coordination and integration of Center components and activities. For example, the clinical and data management cores with the neuropathology and education components;
Direction for future planning and optimal utilization of resources;
Faculty recruitment, retention, and tenure/promotion activities, including recognition of team science;
Support and advice for the Center Director in oversight of the activities of the Center;
Interaction with the scientific and lay communities to develop relevant goals for the Center;
Coordination and organization of external and internal advisory committee meetings;
Coordination and organization of development project advertisement, review, and submission of development projects to NIA for approval;
Assurance of compliance with human subjects, animal welfare, scientific integrity, data and sample sharing, as appropriate, and financial policy requirements of NIH;
Consent that will allow broad sharing of biological samples.
Support not only local, but also broad national and international data sharing
Interaction with other Centers and other researchers to develop trans-ADRC and outside research projects;
Timely and routine submission of appropriate Center data sets and samples to the NACC, NCRAD and SCAN;
Interaction and involvement with other research programs and grant administration of the University, including the provision of core resources for development of related research; and
Coordination with NIA on media coverage of the latest research findings from the Center.

Present plans to establish and operate Center advisory panels, including the following:

An executive committee, composed of CLs and the administrator, to advise the Director in making scientific and administrative decisions related to the Center. The executive committee may consist of leaders both from within the institution and from other institutions and should provide guidance on monitoring and developing the scientific content and direction of the Center.
An External Advisory Committee (EAC) to conduct and provide annual evaluations of the programs of the ADRC, research sharing and progress, the effectiveness of communications within and outside of the ADRC, interactions with NACC, NCRAD and SCAN, and any other activities for which outside expertise is required or desirable. EAC members should not be named in the application and should not be contacted for participation in the committee prior to award. The NIA Program Officer should be invited to attend EAC meetings as a non-voting member. A copy of the advisory committee report must be routinely sent to NIA with the annual RPPR and should include a list of committee members.
A review panel to assist in selecting developmental projects. Criteria for selecting committee members, how they will be identified, the operating procedures of the group, and the frequency of meetings should be described. Review should include a biostatistician as well as scientists from outside the Center. New applications should not identify committee members in the Center application. Members from the EAC may serve as reviewers for the developmental project applications, provided their expertise is appropriate for the submitted applications.

Provide evidence of successful overall integration of components to promote the theme(s) of the Center as well as interaction within the academic and local, national, and international research communities.

Describe the most important contributions to research on AD, ADRD, and aging utilizing component resources. Basic functions of the components should be briefly summarized. Any developmental work carried out by the component should also be presented.

Developmental Projects: A plan to support one to three developmental projects must be included in the application. Describe the process that will be used for soliciting, evaluating, selecting, and monitoring the developmental projects. The announcement for developmental projects funding should include a description of data, samples, and scans available through NACC, NCRAD and SCAN, including their websites. Use of these resources should be strongly encouraged. Use of existing resources at the Center, particularly those that are unique to the Center, should also be encouraged. This funding mechanism is intended to allow an investigator the opportunity to develop preliminary data sufficient to provide the basis for an application for independent research support. Developmental projects are designed for postdoctoral or junior faculty level investigators, but may be awarded to a more senior investigator whose research is primarily in areas other than AD/ADRD research and who wants to work in the dementia research field or who wants to try a new hypothesis, method, or approach that is not an extension of ongoing AD research. Any one investigator is eligible only once for developmental project support, unless the additional proposed developmental project constitutes a real departure from the investigator's ongoing research. The developmental project term is 1 to 3 years.

Examples of unacceptable developmental projects are:

Clinical trials. Investigators interested in clinical trials should consider applying to PAR-21-360.

No developmental project applications should be submitted with the Center application. Funds designated for developmental projects are restricted until the developmental project applications receive NIA approval. Successful Center applicants should conduct a competition and submit the successful developmental project applications to NIA for funding after receiving a request for JIT. In subsequent years, depending on length of projects, competition for developmental project awards should be timed so successful applications can be submitted with the RPPR for NIA review.

Provide evidence of productivity of previously funded developmental projects.

Data Management and Sharing Plan:

The Data Management and Sharing Plan submitted to the Overall component of the application must include elements to address all proposed activities of this component.

Appendix:

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 (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined 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, you must include 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.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Clinical Core

When preparing your application, use Component Type Clinical Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Clinical Core)

Complete only the following fields:

Applicant Information
Type of Applicant (optional)
Descriptive Title of Applicant’s Project
Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Clinical Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Clinical Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project /Performance Site Location(s) (Clinical 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 additional entries.

Clinical Cores of ADRCs may be based in university medical center neurology or psychiatry department memory disorders clinics, or in other departments. Applicants are encouraged to include special populations, such as understudied populations and those at higher risk for AD/ADRD, an existing epidemiologic cohort, or a community population.

Research & Related Senior/Key Person Profile (Clinical Core)

In the 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 the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a 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.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
The Clinical Core Leader may be any clinician with expertise in diagnosing AD and other neurodegenerative diseases. The Clinical Core Leader must have a track record of research in some aspect of neurodegenerative disease, including interactions with key personnel from other components within the proposed center and leaders in the field from other institutions.

Budget (Clinical Core)

Budget forms appropriate for the specific component will be included in the application package.

