SPA Negotiates Terms

Summary

Once you establish a relationship with a sponsor for your clinical trial or patient treatment and have an agreement in place – you must submit the contract terms to Sponsored Programs Administration (SPA) for review and negotiations through eAgreements.

Please note:

SPA manages the negotiation of clinical research industry and clinical and nonclinical non-industry research agreements.
Department is not authorized to negotiate terms on behalf of the institution.
A UT Southwestern official, such as Human Research Protection Program (HRPP), Institutional Review Board (IRB) , or SPA, must sign the agreement indicating their consent to the contract terms. Otherwise the agreement is not valid.

Estimated Duration for Contract Reviews

The duration of contract reviews varies based on your sponsor, agreement, or contract type.

How to Submit Research Contracts

Request Draft Agreement

Obtain a draft agreement from your sponsor for the clinical trial.
Submit Contract

You have to submit your contract through the eAgreements system simultaneously while completing the IRB application and requests for Coverage Analysis.

What’s the Status of My Contract?

You can locate the status of your contract under the My Inbox tab in eAgreements.

eAgreements Contract Review Stages

The following details the stages your contract will route through during the review 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 the 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.

Terms and Definitions

Agreement: Describes the actions two or more entities have agreed to and defines the obligations each party has to the others.
Contract Research Organization (CRO): An organization contracted by the sponsor to perform research-related functions for a clinical trial.
Coverage Analysis: A systematic review that examines clinical trial protocols and determines what to bill to the study sponsor or the insurance company.
Institutional Review Board (IRB): Responsible for reviewing, prior to its initiation, research involving human participants, ensuring the rights, welfare, and privacy of human participants are protected.
Master Clinical Trial Agreements (MCTA): Legally binding contract between a sponsor, site, and researcher that describes each party's responsibilities and obligations for a clinical trial.
Treatment Use Agreement: Contract between a health care provider and a patient, specifying how treatment will be provided, specifically emergency/compassionate use of study drugs not available to patient(s).

View All Terms & Definitions

Expert Tips

Amendments
When is an amendment required?
An amendment is required when there is a change to the protocol or budget, change to the terms of the agreement, change to the Clinical Trial Agreement, or when a third party is associated with the study.

When is an amendment not required?
If there is a change in banking information and addresses for notices/payment address, we will not require an amendment.

When are other approvals required?
- If there is a protocol/PI change of the study, an IRB modification is required.
- If there is a budget change to the study, a potential Coverage Analysis is required.
- If there are changes to the study’s procedures, a Coverage Analysis modification is required.
- If your budget decreases or increases without a change to schedule of procedures, a Coverage Analysis modification may not be required.
Third-Party Change in Sponsor Amendment
If a contract has been assigned to a third party, IRB approval may be required. Please consult with the IRB office.

Treatment Use Agreement Amendments
If SPA does not receive enough notice or it is signed by the PI directly.
Budget Changes
How are budget changes managed?
- Departments are responsible for negotiating the actual budget number.
- SPA is responsible for negotiating the Institution’s fees and payment terms.
IRB Approvals

We only require IRB approval if a study is initiated by an investigator. For example, if the PI wrote the study protocols. If you believe your study’s protocols need IRB approval, please visit UTSW IRB.