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 to SPA, where it will be assigned to a 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 an outside entity who has a direct relationship with a UT Southwestern 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.
Withdrawn: The agreement is currently withdrawn, pending final items and must be resubmitted by the Department.
Active/Approved: The agreement has been fully executed.

How to Get Your Agreement Fully Executed

Industry Agreements

Confirm the Budget
Confirm the budget and ensure your regulatory requirements are completed.
Verify the Institutional Fees
Work with your contract specialist to verify the institutional fees for the startup invoice.
Obtain Budget Approval
SPA routes the agreement to the Department to initial the budget pages of your agreement to confirm that the specified details are accurate.
Confirm Agreement Activation
Confirm activation of your agreement in eAgreements and PeopleSoft.
Watch for ServiceNow Ticket
Be on the lookout for a ServiceNow ticket that informs the SPA Award Setup Team that your agreement is ready for award set up.

Non-Industry Agreements

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.
Confirm Personnel
Confirm project personnel with SPA’s Award Setup Team.
Review Department ID Number
Review the PeopleSoft department ID number as specified in the proposal.
Review Budget
Review the proposed budget to ensure correct cost calculations, including current facilities and administration (F&A) rate.
Ensure Submission
Ensure submission in eGrants and eAgreements.
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.

How to Submit Your Industry Clinical Research Agreement

You can submit your contract through the eAgreements system simultaneously as the IRB full or partial application is completed. However, you may submit a contract review request before submitting your IRB application.

For step-by-step assistance with submission of your agreement, by contract type, please reference the following guidance materials:

To begin the contract review process, submit the following required documents:

Sponsor agreement template draft
Coverage analysis draft submitted in Velos
Consent document draft (either in eAgreements or eIRB)
Protocol draft (either in eAgreements or eIRB)
Budget draft (final budget if Statement of Work (SOW) is being submitted)
IRB application draft

Expert Tips

How can I manage Clinical Trial Agreement (CTA) revisions?

SPA’s Industry and Non-Industry Agreements teams will review and approve all sponsor clinical trial agreement changes through eAgreements. All study-specific questions will be sent to the department for confirmation.
How do I submit a Clinical Trial Agreement (CTA)?

Reference the Clinical Trial Submission Guide for guidance on how to submit your agreement.
How long does it take to get my COA?

Once your agreement is fully negotiated, inclusive of your approved budget and department number, it will take up to two days for your agreement to transition to the Setup Team to begin the award setup process.
What type of agreement do I have and which office will it route through?

You can use the Contracts and Agreements Pathfinder (CAP) tool, where questions auto-populate depending on answers of your agreement type, to determine which office your agreement will route through. If you have additional questions, please submit a ServiceNow ticket.