Thinking about conducting a clinical trial? Submit a CTSU Intake Form early to initiate a CTSU partnership. The CTSU Intake Form jump starts consultative services and the pre-award process, as appropriate, including starting the contracting processes, proposal development, budget development, connections to additional resources, and much more.
The CTSU will work with the PI & Study Team to shepherd the trial through the Feasibility Review process. All new clinical trials in a CTSU must go through a Feasibility Review. The objectives of the review are:
- To define priorities for the use of the CTSU and institutional resources.
- To ensure scientific review for all trials conducted by Medical School faculty.
- To improve the overall quality of clinical trials at the Medical School.
- To achieve a high success rate of trial performance
- To deliver service excellence in support of all faculty, especially early-career investigators, in conducting clinical trials.
Approval from the Feasibility Review is required before (1) submitting an IRB application (eResearch Regulatory Management Application), (2) negotiating a budget, and (3) full negotiation of the contract, if applicable. Upon notification of approval from the Feasibility Review, all three activities will occur in parallel and will be actively managed by the CTSU, who will shepherd the project through the entire pre-award process.