Mandatory Entry of Research Studies into Epic
- Applies to: UF Human Subjects Research
- Effective date: 12/01/11
- Last Revised: 01/08/20
Any UF clinical research study that involves at least one of the following criteria must be uploaded into the Epic electronic medical record system:
- *Protocol-required Medicare Qualifying Routine Costs (M1 or M0 on billing plan)
- Protocol-required items/services that create a charge in Epic to be paid by study (S on billing plan)
- Using UF Health Investigational Drug Services (IDS)
- Using Epic myChart functionality
*Non-qualifying studies that have protocol-required billable conventional care (M on billing plan) and that do not meet any other upload criteria will NOT be uploaded to Epic. Note: A study that does not meet the above criteria may need to be uploaded into Epic after study start-up in the event of a study-related adverse event or injury.
Mandatory Entry of Research Participants into Epic
All study participants who will receive protocol-required items or services that generate a patient-based charge in Epic must be added to Epic and associated with the appropriate study in Epic through OnCore (or directly in Epic for legacy studies – see below).
Research Studies that are in OnCore AND Epic with Active Interfacing
For studies that are in OnCore and Epic with the OnCore-Epic interface activated, study and participant information must be maintained in OnCore, which then updates the associated records in Epic. Study teams are responsible for:
- Verifying the study record in OnCore.
- Maintaining accurate staff records in OnCore.
- Entering each new participant into OnCore as the participant is enrolled.
- Maintaining each participant’s enrollment status in OnCore.
- Associating all participant’s protocol-required Epic encounters and orders to the appropriate research study in Epic.
Research Studies that are in Epic AND OnCore without Interfacing (Legacy)
For legacy studies that are in Epic and OnCore where the OnCore-Epic interface has not been activated, study and participant information must be maintained in Epic and OnCore separately. Study teams are responsible for:
- Verifying the study record in OnCore and Epic.
- Maintaining accurate staff records in OnCore and Epic.
- Entering each new participant into OnCore and Epic as the participant is enrolled.
- Maintaining each participant’s OnCore and Epic data fields, including enrollment status, start and end dates, etc.
- Associating all participant’s protocol-required Epic encounters and orders to the appropriate research study in Epic.
Research Studies that are in Epic but NOT OnCore (Legacy)
For legacy studies that are in Epic but NOT in OnCore, study and participant information must be maintained in Epic. Study teams are responsible for:
- Verifying the study record in Epic.
- Maintaining accurate staff records in Epic.
- Entering each new participant into Epic as the participant is enrolled.
- Maintaining each participant’s Epic data fields, including enrollment status, start and end dates, etc.
- Associating all participant’s protocol-required Epic encounters and orders to the appropriate research study in Epic.