Click here for the memorandum.

All industry-funded clinical trial agreements will be assessed an up-front, non-negotiable Study Management Fee of $7,500 as noted in the UAB Standard Non-Negotiable Fee Schedule for Industry-Sponsored and/or Industry-Funded Clinical Trials. It is separate from any applicable Department-specific fees associated with conducting the trial. Beginning on January 1, 2024, UAB will revise its annual Study Maintenance Fee to $2,750 for ongoing trials and relevant Close-out Fee to $250 at the completion of the clinical trial. The annual fees will be due each year on the anniversary date of the study’s contract execution and is applicable until the study is in a status of Completed with the UAB OIRB. All relevant fees may be found on the Clinical Trials Administrative Office site located here:
https://www.uab.edu/medicine/ctao/images/External_Standard_Fee_Schedule_Signed.pdf

The Study Management Fee addresses costs associated with reviews and work conducted on industry-funded protocols by several areas involved in the activation process which includes the following:

• The Office of the IRB (OIRB) performs a pre-review of the protocol for UAB and WIRB requirements prior to submission and review by the commercial IRB. The OIRB also stores, maintains, and updates the file, as well as assists the reviewing IRB with local matters, through the life of the protocol at UAB. The UAB OIRB may agree to serve as a multi-site trial’s single IRB under certain circumstances. If applicable, the UAB IRB will conduct an expedited or full review. In the event that the UAB IRB agrees to serve as the Reviewing IRB, there is an additional initial review fee of $1,500 per site for external sites and a continuing review fee (required at least annually) of $1,000 per site.
  

  Please see the Single IRB webpage.

• The Office of the Conflict of Interest Review Board (OCIRB) must review the responsible personnel on the project and their associated financial interests to ensure any conflicts that may exist are managed appropriately. These reviews occur as needed throughout the life of the protocol at UAB.
• The Office of Clinical Billing Review (CBR) within the Clinical Trials Administrative Office is responsible for conducting a Medicare coverage analysis for all clinical trials with activities billed through the UAB Health System per UAB policy. This analysis provides an approved billing plan based on an objective determination of items/services that can and cannot be billed to third party payers using Medicare and local payer coverage rules along with clinical care billing guidelines. CBR also evaluates any subsequent protocol amendments that modify the items/services required by the study and modifies the approved billing plan as needed. The approved billing plan is used to facilitate an accurate and appropriate clinical trial billing process.
• OnCore Enterprise is the University’s clinical trial management system (CTMS) designed for clinical research operations and data management at both the participant and study level. OnCore serves as the system of record for all clinical research studies with clinical billable services as well as the source by which study and participant information flows to the health system’s electronic health record. It is managed and maintained by the UAB OnCore team. The team supports calendar building, reporting, education and training. For more information about OnCore, please visit the CCTS website: https://www.uab.edu/ccts/research-commons/oncore.
• PowerTrials integrates the clinical trial information into the workflow of the electronic health record to enhance both patient safety and appropriate billing practices for the University. PowerTrials ensures availability of Research Study Summaries at the point of care to enhance patient safety and the development of PowerPlans to provide the foundation for appropriate billing practices.

There are no UAB fees for clinical trials funded by federal, nonprofit, or UAB/internal sources. These above referenced fees are direct costs. Applicable indirect costs (IDC) will also be applied.

Additional information is available as Frequently Asked Questions.