Study Management Fee

Study Management Fee

Office of Sponsored Programs Guidance Study Management Fee

Study Management Fee

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Effective February 15, 2019, all industry-initiated and sponsored clinical trial agreements will be assessed a non-negotiable Study Management Fee. The fee is $5,500 or $4,500 (see below*). It is separate from any applicable Department-specific fees associated with conducting the trial. Beginning in January 2020, UAB will also charge a Study Maintenance Fee of $1,000 annually for ongoing trials. The annual Study Maintenance Fee is due each year on the anniversary date of the study’s initial submission to the OIRB and is applicable until the study is in a status of Completed with the UAB OIRB.

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

  • The Office of the IRB (IRB) performs a pre-review of the protocol for institutional and WIRB requirements and stores, maintains, and updates the file through the life of the protocol at UAB. If applicable, the UAB IRB will conduct an expedited or full review.
  • 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 Clinical Billing Review (CBR) unit of the Clinical Trials Administrative Office is responsible for conducting a Medicare coverage analysis for all clinical trials 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. The 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, serves as the source by which study and participant information flows to the health system’s electronic health record, and 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 CTAO website. ( https://www.uab.edu/medicine/investigators/oncore-enterprise )
  • 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. Power Trials 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.

The breakdown for the Study Management Fee is as follows:

  • $4,500 covers all the costs above for “convened” reviews of industry-initiated and sponsored protocols by any outside IRB (such as WIRB) or “expedited review” by UAB IRB.
    • When WIRB or another outside IRB reviews a protocol, UAB charges a one-time fee of $4,500 for coordinating the initial review process and record keeping. Any fees charged by the outside IRB for their review is separate from the UAB fees described above.
    • For expedited review conducted by the UAB IRB for industry-sponsored protocols, the UAB Study Management Fee is $4,500.
  • $5,500 covers all the costs above for “convened” review by UAB IRB of industry-initiated and sponsored protocols.
    • UAB charges a fee of $5,500 for providing convened review of protocols that are sponsored by industry but will not be reviewed by an outside IRB.

There is no UAB Study Management Fee for review of protocols that are UAB investigator-initiated or for studies funded by federal or nonprofit agencies.

Additional information is available as Frequently Asked Questions.