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 Advancing Translational Sciences (NCATS)

Funding Opportunity Title

Clinical and Translational Science Award (U54 Clinical Trial Optional) 

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

Reissue of PAR-18-464

Related Notices
Funding Opportunity Announcement (FOA) Number

PAR-18-940

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.350  

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to invite applications to participate in the Clinical and Translational Science Award (CTSA) Program which supports high quality translational science and clinical research locally, regionally and nationally and fosters innovation in research methods, training, and career development.   

Key Dates

 

Posted Date

September 27, 2018

Open Date (Earliest Submission Date)

December 25, 2018  

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

January 25, 2019, April 15, 2019, August 15, 2019, December 16, 2019, April 15, 2020, August 17, 2020, December 15, 2020, April 15, 2021, August 15, 2021, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

June 2019, September 2019, January 2020, May 2020, September 2020, January 2021, May 2021, September 2021, January 2022   

Advisory Council Review

  New Dates October 2019, January 2020, May 2020, October 2020, January 2021, May 2021, October 2021, January 2022, May 2022

Earliest Start Date

New Dates December 2019, April 2020, July 2020, December 2020, April 2021, July 2021, December 2021, April 2022, July 2022

Expiration Date

August 16, 2021

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted.

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Table of Contents

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

    Section I. 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. Funding Opportunity Description

    Purpose

    The purpose of this funding opportunity announcement (FOA) is to invite applications for the Clinical and Translational Science Award (CTSA) Program hubs, which support high quality collaborative translational science locally, regionally, and nationally; foster scientific and operational innovation to improve the efficiency and effectiveness of clinical translational research; and create, provide, and disseminate domain-specific translational science training and workforce development.

    Background

    The development and implementation of clinical interventions that demonstrably improve human health is currently a complex, recursive, and inefficient process, that leads to delays of years or decades before discoveries in biomedical research result in health benefits for patients and communities.  The National Center for Advancing Translational Sciences (NCATS) conducts and supports research in the science of translation, to discover the mechanistic and operational principles of the intervention development and dissemination process, thereby providing the scientific foundation for improvements in translational efficiency that will accelerate the realization of interventions that improve human health.

    Specific Objectives

    A CTSA Program hub is an integrated research and training environment for translational and clinical science, which catalyzes the development, demonstration, and dissemination of methods and technologies that dramatically improve efficiency and quality across the translational research spectrum. The academic health centers that make up the CTSA Program are referred to as “hubs” to indicate their central role in their local environments where they coordinate and collaborate with multiple “spokes” such as affiliated hospitals, clinics, and community health centers.   Each CTSA Program hub functions as a local center of innovation in translational science and operations, the nature of which will build on local institutional strengths and in particular geographic/demographic needs.  In aggregate, the diverse CTSA Program hubs form a network whole that is much greater than the sum of its parts, with hubs bringing complementary strengths to each other via the CTSA Program locally, regionally, and nationally.  Thus, hubs must also have certain common capabilities in order to both serve as a field-leading center for translational innovation locally, and a participant in multi-hub collaboratives regionally and nationally.  CTSA Program hubs should be agents of continuous improvement as they identify gaps and opportunities in the research process and develop, instantiate innovative solutions at their institutions, and share those solutions with the other CTSA Program hubs. This modus operandi will maximize the progress at both individual hubs and in translational science broadly, obviating duplication and leveraging each hub’s strengths to bolster the others and translational science as a whole. This network aspect of the CTSA Program will also facilitate innovation in multi-center research, harmonization of standards and best practices, enhance translational training through sharing curricula and online training modules/courses, and will provide opportunities for cross-hub and sector research training and career development opportunities, both within and outside of the CTSA Program. Realizing these synergies will also maximize the nation’s investment into the CTSA Program.

    The overall purpose of the CTSA program is to deliver scientific and systems change that solve the many outstanding problems limiting the efficiency, effectiveness, and reach of clinical translational research, and thus get more treatments to more patients more quickly across the country.  To do that, the program focuses on widely appreciated systematic barriers including but not limited to:

    • Data interoperability
    • Biomarker qualification process
    • Regulatory science
    • Clinical trial networks
    • Patient recruitment
    • Electronic Health Records for research
    • Harmonized IRBs
    • Clinical diagnostic criteria
    • Clinical outcome criteria (e.g., PROs)
    • Adaptive clinical trial designs
    • Shortening time of intervention adoption
    • Methods to better measure impact on health (or lack thereof)
    • Data transparency/release
    • Integration of project management
    • Incentives/credit for team science
    • Incentives/credit for health improvements
    • Education/Training (scientific and cultural)
    • Collaborative structures

    Innovations in these and related areas will be catalytic to translational efficiency and the development and delivery of interventions that improve the health of individuals and communities.  It is not expected that every hub should have the expertise or capability to address all these issues, but the aggregate program can and should.  Beyond these strategic focus areas, this FOA defines domains of activity for the CTSA Program hubs that are intended to advance progress in these areas broadly, as well as a set of standards and resources that should be available at each hub to allow it to serve as a leading center for translational innovation and facilitate collaboration among the hubs.  An important operational principle of all NCATS programs, including the CTSA Program, is to maximize impact via a catalytic approach: developing, demonstrating utility of, and then disseminating improvements in translational science and operations.  Depending on the problem being addressed, CTSA Program hubs are expected to develop and demonstrate solutions to translational roadblocks individually, as groups of hubs, and on a national level.

    Domains of activity that currently serve as organizing principles for the CTSA Program hubs' activities, and which each hub should therefore address, are:

    • Methods/Processes: scientific study of, and innovation in, the individual steps of the translational process, and its integration into an efficient system of translation from discovery to community
    • Collaboration/Engagement: research in the structures, rationales, operations, purposes, outcomes, and metrics of engagement with stakeholders at each step of the translational process to elucidate principles and practices that make translation maximally efficient, focused, and relevant.
    • Informatics:  development, demonstration, and dissemination of informatics and IT innovations that accelerate both the science and operations of clinical translation. 
    • Integration Across the Lifespan:  development of scientific insights, and operational processes, that will ensure that translational advances are realized in all populations, including children, pregnant and lactating women, the elderly, and other special populations, with particular emphasis on life stage transitions.
    • Workforce Development – innovations in the substance and culture of translational science workforce development, to create and sustain a robust, supported workforce with the skills, knowledge, and institutional environment necessary for continuous improvement in translational research and science.

    CTSA Program hubs are expected to develop, demonstrate, and then disseminate solutions to roadblocks that currently limit the efficiency and effectiveness of clinical and translational science research. In response to this FOA, applicants should include plans for developing tools and methods directed at identified chokepoints in the translational process demonstrating their value across the CTSA Program hubs, and ultimately, disseminating successful strategies more broadly.  Plans should promote a research-friendly environment where patients, clinicians and other stakeholders have easily accessible opportunities and resources to contribute to research. The environment should facilitate the rapid integration of advances in translational research. In addition, the application should include plans for the adoption and implementation of innovative policies and infrastructure that improve the quality of human subject protections and promote a culture of responsibility, while minimizing investigator burden and measurably decreasing administrative delays.

    Disease and condition-specific research supported by NIH Institutes and Centers should be demonstrably enhanced by the translational science advances, expertise, and resources of the CTSA Program hubs. The CTSA Program infrastructure will provide innovation and support for all scientific/medical communities engaged in clinical and translational research.

    In training and operations, CTSA Program hubs should intentionally promote and incentivize the team science required for translational research, and the development and nurturing of the translational research workforce.  To meet the training and career development needs of translational science, NCATS encourages innovative research training and career development programs that impart the knowledge, skills, and approaches required for high quality translational science.  CTSA Program-supported education programs should provide training in rigorous research methodologies, elimination of bias in experimental design and reporting, and knowledge of regulatory sciences and entrepreneurship. Opportunities for trainees to gain direct experience with parts of the translational ecosystem outside academia are also important, such as research externships in industry, regulatory agencies, nonprofit patient-advocacy groups, or other CTSA Program hubs with strengths different from their home hub. CTSA Program hubs are encouraged to collaborate with each other to leverage resources and expertise in education and training initiatives.  As with all NIH training, this funding opportunity particularly seeks to facilitate the training of scholars from diverse backgrounds underrepresented in translational science.

    Program hubs contribute to the education and ongoing workforce development of the members of the clinical and translational research team. Trainees master core competencies in their own discipline, while gaining knowledge of other disciplines to confer the capacity to effectively communicate and collaborate across multidisciplinary teams. For study personnel engaged in NIH funded clinical trials, continuing education must include Good Clinical Practice (GCP) training as a minimum standard (https://ncats.nih.gov/files/gcp-training.pdf).  CTSA Program hubs must advance team science and develop academic promotion criteria that help create a viable career path for translational scientists.

    The CTSA Program hubs’ TL1 and KL2 programs are complementary and focus on the education of pre- and postdoctoral trainees, and on the career development of early-career translational researchers, respectively.  Hubs are encouraged to innovate in research training and career development methods and structures and may include non-degree opportunities tailored to the specific needs of the workforce at the hub.

    Translational science research is a team-based endeavor that requires input from many different disciplines, sectors, and points of view to be successful.  CTSA Program hubs should therefore support partnerships that give trainees experience outside of their particular discipline, both within the academic domain and with stakeholders and sectors outside it, such as patients, non-profit organizations, regulatory agencies, and industry.  CTSA Program hubs should develop a methodological framework for discovering, demonstrating and disseminating successful collaboration models.

    To assure that it reaches all populations, translational science research should include the study of subpopulations with distinct characteristics, including pediatric, geriatric, and other special populations. Hubs should aim to include underrepresented populations, address health disparities, and approach cultural factors as a variable to be examined when developing and testing translational innovations.  Approaches could include designating a point person at the hub for research in these special populations, for example, as appropriate for the individual Program strengths and interests.  CTSA Program hubs should seek to implement methodological innovations to integrate special populations into translational research.

    The CTSA program includes other components that applicants may take into consideration in responding to this FOA.

    The Trial Innovation Network (TIN) develops, demonstrates, and disseminates innovations in the science of designing, recruiting for, performing, analyzing, and promulgating results of studies in humans. Among other activities, the TIN supports multi-site clinical studies through provision of centralized infrastructure such as single Institutional Review Boards (sIRB), data-driven site selection, targeted recruitment strategies, and other efficiencies such as streamlined subcontracting.

    The CTSA Program Coordination Center provides tools and support for flexible and effective collaboration, coordination, and communication among all the hubs and other components of the CTSA Program.  

    The CTSA Program Data to Health Coordinating Center (CD2H) is intended to support a collaborative informatics community, develop Good Data Practice (GDP) for information stewardship, promote software standards for interoperability, and stimulate the use of cutting edge biomedical research informatics and data science education for CTSA Program researchers.

    This FOA calls for applications from medical research institutions to participate as hubs in the CTSA Program.  Each application must consist of 2-3 parts which are submitted as a single application, but will be separated at the time of award:

    • UL1 award (required) for a translational science hub that provides A. Administrative Core; B. Informatics; C. Community and Collaboration; D. Translational Endeavors; E. Research Methods; F. Hub Resource Capacity; G. Network Capacity; and H. Optional Functions. A through G are required parts of the application, and H is optional; 
    • KL2 award (required) to support advanced translational research for early-career post-doctoral researchers (I. Inst Career Dev Core);
    • TL1 award (optional) to support translational research training for pre- and post-doctorates (J. National Research Service Award (NRSA) Training Core).

    The UL1 will receive one score encompassing all functions (A-H). The KL2 and TL1 components will be reviewed by training and career development experts and will receive separate scores. The overall impact score for the U54 will include the balance of all components.  When NCATS issues the separate yet linked KL2 and (optional) TL1 awards, it will formally designate as PD/PIs those individuals identified with the Project Role of “Other-Project Lead” KL2 and TL1 (if applicable) in the application.  Meritorious KL2 and TL1 awards will only be made when the associated UL1 is funded. NCATS has defined a CTSA Program hub as including both the UL1 and KL2 components with or without the optional TL1 and therefore a CTSA Program hub award might include a UL1 and KL2 or UL1, KL2 and TL1. The UL1, KL2, and TL1 awards will each maintain their own, separate budgets.

    Frequently Asked Questions:

    Questions may be submitted to CTSAFOAQuestions@mail.nih.gov.

    NCATS will post answers to frequently asked questions on the NCATS CTSA Program Funding Information page at https://ncats.nih.gov/ctsa/funding.

    See Section VIII. Other Information for award authorities and regulations.

    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.  

    Application Types Allowed

    New
    Renewal for RFA-TR-14-009, PAR-15-304, PAR-18-464, and this FOA.
    Resubmission for PAR-15-304, PAR-18-464, and this FOA.

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Optional: Accepting applications that either propose or do not 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.

    Award Budget

    Award budgets for the sum of UL1 and KL2 awards are limited to between $3M and $7.5M in direct costs.  Within that range, support is limited to 2.5% of total institutional NIH funding in the fiscal year prior to the time of application.  Budgets for the TL1 awards are based on the size of the hub, defined as the U plus the K components, and are considered separately.  See Administrative Core – Budget Section for details.

    Award Project Period

    The project period is limited to five years.    

    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    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:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   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)

     Organizations with active grants funded under FOAs PAR-14-009, PAR-15-304- & PAR-18-464 that have more than 16 months of remaining support at the date of submission are not eligible.  

    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) 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.

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM) (formerly CCR) – 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. 
    • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

    For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

    It is expected that any UL1 award PD(s)/PI(s) will be an established clinician/scientist who reports directly to an official with broad trans-institutional authority, and who personally has the authority and influence necessary to successfully promote translational and clinical research locally, to partner with internal and external stakeholders, support the CTSA Program activities as described below, and fully integrate the hub into the CTSA Program nationally. This may include authority, perhaps shared with other high level institutional officials, over requisite space, protected time, promotions, institutional review boards, contracting, budgeting for clinical research, and staff qualification and certification. In loosely coupled organizations that consist of university and hospital units, the CTSA Program PDs/PIs should have the authority or influence, personally or on their leadership team, to integrate these independent parts of the organization toward CTSA Program goals. If the PD/PI oversees the institution's business office, a plan on how potential conflicts of interest will be managed must be developed.

    The CTSA Program PDs/PIs are expected to commit at least two person months and preferably three to six person months effort on the UL1 award annually. For CTSA Programs with multiple PD/PIs, each PD/PI must contribute at least two person months effort. The UL1 PD(s)/PI(s) may not be a PD/PI on a KL2 or TL1 award.  Those with designated responsibility for defined areas of the CTSA Program should, in general, possess the knowledge, leadership, and administrative skills and capabilities necessary to direct those programs locally and to speak for the CTSA Program hub in national forums.  