Research patient care costs (both inpatient and outpatient expenses) will be considered in the context of other existing institutional clinical resources. Attempts should be made by the applicant institution to utilize existing clinical facilities. Costs relating to the clinical efforts of the ADRC may be funded through the ADRC, provided there is no overlap of funding. Only those research patient costs directly related to ADRC activities may be charged to the ADRC.
The CL of this component must commit and sustain a minimum of 1.2 person months of effort. For applications with multiple CLs, a minimum effort of 0.8 person-month is required per additional CL.
Provide sufficient resources and staff for the following activities:

a. Annual participant evaluation and data capture, including social determinants of health and COVID data

b. If there is a plan to include participants who speak other languages, ensure that there are sufficient staff (coordinators, psychometrists, clinicians, etc.) to support this plan

c. EHR and CMS consent processes

d. Digital data capture including devices, licenses, and staff

e. Staff (e.g., genetic counselors and/or social workers) trained to provide tailored return of results when appropriate

f. Longitudinal blood sample collection for all participants that include staff phlebotomists and necessary materials

PHS 398 Research Plan (Clinical Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly state how the Clinical Core will contribute to the goals of the ADRC and outline interactions of the Clinical Core with each of the other components of the Center.

Clearly describe the target population for which the Clinical Core will provide well-characterized, longitudinally followed research participants for cutting-edge research projects. Such projects might involve: clinico-pathological correlations, comparison of disease states to normal aging (including those using biological samples or imaging) and/or distinguishing AD from other dementias, better understanding how multiple dementias present clinically, and/or drug/intervention studies. There should be a focus on populations most at risk for AD/ADRD.

Research Strategy: The Research Strategy should be organized into the following sections: Significance, Innovation, and Approach. Below is a description of what each section should entail:

Significance: Explain the role of the Clinical Core in the Center and as a resource for other research activities in AD and other neurodegenerative diseases. Establish and justify sample sizes for cohort and for different subpopulations, including how the proposed cohort reflects burden of disease. If the Clinical Core will include special populations, describe the characteristics of the population and justify the added scientific value to research at the Center resulting from the inclusion of this group, so that peer reviewers can evaluate the comparative strengths and weaknesses of the proposed Clinical Core. Clearly describe the significance of additional (non-UDS) assessments to be collected.

Approach and Innovation: Define and justify the participant catchment area based on the geographic region of the proposed center and its population-based metrics (e.g. using census tracts, zip codes, county or state lines, or other geographically defined boundaries) and describe how the recruitment strategies will impact the planned analyses. Different racial and ethnic groups should not be compared if they are recruited in different manners.

Longitudinal data, including clinical, cognitive, behavioral, functional, imaging, and biomarker characterization on participants through the spectrum from normal aging to dementia should be collected according to the UDS protocol available through NACC. Applicants should state in this section of the application that they agree to collect and provide the UDS to NACC, where it will be combined with data from other Centers and made available to scientists for collaborative studies. Participants should be enrolled in the Clinical Core with the intent of longitudinal follow-up.

Describe all non-UDS data to be collected and shared.

Clearly describe the procedures for working across the Center to increase the number of participants who agree to autopsy, especially participants from the following groups: populations understudied in AD/ADRD; populations with a higher risk of being diagnosed with AD/ADRD; cognitively unimpaired people and people living with mild cognitive impairments (MCI) or early in the course of AD/ADRD. The consent process is the responsibility of the Clinical Core.

Protocols for providing for return of results to participants should be clearly described, including to whom and which results will be provided as well as who will be providing the results.

Describe procedures related to collection, storage, and distribution of biological samples that may include, but are not limited to, cell lines, cerebrospinal fluid (CSF), blood, and plasma. ADRCs are expected to obtain blood samples longitudinally on all participants. ADRCs are strongly advised to contact NCRAD as they prepare their application for assistance in meeting sample sharing requirements, including procedures as well as consent forms and budget issues. Particular attention should be paid to best practices for collection and use of biospecimens detailed in documents available on the NACC’s website . Applicants should describe protocols for multi-center projects involving specimen collection that will be utilized by the Clinical Core.

Describe interactions with other components. Describe the types, with specific examples, of research projects and clinical trials that use or will use the component and how other research activities will benefit from the existence of the Clinical Core. Whenever possible, Clinical Cores should seek opportunities to utilize high-quality data collected during clinical care, this may include EHR and CMS data; evaluate cross-correlations between research tools and clinical measures; validate biomarkers and other diagnostic measures; reduce duplication of effort, costs, and participant burden (e.g., by implementing quality assurance, process evaluation, and cost-utility measures); and develop, test, and validate novel and emerging endpoints for translation into practice while ensuring privacy and protecting participant health information. Describe opportunities to collaborate with already well-described epidemiologic cohorts and/or initiate new cohort studies.

Explain how the Clinical Core will maintain a volunteer registry that is separate from the Clinical Core. Describe how registry participants will be recruited (i.e., catchment area, geographic recruitment, internet based, according to particular risk factors, etc.), evaluated, and diagnosed. The registry should track number and reasons for those lost to follow-up and conduct longitudinal follow up of registry participants. The participants in the registry may be considered a trial-ready cohort and may be assessed remotely by telephone, web-based assessment, or another mobile assessment tool. Describe efforts to include and retain participants from groups traditionally understudied in research in the registry.

Clearly summarize recent resources used in affiliated research projects (both funded by the Center and externally funded) and new insights obtained from these studies. Describe demographic information, including numbers of participants recruited, diagnosis, relevant risk factors, percentage follow up, dropout rate and reasons for drop out, and diagnostic accuracy confirmation by autopsy. Describe the most important contributions to research on AD/ADRD and aging utilizing core resources.

New applications: Describe preliminary organizational work, institutional experience with AD and other neurodegenerative disease research, potential for developing transformative research, and specific plans for implementation of the new program.

Data Management and Sharing Plan:

The Data Management and Sharing Plan submitted to the Overall component of the application must include elements to address all proposed activities of this component.

