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Clinical Trial Agreements

Summary

A Clinical Trial Agreement is a contract between the University and a sponsor for funding and executing research at UT Southwestern.

Types of Agreements

All agreements start with your department and must route through your assigned contract specialist. 

  • Industry Agreements
    Funded by an industry sponsor 
  • Non-Industry Agreements
    Funded by the state, federal government, private organization, or foundation
  • Personal Agreements
    Funded by outside an entity with a direct relationship with an UTSW employee. These agreements are handled by the Conflict of Interest Office.

eAgreements Review Process

Your agreement will undergo internal review. The following details each stage of the assessment process.

  • Pre-submission: The agreement has been entered, but it hasn’t been submitted by the department.
  • Unassigned: The agreement has been submitted, but it hasn’t been assigned to a specialist.
  • Internal Review: Internal SPA team is working on reviewing the agreement terms.
  • External Review: The agreement is with external sponsor pending external review.
  • Clarification Requested: The agreement is with the department pending requested information.
  • Routing for Signatures: The agreement is routing for signatures both, internally and externally.
  • On Hold: The agreement is on hold.
  • Active/Approved: The agreement has been fully executed. 

How to Get Your Agreement Fully Executed  

Industry Agreements

  1. Confirm the Budget
    Confirm the budget and ensure your regulatory requirements are completed.

  2. Verify the Institutional Fees
    Work with your contract specialist to verify the institutional fees for the startup invoice.

  3. Obtain Budget Approval
    Ensure that your department contact initials the budget page of your agreement to confirm that the specified details are accurate.

  4. Confirm Agreement Submission
    Confirm submission of your agreement in eAgreements and PeopleSoft.

  5. Watch for ServiceNow Ticket
    Be on the lookout for a ServiceNow ticket informing you that your agreement is ready to set up.

Non-Industry Agreements

  1. Meet Sponsor Requirements
    Ensure that all sponsor requirements are met, including any necessary accompanying documents that are routed to the appropriate SPA personnel for required endorsements, signatures, and certifications.

  2. Confirm Personnel
    Confirm project personnel with SPA’s Award Setup Team.

  3. Review Department ID Number
    Review the PeopleSoft department ID number as specified in the proposal.

  4. Review Budget
    Review the proposed budget to ensure correct cost calculations, including current facilities and administration (F&A) rate.

  5. Ensure Submission
    Ensure submission in eGrants and eAgreements.

  6. Review Subrecipient Profile Questionnaire
    Review Subrecipient Profile Questionnaire (SPQ) or FDP Clearinghouse.

Personal Agreements

UTSW faculty and employees who engage in external activities and employment may be asked to enter into a binding consulting agreement (personal agreement) with the outside entity that describes the scope of work, compensation, and other information about the activity. All contracts must contain these three components:   

  • Uniform Terms and Conditions
  • Inclusion Paragraph that includes Uniform Terms and Conditions
  • Scope of Work (SOW) for the contract

Please visit the Contracts and Personal Agreements page for more information.

Expert Tips

Training Opportunities

Taleo Learn Training Modules

Ask for Guidance

Inquiries reviewed and assigned within 4 hours, Monday – Friday 8 a.m. – 5 p.m.

Open a ServiceNow TicketWhich SPA Team Can Help

Leadership

Julia Spesivtseva, , M.B.A., MHSM

Director, Clinical Research Services

julia.spesivtseva@utsouthwestern.edu

Cheryl Anderson, CRA

Director, Pre-Award Administration

cheryl.anderson@UTSouthwestern.edu

Jamie Maiden, M.B.A., CIP, CRCP

Assistant Director, Pre-Award Administration

jamie.maiden@utsouthwestern.edu

Contact Us

Tiffany Moneit

Lead Industry Contracts Specialist

tiffany.moneit@utsouthwestern.edu

Kenneth Chalk

Lead Non-Industry Contracts Specialist

kenneth.chalk@utsouthwestern.edu