Coverage analysis is the process of evaluating each clinical research study to:
VCU requires a Coverage Analysis Screening Form for each clinical research study to document whether a coverage analysis is required for a particular study. If a coverage analysis is not required, the screening form is retained with other essential documents. If a coverage analysis is required (the study involves billable services), then:
Contact your school or center research administration office for the support of an institutionally designated VCU coverage analysis specialist. The timing for beginning the coverage analysis process may depend on your study sponsorship type. Typically, corporate-sponsored research requires a coverage analysis as part of the budget development process, while competitive submissions may only require a screening form or draft qualification form at the time of a proposal submission. In this case, a final coverage analysis is required at the time of award.
Both the School of Medicine Research Administration Office and Massey Cancer Center Clinical Trials Office offer full-service coverage analysis services through an institutionally designated coverage analysis specialists. Additionally, the School of Medicine provides requisite coverage analysis services to schools/centers (fee-based).
You will need a VCU eID and password to access the following forms.
Coverage Analysis Form 1 – Screening
Coverage Analysis Form 2A – Non-Devices
Coverage Analysis Form 2B – Devices
Coverage Analysis Form 3 – (discontinued)
Coverage Analysis Form 4 – (discontinued)
Coverage Analysis Form 5 – Amendment
Lisa Richman Ballance, M.A., CPW, CCP
Executive director for clinical research and compliance
F. Gerard Moeller, M.D.
Associate vice president for clinical research
Clinical research communications specialist
FDA program manager