Sponsored Projects Administration

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 TASKS/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.