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.

The Proposal Development (PD) module is used in conjunction with the Agreement (AGT) module to submit Clinical Trial Agreements to SPA for processing. Each Clinical Trial Agreement must have a Proposal record and an Agreement record in START. (These records are linked in START.)

• The Agreement module is used for: Submitting the Agreement itself to SPA for review and tracking the status of negotiations of legal terms.
• The Proposal module is used for: Submitting Project information to SPA for project and budget review and approval, regulatory approvals, and financial account set up.

*See "Contract/ Coverage Analysis/ Proposal Record Workflow Document" for a visual overview of the process under “Tools and Resources/” Forms and Templates” within the Clinical Research Finance section.

DEPARTMENT TASKS/RESPONSIBILITIES

1. Conduct a Feasibility assessment

2.Submit new START Agreement record to SPA. Submit the contract via START by creating a New Agreement record. (Select type “Clinical Trial Agreement”) See START guidance document “Clinical Trials-PD

• Complete Agreement Information Form
• Upload a copy of the draft agreement provided by sponsor
• Upload a copy of Protocol

 3. Submit protocol to IRB

• This initiates the coverage analysis build process in SPA.

 4. Submit a new Proposal Development (PD) Record to SPA for budget review and approval after the following have been completed:

• Billing Coverage analysis has been completed (SPA staff or START will send notification once completed CA is uploaded into START)
• Internal budget has been completed (see CAIB tool guidance document under tools and forms Clinical Research Finance)
• Budget negotiations with Sponsor have been completed by the PI/Study team.

 5. Upload required documents. The PD record must be completed accurately and data entered into all tabs. The following documents must be uploaded under the attachments tab:

• Copy of Final budget with sponsor
• Copy of the CAIB tool with completed internal budget information
• Copy of IRB approval(s)
• RCOI form signed for everyone listed as members of the study team on the R&A form

SPA TASKS/RESPONSIBILITIES

Negotiate legal terms of the agreement with sponsor on behalf of the PI and the University. Note To ensure SPA’s efforts are s in line with department priority, SPA prioritizes agreements in which the Proposal records have been submitted to SPA for budget review.

Ensure a billing coverage analysis is built and uploaded into START. SPA creates a separate Agreement (AGT) record in START for the coverage analysis (linked to the CTA AGT and CTA PD records if available). START will send notification to the Department once the CA AGT record has been completed.

Route the final agreement with PI signature for institutional signatory to sign via START.

Prior to routing for institutional signature SPA will confirm the below items have been completed and/or uploaded under the PD record:

• Coverage analysis AGT record status of “Approved”
• Final Agreement with PI signature
• PD record submitted to SPA (must be signed off by PI and DMO via START automated e sig routing)
• PD record completed accurately and completely
• Ensure all required documents have been uploaded under the PD record

Submit Proposal Record (PT) to Post Award Finance via START to set up a financial account for the study.

Post Award Finance team send out award set up notice via email.