Clinical Trial Coverage Analysis, Billing & Budget

Last revised: 
08/01/2016

What is a Coverage Analysis?

Leading institutions use a formal Coverage Analysis process to ensure compliant clinical research billing (CRB).  A Coverage Analysis identifies all clinical items or services associated with a particular clinical trial, including identification of the financially accountable party, such as the trial sponsor, other funding source, patient, or a third party payor.  The outcome of the Coverage Analysis process is sometimes called the “Billing Grid”.  

OnCore and Coverage Analyses

OnCore (Online Collaborative Research Environment) is the current system of record for Coverage Analyses performed on trials conducted at UCSF. OnCore provides a secure, standardized, and reportable database, and permits efficient sharing of protocol information between the Study Team and the Coverage Analyst.  For clinical trial services performed at UCSF Medical Center, OnCore also retains information that will be used for the “APeX study build.”

Effective July 1, 2014, the Office of Research requires ALL clinical trials and human subject research protocols in which there are medical procedures to have a Coverage Analysis completed in OnCore by one of the 3 approved Coverage Analysis (CA) offices. This directive includes both new and legacy studies. Also new since the July 1, 2014 date is that the study team will be required to initiate the OnCore record by entering their new study data and uploading required documents directly into OnCore.

Once the initial billing grid recording the service provider and location for each protocol service is completed for your new study, the Clinical Research Services group can provide costing estimates.

Who to Contact for Submission Questions:

Who Will Create My Budget?

  • Non-industry Sponsored Clinical Trial budgets are facilitated by Research Management Services (RMS). See the RMS staff assignments.
  • Industry Sponsored Clinical Trial budgets are facilitated by the The Industry Contracts Division (ICD).
  • Cancer Center: The Cancer Center Investigational Trial Resource (ITRdevelops industry sponsored, clinical oncology trial budgets for the same groups listed earlier under the CA section. If ITR does the industry sponsored CA, it also develops the budget. Contracting still goes through the Contract Officers in the ITA.
  • Division of Cardiology: Carol Maguire, Administrative Director of Clinical Research: carol.maguire@ucsf.edu
Contact the MSO/Division Administrator for your department if you are uncertain about who provides pre-award services.
 
 

Additional Tools

  • What to Consider in a Budget
  • Lab Pricing: Go to IRIS-> then go to My assistant (on the left)-> then go to operational procedures and then click on the charge master. This document lists all the research prices for all services at UCSF.