Either approach to providing a detailed budget justification satisfies PAR-21-293 instructions. Any questions on the budget justification applicable to the FOA requirements will be reviewed and analyzed during pre-award negotiation. Applicants should provide enough detail in the budget justification such that any reviewer could reasonably determine whether the application is in compliance with the FOA budgetary limitations.

Relevant text from PAR-21-293: A single budget is required; include funds requested, as per notes below. Budget justifications must be broken out by Element and Module. Subaward budgets should follow the same format.

How do applicants verify their funding tier?

Applicants are strongly encouraged to verify their funding tier calculation with NCATS in advance of application submission through the Clinical and Translational Science Award (CTSA) FOA Questions mailbox (CTSAFOAQuestions@mail.nih.gov). Requests to verify the funding tier calculation should be submitted by the institution’s authorized organization representative. Once NCATS verification is received and recorded, the applicant should include a note in the R&R Budget Section of the application that NCATS has reviewed and accepted the funding calculation prior to submission. In some circumstances, the division of organizations as listed in the NIH RePORTER data table may split two organizations that maintain a legally/financially binding relationship outside the CTSA Program necessary for eligibility in the CTSA hub Program. A CTSA hub must maintain an integrated research and training environment for clinical and translational science. If you believe that your CTSA hub requires two organizations to be considered prime for the baseline eligibility requirements to be met, please complete the following process:

1. Send an official request for dual prime partnership consideration to the CTSA FOA Questions mailbox (CTSAFOAQuestions@mail.nih.gov). The request must be submitted via an authorized organization representative and include a substantial justification for consideration.
2. The justification must specifically detail the type of legal/financial relationship and provide background as to how this relationship exists without federal grant funding involvement.
3. NCATS will review each request as submitted. If dual prime organization is permitted, the applicant must include a copy of the NCATS acceptance in the grant application. Failure to include the NCATS acceptance in the grant application may render the application ineligible for funding consideration. (Note: Regardless of the decision, only one organization can serve as the applicant organization.)

For more information, visit the CTSA Program UM1 Budget Request Tables web page. 

Per Uniform Guidance Section 75.306, “Under federal research proposals, voluntary committed cost sharing is not expected. It cannot be used as a factor during the merit review of applications or proposals but may be considered if it is both in accordance with HHS award agency regulations and specified in the Notice of Award. Criteria for considering voluntary committed cost sharing and other program policy factors that may be used to determine who may receive a federal award must be explicitly described in the notice of funding opportunity.” There has been a rise in voluntary committed cost share proposed in applications submitted in response to the Clinical and Translational Science Award (CTSA) Hub program. NCATS has an obligation to ensure that voluntary committed cost share is not considered as a factor of merit review because cost share is neither expected nor required for this program. Therefore, NCATS has provided explicit guidance in the notice of funding opportunity as to how voluntary committed cost share will be considered. Applicants considering proposing voluntary committed cost share in a grant application should work directly with their Office of Sponsored Programs and/or Authorized Organization Representative to understand their institutional policies and procedures for voluntary committed cost share prior to submitting their applications.

Clarification: Note the following definitions:

• Direct Funding: Full and/or partial funding allocated directly to the project from the federal funds awarded.
• Voluntary Committed Cost Share: In accordance with Uniform Guidance 2 CFR 200.306, voluntary committed cost share is cost sharing pledged by the grantee institution on a voluntary basis that is quantified in either the proposal budget or narrative and becomes a binding requirement of the award.
• Voluntary Uncommitted Cost Share: Any effort or resource contributed to a sponsored award that was not included in either the proposal budget or narrative or committed to the sponsor prior to award.

Relevant text from PAR-21-293: This funding opportunity announcement (FOA) does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicants should describe the institutional environment and available resources in the resources section of the application. Any applicant identifying voluntary committed cost share in the budget sections of the application will be bound to the cost share commitment for the entire approved project period. Personnel effort requested without salary support will be considered voluntary committed cost share, and the applicant institution will be bound to the relevant salary, fringe, and associated facilities and administrative (i.e., indirect) costs for the entire approved project period. Voluntary committed cost share will not be accepted and will not be considered in the review score for the following categories: key personnel (PD/PIs, module and program leaders/co-leaders), the Resource and Services Module, the CTS Pilot Module, or the CTS Research Program Element. Voluntary committed cost share for other items identified after peer review will be considered; however, any alteration in cost share commitments for the specified categories prior to award will deem the application ineligible for award. Future award consideration would require submission of a revised application.

