Research Overview PowerTrials and Related Research Processes

1. Research OverviewPowerTrials and Related Research Processes

2. Cerner PowerTrials… • Promotes patient safety by making protocol and subject information from OnCore available to IU Health clinicians in PowerChart • Notifies study contacts when subjects in active studies present to an IU Health facility for care. • Offers the opportunity to prescreen for eligible study subjects across the entire IU Health statewide system

3. OnCore to PowerTrials Process Flow

4. Overview of OnCore Process Flow

5. Overview of Process Flow

6. Preparation- CAT Team • Does your study need to be in PowerTrials? • Full or Deferred IRB Review • IU Health Study Site • Individual subject enrollment using an IU Health MRN • Add PowerTrials Creator role • Add PowerTrials Study Contact(s)

7. Open to Accrual Push • Coverage analysis team (CAT) uses the RPE push to manually create the protocol in PowerTrials • Research Coordinators enter a clinical research enrollment note in PowerChart for each study subject

8. Enrolling Subjects • Subjects automatically sent to PowerTrials when enrolled on study. • Message Center notifications begin at on study subject status and stop at off study subject status once the study is closed • Research Coordinator periodically review subjects automatically being sent to PowerTrials for any subjects that failed to successfully cross into PowerTrials (discrepant)

9. Closing Study- CAT • CAT uses the RPE push to manually close the protocol in PowerTrials at Closed to Accrual and IRB Study Closure

10. Summary of PowerTrials Related Coordinator Responsibilities • Document IRB approval in OnCore • Research Unit Sign-Off • Follow Minimum Requirements for subject entry in OnCore (especially order of statuses) • Enrollment clinical note in PowerChart • Monitor for discrepant subjects • Use the RPE to push any updates to the PowerTrials Study Contact role while the study is open

11. Enrollment Clinical Notes

12. Recruitment Policy • Physician Investigator recruiting his/her own patients • Clinical note electronically signed off by the PI • Physician Investigator recruiting patients from any IU Health affiliated facilities who may or may not be his/her own patients • Clinical note electronically signed off by the PI • Clinical note sent to treating physician for review • Patient Self-Referral • Clinical note sent to treating physician for review • Investigator is not a member of the IU Health work force and protocol has potential impact on patient's clinical care

13. Adding a Clinical Note • Select Add Clinical Note • Select “Research/Clinical Trial Records” Type • Create Note • Modify “Associated Providers” based on applicable scenario type from the recruitment policy • Sign

14. Enrollment Clinical Note

15. Research Opt-Out Processes

16. Steps to Opt-Out • Acknowledge option • Clinical Research Systems (CRS) team will follow-up • Send Secure e-mail to clinicalreseachsystems@iuhealth.org • Full name • MRN • DOB • Phone • CRS contacts patient and explains the proces

17. Results of Opt-Out • Exclusion from PowerTrials prescreening • Exclusion from all feasibility and recruitment data requests from the Enterprise Data Warehouse • All research coordinators are expected to check and verify that a patient has not opted out before approaching the patient about study participation

18. Clinical Research Band

19. Resources OnCore RPE-PowerTrials Support Cheryl Yacone BSN, RN Sr. Clinical Analyst, IS Research Team cyacone@iuhealth.org (317) 963-0545 PowerTrials Prescreening Rule Support Bryan Gordon-Smith BSN, AAS Sr. Clinical Analyst, IS Research Team bgordons@iuhealth.org (317) 962-9139 OnCore Support oncore@iupui.edu (317) 278-2600 Office of Clinical Research Website https://ocr.iu.edu/