Getting Your Research Study in Epic
Getting Your Research Study in Epic Heading link
Human subject research which utilize services or resources provided by the University of Illinois Hospital and Clinics, UIC College of Medicine office-based clinics, Mile Square Health Center, or Ryan White Infectious Disease Clinics (this includes both inpatient and outpatient services, including but not limited to ancillary services such as clinic visits, professional medical services, medical supplies, lab, pharmacy services, and imaging, whether for research purposes or standard of care) must adhere to the following procedures:
New Research Studies Heading link
As soon as you have received an UIC IRB protocol number after submitting your study to the UIC IRB, submit the Epic Study Build Request by clicking https://redcap.link/StudyBuildRequest.
For research studies involving study drugs, you will receive an Investigational Drug Build Request Form via email after submitting the Epic Study Build Request. You may find it helpful to work with the Study Sponsor by providing them direct access to the Investigational Drug Build Request form to assist with obtaining accurate information. You will be able to forward the Investigational Drug Build Request Form email (which includes the form URL link) directly to your Study Sponsor to assist with completion. A blank PDF file of the Investigational Drug Form will also be available for download once you access the form URL link.
Upon completion of the Epic Study Build Request, the Investigational Drug Build Request, if required, and after obtaining all necessary approvals to activate your study, the Clinical Research Finance Office (CRFO) will designate the research study as in Epic.
Research Study Change Requests in Epic Heading link
Submit the online Epic Study Change Request Form (or PDF version to the CRFO at firstname.lastname@example.org) for all changes in the Epic Research Administration Record which are only accessible for modification by the CRFO as follows:
- Fields requiring prior IRB approval before the CRFO will make the change include the following:
- Principal Investigator (PI) (requires IRB approval documentation)
- Sponsor (may impact funding agency) (requires IRB approval documentation)
- Protocol Status Change from Active (excluding interim protocol status changes, e.g. open to accrual, closed to accrual, follow-up, etc.) to Terminated (Final Report) (requires IRB acknowledgement documentation)
- Note: For OnCore Oncology fields which may override the CRFO fields noted as requiring IRB prior approval, those required IRB documents will be viewable by the CRFO in the OnCore system
- Change from Billing Active to Inactive: For studies who have completed all patient related billing activities (no patients on study, all associated charges are cleared) and are in the data analysis portion of the study (not Terminated/All patients off study), the CRFO will change the study from Billing Active to Inactive.
If you have any questions about getting your research study ready and active in Epic, please contact the CRFO at email@example.com.