The term “monetary support” means “voluntary committed cost share” in the sentence “Access to and utilization of substantial and well-integrated resources; does not include monetary support, which is neither required nor recommended for applications submitted to this FOA.”

Relevant text from PAR-21-293: Note that cost sharing is not required.

Can applicants request an abbreviated funding period to get the grant award to start on a particular date?

NCATS grants management staff will take into consideration the requested start date, any prior grant cycle project period end dates and award timing when making approved budget period decisions. Refer to the FOA for application due dates and review and award cycles for earliest start date.

Relevant text from PAR-21-293: The scope of the proposed project should determine the project period. The maximum project period is seven years.

In accordance with the NIH Grants Policy Statement, NIH generally applies the additive alternative to all recipients unless otherwise specified in the Notice of Award. Regardless of the alternative applied, program income may be used only for allowable costs in accordance with the applicable cost principles and the terms and conditions of the award. The FOA does not discourage nor require program income to be earned. For more information, see Section 8.3.2 Program Income of the NIH Grants Policy Statement.

Can a collaborator or an affiliate’s budget be used to calculate the maximum direct cost budget?

No. For the purposes of PAR-21-293, NCATS will ONLY recognize the term “partner”, and NOT “collaborator” or “affiliate” (or any other term), to determine the maximum direct cost budget requests.

As per NOT-TR-22-032:

• Collaborator/Collaborating Institution(s): Have a significant role in one or more aspects of the CTSA UM1 hub and may be included in more than one CTSA UM1 hub application. For the purposes of this FOA, NIH funding to the collaborating institution is not included for determination of maximum direct cost budget requests.
• Partner/Partnering Institution(s): Must be effectively integrated into the proposed activities of the CTSA UM1 hub and are necessary for attaining its strategic goals and research priorities. A Partnering Institution may be included as a partner in only one CTSA UM1 hub application. For the purposes of this FOA, NIH funding to the partner/partnering institution is used for determination of maximum direct cost budget requests.

Reference: PAR-21-293:

Determination of Allowable Budget Request

The maximum direct cost amount (DC) that may be requested for the UM1 budget is based on the sum of two NIH funding components: A) 5-year average of the most current NIH DC funding of the applicant institution, plus B) 5-year average of the most current NIH DC of any partner(s).

Letters of Support:

All Partnering Institutions must provide a letter of support signed by the authorized organizational representative (AOR) stating its role as a Partnering Institution and affirming its unique relationship with the CTSA UM1 hub applicant institution; applications that do not contain Partnering Institution letter(s) of support are incomplete and will not be reviewed. Only Collaborating institutions with substantial involvement in the application should submit a letter of support.

For more information see: CTSA Program UM1 Budget Request Tables. This page provides a list of institutions that are partners of CTSA Program hubs.

May researchers who recently submitted an application to PAR-18-940 apply to the new opportunity (PAR-21-293)?

You may not submit an application to PAR-21-293 prior to receiving the summary statement for an application under review for PAR-18-940. Please see NOT-OD-18-197: NIH/AHRQ Application Submission/Resubmission Policy. Specifically:

• Any application overlapping other Public Health Service (PHS) applications that are funded, pending initial peer review (e.g., pending summary statement release) or pending appeal of an earlier review will not be accepted. This includes derivative or multiple applications that propose to develop a single product, process or service that, with non-substantive modifications, can be applied to a variety of purposes.
• Please see Addendum B within the notice about Overlapping Applications.

Can a partner be a collaborator with other hubs?

A partner may be a collaborator with another hub, and a collaborator may be a partner with another hub.

Relevant text from PAR-21-293: A Partnering Institution may be included as a partner in only one CTSA UM1 hub application. Note that Collaborating Institution(s) have a significant role in one or more aspects of the CTSA UM1 hub and may be included in more than one CTSA UM1 hub application.

Will current grantees (active grants funded under FOAs PAR-15-304, PAR-18-464 & PAR-18-940) be considered as new or renewal applications?

All applications will be considered as new.

The FOA PAR-18-940 directed applicants to describe their capacity to collect data to evaluate their impact on the CTSA Program mission and to include a plan and timeline for implementation of the CTSA Program Common Metrics, including the collection of common metrics data and submission of data to the CTSA Program Coordination Center. There is no mention of the Common Metrics Initiative in the new FOA (PAR-21-293). Will this reporting structure carry on in the next grant?

