1. Research Overview PowerTrials and Related Research Processes
6/30/2019

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 sent to treating physician for review
Patient Self-Referral
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 to
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
6/30/2019

19. Resources OnCore RPE-PowerTrials Support Cheryl Yacone BSN, RN
Sr. Clinical Analyst, IS Research Team
(317)
PowerTrials Prescreening Rule Support
Bryan Gordon-Smith BSN, AAS
(317)
OnCore Support
(317)
Office of Clinical Research Website
6/30/2019