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Which Protocols Need to Be in OnCore?

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.

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Definitions:


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

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?

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 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.

  1. Studies/Trials that Require Orders in Epic – Any study that includes an order for a procedure, lab, medication, or item/service that must be generated in Epic. Including:

    1. Studies/trials that involve radiology scans with contrast/tracer or other related medications that are ordered from BJH/SLCH;

    2. Studies/trials that require a clinical result to be in Epic;

    3. Studies/trials that require a professional read/interpretation to be in Epic.

Need more help? Contact the OnCore Support Team: oncore@wustl.edu