With the current CLIC grant ending in the summer of 2022, the support of the Common Metrics Initiative also will sunset.

New collaborative, metrics-related activities will be supported through PAR-21-203: Clinical and Translational Science Awards (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Not Allowed). Topic areas that would be supported with this opportunity for applications submitted by the June 21, 2021, receipt date were Health Informatics and Demonstrating Research Impact: Leveraging innovative approaches to assess, quantify, and communicate research impact for large networks (NOT-TR-21-025).

Please refer to the recent communication to CTSA Program Consortium members and to the September 22, 2021.

Applicants for the new FOA (PAR-21-293) are expected to have a strong Continuous Quality Improvement (CQI) program, which is an ongoing cycle of collecting data and using it to make decisions to gradually improve program processes. This is described in the Strategic Management Element/Module of the new UM1 FOA (PAR-21-293).

Relevant text from PAR-21-293: Strategic management also includes the ongoing planning, monitoring, analysis and assessment of all that is necessary for an organization to meet its goals and objectives; CTSA hubs are expected to undertake all of these activities. Monitoring is tracking the implementation of the adopted strategies through periodic data collection to provide early indicators of progress and areas for improvement. Analysis is conducted to determine the effectiveness of a specific program or model to understand why it may or may not be working with the goal of improvement. Each CTSA hub is expected to have a strong Continuous Quality Improvement (CQI) program, which is an ongoing cycle of collecting data and using it to make decisions to gradually improve program processes.

To provide hubs with the flexibility to choose the evaluation method, the FOA does not specify a certain type of evaluation method. Applicants should provide a clear justification for the use of the evaluation methods selected for their hub program and sufficient details for how it will be implemented and used to improve activities.

The current consortium-wide activities are supported through cooperative agreements that have different project end dates that can be found on the table of activities funded under the CTSA Program (under the Consortium Centers column). New collaborative activities will be supported through the funding opportunity PAR-21-203: Limited Competition: Clinical and Translational Science Awards (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Not Allowed). Thus, applicants should describe their commitment to interfacing with current and potentially new national collaborative activities.

Relevant text from PAR-21-293: Element B: Strategic Management: Hub Liaison Team. Each CTSA hub must appoint a Hub Liaison Team (HLT) to function as an interface between the hub and the national collaborative activities of the CTSA Program. Current national collaborative activities of the CTSA Program include development and application of innovative approaches to collection, analysis, use and sharing of various types of data; collaborative infrastructure to support scientific, training, governance, workgroup and other types of CTSA consortium activities; consideration of participation in clinical trials; identification and dissemination of innovations in clinical trials; and a collaborative informatics community.

CTSA Hub senior leadership and HLT may be completely separate or may overlap.

Relevant text from PAR-21-293: Element B: Strategic Management: Hub Liaison Team. Each CTSA hub must appoint a Hub Liaison Team (HLT) to function as an interface between the hub and the national collaborative activities of the CTSA Program. Current national collaborative activities of the CTSA Program include development and application of innovative approaches to collection, analysis, use and sharing of various types of data; collaborative infrastructure to support scientific, training, governance, workgroup and other types of CTSA consortium activities; consideration of participation in clinical trials; identification and dissemination of innovations in clinical trials; and a collaborative informatics community.

An individual may have more than one leader role, and co-leaders are allowed.

One of the CTSA Program Goals is to promote partnerships and collaborations to facilitate and accelerate translational research projects locally, regionally and nationally. Applicants are provided the flexibility within the UM1 mechanism and a single budget to balance the emphasis within the hub’s activities and are encouraged to leverage their strengths to drive innovation that would have impact on the hub’s stakeholders and communities. This allows the hubs to showcase their unique strengths and capabilities that are expected to strengthen the consortium as a whole and advance clinical and translational science. New collaborative activities will be supported through the funding opportunity PAR-21-203: Clinical and Translational Science Awards (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Not Allowed). Furthermore, applicants should plan to describe their Hub Liaison Team.

Relevant text from PAR-21-293 (Hub Liaison Team): Each CTSA hub must appoint a Hub Liaison Team (HLT) to function as an interface between the hub and the national collaborative activities of the CTSA Program. Current national collaborative activities of the CTSA Program include development and application of innovative approaches to collection, analysis, use and sharing of various types of data; collaborative infrastructure to support scientific, training, governance, workgroup and other types of CTSA consortium activities; consideration of participation in clinical trials; identification and dissemination of innovations in clinical trials; and a collaborative informatics community.

