Clinical Research Billing

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Clinical Research Billing - Preliminary Coverage and Billing Analysis

Documents Required for Clinical Trial Master Matrix (CTMM) and Coverage Analysis (CA) Reviews

  • Protocol
  • Informed Consent Form
  • Budget (Draft)
  • Clinical Trial Master Matrix workbook
  • Investigator’s Brochure

When and How to Submit Documents

  • Materials should be submitted prior to IRB submission
    • IRB will not issue approval without:
      • a reviewed copy of the Clinical Trial Master Matrix and
      • a completed Coverage Analysis report or
      • a completed CTMM/CA Determination Checklist stating that the study does not require CTMM or CA
    • Documents should be submitted in electronic format via e-mail to:
      • Clinical Research Financial Compliance Specialist (Grace Videtich) 
      • Clinical Trials Business Analyst (Katie Penas)

Clinical Research that Requires a  CTMM and CA

Any study that includes clinical care activities conducted at TNMC/UNMC/UNMC-Physicians clinics or facilities regardless of the funding source or lack of funding source. Examples may include but are not limited to:

  • Federal, state, foundation, external hospital, or university funding
  • Research that may or may not have funding provided
    • Investigator initiated 
    • Consortium  
    • Cooperative group
    • Collaborative group
  • Commercially funded clinical research
  • CRC Pilot Study Support Fund (formerly known as Research Support Fund)

Research that DOES NOT Require a CTMM and CA

Any study that does not include clinical care activities or has no potential to create a bill for technical fees and/or professional fees for TNMC/UNMC/ UNMC-Physicians clinics or facilities. Examples may include but are not limited to:

  • Retrospective studies that evaluate events that have already occurred including studies that rely exclusively on previously collected administrative records, medical data or other available data
  • Laboratory analysis studies utilizing residual human tissue samples or human tissue samples obtained from another entity (non-clinical bio-banked materials)
  • Studies conducted at sites other than TNMC/UNMC/UNMC-Physicians clinics or facilities
  • Observational studies
  • Survey studies