The Liason to Trial Innovation Centers module has the following goals:
- Facilitate start-up and implementation of clinical studies by accelerating IRB and contracting processes
- Foster collaboration with other CTSA hubs and external entities in sharing of regulatory resources and processes
- Connect UTHSC investigators and potential external collaborators through marketing of studies and other research opportunities
The iRISE LTICs accelerates and streamlines initiation and implementation of multi-site clinical studies. A Project Manager coordinates site initiation of studies with external stakeholders. This Project Manager supports applications for IRB approval and assists in execution of trial-specific amendments to existing contracts and the master contract agreements that will be established with the national CTSA consortium. The Project Manager also works with local and external Investigators, local hospital systems and/or individual clinics to review research-related procedures and services. This includes review of billing procedures for research services versus billing for standard of care procedures prior to study implementation for billing compliance. A contracting specialist works closely with the Project Manager on contracts, as well as on negotiation and execution of confidentiality agreements, clinical trial agreements, indemnification, vendor agreements, and material transfer agreements.