Contracts may be extended upon mutual agreement between the parties by the establishment of an amendment that specifies the new end date of the period of performance.

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

• Submit Word version of Contract to SPA by emailing it to CRF@uth.tmc.edu
• Submit current IRB approval letter to SPA, if applicable
• Route the final agreement for PI signature - submit to SPA

SPA TASKS/RESPONSIBILITIES

• Negotiate legal terms of the agreement with collaborator on behalf of the PI and the university.
• Obtain PI Read and Understood approval (either signature or electronic approval)
• Route the final agreement with PI signature, if applicable, for institutional signatory to sign
• SPA will send to Sponsor collaborator for full execution
• SPA will assure PI has a copy of fully executed agreement and will retain a copy for institutional record.
• Initiate process with Post Award Finance to extend the period of the financial account for the study.