Feasibility Trials of the NIH Music-based Interventions Toolkit for Brain Disorders of Aging (R34 Clinical Trial Required)

Feasibility Trials of the NIH Music-based Interventions Toolkit for Brain Disorders of Aging (R34 Clinical Trial Required) is sponsored by National Institutes of Health (NIH). Supports feasibility trials of music-based interventions for brain disorders of aging, including Alzheimer's disease and related dementias.

Expired PAR-24-168: Feasibility Trials of the NIH Music-based Interventions Toolkit for Brain Disorders of Aging (R34 Clinical Trial Required) 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 ) Components of Participating Organizations National Center for Complementary and Integrative Health ( NCCIH ) Funding Opportunity Title Feasibility Trials of the NIH Music-based Interventions Toolkit for Brain Disorders of Aging (R34 Clinical Trial Required) August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023.

See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 .

Funding Opportunity Number (FON) Companion Funding Opportunity See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to ressiue PAR-23-256 “Feasibility Trials of the NIH Music-based Interventions Toolkit for Brain Disorders of Aging (R34 Clinical Trial Required)” in order to support proof-of-concept feasibility trials guided by the NIH Music-based Interventions (MBI) Toolkit for research on brain disorders of aging.

These early phase clinical trials will generate evidence supporting the validity of the NIH MBI Toolkit’s guiding principles as well as the necessary pilot data to design a subsequent clinical efficacy or effectiveness study (or pragmatic clinical trial) using music-based interventions in the context of brain disorders of aging, including but not limited to Alzheimer’s disease and Alzheimer’s disease-related dementias, Parkinson’s disease, and stroke.

The data collected should address gaps in scientific knowledge in order to facilitate development of a competitive large-scale clinical trial. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 Days prior to the application due date. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

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.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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 Announcement Section I.

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

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

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description The purpose of this Notice of Funding Opportunity (NOFO) is to reissue PAR-23-256 "Feasibility Trials of the NIH Music-based Interventions Toolkit for Brain Disorders of Aging (R34 Clinical Trial Required)" in order to support proof-of-concept feasibility trials guided by the NIH Music-based Interventions (MBIs) Toolkit for research on brain disorders of aging.

These early stage clinical trials will generate evidence supporting the validity of the NIH MBI Toolkit' s guiding principles as well as the necessary feasibility data to design a subsequent clinical efficacy or effectiveness study (or pragmatic clinical trial) using music-based interventions (MBIs) in the context of brain disorders of aging, including but not limited to Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD), Parkinson’s disease, and stroke.

The data collected should address gaps in scientific knowledge in order to facilitate development of a competitive clinical efficacy or effectiveness clinical trial.

This NOFO will not support randomized clinical trials that propose to test or determine efficacy or effectiveness of MBIs, including preliminary efficacy or effectiveness, nor will this NOFO support repetition of feasibility or acceptability research that has been previously conducted in the same or similar patient population with the same or similar intervention.

Applications that propose solely to write a protocol or manual of operations or to develop infrastructure for a clinical trial are not appropriate for this announcement. Applications must propose to conduct a feasibility clinical trial applying the guiding principles detailed in the NIH MBI Toolkit ; a subsequent efficacy or effectiveness trial should have the potential to make a significant impact on public health.

Empirical evidence supports that music engages many different areas of the brain and may aid in strengthening the neural networks and pathways involved in sensorimotor processes, emotion, affect, and memory.

Music-based interventions (MBIs) may represent a valuable therapeutic opportunity for a wide range of disorders impacting these domains, especially given that these interventions are frequently low-cost, mostly devoid of side effects, potentially scalable in healthcare systems, and generally well accepted by patients.

However, reports of the beneficial effects of music on human health have largely emerged from anecdotal evidence of small-scale clinical trials, and the scarcity of data from rigorous, well-powered studies presents a major limitation to widespread application of MBIs.

Harnessing the therapeutic potential of music is of wide interest across NIH: 21 of NIH’s 27 Institutes and Centers have representatives in the Trans-NIH Music and Health Working Group. This group supported the issuance of three NOFOs in 2019 that were designed to promote research on music and health.