    2. Cost Sharing

    This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

    3. Additional Information on Eligibility
    Number of Applications

    Applicant organizations may submit only one application per institution (normally identified by having a unique DUNS number or NIH IPF number

    The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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 NOT-OD-11-101).

    Additional Information on Eligibility for the Institutional Career Development Core (KL2)

    Scholar Candidates

    Scholars supported under the KL2 component must have a research or health-professional doctoral degree or its equivalent.

    Scholar appointments

    Candidates must have a full-time appointment at the applicant institution or a partnering institution. Support is provided for a minimum of two years and a maximum of five years of consecutive funding for each scholar, consisting of 12-month appointments.

    Selection restrictions

    The Institutional Career Development Core will support early-career post-doctoral translational researchers. In keeping with the type of mentoring and career development being provided by the CTSA Program, a KL2 scholar candidate who is already in the process of applying for an independent mentored career development grant, a P01 grant, or R01 grant is likely too senior for the KL2 award.

    At the time of their appointments, scholars must not have pending an application for any other PHS mentored career development award (e.g. K07, K08, K22, K23) that duplicates any of the provisions of the K component. Former or current PDs/PIs on any NIH research project grant [this does not include NIH small grants (R03), exploratory Developmental (R21) or SBIR, STTR (R43, R44 grants)] or equivalent non-PHS peer reviewed grants that are over $100,000 direct costs per year, or project leaders on sub-projects of Program project (P01) or center grants (P50) are NOT eligible to participate as scholars. Appointed scholars are encouraged to apply for individual mentored K awards (e.g. K07, K08, K22, K23) and independent awards (R01, R03, R21); if successful, scholars may be required to reduce effort on the mentored career award to a minimum of six-person months and hold concurrent support from their mentored career award and a competing PHS research grant on which they are the PD/PI or component lead or terminate the KL2 appointment depending on Program requirements (See NOT-OD-08-065). 

    Additional Information on Eligibility for the Training Core (TL1)

    Trainee Candidates

    Trainees supported under the TL1 component may be pre-doctoral or post-doctoral candidates seeking a research or health professional doctoral degree or its equivalent. All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Details on citizenship requirements and the full description of the eligible degree options are available at NRSA Policy Statement for Institutional Research Training Grants.

    Pre-doctoral Trainees

    Pre-doctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA trainee appointment. Individuals currently supported by other Federal funds are not eligible for trainee support from the TL1 component.

    Post-doctoral Appointments

    Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a PhD, MD, DDS, or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: DMD, DC, DO, DVM, OD, DPM, ScD, EngD, AuD, DPT, DPH, DNSc, PharmD, ND (Doctor of Naturopathy), DSW, PsyD as well as a doctoral degree in nursing research or practice. Documentation by an authorized official of the degree- granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable.

    Trainee Appointments

    Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the NIH awarding unit, or when trainees are appointed to approved, short-term (2-3 months) training positions.

    No individual trainee may receive more than five years of aggregate NRSA support at the pre-doctoral level or 3 years of support at the post-doctoral level, including any combination of support from institutional training and individual fellowship awards.

    Section IV. Application and Submission Information
    1. Requesting an Application Package

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

    Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

    Letter of Intent

    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:

    Carol Lambert, Ph.D.
    Telephone: 301-435-0814
    Fax: 301-480-4660
    Email: lambert@mail.nih.gov

    Page Limitations

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    12 pages

    Admin Core (Use for A. Administrative Core)

    12 pages

    CTR* Core (use for B. Informatics)

    6 pages

    CTR Core (use for C. Community and Collaboration)

    6 pages

    CTR Core (use for D. Translational Endeavors)

    6 pages

    CTR Core (use for E. Research Methods)

    6 pages

    CTR Core (use for F. Hub Research Capacity)

    6 pages

    CTR Core (use for G. Network Capacity)

    6 pages

    CTR Core (use for H. Optional Functions)

    6 pages

    Inst Career Dev (Use for I. Institutional Career Development Core)

    25 pages

    NRSA Training (Use for J. NRSA Training Core)

    25 pages

    *Clinical and Translational Research

    Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

    Instructions for the Submission of Multi-Component Applications

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

    The application should consist of the following components:

    Overall: required

    A. Administrative Core: required; maximum of 1

    B. Informatics: required; maximum of 1

    C. Community and Collaboration: required; maximum of 1

    D. Translational Endeavors: required; maximum of 1

    E. Research Methods: required; maximum of 1

    F. Hub Research Capacity: required; maximum of 1

    G. Network Capacity: required; maximum of 1

    H. Optional Functions; optional; maximum of 2

    I. Institutional Career Development Core: required; maximum of 1

    J. NRSA Training Core: optional; maximum 1

    Overall Component

    When preparing your application in ASSIST, use Component Type ‘Overall’.

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

    SF424 (R&R) Cover (Overall)

    Complete entire form.

    PHS 398 Cover Page Supplement  (Overall)

    Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

    Research & Related Other Project Information (Overall)

    Follow standard instructions.

    Project/Performance Site Location(s) (Overall)

    Enter primary site only.

    A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

    Research & Related Senior/Key Person Profile (Overall)

    Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

    A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

    Budget (Overall)

    The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.  

    A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

    PHS 398 Research Plan (Overall)

    Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

    Specific Aims: Describe the specific aims for the CTSA Program hub to act as a catalyst for high-quality clinical and translational science research, locally and nationally  

    Research Strategy: This section describes the overall vision, the track record in clinical and translational science research, the integration of healthcare and research and the development of a multi-disciplinary research workforce.

    Vision and Strategic Goals

    The applicants should summarize their overall strategic goals and vision for workforce development to ensure that translational science investigators and their teams have the skills and knowledge necessary to advance the translation of discoveries. Applicants should ensure high research quality through training of translational science staff at all levels in appropriate, rigorous research methodology and implementation, in research ethics, and for all those involved with human subject research this includes training in good clinical practice (GCP), refreshed every three years, as a minimum standard.

    The applicants should describe their overall vision for creating a translational science research environment within their own CTSA Program hub, and within the CTSA Program as it is implemented nationally.  Applicants should describe areas their hub will focus on and/or any unique strength or opportunity. Strategic goals under such a vision may include increased incentives for teamwork, facilitation of the assembly of multi-disciplinary translational teams, promotion of collaborative efforts, and increased knowledge and awareness of what works best in team science.

    Coordination with any local partner institutions and with other CTSA Program hubs is important to improve translational research, and to develop, to demonstrate, and to disseminate new research tools or methods.  Applicants should describe the opportunities and challenges in improving clinical and translational science research and training, along with innovative solutions.

    The applicants should describe their vision for engagement of local and national communities in all phases of translational research, as well as increased collaboration with interdependent stakeholders (patients, clinicians, healthcare delivery systems, categorical NIH Institutes and Centers, other federal agencies, and industry).

    The applicants should summarize their vision for incorporation, where possible, of translational research across the lifespan, with focus on seamlessly integrating pediatric, geriatric, and under-represented populations into translational research. 

    The applicants should articulate their strategic goals for improving and streamlining methods, and processes aimed at quality improvement.  This includes understanding and minimizing barriers, recognizing and filling gaps, enhancing the use of parallel processes, focusing on quality control and assurance, monitoring outcomes, and obtaining feedback from stakeholders.  The vision should describe the CTSA Program hub commitment to innovation in processes and methods locally, as well as in the context of the national CTSA Program. The applicants should describe their plans for and commitment to participating in the Trial Innovation Network with other CTSA Program hubs to study important clinical questions funded by NIH Institutes/Centers and other sponsors, including multi-site cohort studies or trials.

    Track Record in Translational and Clinical Research

    Briefly describe the institution’s contributions to translational and clinical research over the past 5 years with emphasis on high impact achievements that have advanced research towards better methods and improved health.  This section should address the 5 strategic goals: (1) Workforce Development; (2) Collaboration/Engagement; (3) Integration across the Lifespan; (4) Methods/Processes; and (5) Informatics. This section should discuss prior accomplishments and progress in translational research efforts.

    Integration of Health Care and Research

    Specific focus should be placed on the coordination between the health care delivery system and the translational science research enterprise to ensure synergy and early engagement, to avoid downstream obstacles, to disseminate advances in the research domain more seamlessly into clinical care settings, and to prioritize and address translational science research problems identified in the health care delivery context.  The applicants should describe the system-wide approaches on how patients receiving care at the hub will be made aware of ongoing research and invited to participate in research opportunities. 

    This section should also explain how clinicians at health care facilities and in the community, are integrated into the research enterprise as active partners, including their history of referring individuals to participate in research, their plans to engage them in research, and plans to partner with them in the conduct of research and promotion of research findings. The CTSA Program hubs are encouraged to coordinate and collaborate with other hubs, and to adopt and utilize improved tools developed by others.

    This section may also describe a research-friendly environment where patients seeking clinical care at the CTSA Program hub could be routinely offered opportunities to contribute to translational research.

    Workforce Heterogeneity

    Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational science research to policy formation–requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure its position as a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from varied backgrounds to include professional, educational, age, cultural, gender, etc., as well as diversity in ethnicity, race, and under-represented minority status.

    Research shows that heterogeneous teams working together and, capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from varied backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a heterogeneous NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved, or health disparity populations participate in, and benefit from health research, and enhancing public trust.

    In spite of tremendous advancements in scientific research and information, educational research opportunities are not equally available to all.  This Program encourages institutions to diversify their student and faculty populations and thus to enhance the participation of individuals currently underrepresented in the biomedical, clinical, behavioral and social sciences research enterprise, as described in NOT-OD-18-210.

    Letters of Support: Letters of Support should affirm the institution is in agreement with participation in the CTSA Program as a hub and as part of a collaborative translational science consortium.  Considerations include how the applicant institution and any partner institutions anticipate participation in NIH programs with full reliance on a single IRB, the use of pre-negotiated master subcontracts, and providing transparent fee for service cost listings for research items associated with NIH multi-site clinical trials.

    The application must include a letter of support from an authorized institutional official stating that the institution is willing to work under a central IRB, is willing to use master subcontract agreements/trial agreements (see for example https://www.ott.nih.gov/resources#MCRDA) and is willing to work under a transparent cost structure for per patient cost.

    There is no cost sharing requirement under this FOA.  Indication of institutional resources provided to contribute to the success of the Program will be considered positively in the programmatic evaluation of applications.  Examples may include ensuring adequate facilities or providing additional support to ensure successful collaborations.

    The application is also expected to include letters from the officials responsible for intellectual property issues at the applicant institutions (including sub-contractor institutions) stating that the institution supports and agrees to abide by any Resources and Data Sharing Plan and the Software Sharing Plan submitted in the application.  These letters should be clear expressions of commitment consistent with achieving the goals of the Program. Applicants are encouraged to limit their letters of support to no more than 30.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    A Resource Sharing Plan for the CTR Cores should be described under the Administrative Core.

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information (Overall)

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

    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

    PHS Assignment Request Form (Overall)

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

    A. 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.

    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.   
    Budget (Administrative Core)

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

    CTSA Program U54 applications submitted to this FOA shall consist of a single applicant institution, plus the possibility of one or more participating partner institutions that are effectively integrated into the proposed activities. Applicant organizations and institutional partners whose annual NIH funding is utilized in the calculation of the budget request may not include “pass through” funding when determining the total Direct Costs (DC). A partner institution's NIH base funding may be used for the purposes of determining the maximum total award in direct costs for the CTSA Program hub application.  Institutional partners included in a CTSA U54 application from one institution may not be included as partners in another CTSA U54 application from a different institution. Each partnering institution must provide a letter of support signed by its authorized organizational representative (AOR) affirming their unique partnership with the current CTSA applicant institution and defining whether it is a participating partner institution or collaborator.

    An institution may commit to more than one CTSA Program application as a collaborator. As a collaborator, the institution would not be able to use its NIH base for the purpose of calculating the “maximum total amount that can be requested.”

    The maximum total amount that can be requested per year for the U and K awards is 2.5% of the total institutional NIH direct cost (DC) funding for the Federal Fiscal year prior to the submission of the application and is listed at https://ncats.nih.gov/files/nih-prior-FY-award-data.xlsx.  The maximum award amount may not exceed $7.5 million direct costs even if 2.5% of institutional NIH direct costs exceeds this amount. The minimum award amount is $3 million direct cost, even if 2.5% of institutional NIH direct cost are less.

    Applicants must summarize in the first paragraph of the budget justification how they determined the maximum amount they could request by providing: 1) the name of the applicant institution; 2) the name of partner institution(s), if any; 3) the NIH DC funding amounts for each of these institutions from the currently provided NIH Funding table; 4) the total NIH DC funding amounts for applicant and partner institutions; and 5) multiply by 2.5%. If the result is less than $3 million in direct costs, applicants may request $3 million in direct costs; requests for more than $7.5 million in direct costs are not allowed. In addition, existing CTSA Program hubs should note the three and four-year phase-in plans described in the following paragraph.  As a general principle, the amount requested should be well justified and depend on the work proposed.

    If the applicant institution is currently funded by the CTSA Program at a higher level (i.e., >30% above the maximum allowable amount that can be requested under this FOA, measured as direct costs, including only the UL1 and KL2 awards and excluding supplement and carryover actions), then the amount requested may be phased in over 3 years if needed to meet the award budget expectations described in this FOA by the beginning of year 4. It is expected that at least 25% of the reduction is proposed for year 1 funding, 50% for year 2, and 75% for year 3.

    The administrative core budget should cover travel expenses for appropriate personnel (up to five people) to attend an in-person CTSA Program meeting. If additional staff are identified to attend, additional justification is required as part of the Budget Justification.

    The expectation is that administrative operations be streamlined so that the direct cost for administration does not exceed 10% of all UL1 direct costs. (The UL1 includes the following components: Overall, Admin Core, CTR Cores B-H.) Staff salaries and non-trainee personnel travel for the optional NRSA Training Core may be included here.

    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:  Describe the specific aims to address organization, governance, collaboration, communication, as well as evaluation, continuous improvement, quality and efficiency, and Common Metrics.     

    Research Strategy:   

    Organization, Governance, Collaboration and Communication

    Describe the organizational and governance structure and provide an organizational chart.  This section should describe the proposed relationship of the applicant institution and any participating partner institutions, including: what each partner will contribute; how each partner will have input and participate in decision making; and how the partners will maintain ongoing communication.  It is critical that the inclusion of any partner institutions be well justified, that they each contribute essential elements or unique strengths to the overall Program, and that there is a strong plan on how the partners work closely and directly together.

    Applicants should also describe the leadership succession plan for critical positions in the governance structure. 

