Trial Innovation Unit (TIU)
The Trial Innovation Unit (TIU) is a new component of the CTSA grant to improve efficiency of multi-site trial implementation and provide opportunities for trial innovation.
Investigators may request a TIU consult during the grant planning (pre-funding) or grant implementation (funded) stages.
By integrating existing ICTR resources and personnel, the TIU supports:
• Single-site trials with potential for multi-center expansion
• Multi-center trials being prepared for Trial Innovation Network (TIN) submission
• TIN-assigned multicenter trials
• Investigators with underdeveloped protocols interested in TIN support
The TIU Process Flow
All requests for TIU evaluation must proceed through the ICTR’s Connection Request. We recommend you contact the ICTR research navigator, who can direct you to the services you need. The navigator will determine if it is appropriate to refer your study to the ICTR Studio, a multidisciplinary service center that provides in-depth consultations. ICTR Studio staff will determine if the proposal should undergo a comprehensive studio consultation or be referred for a TIU consult for multi-center trials.
If the study is recommended for a consult, the navigator will work with the project principal investigator (PI) to provide a comprehensive description of the study plan to the TIU Proposal Assessment Team (PAT). The PAT will decide whether to refer the PI to the ICTR for core services, refer the PI to the Division of Brain Injury Outcomes (BIOS) for study implementation assistance, or provide no further support.
TIU Associated Costs
The TIU consult is funded by the current CTSA grant from the National Center for Advancing Translational Sciences (NCATS). Services rendered by the ICTR cores and BIOS are supported by fees charged to the program grant.
Brain Injury Outcomes (BIOS)
The TIU is supported by the Division of Brain Injury Outcomes (BIOS), a JHU-based academic research organization with experience in developing and supporting commercial and non-commercial clinical trials. Led by Daniel Hanley, MD, BIOS has unique expertise in the coordination and management of trials across all areas of human subject research.
BIOS services are fee based and include the following:
- Grant writing assistance
- Protocol development and refinement
- sIRB (single IRB) coordination and reliance agreements (SMART IRB)
- Standard contracting coordination
- Cohort discovery and site selection assistance
- Budget planning and development
- DSMB charter and reporting template development
- Biostatistics planning and analysis
- Comprehensive risk assessment
- Recruitment and retention plan development
- Database design and management
- Accelerated project start-up
- Clinical project management
- Clinical site monitoring
- Brain imaging reading center
Commitment to Training and Mentorship
The TIU is committed to facilitating the development of investigative expertise. K-grant, T-grant, and other early career investigators are invited to participate in project evaluation, trial simulation, and planning activities. Biostatistical doctoral and postdoctoral candidates may participate in statistical analysis plan development and reporting.
ICTR Connection Request
Brain Injury Outcomes (BIOS)
Trial Innovation Unit Handout