A clinical trial budget amendment is a formal agreement between UTHealth and a sponsor (typically an industry sponsor) that modifies an existing fully signed clinical trial agreement between UTHealth and the sponsor. The amendment modifies the budget and/or payment section of the clinical trial agreement.

PROCESS

If a Principal Investigator needs to modify the budget and/or payment schedule to an existing clinical trial agreement, his/her research team should communicate directly with the sponsor or CRO and request a formal amendment to be emailed to Sponsored Projects Administration for review/signature.

DEPARTMENT TASK/RESPONSIBILITIES

• Communicate with the sponsor/CRO about the need for a formal amendment.
• Negotiate the revised budget with the sponsor.
• Request that sponsor email a word document of the amendment to [email protected]
• Contact Clinical Research Finance team to determine if an updated Coverage Analysis is required.
• Provide updated research assurances to the specialist in Sponsored Projects who is reviewing the contract amendment.

SPA TASKS/RESPONSIBILITIES

• Negotiate legal terms of the amendment with the sponsor on behalf of the PI and the university.
• Route the final amendment for institutional signature.
• SPA will ensure that the sponsor has a copy of the fully signed amendment.
• SPA will provide the PI and his/her department a copy of the fully executed amendment.
• SPA will send the fully signed amendment to PAF team so that they can update the financial system.