This sentence is provided in Element B: Strategic Management — Strategic Management Module; Element C: Training and Outreach — Workforce Development for Clinical Research Staff Professionals Module; and Element C: Training and Outreach — Community and Stakeholder Engagement Research Module. Applicants are provided the flexibility within the UM1 mechanism and a single budget to balance the emphasis within the hub’s activities and are encouraged to leverage their strengths to drive innovation that would have impact on the hub’s stakeholders and communities. This allows the hubs to showcase their unique strengths and capabilities that are expected to strengthen the consortium as a whole and advance clinical and translational science.

Previous FOAs (PAR-18-940, PAR-18-464 and PAR-15-304) specifically described support for identifying opportunities, establishing best practices for including an increased range of the study population, providing consultations, fostering collaborations, and effecting policy changes to enhance opportunities for integrating special populations (e.g., pediatrics, geriatrics, populations affected by health disparities, rare disease populations or other special populations). The current FOA uses the term underserved: For the purposes of this FOA, used in the context of health disparities related to population-based health, a population is defined by the Minority Health and Health Disparities Research and Education Act of 2000 (Public Law 106-525) as a health disparity or underserved population if there is a significant disparity in the overall rate of disease incidence, prevalence, morbidity, mortality or survival rates in the population as compared to the health status of the general population. These activities may be encompassed under Element C: Training and Outreach — Community and Stakeholder Engagement Research Module.

Team Science activities are supported under Element C: Training and Outreach.

Relevant text from PAR-21-293 (Element C: Training and Outreach): Team science should be emphasized, as CTS is a collaborative endeavor that requires approaches to solving problems that cut across disciplinary boundaries. Institutions and investigators should create a culture where members of CTS research teams and other clinical professionals are encouraged to engage in collaborations and professionally recognized (through academic promotion and tenure process) for these efforts.

Yes. See the following relevant text from the FOA:

Relevant text from PAR-21-293 (Element C: Training & Outreach): Personnel support for the required and optional companion training and education activities to ensure activities are conducted as an integrated endeavor may be included if costs are not duplicative. Applicant institutions should include a statement providing assurance that the activities and costs are not duplicative with the UM1 activities. Failure to provide an assurance statement may result in the removal of potential duplicative costs prior to award.

No. See the term “e.g.” in the following relevant text from the FOA:

Relevant text from PAR-21-293 (Element D: Clinical and Translational Science Resources and Pilots): This element provides support for clearly defined activities, services and resources that are instrumental to the completion of a project. While it is the expectation of NCATS that clinical research infrastructure and personnel will be supported by the academic health institutions where CTSA hubs are located, or from other sources, NCATS recognizes that in compelling cases, e.g., an emergent need in response to a public health emergency, there may be a need to provide limited, additional support for clinical research activities, including staff, central coordination of trials and patient-level evaluations.

This section should include only information about the establishment and management of the CTS Pilot Module and should not include any proposed pilots.

Relevant text from PAR-21-293 (Element D: Clinical and Translational Science Resources and Pilots — Clinical and Translational Science Pilot Module): Only the CTS Pilot Module should be described in the application; specific pilot projects must not be included in the UM1 application and will not be reviewed by the panel evaluating the UM1 application. Pilot projects will be solicited and awarded by the hub after the UM1 hub award has been received; progress on all pilot projects awarded with UM1 funds must be submitted annually with the grantee’s Research Performance Progress Report or by another method as directed by NCATS.

The applicant/application should describe:

• the overall administration of the module, membership and responsibilities of the management committee, and plans for data management and communications
• the various advisory committees, both internal and external, that will be consulted and the role they will play
• a plan for implementing the module, including guidelines for applicants; eligibility and characteristics of applicants; and processes and procedures for solicitation, scientific review, selection, award, communication, progress tracking and evaluation
• the process to ensure compliance with all federal regulations and NIH policies, including but not limited to human subject protections, genetic material, stem cells and animal studies because oversight of Resources and Services (R&S) Module activities are the responsibility of the institution

Yes.

Relevant text from PAR-21-293 (Element D: Clinical and Translational Science Resources and Pilots): The R&S Module provides core resources and services that address the many stages of CTS research, including planning, conduct, analyses, implementation and dissemination. The use of R&S to augment research activities supported by other funding sources (i.e., non-NCATS funding) does not require NCATS prior approval.

Please see the following references and relevant text from PAR-21-293 and examples.