Appendix:

PHS Human Subjects and Clinical Trials Information (Clinical Core)

Other Requested Information: Each component should include an attachment that indicates that the details of the study are included in the Overall component within this attachment.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Data Management and Statistical Core

When preparing your application, use Component Type Data Management Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Data Management and Statistical Core)

Complete only the following fields:

Applicant Information
Type of Applicant (optional)
Descriptive Title of Applicant’s Project
Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Data Management and Statistical Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Management and Statistical Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project /Performance Site Location(s) (Data Management and Statistical 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 additional entries.

Research & Related Senior/Key Person Profile (Data Management and Statistical Core)

In the 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 the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a 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.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
This CL's biosketch should reflect awareness of, and experience with, database management practices, computing, statistics, and bioinformatics. The CL may be primarily a data manager or a statistician. The CL should have the time and the authority to work administratively with other cores. The CLs should have a publication track record with other key personnel at the Center.
The DMSC should include the following:

a. A systems manager for computing and database management who will be the architect of the database structure and responsible for its maintenance;

b. A systems analyst with sufficient background to select and implement database management software, represent data structures, specify and organize data flow, construct detailed error-check programs, develop/implement data checking and cleaning procedures, and provide for data entry and access, as well as information distribution through electronic means (e.g., the internet or intranet); and

c. A statistician who can consult with researchers on design and analysis of their projects, if the CL is not a statistician.

d. If this component is responsible for website management, the CL should reflect expertise in this domain.

Budget (Data Management and Statistical Core)

The CL of this component must commit and sustain a minimum of 1.2 person months of effort. For applications with multiple CLs, a minimum effort of 0.8 person-month is required per additional CL.
Data infrastructure, management, and networking with the larger Center program is a priority of NIA. The DMSC should have sufficient resources and staff for the following activities:

a. Ensuring data interconnectedness between the components, including tracking biosamples and images as well as integrating novel data

b. Ensuring that availability of samples and data is clear to interested investigators from within and outside the ADRC

c. Supporting data needs for all components, including those related to digital neuropathology, remote and other digital data from cognitive assessment, and electronic medical records integration

d. Performing and completing required upgrades to systems

e. Implementing software programs

f. Collecting NIA-requested data and submitting data to NACC, including changes to the UDS

g. Ensuring that Center personnel understand and can utilize data systems

h. Providing data and statistical support for Research Education Component scholars, development projects, and other affiliated research projects

PHS 398 Research Plan (Data Management and Statistical Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly state how the Data Management and Statistical Core will contribute to the goals of the ADRC and outline interactions of the core with each of the other components of the Center.

Describe how the Data Management and Statistical Core will use current data analytic and bioinformatics technologies to collect, analyze, and integrate data from across the ADRC. Highlight efforts to modernize, where applicable, and standardize electronic data capture (EDC) and database structure across ADRCs to augment Center-NACC, Center-Center, and Center-NIH interactions. Describe both database and statistical services that will be provided to each of the components, the Research Education Component, and developmental projects.

Research Strategy: Organize the Research Strategy into the following sections: Significance, Innovation, and Approach. Below is a description of what each section should entail:

Significance: Explain the role of the Data Management and Statistical Core in the Center as a whole, and as a resource for other ongoing activities in AD and other neurodegenerative diseases.

Approach and Innovation: State how the system infrastructure will improve data capture and provide accurate, timely data about the resources of the Center across all relevant cores.

Describe the promotion of access to ADRC resources, both within the ADRC program and within the larger AD/ADRD research community.

Illustrate how the Data Management and Statistical Core will enable access to dynamic developments, e.g., new molecular and imaging data being generated from living and deceased research participants, as well as new clinical data being constantly updated.

The Data Management and Statistical Core should have the capacity to prepare the current UDS for transmission to NACC, which in turn will make appropriate data sets available to qualified investigators for further research. All participants should be appropriately consented to share data broadly. The institution will be responsible for monitoring the data sharing policy. Include a data management plan that covers at least the following:

Data flow schemes;
Data forms (electronic or hard copy; following Data Management and Statistical Core and affiliated project specified content);
A Center-wide system of subject ID numbers that meets privacy standards;
Adequate systems for storing, protecting, tracking, and sharing raw data within and across the components and affiliated projects and within the Data Management and Statistical Core itself;
A mechanism to track data edits; and
Longitudinal follow-up data storage/retrieval consistent with the protocols of the Center.

Applicants should describe how the Data Management and Statistical Core will fulfill the following required functions, outlining collaborations where applicable:

Ensure the availability of data, preferably individual level, collected by the ADRC in addition to the UDS to researchers both within and outside of the ADRC;
Connect data from other grants that utilize resources of the ADRC, where relevant, and make this available to other researchers;
Enable real-time data analysis;
Support scheduling and prioritizing study participants and biospecimens for clinical, neuropath, biomarker, and other components and associated research projects;
Sample, tissue, imaging, digital neuropath, other post-mortem imaging, and other data inventory and tracking, including requests;
Track fulfillment data, including time, and assess requests that are not fulfilled to improve responsiveness and processes;
Develop, implement, and maintain a tracking system for activities of the Outreach, Recruitment, and Engagement Core recruitment, retention, calls to Center, a volunteer database, and pre-post assessments;
Design, maintain, and track usage of the Center’s website;
Develop improved mathematical models that might help, e.g., identify mediation or improve understanding of the interactions of multiple variables on cognitive decline;
Develop enhanced statistical techniques to improve study design, with a focus on issues relevant to detecting cognitive decline early in the disease process; and
Provide a mechanism for data science education relevant to neurodegenerative disease research.

Describe how Data Management and Statistical Core staff, including statisticians, will work with:

Clinical and research personnel to ensure that their data are in an appropriate form for storage, transmission, and analysis;
Primary data collectors and have their cooperation to reconcile errors and missing or incomplete data elements as discovered through error check programs or through hands-on inspection procedures;
NACC staff and respond appropriately to data calls issued by NACC.

