4.6. Will the study involve any of the following activity PROSPECTIVELY at WUSM or any BJC hospitals, even if subjects or their insurance will not be billed for the item or service, and regardless of the study funding source (including studies with departmental or no funding)?

Procedures, tests, examinations, hospitalizations, use of Pathology, Laboratory, Cardiology, or   Radiology services, use of clinic facilities or clinical equipment, or any patient care services,   including services conducted in the Clinical Research Unit; or Physician services or services   provided by non-physicians who are credentialed to bill (ARNPs, Physician Assistants, etc.)

If yes, answer question 4.6a.

If no, this study does not have Billing Risk.

4.6a. Will any of the prospective activities EVER use clinic facilities or clinical equipment OUTSIDE of a Designated Research Area? A Designated Research Area is one which does not schedule, order, or result/document via Epic. No insurance information is collected from subjects in a Designated Research Area. Labs ordered under a study specific de-identified BJC account can be considered as being sent to a Designated Research Area.

Examples of Designated Research Areas:

-CTRU (Clinical & Translational Research Unit)
-CLCS (Core Laboratory for Clinical Studies)
-ID-CRU (Infectious Disease-Clinical Research Unit)
-NCRU (Neuroclinical Research Unit)
-ADRC (Alzheimer's Disease Research Center)
-CCIR (Center for Clinical Imaging) Studies that request or require a professional radiology read be done and documented in Epic, this question must be answered "Yes“

If yes, this study has Billing Risk.

If no, this study does not have Billing Risk.