References:

• The Emerging Field of Translational Science
• Publications:
  • Translating Translation (2018) Christopher P. Austin, Nature Review Drug Discovery, Vol. 17.
  • Opportunities and Challenges in Translational Science (2021) Christopher P. Austin, Clinical and Translational Science
  • Transforming Translational Science Fact Sheet
  • Biomedical Translation YouTube Video

Relevant text from PAR-21-293:

• Translation: Defined by NCATS as the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and communities from diagnostics, preventions and treatments to medical procedures and behavioral changes.
• Translational Research (TR): Defined by NCATS as the endeavor to traverse a particular step of the translational process for a particular target or disease.
• Translational Science (TS): The field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process.

The CTS Pilot Module must support both the management and oversight of the CTS Pilot Program and the pilot projects. Pilot projects must be focused on translational science (i.e., focused on understanding a scientific or operational principle underlying a step of the translational process with the goal of developing generalizable principles to accelerate translational research). Translational research projects (i.e., projects focused on crossing a particular step of the translational process for a particular target or disease) are not allowed. Projects are intended to (1) explore possible innovative new leads or new directions for established investigators, (2) stimulate investigators from other areas to lend their expertise in research in CTS, and (3) provide initial support to establish proof of concept.

Examples of activities that may be supported:

• development of new research methodology and/or new technologies/tools/resources that will advance CTS and thus increase the efficiency and effectiveness of translation
• early-stage development of new therapy/technology with generalizable application to an identified translational roadblock
• demonstration in a particular use case(s) that the new methodology or technology advances translational science by successfully making one or more steps of the translational process more effective or efficient
• dissemination of effective tools, methods, processes and training paradigms
• feasibility/proof of concept studies to support future CTS projects
• secondary analysis of existing data (e.g., projects using the National COVID Cohort Collaborative [N3C] Data Enclave)

For Element D: Clinical and Translational Science Resources and Pilots — Resources and Services (R&S) Module, the FOA states that there must be a formalized management plan that addresses solicitation, review, prioritization, funding level, tracking and evaluation. Is this directed at the services or suite of services that the hub chooses to provide? Does the application have to include the management and evaluation plan in addition to a justification for why those services were chosen?

Please refer to the review criteria:

• Significance: To what extent do the proposed resources, services and educational activities (exclusive of the required K12 activities and any activities in companion FOAs) address important needs or critical barriers for CTS researchers and research teams (including planning, conducting, analyzing and disseminating), and will they enable investigators to achieve their research goals?

Relevant text from PAR-21-293 (Element D: Clinical and Translational Science Resources and Pilots): The R&S Module must promote broad access and provide clear funding expectations. The structure, organization and specifics of the R&S Module are expected to vary among applicants. However, a formalized management plan is required that addresses policies for solicitation, review, prioritization, funding level with justification, progress tracking and evaluation. The particular resources and services selected must be well justified and offer significant value to investigators at participating and collaborating institutions.

Yes. Awardees will have access to the NCATS GitHub to share and host repositories for version control and collaboration.

Relevant text from PAR-21-293 (Resources Provided by NCATS): Specified support services will be provided through grants, contracts, and/or NCATS for certain CTSA consortium activities, e.g., use of a specified NCATS vendor for organization of workshops or provision of certain UM1-related data. Specific requirements for UM1 awardees are described in the Terms and Conditions of Award.

In support of the NCATS goal of promoting and facilitating the development and dissemination of interoperable assets, such as algorithms and software, the NCATS Information Resources Technology Branch (ITRB) may provide access to various public cloud services and high-performance computing services for the needs of the awardees. This enables the awardees to offer their systems, projects, and research in a secure environment with simplified implementation, deployment and operational reliability. Through these services, NCATS ITRB will enable the awardees to gain a self-service capability. NCATS ITRB may provide the following, pending consultation with the awardee and the NCATS program official:

• infrastructure as a Service (IaaS) on any of the major public cloud providers via NCATS’ Federated Authorization Service
• access to NCATS' Federated Authorization Software as a Service (SaaS) to any of the CTSA awardees systems and applications, various Common Cloud Engineering and Support Services

The suggested period of a project in Element E: Clinical and Translational Science Research Program is two to three years. The maximum length a project may be is seven years, the same length of the UM1 award.

Each CTS project may not be less than $125,000 per year in direct costs for a suggested period of 2–3 years.

Relevant text from PAR-21-293: Direct costs for the CTS Research Program must not exceed $500,000 per year in direct costs. Each CTS research project may not be less than $125,000 for a suggested period of 2–3 years.