Demonstrate a clear plan for how the statistical consultant will:

Be involved in the design and analysis of studies using participant data and/or biomaterials from the components;
Work closely with the data manager to ensure analysis files are produced that are consistent with the needs of the question at hand; and
Provide consultation with developmental project applicants and awardees as well as with Research Education Component scholars and affiliated research project investigators.

Summarize progress and activities related to data collection, data management, and statistical consulting activities. Describe the most important contributions to research on AD/ADRD and aging utilizing core resources. Basic functions of the Data Management and Statistical Core should be briefly summarized. Include progress and interactions with NACC, as well as descriptions of any novel data analysis or study design strategies that have been developed. Present evidence for meeting timetables for data transfer in the proper format to NACC. Any developmental work carried out by the Data Management and Statistical Core should also be presented. Provide evidence for advanced data analytic capabilities.

New applications: Describe preliminary organizational work, institutional experience with AD and other neurodegenerative disease research, potential for developing new and exciting research, and specific plans for implementation of the proposed program.

Data Management and Sharing Plan:

The Data Management and Sharing Plan submitted to the Overall component of the application must include elements to address all proposed activities of this component.

Appendix:

PHS Human Subjects and Clinical Trials Information (Data Management and Statistical Core)

Other Requested Information: Each component should include an attachment that indicates that the details of the study are included in the Overall component within this attachment.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Neuropathology Core

When preparing your application, use Component Type Neuropathology Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Neuropathology Core)

Complete only the following fields:

Applicant Information
Type of Applicant (optional)
Descriptive Title of Applicant’s Project
Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Neuropathology Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Neuropathology Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Facilities and Other Resources: Provide a description of all resources available for biological sample collection, storage, and distribution for the Center.

Project /Performance Site Location(s) (Neuropathology 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 additional entries.

Research & Related Senior/Key Person Profile (Neuropathology Core)

In the 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 the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a 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.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
The CL should have a track record of research in some aspect of neurodegenerative disease, preferably including interactions with key personnel from other components, as well as other Centers. The CL should have demonstrated knowledge of standard protocols, as well as expertise in state-of-the-art techniques for diagnosis of neuropathological specimens and a track record of sharing and collaboration.

Budget (Neuropathology Core)

The CL of the Neuropathology Core must commit and sustain a minimum of 1.2 person months of effort. For applications with multiple CLs, a minimum effort of 0.8 person-month is required per additional CL.
Funds for collection, tracking and sharing of biospecimens, including postmortem tissues, from Center clinical core and any other proposed participants should be included. Funds should support staff, software and infrastructure needed for state-of-the-art tracking and an on-line catalog of available samples that is updated regularly, as well as a rapid on-line review system so that requests can be processed in a timely manner. The NIA-funded biorepository, NCRAD, can help ADRCs share samples with other researchers more easily and cost effectively. Applicants are strongly encouraged to contact NCRAD during the preparation of the application. NCRAD can assist with budget questions related to sample preparation and sharing through their biorepository.
Neuropathologists from the ADRCs meet yearly to share ideas and discuss technical aspects of tissue sampling, development of standardized tissue processing for various research protocols, cataloging and data management, and banking and distribution of tissues and biological samples. The CL, as well as an early-stage investigator interested in neuropathology, should have funds budgeted to attend this meeting.

PHS 398 Research Plan (Neuropathology Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly describe how the component will contribute to the goals of the ADRC and outline interactions of the Neuropathology Core with each of the other components of the Center.

Describe the strategy for collection, tracking and distribution of samples for cutting edge research, locally as well as in cooperative research across ADRCs and with other researchers.

All biosamples must come from individuals who have consented to banking and sharing broadly. Although CC participants should be prioritized, clear plans to obtain additional autopsies on other people that may enhance the overall scientific endeavor may be included. These may be clinical trial participants, people at high risk for AD/ADRD, such as those living with Down Syndrome, or those from groups understudied in research in general, and in autopsy cohorts in particular. If such cases are planned, describe how they will be obtained and ensure that the samples and data can be made available to the wider research community.

Applicants may utilize NCRAD for banking and sharing of samples. Applicants are strongly advised to consult the NCRAD website for information about samples banked at the repository.

Research Strategy: Organize the Research Strategy into the following sections: Significance, Innovation, and Approach. Below is a description of what each section should entail:

Significance: Explain the role of the Neuropathology Core in the Center as a resource for other national and international research activities focused on AD and other neurodegenerative diseases. Describe how the Neuropathology Core will utilize state-of-the-art post-mortem diagnostic procedures to understand the relationships of pathology to clinical symptoms. Define the samples/biospecimens and other data that will be collected and how their collection will support the aims of the ADRC and other research supported by the ADRC infrastructure.

Approach and Innovation: Describe procedures related to criteria for diagnosis and the collection, storage, and distribution of brain tissue and other biological samples and related data, including, but not limited to, cell lines, cerebrospinal fluid (CSF), plasma and digital neuropathological data or postmortem imaging. Biomarker storage, tracking, and sharing may be included in the Neuropathology Core (e.g., if biomarker core is focused on imaging) or in the Biomarker Core.

Describe, for all autopsy cases, the facilitation of DNA extraction and collection of biosamples for storage through NCRAD. Specimen collection, data gathering, and storage activities should be coordinated with those of the Clinical Core, Outreach, Recruitment, and Engagement Core, and Data Management and Statistical Core. If there is a plan to obtain clinical information from family or other source postmortem, describe the process.

Describe how outside investigators will have access to the Center's samples and view the catalog of biospecimens for the proposed ADRC.

