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, aSponsored Research Agreementis required. SeeClinical Trials- PI Initiatedfor 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.

如果已经确定,π/部门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

DEPARTMENT TASKS/RESPONSIBILITIES

• Conduct a Feasibility assessment
• Submit Contract to SPA atCRF@uth.tmc.edu. Include a copy of :
  • Draft agreement
  • Protocol
  • Draft ICF
  • Draft Budget Proposal
• Submit protocol to IRB
• Negotiate budget with sponsor
  • Include SPA Clinical Trial Administrator on the cc during the negotiations. Budget status will indicate departmental prioritization status
• Complete Coverage Analysis (CA) documentation:
  • Complete all tabs within UTHealth Coverage analysis (CA) excel form
  • PI signs “Billing Attestation” form (By signing PI confirms CA is accurate and assures oversight of research billing process for this study.)
  • PI completes and signs “Qualifying Trial Assessment” form
• Complete theR&Aform- submit to SPA
  • PI & Chair/DMO signature required
• Complete a conflict of interest formRCOIform for each member of the study team- submit signed form to SPA
• Route the final agreement for PI signature - submit to SPA

SPA TASKS/RESPONSIBILITIES

• Negotiate legal terms of the agreement with sponsor on behalf of the PI and the University.
• Build out the coverage analysis shell for the study team to enter in costs, effort, and coverage information.
• Route the final agreement with PI signature for institutional signatory to sign.
• Contract will not be submitted for institutional signature until the below items are received:
• Final Agreement with PI signature
• Copy of Final budget
• Copy of IRB approval
• Coverage analysis documentation received and approved by SPA-CRF team
• R&A form signed by PI and Chair/DMO
• RCOI form signed for everyone listed as members of the study team on the R&A form
• Initiate process with post award to set up a financial account for the study.
• Post Award Finance team send out award set up notice via email.