Clinical Trials

If you are interested in conducting a clinical trial, please complete the OPeN Research Support Form. Click on “Submitting a Confidential Disclosure Agreement (CDA or NDA)” to submit the form, and we will contact you with more details.

Below is the current process for conducting clinical trials:

1. The sponsor sends the CDA/NDA to UT which is completed and signed by UT signatories. Once complete, the sponsor sends the protocol for the PI to review. The OPeN research team is also available to review protocol feasibility and to complete the Feasibility Questionnaire. If the PI wishes to move forward with the clinical trial, the PI should complete the following steps:

• Contact OPeN to coordinate the Pre-Selection Visit (PSV) and other initial activities with sponsor representatives.
• Submit the Local Neurosciences Leadership Notification Form to schedule a meeting to discuss the trial.
• Submit the Office of Sponsored Projects Sponsored Project Notification Form at least four weeks in advance of the sponsor deadline.

2. After our site is selected, OPeN will assist PIs in submitting to the IRB and the SAT. The OPeN team will also help with coordinating other needed regulatory items with UT (budget, medication management, etc.) and study conduct activities for the clinical trial.