Inform whether the lay public can obtain an autopsy through the Center and what information is provided to the public regarding brain autopsy. Describe the process for providing an autopsy report to the family.

Provide a description of interactions with the Research Education Component to help educate the next generation of neuropathologists, including personnel exchanges with other Centers as well as cross-disciplinary mentoring within the Center and any on-line educational videos or other educational materials.

Describe the procedures to provide coded samples to investigators that protect the identity of the participants.

Describe the procedures and processes to prevent catastrophic loss of stored specimens.

Describe how the Neuropathology Core will provide a resource for research studies that include clinical-pathological correlations across Centers. To do so, ADRCs should agree to follow standardized procedures whenever possible so data can be combined across Centers.

Expound on the use of tissues and other biological samples stored at the Center and describe how they will be used to support specific research efforts of investigators affiliated with the local Center and other scientists. If tissue will be obtained from people who were not part of the Clinical Core, describe the source and scientific value (e.g., tissues from people living with other dementia diagnoses or tissues of high scientific interest, such as those from participants in clinical trials). If proposing developmental work, describe the role of this work and its significance to the Neuropathology Core, the Center, and other research activities.

Provide a description of novel technologies or techniques that will be used to increase the value of stored tissues and fluids, especially those that have longitudinal data available, and how the technologies or techniques will be shared with the wider research community.

To facilitate data sharing and cross-Center comparisons of diagnosis, all Centers should follow the best practices described on NACC’s website. If tissue from other diseases is collected, list the clinical diagnostic criteria used. More detailed criteria for local research purposes should also be described. Pathology data should be included in the data set transmitted to NACC as defined by the UDS (new applicants may get detailed information from NACC).

Clearly summarize resources used in local or other research projects and new insights obtained from these studies, as well as type and quantity of tissue or other biosamples provided to investigators both funded by the Center and by other means. Describe the most important contributions to research on AD/ADRD and aging utilizing Neuropathology Core resources. Basic functions of the Neuropathology Core should be briefly summarized. Any developmental work carried out by the Neuropathology Core should also be presented.

New applications: Describe preliminary organizational work, institutional experience with AD and other neurodegenerative disease research, potential for developing or contributing to new and exciting research, and specific plans for implementation of the new program. Applicants should obtain the most recent best practice guidelines for biospecimens and the pathology data set from NACC’s website.

Data Management and Sharing Plan:

The Data Management and Sharing Plan submitted to the Overall component of the application must include elements to address all proposed activities of this component.

Appendix:

PHS Human Subjects and Clinical Trials Information (Neuropathology Core)

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Outreach, Recruitment, and Engagement Core

When preparing your application, use Component Type Recruitment Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Outreach, Recruitment, and Engagement Core)

Complete only the following fields:

Applicant Information
Type of Applicant (optional)
Descriptive Title of Applicant’s Project
Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Outreach, Recruitment, and Engagement Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Outreach, Recruitment, and Engagement Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Other Attachments: Provide a list of recruitment materials. Do not provide recruitment materials themselves.

Project /Performance Site Location(s) (Outreach, Recruitment, and Engagement 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 additional entries.

Research & Related Senior/Key Person Profile (Outreach, Recruitment, and Engagement Core)

In the 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 the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a 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.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
The CL(s) should have expertise and a track record of publishing on recruitment/outreach and an understanding of what is needed for retention of participants in dementia research. The leadership team should also have experience in evaluation, as it is critical to assess effectiveness of outreach/engagement programs. The CL should also have experience recruiting understudied and populations relevant to the proposed Center.

Budget (Outreach, Recruitment, and Engagement Core)

The CL of the Outreach, Recruitment, and Engagement Core must commit and sustain a minimum of 1.2 person months of effort. For applications with multiple CLs, a minimum effort of 0.8 person-month is required per additional CL.
Provide resources to support a minimum of 24 person months of effort for full time recruitment specialists.

PHS 398 Research Plan (Outreach, Recruitment, and Engagement Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly describe how the Outreach, Recruitment, and Engagement Core will contribute to the goals of the ADRC and outline interactions of the core with each of the other components of the Center.

Summarize the outreach, engagement, and recruitment needs of the Center, as well as local academic researchers. Outline engagement, recruitment, and outreach plans in light of the needs of the research that will rely on the Center. Include a description of how the Outreach, Recruitment, and Engagement Core will enhance recruitment and retention of volunteers into AD and ADRD research, including clinical trials. Describe how the Center will provide information and resources to the local community as well as more broadly.

Research Strategy: Organize the Research Strategy into the following sections: Significance, Innovation, and Approach. Below is a description of what each section should entail:

Significance: Explain the role of the Outreach, Recruitment, and Engagement Core in the Center and as a community resource on AD/ADRD.

Innovation: Describe novel aspects of the proposed Outreach, Recruitment, and Engagement Core.

Approach: Provide an assessment of the outreach, engagement, recruitment, and retention needs that are unique to the Center, as well as to the geographical area in the vicinity of the ADRC, including identifying understudied groups. The assessment should be conducted in collaboration with those communities and include information about census data and community organizations, as well as an evaluation of the outreach, engagement, and recruitment activities and needs of each research study supported by the Center. Other proposed activities should be clearly described in the application.

Depending on the local needs identified, the Outreach, Recruitment, and Engagement Core should coordinate with other components for recruitment and retention of participants for particular research protocols and clinical trials, with a special emphasis on understudied populations. An outreach/engagement plan should address the needs identified, including both strengths and barriers (e.g., parking/transportation). Efforts to avoid or address selection bias should be clearly described. Retention efforts should be clearly described, including tracking, contact, and scheduling methods as well as incentives or activities to maintain engagement, particularly for hard-to-reach participants.

