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Study Financials

Contract and Budget Support

Our groups serve as liaisons for investigators to interact between sponsors and institutions (including the University). Clinical research groups have access to a full-time contracts specialist who prepares and negotiates contracts with external agencies to institutional standards.  As such, our groups are able to facilitate both UT-based and hospital/health care system-based studies with a wide variety of contracting standards. For example, one of our groups works closely with a large local hospital system to prepare and assist in the execution of contracts, subcontracts, and confidentiality agreements between sponsors and the investigator’s institution. 

Assistance in budget preparation is provided as well through close interaction with the directors of the various clinical trial units, the investigator, and the sponsors through the budget/contracts specialist. The goal of contract and budget support is to ensure adequate payment for services provided to a sponsor, and to ensure that neither the investigator nor their institution stand to lose money by conducting clinical research. Within the UT Clinical Trials system, the contracts specialist represents the investigator first and the institution second, with the aim of facilitating and expediting all funded studies.

Subject Tracking and Invoicing

As clinical research studies have evolved in complexity, size, and volume, so have the complexities of clinical study management. Traditional methods of clinical research operations management can no longer adequately handle the diverse study management needs of today’s research environment if the clinical research is to continue to grow and thrive. As such, UTHSC’s research groups have implemented a full web-based system to manage clinical research to enhance management and conduct of clinical research studies at the level of the investigator and research team, while also supporting and enhancing institutional standards and study metrics assessment. One such example is MERGE e-Clinical Clinical Trials Management System (CTMS) which has been adopted by the UT Office of Clinical Research and includes the following components:

  1. Contacts database
  2. Study descriptors
  3. Budget and financial tracking
  4. Electronic document development and storage
  5. Document and event tracking
  6. Subject information, scheduling and enrollment tracking
  7. Reporting

Timely submission of invoices and reimbursement are also greatly aided within this CTMS, and are intrinsic to its value. Access to the CTMS and support for studies through it is provided to all interested investigators at UTHSC as part of the study overhead and support costs for conducting research.

May 26, 2022