    Applicants should describe how their CTSA Program hub will engage with national CTSA Program activities including but not limited to 1 annual in-person CTSA Program meeting.  Applicants should indicate their willingness to serve on the Steering Committee (SC), consisting of 12 rotating CTSA Program UL1 PIs, one KL2 PI, one TL1 PI, one representative each from The CTSA Program Coordination Center (CC), The CTSA Program Data to Health Coordinating Center (CD2H-CC),  and the Trial Innovation Network,  the NCATS Center Director, and NIH staff. NCATS expects that SC members regularly participate in monthly PD/PI calls, communicate via email in the interim, participate in 2 annual in-person Steering Committee meetings, and hold regular SC meetings amongst themselves.  Applicants should also describe their willingness to participate in telephone and email communications between the Steering Committee members and the hub PDs/PIs they each represent.

    Applicants should describe plans for managing competing institutional perspectives, differences across the institution in culture and access to resources and sharing of institutional expertise and resources.  Plans for collaborative leadership and communication should consider a broad and inclusive range of internal and external partners and stakeholders.  If an applicant institution has a substantial collaborative partnership with another federal entity, a detailed description of the plan, aim, and deliverables should be provided.  Identify the collaborative team and synergies between the CTSA Program hub and the federal agency.  To promote synergy between the UL1 award lead, the KL2 award lead, and if applicable, the TL1 award lead, a collaborative leadership and communication plan between research, career development, and training should be described that integrates the educational Programs of degree-granting institutions in clinical and translational science with the other partners at the CTSA Program hub.

    Evaluation and Continuous Improvement

    NCATS is working with the CTSA Program Steering Committee and the investigator community to develop a set of common metrics across the CTSA Program hubs.  The Common Metrics platform has been established to define milestones captured across the CTSA Program hubs that will improve efficiency and scalability of best practices. Applicants should describe their capacity to collect data to evaluate their impact on the CTSA Program mission.

    Applicants should also describe how they will consult their External Advisory Committee (EAC), a group that each CTSA Program hub must contain. This EAC should meet annually to review progress and offer recommendations to the CTSA Program PD(s)/PI(s). Applicants with an existing EAC should name the members of their EAC and should describe changes they have made in response to EAC recommendations.

    Applicants without an existing EAC should describe their plans for establishing an EAC; the types of expertise to be represented in the EAC should be broad and include stakeholders that can bring a range of important perspectives such as patients, community-based clinicians, health systems representatives, experts in informatics, and industry.  Applicants should describe their plan for EAC membership accordingly but should not specify names and should not contact potential EAC members in advance of review of the application. In this section, applicants must also describe how the internal leadership and the external advisory board will be presented with metrics and related information so that they can take corrective action as needed or identify particularly winning strategies for further dissemination.

    Whenever possible, applicants should consider an experimental approach to evaluating innovations in training or research implementation.  Different units of one CTSA Program hub, or several collaborating CTSA Program hubs could, for example, be randomized to the innovative intervention in training or research, and then prospectively compared to those randomized to standard practice.  This will allow for subsequent data-driven decisions.

    Applicants should include a plan and timeline for implementation of the CTSA Program Common Metrics, including the role of the UL1, KL2, and TL1 PI as applicable, formation of hub Common Metrics team, collection of common metrics data, development of “Turn the Curve Plan” and related strategic planning activities, monitoring of plan, and entry into software platform.  Applicants should be prepared to work closely with the CTSA Program Coordination Center (CC) on this activity. A description of the CTSA Program Common Metrics can be found here.

    Quality and Efficiency

    This section should describe the CTSA Program hub’s overall commitment to quality and plans to ensure safe and ethical human subject research, including the appropriateness of study design, feasibility, recruitment, timely closure of futile studies, research study workflow, analysis, and dissemination of results. Applicants should also describe how they will provide high quality study drug management.

    Applicants should describe how quality will be planned, monitored, and how interventions will be implemented when needed. Applicants should also describe how they will foster innovative methods and operational principles; how they will demonstrate the effectiveness of the innovation; and if useful, how they plan to disseminate their findings.  

    Applicants should also describe a system-wide approach to increase efficiency that includes plans for parallel processing, monitoring research timelines, review processes to identify opportunities for increased efficiency, and systematic approaches to streamlining administrative processes through innovation.

    Letters of Support: Only letters of support specific to the ‘Administrative Core’ should be attached to this section.   

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    The CTSA Program encourages sharing of resources with broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication. In addition, the CTSA Program encourages sharing of research data in a timely manner with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Thus, the CTSA Program expects awardees to implement a Resource and Data Sharing Plan consistent with achieving these program goals.

    The CTSA Program encourages sharing of software and code that are developed or modified to accomplish aims of this program. This may include, but is not limited to, software, tools, or code sets for: extraction and use of data for research from clinical systems; implementation of new efficient workflows for research studies; innovative networking to connect scientists, patient communities, industry, resources, data, and ideas; novel analytic and analysis programs; and educational tools. While software development is not the primary goal of this program, it is expected that software or sets of code may be developed under this program. Thus, awardees and their sub-contractors are expected to implement a Software Sharing Plan consistent with achieving the goals of this program.

    A Resource and Data Sharing Plan is expected to be included in the application and should include a plan for the sharing of software. There is no particular software dissemination license required for this program. However, NIH does have goals for software sharing and reviewers will be instructed to evaluate the sharing plan relative to the following goals:

    • ·    The software should be freely available to biomedical researchers, health care systems, and research institutions or organizations.
    • ·    The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or components of it into other software packages.
    • ·    The terms of software availability should include the ability of individuals outside the applicant institution and its collaborating organizations to modify the source code and to share modifications with other colleagues.

    This section should encompass the Resource Sharing Plan for all the CTR Cores.

    Appendix:

    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 NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, 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

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

    B. Informatics

    When preparing your application in ASSIST, use Component Type ‘CTR Core.’

    Informatics is a high priority, overarching function that can transform translation at the CTSA Program hubs and nationally across the entire CTSA Program.  Informatics resources, support, expertise, training, collaboration and innovation are critical to a successful translational research environment.

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

    SF424 (R&R) Cover (Informatics)

    Complete only the following fields:

    • ·    Applicant Information
    • ·    Type of Applicant (optional)
    • ·    Descriptive Title of Applicant’s Project- Title this component “B. Informatics”
    • ·    Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (Informatics)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Informatics)

    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) (Informatics)

    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 (Informatics)

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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 need only 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 (Informatics)

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

    Because of its broad scope and overarching importance, there is no recommended limit to scope and budget.  Applicants should plan for robust informatics resources and strong personnel and leadership within a budget range adequate to the scope and critical importance of informatics which will likely exceed the range indicated for “other CTR Cores” described below.

    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 (Informatics)

    Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Informatics component.

    Specific Aims: Describe specific aims for this high priority overarching CTSA Program function.

    Research Strategy:  Biomedical informatics is a critical Program focus for enabling and advancing translational research, which is increasingly data intensive, and requires collaboration across many communities, including healthcare, research, and public health.  Additionally, the increasing amounts and types of data need to be integrated to generate knowledge.  Applicants should propose a synergistic plan to use informatics across the entire spectrum of translational research activities at the hub, in support of pre-clinical and clinical research, as well as community engagement, user training, and education. Approaches that integrate data from differing sources such as clinical databases, research datasets, sensors, mobile technology, social media, patient-generated and publicly available data sources are highly encouraged.

    CTSA Program hubs should offer researchers a user-friendly data management system along with training on its use and some basic support.  CTSA Program applicants should encourage compatibility of their research systems with broadly accepted content and technical standards including those adopted by the Department of Health and Human Services for use in U.S. health care and public health operations.  In addition, as NIH Institutes and Centers adopt common data elements in its domain areas, CTSA Program hubs should ensure its research tools are compatible (see http://www.nlm.nih.gov/cde/) for more information).

    Maintaining the security of study data, particularly in studies involving human subjects, is critical.  Academic institutions should provide low cost and user-friendly infrastructure to assist investigators in ensuring the security of its data, and clear requirements for its use by faculty, staff, and students.

    Applicants should describe their plan for ensuring the security of research data on all studies involving human subjects at all participating institutions.  This plan should address policy, workflow, technical, and oversight/enforcement issues.  The plan should outline anticipated challenges and alternative approaches for surmounting them.

    CTSA Program hubs should work towards a flexible, sustainable digital enterprise where digital assets are interoperable so that, for example, data from the electronic health record (EHR) can be used for research purposes.  Cooperation and coordination among the data stewards in various organizations and institutions on policy issues, and among the managers of those data systems on technical issues are critical.  This section should include a description of the efforts towards interoperability of various informatics platforms, data harmonization, facilitation of data exchange from different and highly varied sources, and the interface of electronic medical records with research data systems.

    Hubs should support a research-friendly integrated IT environment where information on relevant research opportunities is readily available to clinicians and patients via EHR at the time of the clinical encounter.  Other useful features might include notice of a patient’s participation in a research study in the clinical EHR along with associated laboratory or other results, for the benefit of the treating clinician as well as the patient.  Applicants should describe any solutions they already have locally to integrate health care and research data along with any forward-looking plans.  Applicants should indicate if they are currently participating in initiatives that make use of EHR data for research or surveillance and how they integrate participation with these initiatives into their local digital enterprise and network activities.

    Applicants should describe how they will establish and maintain a sustainable research data warehouse and how they will build, grow, train, and maintain a research data warehouse team.  Applicants should describe their ability to query the EHR across the multiple units of their institution and its partners. Applicants should describe their approach for ensuring data quality (fit for purpose) and indicate how they will institute a quality management plan.  Applicants should enumerate the standard terminologies they are currently using, how they will develop and share new standards in cases where none exist, and how new standards will be incorporated.  Applicants should indicate how they will contribute to best practices in research data warehousing across the national CTSA Program and in collaboration with other national initiatives such as might be run by other federal entities.  Applicants should describe their ability to respond to potential recruitment queries with estimates of number of potential participants meeting study entry criteria for age, primary and secondary diagnoses (ICD), current medications, etc., and any plans to increase capacity when needed.

    To accelerate translation, CTSA Program hubs should work towards data sharing and enabling data access, integration and processing.  Applicants should also describe how they might collaborate with other CTSA Program hubs on using common data standards in multi-site projects. Applicants should indicate whether they have initiatives at their hub that support data sharing, how they promote broad use of data, and how they encourage investigators to submit data to repositories (see for example NIH Data Sharing Repositories).  In this context, applications should also describe how they train researchers to prepare for downstream data sharing, such as by providing training and sample language for research-friendly consent forms that support broad data use (not limited to time, place or purpose), and that avoid complex nested formats to the extent possible.

    The informatics team from each CTSA Program hub will be expected to work closely and collaboratively with the CTSA Program Clinical Data to Health Coordinating Center (CD2H-CC) in support of its goal to discover, develop, demonstrate, and disseminate innovation in informatics tools, standards, methods, and processes, and in facilitation of collaboration and consortium activities in the area of innovative informatics solutions that will translate to health benefit.

    Letters of Support: Only letters of support specific to ‘Informatics’ should be attached to this section.

    Resource Sharing Plan: The Resource Sharing Plan for the CTR Cores should be described under the Administrative Core. Do not include a Resource Sharing Plan in the individual CTR Cores.

    Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

    PHS Human Subjects and Clinical Trials Information   

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) 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

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

    C. Community and Collaboration

    When preparing your application in ASSIST, use Component Type ‘CTR Core.’

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

    SF424 (R&R) Cover (Community and Collaboration)

    Complete only the following fields:

    • ·    Applicant Information
    • ·    Type of Applicant (optional)
    • ·    Descriptive Title of Applicant’s Project: Title this component “C: Community and Collaboration”.
    • ·    Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (Community and Collaboration)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Community and Collaboration)

    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) (Community and Collaboration)

    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 (Community and Collaboration)

    • ·    In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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 need only 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 (Community and Collaboration)

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

    The overarching, high priority functions addressed here are highly important for creating the right environment for successful translational research.  They do not have a recommended limit to scope and budget (as done for the specific functions below) because they are critical across almost the entire spectrum of translational activities.  Applicants should budget for robust resources and adequate personnel and leadership for each of these critical functions; community engagement and collaboration and multi-disciplinary team science. The budget range for each area should support to the scope and critical importance of these overarching functions and will likely exceed the range indicated for “specific functions” below.

    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 (Community and Collaboration)

    Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Community and Collaboration component.

    Specific Aims:  Describe specific aims for this high priority overarching CTSA Program function.

    Research Strategy:

    Community Engagement

    Applicants should describe how community engagement will be integrated into the translational science spectrum, and specifically how community engagement will be integrated into leadership, research, communication, and dissemination and implementation strategies at their hub.  Communities to be engaged may be physical or virtual online communities.

    Each institution is encouraged to build on its existing capacity and expertise in community engaged research. In addition, institutions should evaluate which approaches or programs are effective in advancing the process of turning evidence from the laboratory and clinic into practice that improves the health of individuals and the public. The guiding principle is to engage communities in a meaningful way around specific projects and to advance the science of community engaged research.  Applicants should therefore describe how they will use the CTSA Program resources provided to research and develop best practices, information materials, and consultations on how to engage communities around specific projects. 

    Applicants should also describe how they will acknowledge community engaged research in academic policies (such as promotion and tenure), how they will develop culturally competent training, how they will provide training for staff and communities (e.g. training for patients participating in clinical and translational research), how they will foster innovation, and how they will participate in the development, demonstration, dissemination of best practices.  The CTSA Program hubs are encouraged to coordinate and collaborate with each other and with other stakeholders to adopt and utilize tools to avoid duplication and redundancy.

    If successful, community engagement would help ensure that communities and researchers have the capacity to participate as full partners; that communities are consulted for their research priorities; that all stakeholders are respected, valued and rewarded for their time and expertise; that more effective implementation and dissemination strategies are developed; and that there is increased public support for research, and ultimately improvements in the health and well-being of communities.

    Collaboration and Multi-Disciplinary Team Science

    Team science should facilitate approaches to solving problems that cut across disciplinary boundaries, with the goal of advancing clinical research and translation.  Applicants should describe how they will foster collaborations by providing education in team science to promote the development and implementation of multi-disciplinary teams.  Applicants should devise ways to identify best practices in team science, and to implement successful models.

    A major obstacle to team science in academic health centers is the traditional promotion and tenure process, which is focused on individual accomplishment.  Therefore, applicants should describe how team scientists will be evaluated in the academic promotion process, as well as consideration of how such individuals will be professionally recognized and thus incentivized to engage in collaborations.  Applicants should also describe how they envision working with other CTSA Program hubs individually, regionally, and nationally.

    Letters of Support: Only letters of support specific to ‘Community and Collaboration’ should be attached to this section.