Describe the creation of a community advisory board, how members will be selected, their role in developing and addressing research questions, frequency of meetings, and how they will facilitate communication of findings and opportunities with the community.

The methods and techniques to be employed to disseminate information, and the audience targeted to receive the information, must be described, including the following:

1) Descriptions of seminar or lecture series or workshops;

2) Outreach/engagement to specific communities to publicize research;

3) Collaboration with other organizations such as state and local agencies, community/service groups, sports teams, hospitals, religious organizations, business groups, local medical societies, etc.; and

4) Descriptions of materials (e.g., videos and printed matter) to be developed by the Center.

Attention should be directed to issues of cultural sensitivity and, where appropriate, the information should be structured so that it can effectively reach populations relevant to the proposed Center and understudied populations, for example people who do not speak English and individuals with low literacy. Procedures by which the education and outreach activities are closely coordinated with the Clinical Core must be described. Community Based Participatory Research methods must be utilized and described. The outreach activities should support activities of the Centers network as well as recruitment for special NIA initiatives. Collaboration with other ADRCs and the NIA Alzheimer’s Disease Education and Referral Center (ADEAR) in recruitment, education, and coordinated dissemination of educational materials is expected. Collaboration and consultation with RCMARs regarding recruitment and retention of understudied and higher risk elder populations are encouraged.

Applicants should describe how they will conduct other major activities of the Outreach, Recruitment, and Engagement Core, which include:

Liaising with state agencies and community service partners regarding dementia-relevant activities.
Developing and evaluating outreach/engagement programs, which may include evaluating metrics related to the total number of participants, feedback forms, number of participants who sign up to receive information or to be contacted by the Center, pre-post event assessments, etc. Describe how the Center will determine return on investment for recruitment efforts.
Communicating the latest research findings both locally and generally to participants, families, and professionals. These efforts might include website, social media, videos, newsletters, brochures, seminars, workshops, or media appearances, including TV, radio, and print.
Working with the Clinical Core to develop and maintain a local registry/database of potential study volunteers. Utilizing the registry to facilitate rapid enrollment in clinical studies. Evaluating the effectiveness of the registry and describing how adjustments will be made, including with respect to inclusion of understudied populations and/or those at higher risk for AD/ADRD as well as to meet the local research needs.

Describe past efforts to assist the Clinical Core and NIA special initiatives in participant recruitment, including any efforts directed to recruitment of people from understudied populations and/or those at higher risk for AD/ADRD. Provide information about educational activities that effectively impart knowledge to professionals and the lay public. Describe other outreach and engagement activities. Describe the most important contributions to research on AD/ADRD and cognitive aging utilizing core resources. Basic functions of the core should be briefly summarized. Any developmental work carried out by the core should also be presented.

New applications: In addition to the above, describe preliminary organizational work; institutional experience with recruitment, engagement, and outreach for AD and other neurodegenerative disease research; potential for developing or contributing to new and exciting methods; and specific plans for implementation of the new program.

Letters of Support: Include letters of support from community, state, and NGOs that will collaborate with the Center.

Data Management and Sharing Plan:

The Data Management and Sharing Plan submitted to the Overall component of the application must include elements to address all proposed activities of this component.

Appendix:

PHS Human Subjects and Clinical Trials Information (Outreach, Recruitment, and Engagement Core)

Other Requested Information: Each component should include an attachment that indicates that the details of the study are included in the Overall component within this attachment

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Biomarker Core

When preparing your application, use Component Type Biomarker Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Biomarker Core)

Complete only the following fields:

Applicant Information
Type of Applicant (optional)
Descriptive Title of Applicant’s Project
Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Biomarker Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Biomarker Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Facilities and Other Resources: In addition to the information required in the standard instructions, highlight available facilities, equipment, tools, resources, and/or services dedicated specifically to the approaches proposed in the Biomarker Core. Indicate on what basis these resources will be available to the ADRC investigators (e.g., in-lab, freely available, fee-for-service, etc.).

Other Attachments: Provide the standardized protocols that will be used in the Biomarker Core.

Project /Performance Site Location(s) (Biomarker 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 additional entries.

Research & Related Senior/Key Person Profile (Biomarker Core)

In the 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 the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a 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.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
The CL(s) should have a track record of research in some aspect of neurodegenerative disease, preferably including interactions with key personnel from other components, as well as other Centers. The CL(s) should have demonstrated knowledge of standard protocols, as well as expertise in state-of-the-art techniques relevant to the Biomarker Core and a track record of sharing and collaboration.

Budget (Biomarker Core)

The CL of the Biomarker Core must commit and sustain a minimum of 1.2 person months of effort. For applications with multiple CLs, a minimum effort of 0.8 person-month is required per additional CL.
CLs from the ADRCs will meet yearly to share ideas and discuss technical aspects of sampling; development of standardized processes for various research protocols; cataloging and data management; and storing, distribution, and analysis of images and biological samples. The CL, as well as an early-stage investigator interested in the topic, should have funds budgeted to attend this meeting.

PHS 398 Research Plan (Biomarker Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly describe how the Biomarker Core will contribute to the goals of the ADRC and outline interactions between the core and each component of the Center.

Identify which biomarkers will be collected and/or developed and how they will be used to increase the understanding of disease heterogeneity, disease onset, or progression, and/or improve diagnosis. Describe how they will be used to advance translational research (e.g., biomarkers), in combination with other data, that enable molecular profiling of individual AD dementia which eventually leads to development of personalized AD treatments. Describe the exploration of the selected biomarkers' biology that can explain etiology or heterogeneity of disease and determine the quality of the biomarker.

