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Sponsored Projects Administration

A Clinical Trial Agreement (CTA) is an agreement between UTHealth and an Industry sponsor (typically a pharmaceutical or device company) to conduct a clinical study in which the protocol is written and provided by the industry sponsor.   

*Note: If the agreement is regarding a protocol written by UTHealth Faculty, or written as a collaboration between a UTHealth Faculty member and an Industry Sponsor, a Sponsored Research Agreement is required. See Clinical Trials- PI Initiated for more information.

PROCESS

If an UTHealth physician/PI is approached by an industry sponsor to participate in a study, the PI and department administrator should perform a feasibility assessment to determine if it is financially and operationally feasible to participate in the clinical study.

If it has been determined that the PI/Department would like to participate, the PI or designee should submit the contract to negotiate the legal terms of the agreement. 

To expedite start up timelines, the study team should negotiate the study budget with sponsor and submit the protocol to the IRB at the same time SPA is negotiating the legal terms of the contract. NOTE: Agreements with active IRB submissions and active budget negotiations are prioritized.

Industry Sponsored Study Process Checklist [View PDF] 

DEPARTMENT TASKS/RESPONSIBILITIES

SPA TASKS/RESPONSIBILITIES