Element E is limited to six pages for the description of the Clinical and Translational Science Research Program.

Relevant text from PAR-21-293 (Page Limitations — Element E. Clinical and Translational Science Research Project): one required, six pages.

Any Element may have co-leaders (2 leaders). It is not required that a project PI be the leader of the Clinical and Translational Science Research Program.

Relevant text from PAR-21-293: An individual may have more than one leader role, and co-leaders are allowed.

Yes. Each hub is required to request at least one discrete research project in the application with an associated and defined budget. Additional “sample” or “example” projects may be provided if at least one discrete research project is provided with an associated and defined budget.

Relevant text from PAR-21-293: The proposed project(s) within the Program should address a truly significant roadblock in CTS that if successful would have generalizable application.

Describe:

• The overall focus of the CTS Research Program.
• Specific aims, rationale and approach to the selection of the proposed CTS research project(s); and how the project(s) will provide generalizable innovations or insights that increase the overall efficiency or effectiveness of translation.
• A plan for dissemination of successful projects; include a proposed impact statement should the project ultimately be successful.

Review Criteria — Significance:

• To what extent do the Element E program and project(s) propose to address a truly significant roadblock in CTS that, if successful, would have generalizable application?

Review Criteria — Innovation:

• To what extent does the Element E project(s) utilize innovative approaches to accomplish the stated aims?

Multiple projects may be undertaken concurrently. Subsequent projects will require prior approval. Research projects that will be conducted using human subjects and/or vertebrate animals require prior approval by NCATS. See Post-Award Grant Actions: Prior Approval and Reporting of Research with Human Subjects and/or Vertebrate Animals.

Relevant text from PAR-21-293: Multiple projects may be undertaken concurrently. Each hub must request at least one project in this application. Subsequent projects will require prior approval if the project includes research with human subjects, vertebrate animals and/or foreign components.

There are no restrictions to collaborating with other hubs on Element E CTS Projects.

The page limit for Element E is 6 pages, regardless of how many projects are described.

The Clinical and Translational Science Track Record is a required attachment for the application. Applicants may use suggested Template Data Table formats described in CTSA Program Summary Data Guide (CPSDG) or similar table formats. All fields shown in the CPSDG must be provided. This information is used to demonstrate the clinical trial experience of the institutions involved in the UM1 application and likely to participate in clinical trials. Given the page limit, applicants are encouraged to prioritize trials with which the applicant institution was engaged and trials that show a breadth of expertise.

Resource that may be of use are listed on the website ClinicalTrials.gov and Glossary of Common Site Terms.

When is the six-month window for reporting?

The six-month window is up to and prior to the application. Applicants should indicate the timeframe they are reporting.

Do applicants need to include all reportable studies at the CTSA hub and partner institutions, or only those in which the CTSA was involved?

This information is used to demonstrate the clinical trial experience of the institutions involved in the UM1 application and likely to participate in clinical trials. Include NIH-funded single or multi-site clinical trials that showcase the breadth of clinical trials’ experience at the hub. Given the page limit, applicants are encouraged to prioritize trials with which the applicant institution was engaged and trials that show a breadth of expertise.

Column “Funding Source”: The table instructions are to include only NIH-funded trials. However, footnote #4 instructs applicants to enter "institutional, grant, contract, and/or non-profit." Does this mean that trials supported through other funding sources can be included?

Studies funded by other sources can also be included to show the breath of science/trials at the hub.

Column “Months from Actual Start/Completion Date”: What should be included in this column?

Period (in months) since the project started or was completed. From ClinicalTrials.gov (https://clinicaltrials.gov/ct2/home); Glossary of Common Site Terms: (https://clinicaltrials.gov/ct2/about-studies/glossary):

Study start date: The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.

Study completion date: The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.

Column “Actual Cumulative Enrollment”: For multisite trials, should the column “Actual Cumulative Enrolment” include only enrollment at the hub (and partner and collaborator sites) or all participating sites?

Yes, you may report enrollment at the hub (and partners and collaborators) and specify in the table which enrollment (hub or total) you are reporting on.

Column “Primary Endpoint Result Indication”: Is reporting the study primary endpoint(s) sufficient?

Report primary study endpoint which may be extracted from the study registration in Clinicaltrials.gov.

PMID or abstract: The table does not include columns for all items included in the instruction text below it (PMID, impact statement). Please clarify.

The suggested table format likely does not have sufficient room to include a column for an overall impact statement and reference to the PMID. Thus, applicants are encouraged to add this information below the table.

