Clinical Research Tools and Processes in EPIC for Healthcare Professionals

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Clinical research professionals can utilize EPIC tools and processes to streamline study management, patient association, and research data tracking. The system enables the creation of study-specific research records, patient associations, and detailed study descriptions. From building research studies to managing patient data and viewing study associations, EPIC offers a comprehensive platform for conducting effective clinical research in healthcare settings.

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EPIC Tools for Clinical Research Shara Power, RN, BSN, OCN Application Developer, EPIC Beacon Oncology UIHC Healthcare Information Systems

Request Your Study to be Built in EPIC To be able to associate patients to research studies in EPIC, you must first have a study specific research record created. Please submit your request via the I-CART system managed by ICTS https://i-cart.icts.uiowa.edu

Research Studies Activity: Associate Patients to Your Study Once a research record has been created, you can associate your patient You must be listed as part of the study team to complete this action (i.e. PI, Coordinator, Research Nurse etc) Patients can be associated via the Research Studies Activity. o Search for your study by IRB #

Research Studies Activity: Associate Patients to Your Study Complete Appropriate Fields 1. Coordinator 2. Status (required) 3. Active Start Date (required) 4. Comments

Research Studies Activity: View Study Associations Utilize the Research Studies Activity to view current study association details 1. View Study Description and Enrollment Comments 2. See past changes

Research Studies Activity: View Study Associations Utilize the Research Studies Activity to view past study association details o By default, the Research Studies Activity only displays Active associations. Utilize the Show boxes to see other associations.

Clinical Tools for Research: Epic Orders Definitions o Medication Order During Visit: Given during a visit at UIHC; will show on MAR for Nurses After Visit: Prescriptions; will show on medication list for Patient o Procedure Order UIHC Procedure Order: task completed at UIHC Research Procedure order: task completed at study specific location o Smart Set/Order Set Grouping of medication and procedure orders Can be created specifically for your study or can use the generic RSH: Research Standard Orders o Treatment Plan/Infusion Plan Grouping of medication and procedure orders Created specifically for your trial and can only be used in CRU visits

Clinical Tools for Research: Epic Orders Medication Orders Study supplied medications will have an investigational (INV) medication record created in EPIC Request is generated by Investigational Drug Services (IDS) Pharmacy and sent to the EPIC Pharmacy team for development Once the record is approved by IDS, the INV medication record is available to be used in EPIC as well as placed in Smart Sets and Infusion Plans

Clinical Tools for Research: Epic Orders Procedure Orders Research specific procedure orders should be utilized when UIHC services are NOT involved in obtaining results. Research specific procedure orders can only be found in Smart Set RSH: Research Standard Orders Current Orders in the System: Research Vital Signs Research Weight Research Body Measurement Research POC Pregnancy Research Bio-Nutrition-Dietary Research IV Placement Research Blood Draw Research Non-Blood Collection Research Sample Processing only Research Urine Collection Research EKG Research PFT

Clinical Tools for Research: Epic Orders Smart Sets/Order Sets Best for studies that do not have frequently re-occurring visits. Can be used for any visit at UIHC. Easily place multiple orders in the system in a Future status to be used when the patient checks into their research appointment Can customize current Smart Sets on the fly with Ad- hoc Orders Custom Smart Sets can be created for your study. Typically there is a 2-3 month turn around time. Submit an ESC request under Epic Assistance then Orders . Be detailed in exactly what you need in your Smart Set for quicker turnaround.

Clinical Tools for Research: Epic Orders Treatment Plans/Infusion Plans Best for studies that have sequential visits to the CRU for treatment that are time dependent. Allows you to set up an entire plan of therapy at one time. Can customize per patient need by adding and deleting orders. Must be custom created for each trial. Turnaround time is about 1 month. Submit an ESC request under Epic Assistance then Orders . Please specify Treatment Plan in request. Copy of the protocol will need to be sent to Shara Power (shara-power@uiowa.edu) Requires that a study team member communicate any order changes through an established workflow.

Clinical Tools for Research: Reporting Workbench Utilize Reporting Workbench reports customized to your study to find patient visits or monitor all enrolled patients For assistance in creating a Reporting Workbench report for patients enrolled in your clinical trial, please submit an ESC request under Epic Assistance then I Need A Report . RWB reports are not appropriate for extracting large amounts of de- identified clinical data on study patients from EPIC. Those requests still need to be routed through ICTS workflows.

Clinical Tools for Research: Event Notifications Develop study specific event notifications. For example, be notified by an InBasket message when a patient on your study is admitted to the ED. To develop event notifications for a trial you manage, please submit an ESC request under Epic Assistance then Other Clinical Systems Functionality . Please note this will require someone from the study team to be identify as a point of contact for development and maintenance.

Clinical Tools for Research: Recruitment Options Not every trial will qualify or benefit from EPIC recruitment development. Best Practice Advisories (BPA) o Your study must have approval for this type of recruitment from the IRB o Enrollment criteria must exists as discrete data fields in EPIC o Requires someone from the study team to be a point of contact for development and maintenance o Submit an ESC request under Epic Assistance then Other Clinical Systems Functionality . MyChart Questionnaires o Opportunities exist for MyChart to be utilized for patient entered questionnaires for data and potentially recruitment o Your study must have approval for this type of recruitment from the IRB o Enrollment criteria must exists as discrete data fields in EPIC o Requires someone from the study team to be a point of contact for development and maintenance o Submit an ESC request under Epic Assistance then Other Clinical Systems Functionality .