Do I need to include the notice name?

For funding consideration, applicants must include “NOT-TR-23-026” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Are there plans to have the tool (s) and or resource(s) developed available publicly?

Yes. The Trial Innovation Network (TIN) maintains an electronic toolbox of clinical trial resources and disseminates best practices and methods for conducting clinical trials through collaboration webinars. Applicants to this NOSI must review the TIN electronic toolbox to ensure that proposals do not duplicate tools and resources currently offered by the TIN. If you want to learn more about the electronic toolbox, please visit this site: https://trialinnovationnetwork.org/recruitment-retention-toolkit/

Can I submit an application to this NOSI for funding consideration for a tool that is not yet validated or evaluated?

Yes. However, your proposal must meet the time restrictions for the UG3/UH3 funding mechanism. 

Do collaborators listed within the application become full members of the TIN as well?

Only the primary awarding institute(s) are the ones that become members of the TIN. 

Are awardees classified as a RIC or TIC within the TIN?

No. Awardees are classified under AR-TIN within TIN. Successful applicants, funded via this NOSI, will become members of the TIN, have members that are part of the TIN Network Executive Committee (NEC), and adhere to its governance model. 

Can you submit an application to build a tool or resource that has already been funded by NIH?

Applications should include tools and/or resources that are novel in its use of improving participant recruitment and must meet the time restrictions for the UG3/UH3 funding mechanism. Therefore, an applicant must not currently be funded through a different NIH source when applying for this NOSI.

How many awards will be awarded?

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

What type of AI is this NOSI looking to fund?

Applicants are encouraged to include in their proposals the use of AI-based algorithms, natural language processing, predictive analytics, and digital platforms that might develop tools or resources which may include, but are not limited to:

• methods to improve disease progression modeling to advance the use of participant based information that will inform safety and efficacy
• tools and resources that advance the digitalization of clinical trials activities
• innovative ways to incorporate clinical and demographic characteristics of intended populations in the absence of self-identification
• improving rural inclusion in centralized and decentralized clinical trials
• user-friendly dynamic model on the inclusion/exclusion criteria and its impact on participant recruitment in clinical trials. 

What level of ownership will the TIN/CTSA Program have over the tools and or resources developed through AR-TIN?

Applications responsive to this NOSI will be expected to work collaboratively with members of the CTSA Program and the TIN, while also engaging the broader CTSA community, to achieve individual and consortium goals and objectives. Recipients will retain custody of and have primary rights to the data, software, tools and resources developed under these awards, subject to Government rights of access consistent with current HHS, PHS and NIH policies.