If text is added below the table, does it count toward the 5-page limit for this attachment?

The page limit for the Selected Clinical Trial Experience is 5 pages, inclusive of the overall impact statement for each clinical trial and study and reference to any PMID or abstract.

PMID or abstract: It seems unlikely that studies activated within the 6 months prior to submission of the CTSA application will result in publications during this timeframe. Is it permissible to include publication information for any preliminary studies related to the clinical trial?

Yes.

There are two places in the application where Resources and Facilities may be described:

1. Table in Other Attachments: The Resources and Facilities Table must be included to aid in the review of applications. This table will provide a listing of specific resources that are anticipated to be used during the performance period of the UM1 and is limited to five pages. Information provided in the required attachments should not be repeated in the narrative.
2. Facilities and Other Resources Attachment in the R.230 — Project/Performance Site Location(s) Form: Provide an explanation of resources available from each project/performance site on the “Facilities and Resources” attachment of the R.220–R&R Other Project Information Form. The “Facilities & Other Resources” attachment is required. It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Applicants are referred to the review criteria:

• To what degree do the applicant and any partner(s) and/or collaborator(s) have a strong record of CTS research with high-impact achievements in useful methods and procedures leading to improved diagnoses, treatments and strategies for disease prevention?

Relevant text from PAR-21-293: Institution, partners and collaborators’ accomplishments and progress in CTS research efforts and high-impact achievements that are generalizable to the advancement of CTS over the past five years; emphasize those that have advanced better methods and/or improved health.

PAR-21-293 accepts only applications that are part of a collaborative set of multiple applications. A set must contain one application to the UM1 FOA (PAR-21-293) and one application to K12 FOA PAR-21-336.

One UM1 hub application also may submit concurrently with the UM1, while the UM1 application is under review consideration, after the UM1 application is funded or while the UM1 is under consideration for funding:

• One application to PAR-21-336: Limited Competition: Mentored Research Career Development Program Award in Clinical and Translational Science Awards (CTSA) Program (K12 Clinical Trial Optional)
• One application to PAR-21-337: Limited Competition: Ruth L. Kirschstein National Research Service Award (NRSA) Predoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program (T32 Clinical Trial Not Allowed)
• One application to PAR-21-338: Limited Competition: Ruth L. Kirschstein National Research Service Award (NRSA) Postdoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program (T32 Clinical Trial Not Allowed)
• One application to PAR-21-339: Limited Competition: NCATS Clinical and Translational Science Award (CTSA) Program Research Education Grants Programs (R25 - Clinical Trial Not Allowed)
• Two applications to PAR-21-340: Limited Competition: High Impact Specialized Innovation Programs (SIPs) in Clinical and Translational Science for UM1 CTSA Hub Awards (RC2 Clinical Trials Not Allowed)

Note the following:

• The required K12 and any companion optional applications will be awarded only if the UM1 application is awarded.
• See: Notice of Change to Expansion of Eligibility of Optional Companion Applications for CTSA Program Funding Opportunities: PAR-21-293 (UM1), PAR-21-340 (RC2), PAR-21-339 (R25), PAR-21-338 (T32), and PAR-21-337 (T32) (NOT-TR-22-008)

Companion optional applications may be submitted in accordance with the applicable FOA application submission dates under the following scenarios:

• concurrently with the UM1
• while the UM1 application is under review consideration
• after the UM1 application is funded
• while the UM1 is under consideration for funding

While optional companion applications may be submitted concurrently with the UM1 application or at any time the submitted UM1 new or resubmission application remains active, optional companion applications will only be awarded if the UM1 is awarded.

• See: Notice of Change to Expansion of Eligibility of Optional Companion Applications for CTSA Program Funding Opportunities: PAR-21-293 (UM1), PAR-21-340 (RC2), PAR-21-339 (R25), PAR-21-338 (T32), and PAR-21-337 (T32) (NOT-TR-22-008)

UM1 applications should indicate that applications are planned in the future and should describe the intent or future plans to coordinate and integrate these activities with the UM1. The companion FOAs also include a Coordination and Interaction Plan that will provide the current plans.

