The below chart provides guidance on what protocols are required to be entered into OnCore and the extent of these requirements.

Definitions:

1. Clinical Trials – Services/activities that impact or affect the clinical management or treatment of the participant. Includes research that involves:

Drugs, biologics, surgeries, procedures, tests, devices, interventions, treatments,
OR
Reports and results that could impact the present or planned clinical treatment or care of a participant

2. Studies/Trials with Billing Risk – Determined Clinical Research Billing Support Team through Q4.6 on myIRB application

2a.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?

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 2b.
- If no, this study does not have Billing Risk.

2b. Will any of the activities noted above EVER use clinic facilities or clinical equipment that is NOT located in a Research Designated Area (i.e CRU (Clinical Research Unit), CLCS (Core Laboratory for Clinical Studies)?

- If yes, this study has Billing Risk.
- If no, this study does not have Billing Risk.

OnCore Support Services

Which Protocols Need to Be in OnCore?

The below chart provides guidance on what protocols are required to be entered into OnCore and the extent of these requirements.

Definitions:

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