Clinical Trials Budget and Billing Operations

The Office of Research Services (ORS) offers human subject research financial compliance support within the Division of Clinical Trials Budget and Billing Operations (CTBB).

The CTBB, in conjunction with the Grants and Contracts Office (GCO), is the center for coordinating the financial aspect of your clinical research. As such, the CTBB provides the necessary tools for conducting innovative and safe clinical testing in compliance with required financial and regulatory guidelines and billing compliance.

Rules for federal and private payors govern the conditions under which clinical services, items, and tests associated with a research study can be billed to study subjects or their insurers. The complexity of these rules and established procedures requires that the CTBB reviews GCO submissions that involve the consenting of research subjects. The CTBB assures that all related documents for the study are consistent.

Does your Project Require CTBB Review?

Use this checklist to help determine whether your project requires a CTBB review.

The CTBB offers budget templates, standardized fee schedules and tools for identifying services to ease budget development, and billing verification. We also offer continuous training and updates on federal and industrial regulatory requirements in collaboration with other existing programs within MSMC.

The CTBB will evaluate the project budget to determine if reimbursement covers the costs of the study requirements and that the budget includes upfront costs such as administrative start up, pharmacy and PPHS fees, PI and CRC time and effort and/or oversight, and overhead.