Biomarkers of interest are any that can be used for disease monitoring and novel biomarker discovery. These might include various neuroimaging methods, fluid biomarkers, or biomarkers collected in other tissues (e.g., flow, skin, ocular, olfactory), as well as collection of data from mobile and/or wearable devices. An individual Biomarker Core may focus on collecting/developing one or more types of biomarkers. Biomarker Cores can focus on collecting established, standardized biomarkers, or they could be discovery-based and focus on generating high-dimensional omics data (e.g., genomic, proteomic, metabolomic, glycomic) that will be made available to the research community at large for basic, translational, and clinical research.

Research Strategy: Organize the Research Strategy into the following sections: Significance, Innovation, and Approach. Below is a description of what each section should entail:

Significance: Explain the role of the Biomarker Core in the Center as a resource for other local, national, and international research activities focused on AD and other neurodegenerative diseases.

Innovation: Describe novel aspects of the Biomarker Core.

Approach: Describe how the Biomarker Core will provide a resource for research studies, both within and outside of the applicant institution, that seek to understand the heterogeneity of dementia through analysis of imaging and/or biomarkers. To do so, ADRCs should agree to follow standardized procedures whenever possible so that it is possible to utilize data across Centers. There is a biospecimen best practices guidelines document available on NACC’s website.

Describe the procedure for prioritizing which cases will be targeted for biomarker consent as well as the use of biomarkers and data stored at the Center. Describe how the prioritization will be used to support specific research efforts of investigators affiliated with the local Center and other scientists. If collection of special material is proposed (e.g., samples from people with other dementia diagnoses or samples of high scientific interest, such as those from clinical trials) justification should be included. If proposing developmental work, describe the role of this work and its significance to the Biomarker Core, the Center, and other research activities.

Biomarker Cores can focus on sample collection for biomarker discovery, generation of data using the Center’s biobanking resources that can be amenable for biomarker discovery, and/or development of analytical methods for biomarker discovery and development.

Describe the process and web-based tools to make the collected samples, data, and analytics tools available to the local research community and researchers at large. Alternatively, these capabilities can be part of the Data Management and Statistical Core.

The responsibility for collection, storage, tracking, and sharing of biosamples can be part of the Biomarker Core or the Neuropathology Core. Biomarker and imaging data should be included in the data set transmitted to NACC.

Provide a description of interactions with the Research Education Component to help educate the next generation of researchers with expertise in imaging and biomarkers and/or analytics, including personnel exchanges with other Centers, as well as cross-disciplinary mentoring within the Center.

Clearly summarize resource use in affiliated research projects and the new insights obtained from these studies, as well as type and quantity of images, data, and/or samples provided to investigators both funded by the Center and by other means. Describe the most important contributions to research on AD/ADRD and aging utilizing resources of the Biomarker Core. Basic functions of the Biomarker Core should be briefly summarized. Any developmental work carried out by the Biomarker Core should also be presented.

Data Management and Sharing Plan:

The Data Management and Sharing Plan submitted to the Overall component of the application must include elements to address all proposed activities of this component.

Appendix:

PHS Human Subjects and Clinical Trials Information (Biomarker Core)

Other Requested Information: Each component should include an attachment that indicates that the details of the study are included in the Overall component within this attachment.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Research Education Component - Linked Education Project (RL5)

When preparing your application, use Component Type Research Education.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Education Component (RL5))

Complete only the following fields:

Applicant Information
Type of Applicant (optional)
Descriptive Title of Applicant’s Project
Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Education Component (RL5))

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Education Component (RL5))

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project /Performance Site Location(s) (Research Education Component (RL5))

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 additional entries.

Research & Related Senior/Key Person Profile

In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Component Lead and provide a valid eRA Commons ID in the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a 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.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Education Component (RL5))

Budget forms appropriate for the specific component will be included in the application package.

Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.
Funds for salaries and other expenses of the Research Education Component Lead(s), information resources, and support staff may be requested.
The Research Education Component may provide the following to participants: salary, fringe benefits, travel, and research-project-related expenses.
Research Education Component participant costs must be itemized in the proposed budget. Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program. There is no minimum salary or professional effort requirement for Research Education Component participants. Research Education Component participants may receive salary support from other federal sources consistent with the institution's salary scale as long as those sources do not specifically prohibit such salary supplementation. Individuals supported by NIH training and career development mechanisms (i.e., K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by the Research Education Component as participants, but may not receive salary or stipend supplementation from the Research Education Component.
Because the RL5 program is not intended as a substitute for an NRSA institutional training program (e.g., T32), costs to support full-time participants (supported for 40 hours/week for a continuous, 12-month period) are not allowable.
Expenses for foreign travel must be exceptionally well justified.
Indirect costs (Facilities & Administrative costs) are reimbursed at 8% of modified total direct costs, exclusive of tuition and fees and expenditures for equipment.
Set aside funds to travel 3-5 participants to one cycle of the semiannual meeting of the ADRCs each year of the award.

PHS 398 Research Plan (Research Education Component (RL5))

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the contribution of the Research Education Component to the Center's overall goals. Describe how the proposed use of Research Education Component funds for research education activities will provide relevant preparation for a workforce in AD/ADRD research. Describe how the Research Education Component Leader(s) and other mentors will help implement the intended goals of the Research Education Component.

Research Strategy: The Research Strategy must include the following subsections:

Proposed Research Education Program. The application must describe how the proposed program will be distinct from training programs that already exist in the organization. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program.

The research education program must include mentored research experiences that develop state-of-the-art research skills related to AD and ADRD and leverage the interdisciplinary nature of the ADRC. Outline the objectives of the program and the program activities that will be used to meet these objectives. Describe plans to accommodate differences in preparation among participants. Include information about mentored research experiences and other educational activities essential for the proposed program.

Describe the plan for recruiting, selecting, mentoring, and monitoring the progress of individuals who will receive Research Education Component support over the proposed Center award period and describe the abilities that Research Education Component candidates will be expected to acquire. The plan should include use of the external advisory committee.