    Resource Sharing Plan: The Resource Sharing Plan for the CTR Cores should be described under the Administrative Core. Do not include a Resource Sharing Plan in the individual CTR Cores.

    Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.  

    PHS Human Subjects and Clinical Trials Information   

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) 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

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

    D. Translational Endeavors

    When preparing your application in ASSIST, use Component Type ‘CTR Core.’

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

    SF424 (R&R) Cover (Translational Endeavors)

    Complete only the following fields:

    • ·    Applicant Information
    • ·    Type of Applicant (optional)
    • ·    Descriptive Title of Applicant’s Project: Title this component “D: Translational Endeavors”.
    • ·    Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (Translational Endeavors)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Translational Endeavors)

    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) (Translational Endeavors)

    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 (Translational Endeavors)

    • ·    In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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 need only 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 (Translational Endeavors)

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

    The budget will depend on the development needs for each hub to reach the strategic goals. The budget for Translational Endeavors overall should not exceed 15% of the budget request in direct costs.  The amount requested should be well justified and depend on the work proposed.  It is recommended that the funds be apportioned in approximately equal amounts between the two required functions below.  

    Translational Workforce Development (TWD)                          

    Education administration or project management expenses and support for the TWD-liaison to engage in network-wide activities may be included.  Further, the budget may be used for continuing education in translational research for health care professionals who are associated with hubs; and development of innovative, online tools or training collaborations in continuing education in translational research with other CTSA Program hubs, the national CTSA Program consortium, and other entities.

    Pilot Translational and Clinical Studies (PTC)                          

    Most of the PTC funding should be allocated to pilot projects, with a small amount for review and administration of the program.  Support for pilot studies must be directed towards a specific scientific outcome as a unique project or as a stand-alone aim of a larger project. The PTC funds may not directly support any clinical trials beyond phase IIB with the exception of Phase III clinical trials for treatment of rare diseases. See NOT-TR-18-025.

    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 (Translational Endeavors)

    Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Translational Endeavors component.

    Specific Aims:  Describe the specific aims for how the clinical and translational workforce will be trained in clinical research methodology and how the process for soliciting, reviewing, and selecting pilot projects aligned with the aims of the NCATS CTSA program will be addressed.

    Research Strategy:

    Translational Workforce Development (TWD)

    For this function, applicants should describe a comprehensive approach to the continuous development of a multidisciplinary translational workforce at the CTSA Program hub.  This needs to be well integrated with the Career Development and Training components of the overall U54 application.  The workforce development should be directed not only toward physician scientists, but also toward members of translational and clinical research teams, such as pre-clinical translational scientists, research coordinators, and other allied health professionals involved in human subject research.

    Applicants should describe their plans for implementing continuing education in Good Clinical Practice (GCP) of personnel engaged in NIH defined clinical trials. The training opportunities offered should include competencies that are important to translational research such as regulatory sciences or entrepreneurship.  The continuing education programs should be adapted to ensure, to the extent possible, high-level performance by all members of the research team. The continuing education programs may include on-site and on-line opportunities, and should be tailored, practical and interactive. They may be designed around relevant, real-world scenarios to be solved individually or by teams.  The training experience should emphasize that translational and clinical research is a collaborative endeavor.

    Applicants should describe how existing training programs will be offered to the CTSA Program hub staff or adapted to their specific needs, and how they will streamline resources and avoid redundancy by collaborating with other hubs or related training efforts.  To that end, applicants should consider appointing a hub liaison to interact with emerging national CTSA Program training and staff qualification initiatives.

    Pilot Translational and Clinical Studies Program (PTC)

    As a general statement, a translational pilot program is intended to provide funding to support translational research projects of limited scope, duration, and budget. Early to mid-career investigators are encouraged to apply. Pilot studies are expected to be completed within a 1-year timeframe.

    Each CTSA Program hub has the flexibility to tailor a translational pilot program to address local priorities; however, the program should not focus solely on a select disease category or a few diseases or specialties. Pilot studies should be collaborative and innovative in nature and utilize existing CTSA Program resources.

    There is no minimum budget for individual pilot studies, however the budget needs to be commensurate with the needs of the study and directly support the science proposed. To enable the impact of pilot programs to be accurately and effectively tracked, institutions are strongly encouraged to support each CTSA PTC pilot study solely with CTSA Program funds.

    Consistent with the NCATS mission to catalyze translation of discoveries to treatments, the pilot studies funded under the CTSA Program should focus on translational science and clinical research rather than on basic discovery research. A preferred, but not required, characteristic is that such research did not only address a translational research question, but also provided insights that could be generalized to other projects. Such research will advance translational science. Results from pilot studies may also be foundational in the design and conduct of future definitive studies.

    Examples of pilot studies include feasibility studies, secondary analysis of existing data, development of new research methodology and/or new tools, dissemination of effective tools, methods, processes, or early development of new therapy/technology. Additional considerations for allowable pilot studies can be found in the Pilot Program FAQs.

    The U54 application should include a description of the institutional translational pilot program guidelines. These guidelines should address: solicitation, scientific review, IRB review (process for protection of human research subjects), prioritization, business and cost management, progress tracking, and program evaluation. Applicants should not include detailed and specific pilot projects as part of their U54 application and if included will not be reviewed.

    The scientific review of pilot studies must be rigorous and involve a review meeting of a multi-disciplinary scientific committee patterned after an NIH study section.  During the meeting, pilot study reviewers should convene as a group to discuss the applications.  This review format will help to ensure that pilot studies are feasible within the proposed timeframe, have high methodological and scientific quality, and can answer important scientific questions.  Two-level reviews are allowed; a larger group of reviewers with specialized expertise may submit written critiques that are then considered by a smaller multidisciplinary group interacting in real time to make the final decision.  Pilot studies should have a clear path forward along with criteria for go/no go decisions, next steps if the pilot is successful, and a plan for reporting of negative results if not successful.  The CTSA Program hubs are encouraged to coordinate and collaborate with other hubs, and to adopt and utilize tools developed by others to avoid duplication and redundancy. Appropriate policies must be included to ensure translational pilot project compliance with all federal regulations and NIH policies, including, but not limited to, studies involving human subjects, genetic material, stem cells, or model organisms. For studies involving Human Subjects, certification of IRB approval will be required as part of the prior approval request package submitted to NCATS.

    Applicants submitting renewal applications should discuss their experience with or interest in adopting any emerging CTSA Program review standards or participating in reciprocal review to exchange expertise. 

    Metrics:  For all specific functions described above, NCATS in collaboration with the CTSA Program Steering Committee is developing common metrics to measure the impact of the CTSA Program and will work on implementation with successful applicants.  For each function discussed, applicants should describe their commitment to collect common metrics and may propose metrics they favor for each of the required functions. The progress of individual pilot studies, including future independent funding directly attributable to the pilot as well as any publications or products should be tracked as part of the pilot program. 

    Letters of Support: Only letters of support specific to ‘Translational Endeavors’ should be attached to this section.

    Resource Sharing Plan: The Resource Sharing Plan for the CTR Cores should be described under the Administrative Core. Do not include a Resource Sharing Plan in the individual CTR Cores.

    Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.  

    PHS Human Subjects and Clinical Trials Information   

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) 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

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

    E. Research Methods

    When preparing your application in ASSIST, use Component Type ‘CTR Core.’

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

    SF424 (R&R) Cover (Research Methods)

    Complete only the following fields:

    • ·    Applicant Information
    • ·    Type of Applicant (optional)
    • ·    Descriptive Title of Applicant’s Project: Title this component “E. Research Methods”.
    • ·    Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (Research Methods)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Research Methods)

    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) (Research Methods)

    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 (Research Methods)

    • ·    In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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 need only 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 Methods)

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

    The budget will depend on the development needs for each hub to reach the strategic goals. It is suggested that the budget for Research Methods overall not exceed 15% of the UL1 budget request (direct costs) and that the funds be apportioned in approximately equal amounts between the two specific, required functions, below. The amount requested should be well justified and depend on the work proposed. 

    Biostatistics, Epidemiology and Research Design (BERD)      

    Appropriate budget items would include, for example, the support of expert time for consultations, for project management time to coordinate course and training opportunities, and to connect methodology researchers with others who have identified a gap in translation that could be filled through methodological innovation.

    Regulatory Knowledge and Support (RKS)                              

    Appropriate budget items would include, for example, the support of regulatory experts and protocol writers to provide consultations and assistance to investigators who submit IND applications, or in other regulatory matters including innovative strategies such as remote monitoring or risk-based monitoring.  Other appropriate expenditures might include provision of information and access to coursework in regulatory sciences. 

    It is evident that not all research conducted at an academic health center could receive support from finite CTSA Program resources.  Because the mission of NCATS and the CTSA Program is disease-agnostic, these funds cannot be used to offset the cost for a select set of disease-oriented research studies.  As a general principle, the CTSA Program funding should be used to facilitate and catalyze research supported by other funders. 

    An important operational principle of all NCATS programs, including the CTSA Program, is to maximize impact via a catalytic approach: developing, demonstrating utility of, and then disseminating improvements in translational science and operations.  The CTSA Program support should thus focus on providing a foundation that promotes quality, efficiency, collaboration, and ultimately success as defined by impact. This support should also be used to identify roadblocks and to foster innovation to overcome them. 

    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 (Research Methods)

    Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Research Methods component.

    Specific Aims: Describe the specific aims to lay the foundation for high quality research and how high-quality biostatistics and regulatory support will be provided.

    Research Strategy:  For each of the required functions below, applicants should describe how CTSA Program funding will be used to enhance innovation, access, and quality in a measurable way.

    Biostatistics, Epidemiology and Research Design (BERD)   

    The BERD function must include service and continuing education elements to provide support to investigators for translational research design and analyses and provide educational topics and courses for research staff.  BERD also should include an academic research section capable of developing novel tools and methods intended to solve problems and address barriers that impede the conduct of clinical and translational research projects.

    BERD will include user-friendly continuing education courses for research staff at all levels, which are integrated with and stimulated by the work environment so that everyone in the research enterprise is continually exposed to these foundational methods.  BERD cannot provide the entire range of possible coursework, but can facilitate access, raise awareness of learning opportunities, and collaborate with entities such as the department of biostatistics, or with other CTSA Program hubs or external groups.  BERD may also help develop a degree or certificate in clinical and translational biostatistics open to trainees with a range of primary degrees.  Applicants should describe their plans to include innovative approaches such as online continuing education classes or interactive programs.

    BERD will develop and promote innovations in tools and methods intended to address barriers to translational and clinical research.  This will be done in collaboration with internal groups, groups at other CTSA Program hubs or external groups.  BERD cannot support all innovations itself, but helps to identify the gap and opportunity, and to connect the collaborators needed to solve the problem.

    BERD will provide easily-accessible consultations in biostatistics, epidemiology, research design, and analysis.  For each project, adequate methodological support must be planned for and included in any funding request to a sponsor. BERD consultations are intended to assist translational science researchers in understanding the underlying methodological aspects of their research so that they can adequately plan their projects.  BERD consultations are intended to help connect researchers with expert collaborators for additional or ongoing support.

    Applicants should also describe how they might collaborate with other CTSA Program hubs to leverage resources, or to demonstrate and disseminate BERD innovations.

    Regulatory Knowledge and Support (RKS)

    RKS provides regulatory knowledge and facilitates compliance related to clinical and translational research in conformance with IRB policies, State laws, and Federal regulations.  Applicants are encouraged to innovate at all levels of clinical and translational research including, for example, the provision of integrated research education, guidance, services, or tools for protocol and informed consent development, adverse event reporting, safety and regulatory management, and compliance.  Educational resources might be available remotely and could be harmonized or shared with other CTSA Program hubs or external entities.  The Program hubs are encouraged to coordinate and collaborate with other Program hubs, and to adopt and utilize tools developed by others to identify and use best practices.  Regulatory support provided through the CTSA Program should neither take the place of an institutional compliance office nor be responsible for Institutional Review Board (IRB) activities, but should assist investigators, coordinators and others as needed.  The institution should demonstrate innovation to streamline regulatory support without loss of participant protections and should promote regulatory competency, regulatory science, and new regulatory-compliant strategies for emergent technologies.  An example might include improvements to the informed consent form to make it more user-friendly, readable, and informative.  Applicants should describe how they might collaborate with other CTSA Program hubs to leverage resources, or to demonstrate the value of RKS innovation.

    Metrics:  For all specific functions described above, NCATS in collaboration with the CTSA Program Steering Committee is developing common metrics to measure the impact of the CTSA Program and will work on implementation with successful applicants.  For each function discussed, applicants should describe their commitment to collect common metrics and may propose metrics they favor for each of the required functions.

    Letters of Support: Only letters of support specific to ‘Research Methods’ should be attached to this section.

    Resource Sharing Plan: The Resource Sharing Plan for the CTR Cores should be described under the Administrative Core. Do not include a Resource Sharing Plan in the individual CTR Cores.

    Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.  

    PHS Human Subjects and Clinical Trials Information   

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) 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

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

    F. Hub Research Capacity

    When preparing your application in ASSIST, use Component Type ‘CTR Core.’

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

    SF424 (R&R) Cover (Hub Research Capacity)

    Complete only the following fields:

    • ·    Applicant Information
    • ·    Type of Applicant (optional)
    • ·    Descriptive Title of Applicant’s Project: Title this component “F: Hub Research Capacity”.
    • ·    Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (Hub Research Capacity)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Hub Research Capacity)

    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) (Hub Research Capacity)

    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 (Hub Research Capacity)

    • ·    In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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 need only 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 (Hub Research Capacity)

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

    The budget will depend on the development needs for each hub to reach the strategic goals. The budget for Hub Research Capacity overall should not exceed 25% of the UL1 budget request (direct costs), of which not more than 75% may be apportioned to the PCI component.  The amount requested should be well justified and depend on the work proposed. 

    Integrating Special Populations (ISP)     

    Appropriate budget items might include identifying point persons for pediatrics research, for geriatrics research, for populations affected by health disparities, for rare disease populations, or for other special populations. Such a person could identify opportunities, establish best practices for including an increased range of the study population, provide consultations, foster collaborations, and effect policy changes to enhance opportunities for ISP.

    Participant and Clinical Interactions (PCI)

    In general, CTSA Program funding should be used to support clinical research staff only for oversight and quality assurance, but not to support actual research activities that are part of studies and trials conducted at the CTSA Program Hub, unless such support is provided under an established PCI Management program (see below).  The CTSA Program funding may be used to support a limited number of experienced clinical research professionals such as research nurses or coordinators who can facilitate access to resources, can assist study-specific staff, and can provide oversight and help with quality control and assurance.  Support for the study-specific staff conducting the actual research participant evaluations that are not supported through a PCI Management program must be included in the per-patient fee or other funding provided by the NIH ICs or the private sector supporter of that study or trial, as should the study-specific activities of research nurses or coordinators  available to conduct participant evaluations and implement protocols at a CTSA Program Hub. Space to conduct research cannot be charged to the CTSA Program budget.  If research space is provided by the institution for inpatient and or outpatient participant evaluations, the application should describe the space in Facilities and Other Resources, potential availability and if applicable hourly or overnight rates charged for NIH-funded or other research.  Similarly, inpatient and outpatient care costs cannot be charged to the CTSA Program budget. 

