How many awards does NCATS plan to fund?

NCATS plans to fund two to four awards in fiscal year (FY) 2023. Application budgets are limited to $3 million per year in direct cost and must reflect the actual needs of the proposed project.

Relevant text from PAR-22-122: The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. NCATS intends to fund 2-4 awards in FY 2023. The scope of the proposed project should determine the project period. The maximum project period is 5 years.

Please confirm that the total page limitations — as described in the SF424 application guide and the Table of Page Limits — must be followed exactly. For a U24 mechanism, the page limitation is prescribed as 12 pages for the Research Strategy plus the Specific Aims. What is the total page limit, including the Specific Aims for this application?

Confirmed: Applications may not exceed the prescribed page limitations. The Research Strategy section is limited to 12 pages plus one page for the Specific Aims.

Relevant text from PAR-22-122: All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

One of the additional Research Strategy elements required by the parent FOA (PAR-22-122) is a Needs Assessment. Should the Needs Assessment Research Strategy element describe a process for obtaining information on existing utilization and adoption of resources during the funding period of the grant?

No. The Needs Assessment is a required element of the PAR-22-122 application. A Needs Assessment of existing utilization and adoption of relevant resources across the CTSA consortium must be completed prior to the submission of the application and included in the Research Strategy section of the application. Additional detail on the Needs Assessment element is provided in NOT-TR-22-020 and NOT-TR-22-021. The Needs Assessment Research Strategy element is NOT intended to describe a process for a Needs Assessment once the grant application is funded.

The Needs Assessment of a PAR-22-122 application should include an analysis of the current state of clinical trial resources across the CTSA consortium as determined from publicly available information and/or preliminary research, as well as a description of the impact of the clinical trial resources that will be demonstrated and disseminated if the resource center is selected for funding.

Relevant text from NOT-TR-22-020: Provide a needs assessment that includes a review of the landscape and gaps of existing resources (including research capabilities) across the CTSA consortium. This must include an analysis of the existing utilization and adoption. Provide a rationale why the resource has the likelihood to be impactful for the CTSA consortium. Provide a description of how, once demonstrated and disseminated, the resource and/or capability has a high likelihood of having a sustained impact on translational science.

Relevant text from NOT-TR-22-021: Provide a needs assessment that includes a review of CTSA participation in large, multisite clinical studies, resources that are required for or facilitate CTSA participation in large, multisite clinical trials, operational inefficiencies that delay trial start-up and/or recruitment, and clinical trial management and operational processes that are not currently harmonized across the CTSA consortium. Provide a rationale for why continued dissemination of Trial Innovation Network resources has the likelihood to be impactful for the CTSA consortium. Provide a description of how new resources and/or operational innovations, once demonstrated and disseminated, will be likely to have sustained impact on the implementation of multisite clinical studies within the CTSA consortium.

The PAR-22-122 application will describe processes that involve human subjects research. However, the details of the human subjects research will not be known at the time of application and will depend on future proposals submitted for Trial Innovation Network (TIN) consultation. Do future studies that receive TIN resources meet the NIH definition of delayed onset study?

Future proposals that may receive TIN resources through the TIN consultation process can be considered Delayed Onset Studies. In the PAR-22-122 application, a single Delayed Onset Study Record as described in G.500 - PHS Human Subjects and Clinical Trials Information can be used to indicate all potential future proposals that may receive TIN resources through the TIN consultation process.

Is the information on Additional Research Strategy Elements Required for the Parent Funding Opportunity Announcement (PAR-22-122) in NOT-TR-22-020 and NOT-TR-22-021 intended to replace the additional Research Strategy instructions detailed in PAR-22-122?

No. Applicants are expected to follow all instructions in the Notices of Special Interest and in the Parent Funding Opportunity Announcement. The Parent Funding Opportunity Announcement (PAR-22-122 ) provides information on application submission and review. The Notices of Special Interest (NOT-TR-22-020 and NOT-TR-22-021) provide detailed scientific information on the resources that the CTSA Consortium-Wide Centers are expected to demonstrate and disseminate.

Relevant text from PAR-22-122: Applications that do not include the required Dissemination, Evaluation, Management, and/or Sustainability Plans, or do not include a plan to appoint External Scientific Consultants will be considered incomplete and will not be reviewed.

Should Letters of Support from all External Scientific Consultants be included in the PAR-22-122 application?

The PAR-22-122 application must contain letters of support from all External Scientific Consultants that have accepted invitations to serve in that capacity for the proposed CTSA Consortium-Wide Center. However, note that a PAR-22-122 application only needs to contain plans to appoint External Scientific Consultants to be considered complete and acceptable for review.

Relevant text from PAR-22-122: External Scientific Consultants: Applicants must provide a plan for the appointment of External Scientific Consultants to provide advice and comments to the resource center about the activities outlined in this FOA, including progress made towards the overall goals of the FOA, and any changes in scope or governance that might help make the resource center more effective and useful. The composition, roles, responsibilities, and desired expertise of the consultants, frequency of meetings, and other relevant information should be included. Describe how the External Scientific Consultants will evaluate the overall effectiveness of the activities, including the stated expected impact of its activities. Proposed External Scientific Consultants should be named in the application if they have been invited to participate at the time the application is submitted and agreed to participate as an External Scientific Consultant.

NOTE: Applications that do not include the required Dissemination, Evaluation, Management, and/or Sustainability Plans, or do not include a plan to appoint External Scientific Consultants will be considered incomplete and will not be reviewed.

Letters of Support:

Letters of support from External Scientific Consultants should be included in the application if the consultant has accepted the invitation to be an External Scientific Consultant.