The purpose of this Notice is to inform applicants of one of the topic areas for the June 21, 2022 due date of the NCATS CTSA Program funding opportunity announcement (FOA) PAR-22-122, Limited Competition: Clinical and Translational Science Awards (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Optional).
The primary objectives of the TICs are to demonstrate and disseminate innovative ways to increase the quality and efficiency of multi-site clinical research and to provide unique resources for the CTSA Program’s broad range of multi-site clinical studies. The TICs will provide an innovative infrastructure that at a minimum will consist of a consultation process for multi-site clinical studies conducted by CTSA investigators, resources to help CTSA investigators with the single IRB process and implementation of clinical trial agreements, and events that facilitate dissemination of tools and best practices for clinical trial operations throughout the CTSA network. The infrastructure provided by the TICs should be capable of providing resources to a broad range of clinical studies (e.g. diagnostic testing, interventional trials, trials conducted under FDA regulation (IND/IDE), comparative effectiveness, behavioral research) and accessible to clinical trials funded by federal and non-federal sources of support. The TIN consultation process should be able to support investigators at all career stages and levels of clinical trial experience and should be a resource that will enhance the overall quality and efficiency of clinical trials conducted within the CTSA program.
TICs are expected to serve as clinical and/or data coordinating centers for multi-site clinical studies and to have the capacity to participate in clinical trials that are part of a rapid response to urgent public health needs. TICs may incorporate the testing of new methods, processes, and/or tools into their service as a clinical and/or data coordinating center and thus, demonstrate on a large scale the utility of clinical trial operational innovations developed at one or more CTSA Program hubs. TICs are expected to continuously identify, refine, adapt and disseminate clinical trial operational innovations so that the overall quality and efficiency of multi-site clinical research within the CTSA network steadily increases.