    While it is the expectation of NCATS that clinical research infrastructure and personnel receive support from the academic health institutions where CTSA Program hubs are located or from other sources, NCATS recognizes that in compelling cases there may be a justifiable need to provide support for clinical research activities, including staff and patient-level evaluations.  Such cases may include early stage clinical trials, deep-phenotyping studies, or research carried out by scholars or new investigators.

    In order to provide local flexibility to support local clinical research activities, applicants to this FOA may establish a PCI Management program to make funds available to support the clinical research activities listed below:

    • ·    A limited number of clinical research professionals, such as research nurses or coordinators who can facilitate access to resources, provide training, quality control, and/or assist with study-specific tasks as needed and
    • ·    Patient-level evaluations such as laboratory testing or imaging necessary for the conduct of a clinical research study.

    The formal guidelines of the proposed PCI management program should address the following:

    • ·    Solicitation, review, funding level and justification, prioritization, business and cost management, progress tracking, and program evaluation;
    • ·    Must ensure that institutional review is rigorous and includes a meeting of a multi-disciplinary committee patterned after an NIH study section during which reviewers interact as a group in real-time to discuss the requests; and must include appropriate policies to ensure compliance with all federal regulations and NIH policies including, but not limited to, human research protections, genetic material or stem cells. 

    Budget Justification: For all tasks described in the functions above, the amount requested must be well justified.  The budget justification should list each function identified above and a corresponding justification for the associated costs.

    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 (Hub Research Capacity)

    Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Hub Research Capacity component.

    Specific Aims: Describe the specific aims for the integration of special populations (such as pediatric and geriatric) into research and the aims for participant and clinical interactions.

    Research Strategy:  For each of the required functions below, applicants should describe how CTSA Program funding will be used to enhance innovation, access, and quality in a measurable way.

    Integrating Special Populations (ISP)

    Translational Research is needed to ensure that breakthroughs are quickly translated to the benefit of society and all subpopulations within.  Substantial gaps in evidence remain in our understanding of childhood diseases, and of the effect of treatments on children. As a result, clinicians must often rely on data from adults.  Without duplicating information in the Inclusion of Women, Minorities, and Children section, within the PHS Human Subjects and Clinical Trial Information form, applicants should describe efforts to include children as a focus of translational research.

    With the “graying” of the US population, investigators must recognize and adapt to population longevity and the questions so driven.  Without duplicating information in the Inclusion of Women, Minorities, and Children section, within the PHS Human Subjects and Clinical Trial Information form, applicants should describe efforts to include older patients in research. Another special population includes the survivors of formerly lethal childhood diseases.  Research is needed to better understand the impact on and approach to adults with chronic health conditions that originated in childhood, either due to the disease process itself or its treatment.

    In addition to considering longitudinal differences across the lifespan, translational research must also consider cross-sectional differences across populations, such as minority, underserved or health disparity populations. These differences include racial, ethnic or gender differences as well as differences in socio-economic status or in a rural vs. urban environment.  Differences may also include populations such as pregnant women, people with disabilities, and geographically isolated or other “hard-to-reach” groups that are often impacted by health disparities.  Applicants should describe how they might collaborate with other CTSA Program hubs to leverage resources.  Applicants are encouraged to adopt and utilize useful tools developed by others.

    Participant and Clinical Interactions (PCI)

    CTSA Program applicants must describe detailed plans to ensure that high quality human subjects research is conducted at their institutions and that scientifically or ethically flawed studies are identified, disapproved, and used as an educational example at an individual and institutional level. The CTSA application should address the appropriateness of specific study designs, development of realistic recruitment goals, tracking of enrollment, follow-up, submission of high quality data, careful data monitoring, steps to ensure the timely assessment of feasibility and closure of studies that do not meet goals or suggest toxicity or breach boundaries established to identify efficacy, and orderly closeout and publication of results. There should be efficient institutional workflows for planning and conduct of studies, the evaluation of patients by trained personnel, expectation of prompt analysis, and dissemination of results.

    The registration of all clinical studies and trials in clinicaltrials.gov is expected; registration of all “applicable trials” is required, as is the posting of results as required by Food and Drug Administration Amendments Act (FDAAA).  Without duplicating information in the Dissemination Plan, within the PHS Human Subjects and Clinical Trial Information form, applicants should describe any education or support they provide to clinical investigators for registering or reporting on the clinicaltrials.gov website.

    Metrics: For all specific functions described above, NCATS in collaboration with the CTSA Program Steering Committee is developing common metrics to measure the impact of the CTSA Program and will work on implementation with successful applicants.  For each of the functions discussed, applicants should describe their commitment to collect common metrics and may propose metrics they favor for each of the required functions.

    Letters of Support: Only letters of support specific to ‘Hub Research Capacity’ should be attached to this section.

    Resource Sharing Plan: The Resource Sharing Plan for the CTR Cores should be described under the Administrative Core. Do not include a Resource Sharing Plan in the individual CTR Cores.

    Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.  

    PHS Human Subjects and Clinical Trials Information   

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) 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

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

    G. Network Capacity

    When preparing your application in ASSIST, use Component Type ‘CTR Core.’

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

    SF424 (R&R) Cover (Network Capacity)

    Complete only the following fields:

    • ·    Applicant Information
    • ·    Type of Applicant (optional)
    • ·    Descriptive Title of Applicant’s Project: Title this component “G. Network Capacity”.
    • ·    Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (Network Capacity)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Network Capacity)

    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) (Network Capacity)

    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 (Network Capacity)

    • ·    In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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 need only 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 (Network Capacity)

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

    The budget will depend on the development needs for each hub to reach the strategic goals. A budget request in the range of 10-15% of the UL1 budget request (direct costs) is recommended. The amount requested must be well justified and depend on the work proposed. 

    Hub Liaison Team (HLT)                    

    The Hub Liaison Team (HLT) will function as an interface between the CTSA hubs and the national collaborative activities of the CTSA Program, which include the components of the Trial Innovation Network (TIN)  - (Recruitment Innovation Center (RIC)  RFA-TR-15-004; Trial Innovation Centers (TICs), RFA-TR-15-002), the CTSA Program Coordinating Center (CC) (RFA-TR-16-021) and the CTSA Program Data to Health Coordinating Center (CD2H-CC) (RFA-TR-17-006).

    The HLT would include a scientific lead, who should be an experienced researcher with an advanced clinical scientific degree, an operational lead, who should be a research professional with experience and skills to administer and organize the HLT, and  research staff with the following skills:  knowledge of local resources, expertise in working with investigators, IRB expertise, contracting, clinical operations, data standards and exchange, informatics/IT, data analytics, communications including social media, and project management.

    Budget Justification: For the functions described above, the amount requested must be well justified.  The budget justification should list each function identified above and a corresponding justification for the associated costs.

    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 (Network Capacity)

    Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Network Capacity component.

    Specific Aims: Describe the specific aims to address the support of network-wide studies and aims for optional activities in areas of unique strength or opportunity.

    Research Strategy:  Applicants should describe how the CTSA Program hub will connect with the CTSA Program central and network resources, including, but not limited to, how it will support multi-center studies. For each of the activities described below, applicants should describe how CTSA Program funding will be used to enhance innovation, access and quality in a measurable way.

    Hub Liaison Team and the Trial Innovation Network (TIN)

    Applicants should describe how the Hub Liaison Team will execute activities related to the Trial Innovation Network (TIN). These activities include, but are not limited to, the following: 1) disseminating information about the TIN to the hub; 2) working with investigators to assist with proposal submissions to the TIN; 3) identifying local investigators for TIN studies; 4) working with local study teams and IRB/contracting offices to operationalize TIN services, consultations, and trials/studies; and, 5) participating in recruitment activities, such as cohort discovery, community engagement, and recruitment training.

    Applicants should include a brief description (preferably in a table) of all NIH–funded multi-site clinical trials with site activation during the 6 months up to and prior to the application.  Include the following metrics: time from contract received to execution, time from protocol received by the trial PD/PI (or time protocol finalized if local trial) to IRB approval, time from subcontract executed to first patient first visit, and time from IRB approval to first patient first visit.  For investigator-initiated, single-site studies, site activation is the date of IRB approval; for multi-site studies, it is the date when the site is activated by the sponsor.  The “contract received date” is the date the draft contract was received by the Institution (PD/PI or institutional contracting official), whichever comes first.  The contract execution date is the date it was approved by the institution.  For “brief description”, the title of the trial will suffice; applicants may add further description in addition to the title, as needed.

    Hub Liaison Team and other CTSA Program Central Resources

    Applicants should describe how the Hub Liaison Team will execute activities in support of the CTSA Program Coordinating Center (CC), to include assisting the CC in its mission to develop and apply innovative approaches to collection, analysis, use and sharing of various types of data for strategic management of the CTSA Program, and creating an effective collaboration, coordination, and communication infrastructure to support scientific, training, governance, workgroup, and other types of consortium activities within the CTSA Program.

    Applicants should describe how the Hub Liaison Team will execute activities in support of the CTSA Program Data to Health Coordination Center (CD2H-CC), to include assisting the CD2H-CC in its mission to; 1) support and enhance a collaborative informatics community for the CTSA Program, 2) develop Good Data Practice (GDP) for information stewardship, 3) promote software standards for interoperability, 4) foster collaborative innovation in the area of informatics tools, methods, and processes, and 5) stimulate the use of cutting edge biomedical research informatics and data science education for CTSA Program researchers, thereby facilitating collaboration and consortium activities in the area of innovative informatics solutions that will translate to health benefit.

    Letters of Support: Only letters of support specific to ‘Network Capacity’ should be attached to this section.

    Resource Sharing Plan: The Resource Sharing Plan for the CTR Cores should be described under the Administrative Core. Do not include a Resource Sharing Plan in the individual CTR Cores.

    Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.  

    PHS Human Subjects and Clinical Trials Information   

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) 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

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

    H. Optional Functions

    When preparing your application in ASSIST, use Component Type ‘CTR Core.’

    Applicants may include up to two optional functions based on specific strengths and needs of the proposed CTSA Program hub. Each proposed optional function will require its own component.  Applicants may propose optional functions including, for example, Phase 1 trial units, genomics, phenotyping, biomarkers, drug discovery, preclinical development, imaging, or collaboration with Schools of Veterinary Medicine, rural health/telemedicine and others. Optional functions need to be feasible based upon unique opportunity and substantial prior experience.

    These optional functions may also focus on collaborations with other CTSA Program hubs, for example to evaluate the effect of a new or existing tool or method on clinical and translational research at multiple hubs.  Whenever possible, applicants should consider an experimental approach to evaluating innovations.  Different components of one Program hub, or several collaborating hubs could, for example, be randomized or cluster-randomized to the innovative approach, and then prospectively compared to those randomized to standard practice.  This will allow for subsequent data-driven decision making.

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

    SF424 (R&R) Cover (Optional Functions)

    Complete only the following fields:

    • ·    Applicant Information
    • ·    Type of Applicant (optional)
    • ·    Descriptive Title of Applicant’s Project: Title this component “H. Optional Functions”.
    • ·    Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (Optional Functions)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Optional Functions)

    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) (Optional Functions)

    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 (Optional Functions)

    • ·    In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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 need only 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 (Optional Functions)

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

    Budget Justification: For all tasks, the amount requested must be well justified.  The budget justification should list each function and a corresponding justification for the associated costs.

    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 (Optional Functions)

    Introduction to Application: For Resubmission applications, an Introduction to Application is allowed in the Optional Functions component.

    Specific Aims: Describe the specific aims to address optional activities in areas of unique strength or opportunity.

    Research Strategy:  This component allows applicants to propose optional functions for particular strengths and interests. Applicants should describe how CTSA Program funding will be used to enhance innovation, access and quality in a measurable way.

    Letters of Support: Only letters of support specific to ‘Optional Functions’ should be attached to this section.

    Resource Sharing Plan: The Resource Sharing Plan for the CTR Cores should be described under the Administrative Core. Do not include a Resource Sharing Plan in the individual CTR Cores.

    Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.  

    PHS Human Subjects and Clinical Trials Information   

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) 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

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

    I. Institutional Career Development Core

    When preparing your application in ASSIST, use Component Type ‘Inst Career Dev’.

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    Substitute the term “scholars” for all references to “trainees” in the SF424 (R&R) Application Guide, and substitute the term “career development” for all references to “training” in the SF424 (R&R) Application Guide.

    Applicants are advised to frame their Career Development cores in the context of the overall Clinical Research Training and Career Development "ecosystem" of the CTSA Program hubs.

    The proposed Institutional Career Development Core must offer early-career postdoctoral scholars advanced training in translational science research aligned with the CTSA Program goals of advancing therapeutics (drugs, devices, and preventatives), clinical interventions, and behavioral modifications to improve health. The program should offer flexible learning models to engage postdoctoral scholars in team science, individual development plans, advanced research training, and career guidance to those committed to pursuing a career in clinical and translational research.

    SF424 (R&R) Cover (Institutional Career Development Core)

    Complete only the following fields:

    • ·    Applicant Information
    • ·    Type of Applicant (optional)
    • ·    Descriptive Title of Applicant’s Project: Title this component “I: Institutional Career Development Core”
    • ·    Proposed Project Start/Ending Dates

    Project/Performance Site Location(s) (Institutional Career Development Core)

    Follow all instructions provided in the SF424 (R&R) Application.

    Research & Related Other Project Information (Institutional Career Development Core)

    Follow all instructions provided in the SF424 (R&R) Application, with the following additional modifications:

    Substitute the term “scholars” for all references to “trainees” in the SF424 (R&R) Application Guide and substitute the term “career development” for all references to “training” in the SF424 (R&R) Application Guide.

    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 Summary/Abstract: Provide an abstract of the career development core. Include the objectives, rationale and design of the research career development program, as well as key activities in the career development plan. Indicate the planned duration of appointments, the projected number of scholars including their levels (i.e., postdoctoral, faculty), and intended scholar outcomes.

    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.

    Other Attachments: An Advisory Committee is a required component of this career development program.  Provide a plan for the appointment of an Advisory Committee to monitor progress of the career development program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of scholars. The application must include this Advisory Committee component. Applicants should describe their plan for Advisory Committee membership and the types of expertise to be represented in the Committee.  While ongoing advisory committee members should be named, new Advisory Committee members should not be named, nor contacted, in advance of review of the application.

