The purpose of this Notice is to inform potential applicants of the changes in Element D: Clinical and Translational Science Resources and Pilots, Module D2: Clinical and Translational (CTS) Pilot in PAR-21-293 Clinical and Translational Science Award (UM1 Clinical Trial Optional).
Section IV. Application and Submission Information
Currently Reads:
2. Content and Form of Application Submission
R&R Budget
Element D: Clinical and Translational Science Resources and Pilots
Notes:
- Include salary support for each Module Leader/Co-Leader
- Clinical and Translational Science Pilot Module
- Include costs for the review, tracking, management, and overall administration of the Module as well as the Pilot projects:
- Number of Pilot Projects: A minimum of four and a maximum of eight Pilot projects, per year.
- Budgets: Must be between $25,000 and $50,000, direct costs.
- Project Period: Cannot exceed 12 months.
- Cost sharing is not allowed. Pilot projects must be fully supported with NIH funds awarded through this funding announcement (no other funding sources may be used to support these projects). The review process, resources, and expertise developed through this Module may be utilized for the review of other projects not funded through this application; however, NIH assumes no responsibility for those projects and should not receive any reports related to those projects.
- 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.
- 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.
Revised to Read:
2. Content and Form of Application Submission
R&R Budget
Element D: Clinical and Translational Science Resources and Pilots
Notes:
- Include salary support for each Module Leader/Co-Leader
- Clinical and Translational Science Pilot Module
- Include costs for the review, tracking, management, and overall administration of the Module as well as the Pilot projects:
- Number of Pilot Projects: A minimum of four and a maximum of eight active Pilot projects, per budget period.
- Budgets: Must be between $25,000 and $50,000, direct costs.
- Project Period: Cannot exceed 12 months.
- Recipient must ensure that the active number of pilot projects does not exceed the maximum number of pilot projects proposed to be supported per budget year in the competing application.
- Cost sharing is not allowed. Pilot projects must be fully supported with NIH funds awarded through this funding announcement (no other funding sources may be used to support these projects). The review process, resources, and expertise developed through this Module may be utilized for the review of other projects not funded through this application; however, NIH assumes no responsibility for those projects and should not receive any reports related to those projects.
- 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.
- 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.
All other aspects of the Notice of Funding Opportunity remain unchanged.