Relevant text in the companion FOAs — PAR-21-336 (K12), PAR-21-337 (Predoctoral T32), PAR-21-338 (Postdoctoral T32) and PAR-21-339 (R25): Coordination and Interaction Plan (three-page maximum). The application must provide a specific plan describing the partnership between the UM1, the required K12 (PAR-21-336) and any optional components. The application must describe the overarching goals of each component and the coordination, integration, synergy and mutual reinforcement of resources between the components. Include a description of the roles of any shared partners and/or collaborators. Please name the file “Coordination_Interaction_Plan.pdf”. If this attachment is not included, the application will be considered incomplete and will not be reviewed.

Relevant text in the companion PAR-21-340 (RC2): One attachment of no more than two pages called “UM1 and RC2 Coordination and Integration Plan” must be uploaded under Other Attachments. If this attachment is not included, the application will be considered incomplete and will not be reviewed. The UM1 and RC2 Coordination and Integration Plan must provide a specific plan describing the collaboration and integration between the UM1 and the proposed RC2 Program. The application must describe the coordination, integration, synergy and mutual reinforcement of resources between the UM1 and the RC2.

Yes. The Clinical and Translational Science (CTS) Research Program includes CTS research projects that are distinct projects that the hub will propose as part of its UM1 and that will address a specific question or set of questions in clinical and translational science and how the project(s) will provide generalizable innovations or insights that increase the overall efficiency or effectiveness of translation. The SIPs are specialized resources/activities that will help support clinical and translational science projects/studies locally. A UM1 research project may need specialized support for a specific portion(s) of the project, and this specialized resource could come from the hub’s SIP. For example, a hub may have specialized activities/resources in the integration of mobile technologies for enrollment and follow-up of clinical research participants. Expertise and capabilities are deployed within the hub for different types of studies that are ongoing or in the process of being planned. The resource is then provided to the community of investigators at the hub to support their specific studies. The resource is widely available, and results of the utilization, projects and outcomes are tracked over time.

Relevant text from PAR-21-293 (Section IV. Application and Submission Information, 2. Content and Form of Application Submission, SF424 (R&R) Other Project Information, Other Attachments) — Coordination and Integration Plan (use filename Coordination and Integration Plan): The application must include a specific plan describing the partnership between the UM1, the required K12 and any optional components, such as the research education (R25), and/or pre- and postdoctoral training (T32) awards. The UM1 application must describe the overarching goals of each component and the coordination, integration, synergy and mutual reinforcement of resources between the components. Include a description of the roles of any shared partners and/or collaborators. Limited to three pages.

No. The Coordination and Integration Plans are not required to be identical for the UM1 and the K12.

Relevant text from PAR-21-293 (UM1): Coordination and Integration Plan (use filename “Coordination and Integration Plan”). The application must include a specific plan describing the partnership between the UM1, the required K12 and any optional components, such as the research education (R25), and/or pre- and post-doctoral training (T32) awards. The UM1 application must describe the overarching goals of each component and the coordination, integration, synergy and mutual reinforcement of resources between the components. Include a description of the roles of any shared partners and/or collaborators.

Relevant text from PAR-21-336 (K12): Coordination and Interaction Plan (three-page maximum). The application must provide a specific plan describing the partnership between the UM1, the required K12 and any optional components. The application must describe the overarching goals of each component and the coordination, integration, synergy and mutual reinforcement of resources between the components. Include a description of the roles of any shared partners and/or collaborators.

Yes.

Relevant text from PAR-21-293 (Element C: Training & Outreach): Personnel support for the required and optional companion training and education activities to ensure activities are conducted as an integrated endeavor may be included if costs are not duplicative. Applicant institutions should include a statement providing assurance that the activities and costs are not duplicative with the UM1 activities. Failure to provide an assurance statement may result in the removal of potential duplicative costs prior to award.

Yes. The K12 Physician Scientist Award Program required companion application may be resubmitted in accordance with the applicable FOA application submission dates under the following scenarios:

• Concurrently with the resubmitted UM1
• While the UM1 application is under review consideration
• After the UM1 application is funded
• While the UM1 is under consideration for funding

Note that the K12 Physician Scientist Award Program required UM1 companion application must be submitted in accordance with the UM1 and K12 FOAs application submission dates under the following scenario:

• Initial concurrent submission of both a UM1 application to PAR-21-293: Clinical and Translational Science Award and a K12 application to PAR-21-336

See: Notice of Change to Expansion of Eligibility of PAR-21-336 (K12) Required Companion Application for CTSA Program Funding Opportunity PAR-21-293 (UM1) (NOT-TR-22-022)

No. Only the primary UM1 hub institution is eligible to apply for a K12, T32, R25 or RC2.
Please note NIH requires that the prime award recipient perform a substantive role in