Matrix and Coverage Analysis Requirements

Documents Required for Matrix (CTMM) & Coverage Analysis Review

• 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  the Clinical Trial Master Matrix or Coverage Analysis
• Documents should be submitted in electronic format via e-mail to the Compliance Senior Analyst (Grace Videtich) and the Clinical Trials Analyst (Katie Penas)

Research that Requires a Clinical Trials Master Matrix and Coverage Analysis

Any study that includes clinical care activities conducted at Nebraska Medicine/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
• Investigator initiated research, cooperative group research, or collaborative group research that may or may not have funding provided
• Commercially funded clinical research
• CCTR Pilot Grant Program

Research that DOES NOT Require a Clinical Trial Master Matrix and Coverage Analysis

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 Nebraska Medicine/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 Nebraska Medicine/UNMC/UNMC-Physicians clinics or facilities
• Observational studies
• Survey studies

Who to Contact

Clinical Trials Master Matrix (CTMM)
The Research Billing Sr. Associate (RBSA) will provide assistance in preparation and perform review of the matrix prior to submission for Coverage Analysis and IRB submission.  Faculty / Coordinators who have questions or would like assistance with matrix completion may contact the Research Billing Sr. Associate (RBSA) - Cassie Cruz-Montes.

Coverage Analysis (CA)
Clinical Trials Analyst (CTA) will prepare the required Coverage Analysis prior to submission to IRB.  Faculty/Coordinators who have questions regarding the requirements may contact the Clinical Research Center(CRC):

Coverage Analysis for Drugs & Biologicals
Clinical Trials Analyst  –  Katie Penas

Coverage Analysis for Medical Devices
Compliance Senior Analyst - Grace L. Videtich