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Required Workflows for Clinical Research in Epic

Published April 12, 2022

On April 23, 2022, hospital billing will transition from Soarian to Epic. The adherence to Epic required workflows for clinical research is of utmost importance for billing compliance. This change introduces patient-level timelines that will be applied by the Clinical Research Billing and Support team, and align with your OnCore billing calendar. You will now link encounters to a specific point on the patient-level timeline.

Enrollment Start
Below are requirements once a patient/subject has signed informed consent, or is placed on a study if there is a waiver of consent.

If your study is in OnCore, these same requirements apply in OnCore and will be interfaced in near-real-time in Epic. If your study is NOT in OnCore, you will make these changes directly in Epic.

  • Patient has an active Enrollment Status (e.g. On Study, Consented in screening, etc.)
  • Start Date is Date of Consent and was entered within 24-hours of signing consent.

Enrollment Changes
If your study is in OnCore, these same requirements apply in OnCore and will be interfaced in near-real-time in Epic. If your study is NOT in OnCore, you will make these changes directly in Epic):

  • Enrollment status was updated within 24-hours of change (e.g. from consented in screening to on study, or from on study to on treatment, or from on study to follow-up, etc.)
  • End date was entered – If status change is to an “inactive status” (e.g. off study, withdrawn, deceased) within 24-hours.

Study Related Encounters & Orders:

  • Encounters are linked to your study and point on your patient timeline (Encounters include: office visits, admissions, orders only, etc.)
  • Orders have both the research diagnosis and primary clinical diagnosis
  • Orders are linked to your study
  • Radiology orders include the billing modifier of “bill to insurance” or “write off to research” in the order.

Study is Closed with the IRB (HRPO):

  • All subjects have an appropriate “inactive enrollment status” and end date in Epic (e.g. off study, withdrawn, deceased).

For more information on linking to patient timelines, as well as an Epic research checklist for study teams, please visit the Epic Research Learning Home Dashboard. The information is located in the Wave 2 (BJH, SLCH, BJWCH) Research Tip Sheets Component.