    Research & Related Senior/Key Person Profile (Institutional Career Development Core)

    Follow all instructions provided in the SF424 (R&R) Application, with the following additional modifications:

    The Core Leader and any other individuals whose contributions are critical to the development, management and execution of the Core in a substantive, measurable way (whether or not salaries are reimbursed) should be identified as senior/key persons. These would include co-Leader(s), if applicable, and other Core staff. The CTSA Program KL2 PD/PI is expected to commit at least two person months effort on the KL2 award annually. For CTSA KL2 Programs with multiple PD/PIs, a combined effort of at least two person months is required.

    • ·    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 core.
    • ·    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 Lead may not be the PD/PI of the CTSA Program application but should work closely with the CTSA Program leadership to leverage training opportunities and share faculty expertise. The Core Lead will assume the PD/PI role on the KL2 award following a successful review and funding of the U54 application; absent U funding, K awards will not be made. 

    Do not include proposed mentors (other than senior/key persons) in this section. Biographical Sketches for mentors will be included in the PHS 398 Research Training Program Plan Form, Participating Faculty Biosketches attachment.

    PHS 398 Cover Page Supplement (Institutional Career Development Core)

    Follow all instructions provided in the SF424 (R&R) Application.

    PHS 398 Training Subaward Budget Attachment (Institutional Career Development Core)

    Follow the Instructions in the SF424 (R&R) Application Guide with the following additional modifications:

    • ·    Include all personnel other than the Core Lead(s) in the Other Personnel section, including clerical and administrative staff. Also include proposed salary costs for planned scholars.
    • ·    Do not complete the section on Participant/Trainee Support Costs.
    • ·    The CTSA Program Institutional Career Development Program for translational researchers will be programmatically linked but will have a separate PD/PI when awarded, and a budget based on the number of scholars projected.  The maximum number of scholars per year, for any size CTSA Program hub, is 9.
    • ·    If an institution is currently funded under the CTSA Program, and if the number of KL2 scholars currently provided through the CTSA Program award is greater than the number recommended in this FOA, then applicants may choose to describe a transition period of up to three years when needed to reduce the number of KL2 scholars.  This is to allow for a transition to the new model, and to lessen the impact on ongoing career development.  This gives applicants flexibility when budgeting for KL2 scholars within the limit of the Award Budget described in Section II.
    • ·    For each scholar, the following should be budgeted:  Salary support will be provided up to $120,000. In general, 9 person-months (75 percent of the KL2 full-time professional effort) must be devoted to the KL2 program, except for those in surgical specialties, which can have less than 9 person-months (75 percent), but no less than 6 person-months (50 percent), protected time for this program, if sufficiently justified and programmatically approved. Additional support may be requested for research-related activities detailed below.
    • ·    The average total amount budgeted per scholar must not exceed $180,000 in direct costs per year.

    Other Direct Costs:  The K budget should include funds to support K scholar research projects and career development activities. Applicants should request from $25,000 to $50,000 per year/per scholar to cover the following expenses: (a) tuition and fees related to career development; (b) research expenses such as supplies, equipment and technical personnel to supplement those provided by the mentor; (c) up to $2,500 for scholar travel to scientific meetings and research training workshops; and (d) statistical services.

    In addition, mentor support may include up to $10,000 per year for associated laboratory or other research-related expenses. Salary support for mentors is not an allowable budget item.

    PHS 398 Research Training Program Plan (Institutional Career Development Core)

    The PHS 398 Research Training Program Plan Form comprises the following sections:

    Training Program

    Faculty, Trainees, and Training Record

    Other Training Program Sections

    Appendix: Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials or if the FOA specifically instructs applicants to do so.

    Follow all instructions with the following additional modifications:

    Particular attention must be given to the required Training Data Tables 2 and 8C. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the program. Do not include tables not specified in the application instructions.

    Substitute the term “scholars” for all references to “trainees” in the SF424 (R&R) Application Guide and substitute the term “career development” for all references to “training” in the SF424 (R&R) Application Guide.

    Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for the Institutional Career Development Core.

    Training Program Section

    Provide the rationale for the Institutional Career Development Core with a focus on translational science. Indicate how the CTSA Program Institutional Career Development Core will relate to the current training activities at the applicant institution.

    Program Plan: Follow all instructions provided in the SF424 (R&R) Application Guide - Training Program Plan with the following additional modifications:

    Proposed Novel Training: Outline the objectives of the program and novel training program activities that will be used to meet the objectives. Describe for whom the career development program is intended, including the training level(s) of the scholars, the research resources available, and plans to accommodate differences in preparation among scholars. Include information about planned courses, instruction in grant writing, the peer review process, and novel career development opportunities (e.g., optional experiences in industry, entrepreneurial training, community health centers, other CTSA Program hubs or research institutions, governmental and non-governmental organizations).

    Scholars should obtain a working knowledge of career options and the steps required to transition successfully through their chosen career pathway. Describe ideas for integrating a team science approach into career development, and for offering a research curriculum aligned to core competencies in translational research. Early exposure to collaboration leveraging multiple areas of expertise may enhance efforts to cultivate a team approach to tackle challenges in clinical research.  Describe how knowledge will be conveyed about rigorous research methodology to promote best practices and minimize bias in experimental design and reporting.

    Harmonizing career development across a CTSA Program hub requires integrating clinical and translational science across multiple departments, schools, and clinical research institutes in a team science approach. Support for a range of disciplines (including medicine, dentistry, nursing, pharmacy, public health, epidemiology, biostatistics, bioinformatics or bioengineering) should be offered. Describe any plans to collaborate with other CTSA Program hubs. Research training collaboration across the CTSA Program consortium is encouraged. Taking advantage of information technology tools, CTSA Program hubs should seek opportunities to share educational methods and online resources. 

    Sharing resources, and reciprocal exchanges of scholars/mentors, while not required, are strongly encouraged by NCATS.  The exchange can address the research and career guidance needs of scholars and introduce interactive and innovative programs that include “real-world” exposure to different areas of translational research. For those proposing to have scholars participate in externships, a description of how rotations will be built into the scholar’s career development plan and specifically, the scholars’ appointment period should be provided. A scholar’s appointment period may be extended to allow for the externship.

    If a clinical trial is proposed, provide documentation of the PD/PI(s) expertise, experience, and ability to oversee the organization, management, and implementation of the clinical trial, including any feasibility or ancillary study, proposed by Scholar(s).


    Program Evaluation: Describe a plan to review and determine the quality and effectiveness of the career development program. This plan should include the metrics to be evaluated, program outcomes, as well as plans to adjust the program based on feedback from current and former scholars and faculty. Applicants are also expected to work with a CTSA Program-wide Common Metrics initiative to measure the impact of the CTSA Program.

    Institutional Environment and Commitment to the Program: The Institutional Career Development environment should serve as a hub for fostering high-impact research careers in translational research. Describe the environment for career development, emphasizing institutional strengths; justify the number of scholars requested; broadly indicate which disciplines/departments candidates may apply from, quoting any historical program outcome data from the previous 5 years (as applicable). The sponsoring institution must assure support for the proposed core including assurance that sufficient protected time will be allowed for the PD/PI to contribute at least 2 calendar months to the proposed program and that there will be protected time for scholars selected for the program, generally 9 calendar-months, equivalent to 75% or 6-9 calendar-months for surgeons, equivalent to 50%).  

    In demonstrating institutional commitment, applicants should describe any existing career development activities in translational research currently supported by the institution.


    Recruitment Plan to Enhance Diversity: Individuals are required to comply with the instructions for Recruitment Plan to Enhance Diversity as provided in the SF424 (R&R) Application Guide. Applications must include a description of plans to recruit a diverse scholar pool and may wish to include data in support of past accomplishments. Information should be included on both successful and unsuccessful recruitment strategies. 

    Plan for Instruction in the Responsible Conduct of Research: Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide.

    Progress Report (Renewal Applications Only): Renewal applications must provide a Progress Report on career development activities according to the instructions in the SF424 (R&R) Application Guide

    Faculty, Scholars, And Training Record Section

    Include participating faculty biosketches, letters of support, and required data tables.
    Participating Faculty Biosketches

    If the mentor will supervise a Trainee proposing to gain research experience in a clinical trial, provide documentation of his/her expertise, experience, ability to provide guidance and help the Scholar to meet the study timelines.

    Data Tables

    The SF424 instructions provide a detailed description of required data tables 2 and 8C. Include only the tables requested. Tables 2 (Participating Faculty Members), and 8C (Program Outcomes: Postdoctoral) are required. Tables can be found at the following link: https://grants.nih.gov/grants/funding/424/index.htm#data.


    Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    PHS Human Subjects and Clinical Trials Information    

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional modifications:

    Study Record: PHS Human Subjects and Clinical Trials Information

    DO NOT USE. Attempts to submit a full, detailed study record will result in a validation error.

    Delayed Onset Study

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must complete a Delayed Onset Study. 

    J. NRSA Training Core

    When preparing your application in ASSIST, use Component Type ‘NRSA Training.’

    It is critical to follow all Training (T) instructions provided in the SF424 (R&R) Application, with the following additional modifications:

    The Training Core will offer predoctoral students an orientation to translational science and postdoctoral appointees advanced research training aligned with the CTSA Program goals of advancing therapeutics (drugs, devices, and preventatives), clinical interventions, and behavioral modifications to improve health. The training component should serve as a pipeline introducing trainees of various disciplines to translational science research. A variety of predoctoral training options may be offered at the discretion of the PD/PI including short-term training, combined dual-degree training, and intensive year-long training. Health-professional students who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs may also seek an additional doctorate or master's level degree.

    These training tracks serve as a means to attract candidates from multidisciplinary fields and they offer flexibility to meet the research needs of the individual trainees.

    Applicants are advised to frame their Institutional Training core in the context of the overall Clinical Research Training and Institutional Career Development "ecosystem" of the CTSA Program hubs.

    SF424 (R&R) Cover (Training Core)

    Complete only the following fields:

    • ·    Applicant Information
    • ·    Type of Applicant (optional)
    • ·    Descriptive Title of Applicant’s Project: Title this component “J: NRSA Training Core”.
    • ·    Proposed Project Start/Ending Dates

    Project/Performance Site Location(s) (Training Core)

    Follow all instructions provided in the SF424 (R&R) Application.

    Research & Related Other Project Information (Training Core)

    Follow all instructions provided in the SF424 (R&R) Application

    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 Summary/Abstract: Provide an abstract of the entire application. Include the objectives, rationale and design of the research training program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of trainees including their levels (i.e., predoctoral, postdoctoral, short-term faculty), and intended trainee outcomes.

    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.

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

    Follow all instructions provided in the SF424 (R&R) Application, with the following additional modifications:

    The Training Core Leader and any other individuals whose contributions are critical to the development, management and execution of the Training Core in a substantive, measurable way (whether or not salaries are reimbursed) should be identified as senior/key persons. These would include co-Leader(s), if applicable, and other Training Core staff.

    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 core.

    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. 

    The Core Lead may not be the PD/PI of the CTSA Program application but should work closely with the CTSA Program leadership to leverage training opportunities and share faculty expertise. The CTSA Program TL1 PD/PI is expected to commit at least two person months effort on the TL1 award annually. For CTSA Program hubs with multiple TL1 PD/PIs, a combined total of at least two person months effort is required. The Project Lead will assume the PD/PI role of the TL1 award following successful review and funding of the U54 application; absent UL1 funding, TL1 awards will not be made. 

    Do not include proposed mentors and training faculty members (other than senior/key persons) in this section. Biographical Sketches for mentors and participating faculty will be included in the

    PHS 398 Research Training Program Plan Form, Participating Faculty Biosketches attachment.

    PHS 398 Cover Page Supplement (Training Core)

    Follow all instructions provided in the SF424 (R&R) Application.

    PHS 398 Training Subaward Budget Attachment (Training Core)

    Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

    Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff

    The NRSA Training Core is an optional part of the CTSA Program U54 application and will be funded only if the U application is successful. The training component provides stipends at a subsistence allowance to help defray living expenses during the research and clinical training experiences. The maximum budget for a training core is $400K direct cost (DC) for small hubs (total anticipated CTSA amount <$4.5M DC), $600K DC for medium hubs (total anticipated CTSA amount $4.5-$6M DC), and $800K (DC) for large hubs (total anticipated CTSA amount >$6M-$7.5M DC). The amount budgeted per pre-doctoral and post-doctoral trainee must comply with the NRSA stipend levels and allowable costs specified below.

    Part A:  The application should request stipends for trainees.

    Part B: Enter the total costs for Trainee Travel, and training related expenses, following the guidance, below:

    Other Direct Costs: Trainee Travel: Enter the total costs for Trainee Travel, and training related expenses, following the guidance, below: 

    While the maximum request is explained under Budget information, the awarded slots will depend upon the scientific and technical merit of the proposed program as determined by scientific peer review and the relevance of the proposed program to programmatic priorities. Further consideration will address program goals and resources, educational resource sharing, and the availability of funds. Applicants should expect that final budgets may be adjusted post-review depending on these factors.

    PHS 398 Research Training Program Plan (Training Core)

    The PHS 398 Research Training Program Plan Form is comprised of the following sections:

    • ·    Training Program
    • ·    Faculty, Trainees, and Training Record
    • ·    Other Training Program Sections
    • ·    Appendix.

    Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

    Particular attention must be given to the required Training Data Tables. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the program.

    Provide the rationale for the Training Core and the need for the cross-training proposed.  Indicate how the CTSA Program Training Core will relate to the current training activities at the applicant institution.

    Program Plan: 

    Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

    Proposed Novel Training: Outline the objectives of the program and novel training program activities that will be used to meet the objectives. Describe for whom the training program is intended, including the training level(s) of the trainees, the research resources available, and plans to accommodate differences in preparation among trainees. Include information about novel training opportunities (e.g., optional experiences in industry, entrepreneurial training, community health centers, other CTSA Program hubs or research institutions, governmental and non-governmental organizations).

    Describe ideas for integrating a team science approach into translational science research training. Describe how training will be fostered in rigorous research methodology to promote best practices and minimize bias in experimental design and reporting.

    Providing real-world exposure to different areas of translational research is an essential training feature. For those proposing to have trainees participate in externships, a description of how rotations will be built into the individual development plan and specifically, the trainees’ appointment period, should be provided.  Appointment periods may be extended to allow for trainee participation in externships.