Two of these NOFOs ( RFA-NS-19-008 and RFA-NS-19-009 ) supported R01 and R21 awards, respectively, for research related to the fundamentals and application of music in health. The third NOFO ( RFA-AT-19-001 ) utilized a phased R61/R33 mechanism to support research on music and health geared toward the development of MBIs.

These NOFOs were followed in 2020 by the publication of three program announcements with special reviews ( PAR-20-266 , PAR-21-100 , and PAR-21-099 ) to continue NIH’s support for basic, mechanistic, translational, and clinical research on music and health.

In 2021, NIH collaborated with the Foundation for the NIH (FNIH) and the Renée Fleming Foundation to organize three workshops: Laying the Foundation: Defining the Building Blocks of Music-Based Interventions , Assessing and Measuring Target Engagement Mechanistic and Clinical Outcome Measures for Brain Disorders of Aging , and Relating Target Engagement to Clinical Benefit Biomarkers for Brain Disorders of Aging .

Each workshop featured interdisciplinary panels of experts in neuroscience, music therapy and music medicine, behavioral intervention development, clinical trial methodology, and patient and arts advocacy.

Notably, each expert panel included both scientists actively working in the field of music and health as well as experts in a relevant discipline but not directly involved in MBI research, thus bringing fresh and unbiased perspectives to every panel.

The NIH MBI Toolki t, which was recently published by the journal Neurology , is a direct outcome of these workshops that addresses a pressing need for building blocks of music-based interventions, use of a core set of common data elements, recommended functional outcome measures and biomarkers, and a framework and guidelines for music-based intervention research to enhance the rigor and reproducibility of MBI studies.

This R34 NOFO will support proof-of-concept feasibility trials guided by the NIH MBI Toolkit for research on brain disorders of aging.

These early stage clinical trials will generate evidence to determine the validity of the NIH MBI Toolkit ’s guiding principles as well as the necessary data to design a subsequent clinical efficacy or effectiveness study (or pragmatic clinical trial) using MBIs in the context of brain disorders of aging, including but not limited to AD/ADRD, Parkinson’s disease, and stroke.

The NIH MBI Toolkit defines the essential components of MBIs and promotes inclusion in MBI studies of critical elements that enhance rigor and reproducibility, such as a conceptual model or framework to guide the design of the MBI, a clear research question, and supporting data for the hypothesis.

The NIH MBI Toolkit also outlines a core set of common data elements or building blocks that must be included in every MBI, including a comprehensive description of the intervention, a detailed protocol for delivering the intervention, a defined population to be studied, and control groups or comparators.

Validation, dissemination, and implementation of the NIH MBI Toolkit’s guiding principles are viewed as critical steps toward accumulating the large-scale, rigorous, and replicable evidence necessary to incorporate MBIs into clinical practice. This NOFO proposes to build upon the rapidly expanding evidence base linking music and health by supporting feasibility trials guided by the NIH MBI Toolkit for brain disorders of aging.

The R34 planning grant will support planning activities and analyses of existing data needed to design a feasibility and acceptability clinical research project and develop a protocol, to gather data to prepare for a future efficacy trial. . The grant will also support new data collection for assessing feasibility of protocol components (e.g., recruitment strategies, outcome ascertainment).

Applicants are encouraged to review NCCIH guidance on appropriate components of a feasibility study . Since the focus of this NOFO is on the feasibility of the intervention, delivery of the intervention must be limited to one site. All projects should be rigorously designed according to the guiding principles of the NIH MBI Toolkit and within the mission of the participating Institutes, Centers, and Offices.

In addition, all proposed projects should have the potential to increase our understanding of the science of music and health, as well as inform MBIs to enhance normal function and improve health using brain disorders of aging as a model system.

Applications to this NOFO must also address the following specific requirements: State the conceptual framework (e.g., music therapy, behavioral, neural, social) guiding the proposed research (example frameworks are described in the NIH MBI Toolkit ) Address all MBI building blocks as outlined by the NIH MBI Toolkit Identify relevant clinical outcomes and/or biomarkers for brain disorders of aging (examples are provided in the NIH MBI Toolkit ) Propose a multidisciplinary research team with expertise such as clinical trial design, music therapy/music medicine, behavioral intervention development, neuroscience, social science; patient-caregiver engagement is also encouraged.