The research education plans for at least some of the junior faculty and research associates supported through the Research Education Component must provide for the development of combined competence in basic, translational, and clinical research in the areas of AD and ADRD. An emphasis on development of skills for translating basic findings into clinical research, and clinical findings into mechanistic studies, is encouraged. The plan may include establishment of common courses in relation to basic and clinical AD research. Regarding the goal of developing researchers with multidisciplinary expertise in clinical, translational, and basic research (including aging research), applicants should consider the previous training of the individual candidate in determining the nature and extent of research education activities for which Research Education Component support is requested. One training option might include personnel exchange among different Centers, such as ADRC, Udall, Pepper, RCMAR, and AD Translational Centers.

Component Leader(s). Describe arrangements for administration of the program. Provide evidence that the Component Leader(s) is/are actively engaged in research and/or teaching in an area related to the mission of NIA and the goals of the ADRC program, and can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple Component Leaders, describe the complementary and integrated expertise of the leaders, their leadership approach, and governance appropriate for the planned program.

Program Faculty. Faculty should have research expertise and experience relevant to AD and ADRD. Faculty must be committed to continue their involvement throughout the total period of this award.

Describe how the program faculty will serve as preceptors/mentors and provide guidance and expertise appropriate to the level of participants proposed in the application. Describe complementary expertise and experiences of the proposed program faculty, including active research and other scholarly activities in which the faculty are engaged, particularly interdisciplinary work, as well as experience mentoring and training individuals at the proposed career stage(s). For any proposed program faculty lacking research training experience, describe a plan to ensure successful participant guidance by these individuals. Describe the criteria used to appoint and remove individuals as program faculty and to evaluate their participation.

Program Participants. Applications must describe the intended participants and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels for which the proposed program is planned.

Research Education Component support is intended primarily for US citizens and permanent residents, unless there is strong justification otherwise based on exceptional relevance to the NIH and NIA.

Research Education Component support is intended for junior faculty and research associates. At least some participants selected for support through the Research Education Component should hold a clinical doctoral degree. Research education support should be integrated with other sources of career support that they may be receiving (e.g., career awards (NIH or not), fellowships) in concerted programs for research education. One of the goals of the research education program should be to recruit candidates from fields outside of AD/ADRD, such as technology/engineering, data sciences, and traditional and emerging pharmaceutical sciences.

Plan for Instruction in the Responsible Conduct of Research. All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan must address the five required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only online instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, and research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019. The plan should be appropriate and reasonable for the nature and duration of the proposed program.

Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.

Evaluation Plan. Applications must include a plan for evaluating the activities supported by the research education program. A diagram or a table with milestones and timeline is encouraged. The application must specify baseline metrics (e.g., numbers, educational levels of participants), as well as measures to gauge the short- or long-term success of the research education program in achieving its objectives (e.g., publications, awards, or independent research funding). Research education program participants future career achievements should be tracked and included in the progress report. Applicants should obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.

Renewal applications: In addition to above, describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

Letters of Support: A letter of institutional commitment must be attached as part of Letters of Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

Progress Report Publication List: Publications resulting from resources or developmental work carried out by the Research Education Component should be listed, including those arising from research conducted by participants while they were supported by the Research Education Component.

Data Management and Sharing Plan:

The Data Management and Sharing Plan submitted to the Overall component of the application must include elements to address all proposed activities of this component.

Appendix:

PHS Human Subjects and Clinical Trials Information (REC)

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Additional Cores

When preparing your application in ASSIST, use Component Type Additional Cores.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Applicants are expected to include Additional Cores appropriate to the theme(s) of the ADRC that both take advantage of local expertise and provide a resource to the broader research community.

SF424 (R&R) Cover (Additional Cores)

Complete only the following fields:

Applicant Information
Type of Applicant (optional)
Descriptive Title of Applicant’s Project
Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Additional Cores)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Additional Cores)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project /Performance Site Location(s) (Additional Cores)

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 additional entries.

Research & Related Senior/Key Person Profile (Additional Cores)

In the 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 the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a 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.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Additional Cores)

Budget forms appropriate for the specific component will be included in the application package.

The CL of this components must commit, and sustain, a minimum of 1.2 person months of effort. For applications with multiple CLs, a minimum effort of 0.8 person-month is required per additional Core Leader

PHS 398 Research Plan (Additional Cores)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly state how the component will contribute to the goals of the ADRC and outline interactions of the Additional Cores with each of the other component of the Center.

Demonstrate how the proposed component would augment or enhance the present capabilities of investigators using Center resources to enhance or create research at the home Center as well as other Centers and the wider research community.

Research Strategy: Organize the Research Strategy into sections on Significance, Innovation, and Approach. There should be a detailed explanation of the research that will, or could, use the resources of Additional Cores.

Place overall summaries in the approach section of each component. Describe the most important contributions to research on AD/ADRD and aging utilizing resources of the Additional Cores. Applicants should include objectives of the Additional Cores and progress in meeting them. Any developmental work carried out by the Additional Cores should also be presented.

New applications: Describe preliminary organizational work, institutional experience with AD and other neurodegenerative disease research, potential for developing or contributing to new and exciting research, and specific plans for implementation of the new program.

Data Management and Sharing Plan:

The Data Management and Sharing Plan submitted to the Overall component of the application must include elements to address all proposed activities of this component.

Appendix:

PHS Human Subjects and Clinical Trials Information (Additional Cores)

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

2. Administrative and National Policy Requirements

4. Reporting

Expired RFA-AG-24-001: Alzheimer's Disease Research Centers (P30 Clinical Trial Not Allowed)