    Harmonizing translational science research training across a CTSA Program hub requires integrating multiple departments, schools, and clinical research institutes in a team science approach. Support for a range of disciplines (including medicine, dentistry, nursing, pharmacy, public health, epidemiology, biostatistics, bioinformatics or bioengineering) should be offered. Describe any plans to collaborate with other CTSA Program hubs. Evidence should be provided that the CTSA Program supported activities are synergistic (not duplicative) with other funded NIH NRSA Training T32 programs (as applicable). Research training collaboration across the CTSA Program consortium is encouraged. Taking advantage of information technology tools, CTSA Program hubs should seek opportunities to share educational methods and online resources.

    Recognizing the scope of career opportunities, NCATS strongly encourages the use of Individual Development Plans for trainees, including for example areas such as problem solving, communication, team science, time management, and leadership skills, as well as career guidance. 

    Program Evaluation: Describe a plan to review and determine the quality and effectiveness of the training program. This plan should include the metrics to be evaluated, program outcomes, as well as plans to adjust the program based on feedback from current and former trainees and faculty. Applicants are expected to work with a CTSA Program-wide Common Metrics initiative to measure the impact of the CTSA Program.

    Institutional Environment and Commitment to the Program: The sponsoring institution must assure support for the proposed Training Core including assurance that a minimum of 2 calendar months will be allowed for the Training PD(s)/PI(s) to contribute to the proposed training. Describe the training environment, emphasizing institutional strengths; broadly indicate which disciplines/departments candidates may apply from, quoting any historical program outcome data from the previous 5 years (as applicable).

    In demonstrating institutional commitment, applicants should describe all existing T32 research program activities currently supported by the institution.


    Recruitment Plan to Enhance Diversity: Individuals are required to comply with the instructions as provided in the SF424 (R&R) Application Guide. Applications must include a description of plans to recruit a diverse trainee pool and may wish to include data in support of past accomplishments. Information should be included on both successful and unsuccessful recruitment strategies. 

    Plan for Instruction in the Responsible Conduct of Research: Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in Chapter 8 of the SF424 (R&R) Application Guide.

    Progress Report (Renewal Applications Only): Renewal applications must provide a Progress Report on training activities according to the instructions in the SF424 (R&R) Application Guide

    Faculty, Trainees, And Training Record Section

    Data Tables

    Particular attention must be given to the required Training Data Tables.

    Data Tables: The required NRSA tables will differ depending on the type of application (new or renewal) and training focus [e.g., predoctoral, postdoctoral, or a combined (mixed) pre- and postdoctoral program]. The SF424 instructions provide a detailed description of required data tables. https://grants.nih.gov/grants/funding/424/index.htm#data

    Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    3. Unique Entity Identifier and System for Award Management (SAM)

    See Part 1. 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

    Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

    Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

    Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

    For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

    Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

    For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

    All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

    In order to expedite review, applicants are requested to notify the NCATS Referral Office by email at ncatsreferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

    Overall Impact - Overall

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the CTSA Program Hub to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

    In addition, for applications involving clinical trials:

    A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs.  Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

    Scored Review Criteria - Overall

    Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

    Significance

    Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?   

    Specific to this FOA: To what extent does the CTSA Program application clearly describe and justify a strategic vision to innovate translational research and goals?  To what extent do applicants provide a plan to measure these goals?

    In addition, for applications involving clinical trials

    Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI , do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  

    Specific to this FOA: To what degree do the applicants have a strong record of translational and clinical research with high impact achievements in useful methods and procedures leading to improved diagnoses, treatments, and strategies for disease prevention? 

    In addition, for applications involving clinical trials

    With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

    Innovation

    Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

    Specific to this FOA: To what extent are plans proposed for innovation to improve both educational and research methods and processes, including carefully selected, useful metrics? Does the hub institution demonstrate its commitment to innovate such as participating in a centralized, streamlined CTSA Program network, including participating in NIH multi-site trials featuring single Institutional Review Boards and pre-negotiated master subcontracts?

    In addition, for applications involving clinical trials

    Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?  

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

     1) the protection of human subjects from research risks, and

     2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?    

    Specific to this FOA: How have the applicants described their specific aims to act as a catalyst for high-quality clinical and translational research, locally and as part of the CTSA Program network? To what extent are their plans for incorporating local partners and other CTSA Program hubs in translational research and education realistic and are they likely to succeed?

    To what extent have the applicants set forth a convincing plan to establish a Hub Liaison Team with robust interactions with the Trial Innovation Network?

    To what extent have the applicants described how team scientists will be evaluated in the academic promotion process, as well as consideration of how such individuals will be professionally recognized and thus incentivized to engage in collaborations?

    To what extent have the applicants developed academic promotion criteria that help create a viable career path for translational scientists?

    How are they prepared, where possible, to engage in research across the lifespan and in underserved populations?

    To what extent have the applicants described how local and national communities will be integrated throughout all phases of translational science?

    To what extent have the applicants described how Community Engagement will be integrated into the leadership, implementation, research and communications strategies at their hub?

    To what extent have applicants described how they will acknowledge community engaged research in academic policies (such as promotion and tenure)?

    To what extent have the applicants been successful in selecting and mentoring doctoral level scientists in preparation for a career in academic medicine or related fields? How have the applicants been able to follow the careers of mentees and have they defined and well summarized their successes and failures in this endeavor?

    To what extent does the plan for informatics coordination include relevant partners? How strong is the plan to use informatics for all stages of translation – from support of basic research to knowledge discovery, from integration of medical records to community engagement and education?

    To what degree are the plans “state of the art” for the use of informatics in Community and Collaboration, Translational Endeavors, Research Methods, Hub Research Capacity, Network Capacity and any proposed Optional Functions?

    How strong is the focus on interoperability and harmonization among existing informatics platforms? How likely will the plan for management of research data ensure the security of researchers’ data at participating institutions? How feasible and well managed are the implementation timelines, if proposed?  

    In addition, for applications involving clinical trials

    Does the application adequately address the following, if applicable?

    Study Design

    Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

    Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

    Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

    Data Management and Statistical Analysis

    Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

    Environment

    Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

    Specific to this FOA: To what extent does an integrated program across the local health care delivery system and the translational research enterprise exist? How might this integrated program assist in establishing clinical trial feasibility and improve trial recruitment in an efficient and ethical manner?

    How will this CTSA Program hub benefit from unique institutional strengths such as human capital, infrastructure, and skilled partner institutions in the support of clinical and translational research and education?

    In addition, for applications involving clinical trials

    If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

    Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

    If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

    If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?     

    Additional Review Criteria - Overall

    As applicable for the program proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

    Study Timeline

    Specific to applications involving clinical trials

    Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSA Program hubs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

    Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)? 

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

    For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

    Inclusion of Women, Minorities, and Children 

    When the proposed program involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed.  For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

    Resubmissions

    For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

    Renewals

    For Renewals, the committee will consider the progress made in the last funding period.

    Revisions

    Not Applicable.

    Additional Review Considerations - Overall

    As applicable for the program proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

    Applications from Foreign Organizations

    Not Applicable.

    Select Agent Research

    Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .


    Authentication of Key Biological and/or Chemical Resources

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    Budget and Period of Support

    Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

    Overall Impact - Administrative, Informatics, Community and Collaboration, Translational Endeavors, Research Methods, Hub Research Capacity, Network Capacity, and Optional Functions Cores. 

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for a component to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the component proposed).

    Scored Review Criteria - Administrative, Informatics, Community and Collaboration, Translational Endeavors, Research Methods, Hub Research Capacity, Network Capacity, and Optional Functions Cores

    Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each of the criteria. Scores will be assigned to the named components (Administrative Core, Informatics, Community and Collaboration, Translational Endeavors, Research Methods, Hub Research Capacity, Network Capacity, and Optional Functions) as an aggregate.  The aggregate does not need to be strong in all categories to be judged likely to have a major scientific impact. For example, a component that by its nature is not innovative may be essential to advance the field.

    Significance

    How will the proposed specific aims of the administrative core including organization, governance, collaboration, communication, and succession planning result in successful management of the proposed CTSA Program hub?

    To what extent have applicants provided information related to their capacity and commitment to collect metrics measuring impact of their CTSA Program hub?

    To what extent has the applicant described how the interaction between the CTSA Program hub leadership and its External Advisory Committee will lead to identifying opportunities for improvement and action to mitigate problems identified?

    How feasible are the plans to meet the specific aims with regard to informatics, community engagement, team science and collaboration?

    To what extent have the applicants articulated plans to lay the foundation of high quality research by creating and maintaining a skillful, multidisciplinary, and heterogeneous translational workforce supported by state-of-the-art bioinformatics and informed by high quality and innovative biostatistics as well as regulatory and legal experts?

    To what degree does the application set forth plans to create and maintain successful pilot translational and clinical studies; where possible, integrate special populations in translational and clinical research; and retain a limited cohort of experienced clinical research professionals to advise and support study-specific staff? 

    To what extent have the applicants set forth a convincing plan to establish a Hub Liaison Team with robust interactions with the Trial Innovation Network as well as with other CTSA Program central resources? 

    To what extent have the applicants demonstrated their commitment to participating in the activities of the National CTSA Program, including participating in multi-site clinical trials?

    Have the applicants proposed additional functions based upon strengths and interests? How are these extra functions likely to enhance the hub and the CTSA Program in either innovative translational and clinical research or in the education of tomorrow’s investigators?

    Investigators

    How well-matched are the proposed CTSA Program hub investigators to continue the gradual transformation of the Program into a high-performance network marked by not only individual hub excellence but also by a nimble highly responsive aggregate able to develop, demonstrate and disseminate advances in diagnosis, treatment and prevention of human diseases quickly?

    How have hub investigators been successful at innovation in clinical and translational research and in education within the confines of the hub and at the national level? To what degree are investigators committed to innovation in process improvement and the use of common metrics in the management (identification of best practices and problems) of hub and network activities?

    Innovation

    To what extent are the applicants likely to contribute by means of collaboration with other CTSA Program hubs to test innovative ideas in research and education? How does the application reveal a strong track record of innovation and impact in clinical and translational research?

    To what extent does the application include plans to expand translational research to include young or older persons or other special populations?

    To what extent are innovative methods evident, such as experimental approaches to identify best practices in both translational research and workforce education?  To what degree do the plans include not only developing innovations but also using innovations made by others to demonstrate utility and to ultimately disseminate successful innovations?

    Approach

    How strong are the plans to use informatics in support of the entire spectrum of translational research?  How likely to be successful are the applicants' plans to integrate data from different sources such as sensors, mobile platforms, EHR, clinical databases, research datasets, patient reported outcomes and data from other sources?  To what extent do the applicants propose innovative informatics solutions (such as discovery informatics, human-computer interaction, sensors and mobile platforms, or interactive environments and games) in support of translational research, training or education?  To what degree are bioinformatics or informatics innovations proposed in support to the broad range of translational research, education and training functions across the CTSA Program hub?

    How robust is the plan to establish and sustain a research data warehouse?  To what extent do the applicants provide a robust quality management plan for the research data warehouse?  How strong are the plans to recruit, train and support the members of a research data warehouse team?  How likely are they to contribute to best practices in research data warehousing across the CTSA Program network or with other initiatives such as PCORNet? How strong are the plans to use standard terminologies, or if absent, to what extent are the applicants committed to developing and then broadly sharing missing standards?  To what extent will applicants be able to incorporate new standards into their terminology?  How strong is the ability to handle queries from different and highly varied sources?  How robust is the current capacity to handle queries, and what is the ability to scale up?  How likely is it that the applicants will be able to execute a query to determine the number of potential participants meeting study entry criteria? (presume a query for the number of potential participants meeting study entry criteria with regards to age, primary and secondary diagnoses (ICD), current medications and a commonly used laboratory measure)?  To what extent can the applicants query the EHR across the multiple components of their institution, and their partners (including outpatient clinics)?

    To what extent is an appropriate user-friendly data management system proposed with training on its use and basic support? How are challenges and alternative approaches addressed?

    To what extent does the application describe a practical means to engage the variety of local communities with an interest in clinical and translational research, such as patients, clinicians, advocacy groups, and others? To what extent does the application include a description of approaches or strategies to engage communities?  To what extent does the application describe how CTSA Program resources will be used to develop best practices, informational material and consultations on how to engage communities as strong, well prepared and active partners around specific projects?

    To what extent are the applicants committed to using common metrics to identify best practices and opportunities for improvements at both local hubs and across the CTSA Program consortium?

    How will the proposed approaches to the overarching, high-priority functions and specific functions contribute to efficient, high quality clinical and translational research and training?

    To what extent will this applicant support the development of a skillful multidisciplinary and diverse translational science workforce? To what extent is there a commitment to refinement of the academic reward system toward the recognition of translational researchers and team scientists?

    For the overarching, high priority functions (B and C in table Section IV), to what extent has the applicant organized resources and staffing in a realistic fashion? To what extent are resources proposed well justified?

    For the specific functions (D-G in table Section IV), to what extent has the applicant organized proposed resources and staffing? To what extent are resources proposed well justified?

    To what extent are the optional functions well justified? How well do they represent a unique opportunity at the hub? To what extent is an experimental approach to evaluating innovations in the optional function proposed and appropriate?

    How well do the applicants identify obstacles and propose solutions to the creation of a high performance CTSA Program network capable of quickly and efficiently fielding multi-site clinical trials in response to NIH Institutes and Centers invitations?

    Environment

    To what extent is the inclusion of all partner institutions well justified and sound? How likely is the collaboration(s) to be vigorous, balanced and productive?

    How committed is this applicant to becoming a collaborative member of the national CTSA Program

    and an active contributor to the CTSA Program Steering Committee?

    Additional Review Criteria - Administrative Core, Informatics, Community and Collaboration, Research Methods, Hub Research Capacity, Network Capacity, and Optional Functions

    As applicable for the project component proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

    For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

    Inclusion of Women, Minorities, and Children

    When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific  assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the   Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

    Resubmissions

    For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

    Renewals

    For Renewals, the committee will consider the progress made in the last funding period.

    Revisions

    Not Applicable

    Overall Impact - Institutional Career Development Core

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed career development Program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

    Scored Review Criteria - Institutional Career Development Core

    Reviewers will consider each of the review criteria below in the determination of the merit of the career development program and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term career development. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

    Career Development Program and Environment

    Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as biomedical or clinical researchers? Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support?

    Are the content and duration of any proposed novel didactic, career development-related, and research-related activities of the program appropriate? Are appropriate timelines indicated for career progression and transition to independence?

    Does the institutional environment (e.g., research facilities and other relevant resources) of the program contribute to the probability of successful transition to independence? Does the proposed career development program benefit from unique features of the scientific environment, subject populations, and employ team science collaborative training? Is the institutional commitment to the proposed program appropriate?

    If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided?

    Is there sufficient assurance that the required effort of the Core Lead, mentors and scholars will be devoted directly to the career development and related activities? Is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program?

