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

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

OnCore to PowerTrials Process Flow

Overview of OnCore Process Flow

Overview of Process Flow

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)

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

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)

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

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

Enrollment Clinical Notes

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

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

Enrollment Clinical Note

Research Opt-Out Processes

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

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

Clinical Research Band 6/30/2019

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 bgordons@iuhealth.org (317) 962-9139 OnCore Support oncore@iupui.edu (317) 278-2600 Office of Clinical Research Website https://ocr.iu.edu/ 6/30/2019