Prospective applicants should note that funding of a planning grant does not guarantee or imply funding for any subsequent competitive application for support of a full-scale, multi-site clinical trial or clinical research study.

The following are examples of project goals that are appropriate for feasibility trials submitted in response to this NOFO when the literature has not already demonstrated evidence for the proposed (or a similar) intervention and study population: Examine feasibility and acceptability of various conceptual models or frameworks of MBIs (e.g., music therapy, behavioral, neural, or social) Examine feasibility and acceptability of MBIs lacking published data for brain disorders of aging Adapt an MBI to a specific population or disease stage relevant to brain disorders of aging Assess acceptability and adherence to frequency and/or duration of an MBI for testing in a future large-scale, multi-site efficacy or effectiveness clinical trial Determine feasibility of recruitment, retention, and data collection procedures Develop and assess the feasibility of defined protocols for multimodal MBIs Assess the feasibility and acceptability of recruitment, retention, intervention delivery, and data collection procedures of a fully remote MBI intervention Examine acceptability and adherence of control conditions for MBIs and brain disorders of aging Refine an MBI to address challenges with intervention fidelity, participant adherence or retention, selection of appropriate outcomes, and ability to capture outcome measures within designated time frames.

Assess MBI acceptability and adherence at different stages of disease progression Assess feasibility of randomization or other aspects of trial design for MBIs in aging populations Test the feasibility of strategies for integrating MBIs into a healthcare system or other modes of delivery relevant to age-related brain disorders to inform design of future pragmatic trials Investigators should propose a randomized controlled trial design with at least one intervention arm and one comparator arm.

There should be strong rationale for the comparator condition (e.g., time and attention control, usual care, standard of care, sham condition, and/or active comparator(s)) based on the research question planned to be addressed in the future powered trial. Due to lack of rigor and potential expectancy effects, this NOFO will not support studies proposing a waitlist comparator condition.

Pilot or feasibility studies are carried out in preparation for future adequately powered studies and, therefore, should address key issues of process (e.g., recruitment, retention, feasibility, adherence, fidelity) and/or outcomes assessment (e.g., feasibility of the method, frequency, burdensomeness, and duration of data collection procedures).

Given the limited sample sizes that can be supported under this R34 grant mechanism, proposing to conduct fully powered tests of clinical outcomes (i.e., efficacy) or underpowered test of outcomes (i.e., "preliminary efficacy") or attempting to utilize the highly variable point estimate of an effect size for power calculations is not allowed and is noted as non-responsive below.

Applicants should define feasibility/acceptability with quantitative benchmarks corresponding to each assessment category.

Clinical Trials Not Responsive to this NOFO The following types of clinical trials are not responsive to this NOFO and applications proposing such activities will be deemed non-responsive and will not be peer-reviewed: Trials that do not include an aim to assess the feasibility, acceptability, fidelity, and/or adherence to the music-based intervention Studies proposing to analyze data from a feasibility trial to assess efficacy/effectiveness of an intervention or estimate effect size Trials that attempt to assess safety/tolerability of a treatment Repeat feasibility or acceptability studies that have been previously conducted in the same or similar populations (e.g., same age range, clinical diagnosis, and other clinically relevant demographics), with the same or similar intervention, and with the same primary objectives Studies that do not include a music intervention Studies that propose a waitlist control, due to lack of rigor and potential expectancy effects Trials proposing to physically administer the intervention at multiple clinical sites (i.e., multi-site trials) Trials that fail to propose to assess feasibility of interventions for the treatment or prevention of brain disorders of aging Trials that propose to assess feasibility of interventions for the treatment or prevention of cancer (i nvestigators interested in cancer treatment or prevention trials should contact the National Cancer Institute ) Studies to solely develop a protocol, manual of operations, or infrastructure for a clinical trial Studies that are proposing to test the efficacy or effectiveness of the music-based intervention including in a fully remote clinical trial.

Applicants interested in testing the efficacy of effectiveness of a fully remotely delivered MBI can refer to PAR-24-086 . Applications that do not utilize the guiding principles of the NIH MBI Toolkit See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Required: Only accepting applications that propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. This R34 is limited to direct costs requests of up to $450,000 over the entire project period.

Although variations from year to year are permissible, in no case may any year be more than $225,000 in direct costs. The maximum project period is 3 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III.