    Core Lead(s)

    Do the Core Lead and Research Administrator (if applicable) have the experience to develop, direct and administer the proposed program? Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives? Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program? Are the Core Lead(s) currently engaged in research relevant to the scientific area of the proposed program?

    For applications designating multiple Core Leads:

    To what extent is a strong justification provided that the multiple PD/PI leadership approach will benefit the career development program and the scholars?

    To what extent is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the career development program and the complementary expertise of the PDs/PIs?

    Mentors

    Do the mentors have appropriate expertise and experience, as well as track records of past mentoring and training? Are the quality and extent of the mentors’ roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant research?

    Candidates/Scholars

    Is the number of scholars requested per year adequately justified and appropriate?

    Is a recruitment plan proposed with strategies likely to attract qualified and high-quality scholar candidates with professionally varied backgrounds at the appropriate stage in their careers?

    Are there well-defined and well justified recruitment and selection strategies? Is there evidence of a sufficiently large, competitive scholar pool to warrant the proposed size of the career development program? 

    Are the content, phasing, and proposed duration of the career development plan appropriate for achieving scientific independence of the scholar candidates? What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars? Does the plan for selection of the scholars include all eligibility criteria stated in the FOA?

    To what extent is there a description of the process to provide personalized career guidance? Are the content, training track, and proposed duration of the individual (career) development plan appropriate for achieving scientific independence? What is the likelihood that the personalized plan will contribute significantly to the scientific development of the scholars?

    Training Record

    Is there evidence of a successful past training record of the Core Lead and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers? Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the career development plan?

    To what extent have tools been identified to assess program performance including evaluation of the curriculum, diversity, mentors, research training opportunities, and scholars? Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the program objectives?

    Specific to this FOA

    Are the program goals appropriately aligned to the CTSA Program goals to advance translational science involving therapeutics (drugs, devices, and preventatives), clinical interventions, and behavioral modification?

    Are shared resources and reciprocal exchanges addressed in sufficient detail to determine its potential utility?

    To what extent is the proposed research education curriculum aligned with core competencies in translational research?


    To what extent are there innovative or non-traditional learning models or experiential opportunities?

    Additional Review Criteria - Institutional Career Development Core

    As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

    Protections for Human Subjects

    Generally, not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    Inclusion of Women, Minorities, and Children

    Generally, not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    Vertebrate Animals

    Generally, not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    Biohazards

    Generally, not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    Resubmissions

    For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

    Renewals

    For Renewals, the committee will consider the progress made in the last funding period.

    Revisions

    Not Applicable

    Additional Review Considerations - Institutional Career Development Core

    As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

    Recruitment Plan to Enhance Diversity

    Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

    Training in the Responsible Conduct of Research

    All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).  Taking into account the specific characteristics of the career development program, the level of scholar experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components:

    1) Format - Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups, including face-to-face interaction?  (A plan involving only on-line instruction is not acceptable.);

    2) Subject Matter – Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics?

    3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction?  For renewal applications, are all career development faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 

    4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction?

    5) Frequency of Instruction – Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

    For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

    Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

    Select Agent Research

    Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

    Budget and Period of Support

    Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

    Overall Impact - NRSA Training

    Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

    Reviewers will provide an overall impact score to reflect their assessment that the proposed training component will prepare individuals for successful and productive scientific research careers.  The environment, leadership and mentors, and the evaluation plan will all factor into the overall impact score.

    Scored Review Criteria - NRSA Training

    Reviewers will consider each of the review criteria below in the determination of the merit of the training program and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed program plan. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

    Training Program and Environment

    To what extent are the research facilities and research environment conducive to preparing trainees for successful careers as biomedical research scientists?

    To what extent are the objectives, design, and direction of the proposed research training program likely to ensure effective training?

    To what extent do the courses, where relevant, and research experiences provide opportunities for trainees to acquire state-of-the-art scientific knowledge, methods, and tools that are relevant to the goals of the training program?

    To what extent does the program provide appropriate inter- or multidisciplinary research training opportunities?

    To what degree is the proposed training program likely to ensure trainees will be well prepared for research-intensive and research-related careers?

    To what degree is the level of institutional commitment to the training program, including administrative and research training support, sufficient to ensure the success of the program?

    Is the proposed training program clearly distinguished from other externally funded training programs at the institution?

    Specific to this FOA:

    To what extent are the objectives of the program clearly explained and reflective of the institutional strengths?

    Are the NRSA Training program goals appropriately aligned to the CTSA Program goals to advance translational science involving therapeutics (drugs, devices, and preventatives), clinical interventions, and behavioral modification?

    Has the applicant provided a convincing rationale for the novel training and the cross-training, if proposed? 

    Are shared resources addressed in sufficient detail to determine its potential utility?

    To what degree is the CTSA Program hub including the research environment conducive to preparing trainees for successful careers as translational scientists? Is the NRSA Training component sufficiently integrated with the CTSA Program scientific vision?

    To what extent are appropriate institutional resources committed to the proposed program? If multiple sites are participating, are the trainee appointments equitable across the sites and if not, is the distribution justified in terms of the research training experiences provided? Is the NRSA Training component integrated with other institutional training (NRSA) programs at the institution? Does the applicant indicate appropriate institutional and departmental commitment to the program reflected in recruitment efforts, educational resources and equipment, and faculty? Is there sufficient assurance that the required effort of the Program Lead, mentors, and trainees will be devoted directly to the research training and related activities?

    How strong are the applicant's plans to work with other CTSA Program hub sites on shared training

    opportunities and on harmonization in education and training?

    To what degree are the conceptual elements of team-based research included in the scope of program activities?

    To what extent are appropriate advanced degree granting programs offered? Does the proposed program clearly outline a plan to recruit candidates across multiple disciplines ranging from basic science to social science including medicine and allied health fields?

    To what degree does the curriculum offer novel learning models to meet the needs of trainees? Will the curriculum provide appropriate training in clinical and translational research relevant to a broad range of specialties and with appropriate emphasis on the needs of team science?

    To what degree do the curriculum offer innovative methods or access to non-traditional learning experiences?

    Training Core Lead(s)

    To what extent does the Training Core Lead have the scientific background, expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training Program?

    To what extent does the Training Core Lead plan to commit sufficient effort to ensure the Program’s success?

    For applications designating multiple Core Leads:

    To what extent is a strong justification provided that the leadership approach of the multiple Core

    Leads will benefit the training program and the trainees?

    To what extent is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and the complementary expertise of the Core Leads?

    Preceptors/Mentors

    To what extent are sufficient numbers of experienced preceptors/mentors with appropriate expertise and funding available to support the number and level of trainees (including short-term trainees, if applicable) proposed in the application?

    To what extent do the preceptors/mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?

    To what extent do the preceptors/mentors have strong records of training individuals at the level of trainees (including short-term trainees, if applicable) proposed in the program? Are appropriate plans in place to ensure that preceptors lacking sufficient research training experience are likely to provide strong and successful mentoring?

    Trainees

    To what degree is a recruitment plan proposed with strategies likely to attract well-qualified candidates for the training program?

    To what degree is there a competitive applicant pool of sufficient size and quality, at each of the proposed levels (pre-doctoral, postdoctoral and/or short-term), to ensure a successful training program?

    To what degree are there well-defined and justified selection and re-appointment criteria as well as retention strategies?

    Training Record

    How successful are the trainees (or, for new applications, other past students/post-doctorates in similar training) in completing the program?

    To what degree has the training program ensured that trainees are productive (or, for new applications, other past students/post-doctorates in similar training) in terms of research accomplishments, publication of research conducted during the training period, and subsequent training appointments and fellowship or career development awards?

    How successful are the trainees (or, for new applications, other past students/post-doctorates in similar training) in achieving productive scientific careers as evidenced by successful competition for research science positions in industry, academia, government or other research venues; grants; receipt of honors, awards, or patents; high-impact publications; promotion to scientific leadership positions; and/or other such measures of success?

    To what extent do trainees’ subsequent positions in industrial, academic, government, non-profit, or other sectors benefit from their NRSA-supported research training and directly benefit the broader biomedical research enterprise?

    To what extent does the program propose a rigorous evaluation plan to assess the quality and effectiveness of the training and mentors?  Are effective mechanisms in place for obtaining feedback from current and former trainees?

    For applications that request short-term research training positions, is there a record of retaining health professional trainees in research training or other research activities for at least two years?

    To what extent does the evaluation plan describe strategies to engage current and former trainees to assess the quality and effectiveness of the program objectives?

    Additional Review Criteria - NRSA Training

    As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

    Protections for Human Subjects

    Generally, not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    Inclusion of Women, Minorities, and Children

    Generally, not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    Vertebrate Animals

    Generally, not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    Biohazards

    Generally, not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    Resubmissions

    For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

    Renewals

    For Renewals, the committee will consider the progress made in the last funding period.

    Revisions

    Not Applicable

    Additional Review Considerations - NRSA Training

    As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

    Recruitment & Retention Plan to Enhance Diversity

    Peer reviewers will separately evaluate the Recruitment Plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

    Training in the Responsible Conduct of Research

    All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).  Taking into account the specific characteristics of the career development program, the level of trainee experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components:

    1) Format - Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups, including face-to-face interaction?  (A plan involving only on-line instruction is not acceptable.)

    2) Subject Matter – Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics?

    3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction?  For renewal applications, are all career development faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 

    4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction?

    5) Frequency of Instruction – Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, pre-doctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

    Select Agent Research

    Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

    Budget and Period of Support

    Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NCATS  in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

    As part of the scientific peer review, all applications:

    • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
    • Will receive a written critique.

    Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NCATS Advisory Council. The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.  
    • Policies consistent with goals for resource, data and software sharing.
    • Programmatic priorities, including geographic distribution of the CTSA Program hubs and access to special populations.

    NCATS may fund a UL1 & KL2 or a UL1 & KL2 & TL1 depending on the scientific and technical merit of the application components.

    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

    Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

    Section VI. Award Administration Information
    1. Award Notices

    If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

    A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

    Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

    Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

    Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.  ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/ 

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by its IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.  Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

    Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE). 

    Prior Approval of Pilot Projects

    Awardee-selected projects that involve human subjects research require prior approval by NIH prior to initiation. 

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Cooperative Agreement Terms and Conditions of Award

    The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

    The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

    The PD(s)/PI(s) will have the primary responsibility for:

    • Determine approaches, designing, implementing, and setting milestones for advancing translational and clinical research and training
    • Ensure all participating institutions are fully integrated into the CTSA Program hub
    • Implementing the activities at the CTSA Program hub
    • Manage, implement, and track pilot project program activities and future scientific studies/products that stem from projects supported through the pilot program
    • Ensure informatics coordination and data exchange to facilitate translational research, compatibility of research systems with broadly accepted content and technical standards including those adopted by the Department of Health and Human Services for health care and public health operations, and compatibility with NIH Institute and Center endorsed common data elements
    • Implement a data security plan at all participating institutions that ensures the security of research data on all studies involving human subjects
    • Maintain visibility of scientists and resources of CTSA Program institutions to facilitate collaboration
    • Implement a plan to create and maintain a broad culture of responsibility for safe and ethical conduct of research involving human subjects at all participating institutions, which ensures scientifically, and ethically flawed studies are not conducted, enrollment is tracked, and futile studies are closed in a timely manner, workflow for conduct of clinical and translational research is efficient, prompt analysis of results, and dissemination of those results
    • Implement tracking processes, metrics, and milestones including some metrics common to the hubs participating in the CTSA Program
    • Provide disease-agnostic support to translational and clinical researchers. That must facilitate the participation of local investigators in national networks and multi-site studies, particularly those supported by NIH
    • Establish career development opportunities that encourage new investigators to work in clinical and translational science
    • Implement the proposed educational programs in collaboration with other hubs of the CTSA Program, and innovative research training and career development programs activities and assessment of its effectiveness
    • Effective steps toward implementation of the agreed-on policies, procedures, best practices, or other measures established by NCATS
    • Implement a data sharing plan consistent with achieving the goals of sharing research data in a timely manner with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication.
    • Provision of information to the NIH Project Collaborator concerning progress
    • Support of CTSA Program activities to include ensuring active participation in the CTSA Program’s national collaborative activities and network capacity (e.g. CD2H, TIN, CLIC).
    •  Work with a CTSA Program-wide Common Metrics initiative to measure the impact of the CTSA Program.
    • Key personnel as appropriate, along with others, participate in annual meetings

    NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

    The NIH Project Collaborators (PC) will:

    • Assist in coordinating CTSA Program Consortium-wide activities
    • Assist in coordinating activities with other ongoing studies supported through CTSA Program hubs to avoid duplication, encourage collaboration and leveraging of resources, and enhance the development of innovative tools, methodologies, and processes
    • Review and comment on critical stages of implementation at the CTSA Program hub level
    • Facilitate interactions between investigators across CTSA Program hubs as well as with other non-CTSA institutions
    • Coordinate access to resources available through CTSA Program hubs including access to specialized technology cores
    • Facilitate access to fiscal and intellectual resources provided by NIH, industry, private foundations and federal funding agencies
    • Ensure that activities proposed for development or implementation do not overlap or duplicate activities supported by other NIH peer reviewed funding mechanisms
    • Assist in reviewing and commenting on all major transitional changes of an individual CTSA Program hub's activities prior to implementation to ensure consistency with the goals of the CTSA Program 
    • Review institutional resources provided to the project to assess whether they will contribute to its stabilization, sustenance and success, providing feedback to the grantee 
    • Assist the CTSA Program hubs in responding to emerging areas of high priority or national impact, for example public health emergencies
    • Coordinate activities for implementation of the CTSA Program Common Metrics initiative

    Additionally, the NCATS CTSA Program Project Collaborator acting as Program Official will be responsible for normal stewardship of the award and may recommend the termination or curtailment of an investigator or project/program (or an individual award) in the event the partnerships fail to evolve within the intent and purpose of this initiative.

    Areas of Joint Responsibility include:

    None; all responsibilities are divided between awardees and NIH staff as described above.

    Dispute Resolution:

    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

    A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

    We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application processes and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Mary E. Purucker, M.D., Ph.D.
    National Center for Advancing Translational Services (NCATS)
    Telephone: 301-435-0741
    Email: CTSAFOAQuestions@mail.nih.gov

    Peer Review Contact(s)

    Carol Lambert, Ph.D.
    National Center for Advancing Translational Sciences (NCATS)
    Telephone: 301-435-0814
    Email: Lambert@mail.nih.gov

    Financial/Grants Management Contact(s)

    Irene Haas
    National Center for Advancing Translational Sciences (NCATS)
    Telephone: 301-435-0836
    Email: CTSAFOAQuestions@mail.nih.gov

    Section VIII. Other Information

    Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.    

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