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Sponsored Projects Administration

MASTER AGREEMENTSTUDY START-UP AGREEMENT/ SSUA
The University of Texas System and its member institutions have negotiated master agreements with many research sponsors. Master agreements streamline the contract negotiating process since contract terms have already been agreed upon by the sponsor and university. Study Start-Up Agreements (SSUA) are typically used when a clinical sponsor or clinical research organization (CRO) wants to assist the PI and his/her research team by providing startup funding while the clinical trial agreement is being negotiated by Sponsored Projects Administration. Study Start-Up Agreements provide funds to help the PI with costs associated with IRB submission and/or to pay for salary/fringe of study research staff.
Process When SPA receives a clinical agreement from an industry sponsor, SPA will determine whether a master agreement exists for that sponsor. If a master agreement does exist, SPA will ask the CRO or sponsor to use the master agreement. SPA will negotiate the legal terms and conditions of the agreement with the sponsor. If an UTHealth physician/PI is approached by an industry sponsor to participate in a study, the PI and department administrator should perform a feasibility assessment to determine if it is financially and operationally feasible to participate in the clinical study.

If it has been determined that the PI/Department would like to participate, the PI or designee should submit the study start-up contract to SPA to negotiate the legal terms of the agreement.

To expedite start up timelines, the study team should negotiate the study budget with sponsor and submit the protocol to the IRB at the same time SPA is negotiating the legal terms of the contract. Agreements with active IRB submissions and Budget negotiations are prioritized.
Department Task/Responsibilities
  • Submit protocol to IRB (if you are using clinical data with personal identifiers)
  • Complete the R&A form, RCOI form, draft budget proposal, - submit to SPA along with draft ICF and protocol - click here
  • Negotiate budget with sponsor
  • Include SPA Clinical Trial Administrator on the cc during the negotiations which will provide status updates (SPA is also required to have a copy of the final budget).
  • Complete Coverage Analysis documentation
  • Route the final agreement for PI signature - submit to SPA
  • Conduct a Feasibility assessment
  • Submit Study Start-Up Contract to SPA at CRF@uth.tmc.edu
  • Include a copy of:
  • Draft agreement
  • Protocol
  • Draft ICF
  • Draft budget proposal
  • Submit protocol to IRB
  • Negotiate budget with sponsor
  • Include SPA Clinical Trial Administrator on the cc during the negotiations which will provide status updates (SPA is also required to have a copy of the final budget)
  • Complete Coverage Analysis documentation – the Coverage Analysis does not need to be approved before the SSUA is fully executed.
  • 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 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 set up a financial account.
  • Negotiate legal terms of the agreement with sponsor on behalf of the PI and the university.
  • Build out the coverage analysis shell for the study team to enter in costs, effort, and coverage information. Coverage analysis approval is not needed in order to fully execute a SSUA.
  • Route the final agreement with PI signature for institutional signatory to sign.
  • Cannot submit for institutional signature until the below items are received:
  • Final Agreement with PI signature
  • Copy of Final start-up budget
  • Initiate process with post award to set up a financial account for the study