Eligibility Information 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 Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) 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 Recognized) 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 Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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 possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information 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. NATO 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.

Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; 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.

Grants. gov – Applicants must have an active SAM registration in order to complete the Grants. gov registration.

Program 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 Investigator) 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 their organization to develop an application for support.

Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities , NOT-OD-22-019 .

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 How to Apply - Application Guide . This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1. 2 Definition of Terms.

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, per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. 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 NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. 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 instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. 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 plan the review. 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: National Center for Complementary and Integrative Health (NCCIH) All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO. All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: The significance of the proposed clinical trial and importance of the question must be clearly stated.

It is particularly important that there be a discussion of how the trial will test the proposed hypotheses and how or why there is clinical equipoise. The clinical significance and, when applicable, the biological relevance of the future fully powered clinical trial should be clearly stated. The importance of the proposed feasibility trial should be described and why it is necessary to plan the subsequent future trial.

It is particularly important that there be discussion of how the proposed early-stage trial will test the primary hypothesis focused on feasibility and how the results of the trial (positive or negative) will guide decisions about whether a subsequent study is feasible or justified, and/or evidence that additional studies must be completed before proceeding to a full-scale trial.

Applications should address the reasons for selection of the intervention. This may include public health impact if subsequent efficacy trials are conducted and positive, ethical dimensions, and patient/caregiver perspectives on acceptability of the proposed intervention.

Characteristics of any preliminary research results provided in support of the proposed project, whether conducted by the applicant or others, should be described in the application so that peer reviewers may evaluate the strength of the supporting evidence. The applicant should also discuss the limitations of those data.

Explain how the application challenges and seeks to shift current research or clinical practice paradigms or guidelines. If not innovative, explain why alternative innovative approaches are not possible or practical and why the proposed research is necessary to establish feasibility of the intervention. Explain how the application addresses the appropriate regulatory requirements (i.e.,IDE, IRB).

A summary of the proposed feasibility trial protocol should be presented in the Research strategy and should include the items listed below as described in the NIH MBI Toolkit: The conceptual framework (e.g., music therapy, behavioral, neural, social) guiding the proposed research (example frameworks are described in the NIH MBI Toolkit) The intervention characteristics, such as specific elements of music (e.g., pitch, timbre, rhythm), modes of engagement (e.g., active vs passive), dosage, frequency, or relationship to culturally specific music preferences Protocol delivery considerations, such as music characteristics (e.g., live vs recorded), research setting (e.g., laboratory, clinic, community), mode of participation (e.g., individual vs group, in-person vs remote), timescale (e.g., short vs long term, session length and intensity) Without duplicating the details from the PHS Human Subjects and Clinical Trials Information Form, a description of the study population and rationale for testing the intervention in that population A control group or comparator and rationale for selection; for example, the control condition may control for intervention effects that are unrelated to the music or for effects of the specific intervention protocol delivery method Relevant clinical outcomes and/or biomarkers for brain disorders of aging (examples are provided in the NIH MBI Toolkit) A multidisciplinary research team with expertise such as clinical trial design, music therapy/music medicine, behavioral intervention development, neuroscience, social science; patient-caregiver engagement is also encouraged Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide .

Other Plan(s): 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.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide .

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - 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 Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed.

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed. Section 5 - Other Clinical Trial-related Attachments 5. 1 Other Clinical Trial-related Attachments The following attachments must be included as a part of the application.

Attachments permit expansion of certain elements that cannot be appropriately described in the Research Strategy. All attachments listed below must be provided or the application will not be peer reviewed. 1.

Clinical Trial Experience Applicants must provide a detailed table listing the characteristics of trials that demonstrate Key Personnel experience in trial coordination in the last 5 years. One table must be provided for each study record with a unique filename for each study record as an attachment (e.g., "Clinical Trial Experience1. pdf", "Clinical Trial Experience 2.

pdf, etc.) and the table must not exceed three pages. The table columns should include: Applicant's role in the trial A brief description of the trial design Whether the trial(s) were completed on schedule or not 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 How to Apply - Application Guide must be followed.

PHS Assignment Request Form All instructions in the How to Apply - Application Guide must be followed. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 2.

Section III. 1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4.

Submission Dates and Times