Study is Evaluated for OnCore Requirements

Once a study is entered into OnCore, it is essential to enter and track subject accrual. Each subject must be registered in the system individually if your study meets any of the criteria listed below:

• requires IU Health patients to provide written informed consent
• requires Safety Flags in the electronic medical record (EMR)
• requires monitor access to patient data in Cerner requires Medicare Coverage Analysis
• requires the use of Research Billing Tools in OnCore
• are categorized as Interventional

If none of the above criteria apply to your study, you may submit a request for summary accrual. Summary Accrual refers to an OnCore function that reports the total number of participants enrolled in a clinical study using periodic updates. Requests to utilize summary accrual must be submitted to the Office of Clinical Research for approval. This can be accomplished by submitting an application for summary accrual once your study is available in OnCore.

Clinical studies that meet criteria for OnCore may also require connection to PowerTrials. PowerTrials is a module within Cerner PowerChart that integrates with OnCore by automatically transferring patient information from OnCore to the electronic health record (EHR). This integration allows clinicians to view a patient’s clinical trial participation status and access relevant research details within their medical record. Information about study participation is accessible through the banner bar of Cerner, contributing to patient safety across the system. PowerPlans are available to any study using PowerTrials; however, some studies may be required to use this feature depending on the protocol. Additionally, PowerTrials sends notifications to the Principal Investigator (PI) and Primary Study Contact whenever a patient presents to an IU Health facility, which streamlines the workflow for study teams.

In summary, OnCore functions as the central hub for managing clinical research, while PowerTrials displays that information within the patient’s EHR. If any of the following criteria are met, your study will need PowerTrials:

1. Full Board IRB review is required whether through IU IRB or reliance request. 
2. IU Health MRN is used for the subject identifier.
3. An IU Health study site is used. 
4. If the study requires EMR access for monitoring visits.
5. If the study has research-specific billable items.

If you are submitting your study for OnCore entry by the OCR, the Research Systems staff will determine whether the study requires PowerTrials, but you should indicate this on the Office of Clinical Research Protocol Submission Form as well. 

A primary Power Trials Primary Study Contact must be identified. This role serves as the main point of communication for your study and will be listed in OnCore. The PowerTrials Study Contact receives messages in Cerner PowerChart’s Message Center whenever an enrolled patient visits any IU Health facility. It is recommended to identify two PowerTrials Primary Study Contacts to cover vacations and holidays.

If the Powertrials Primary Study Contact changes, update this in OnCore and push the information to PowerTrials. Without the push, changes will not take effect.

There may be times where errors occur when enrolling a patient in OnCore and information is not pushed correctly to PowerTrials. For this, the RPE Console should be checked each time a patient is enrolled in OnCore. Any discrepant subjects should be addressed to avoid errors in communication or updates about a patient. If discrepant subjects are discovered in the RPS Console, please contact ISClinicalResearchSupport@iuhealth.org to have the issue resolved. 

You can visit the OnCore training resources on the OCR webpage for more information on how to do specific OnCore tasks such as this. 

All studies with RCS billing are tracked in OnCore to facilitate compliant clinical research billing. Information about this process is included on the IU Health Research Billing section of our OCR Website here. Including a video that will provide additional details on the process outlined below.  

• When the OCR Financial Compliance team or Cancer Center CTO delegates identify a study with billing through IU Health RCS, the coverage analysis billing grid is considered the source of truth for study billing.
• Participants must be added to OnCore with their IU Health MRN within 48 hours of consenting to a study.
• Participant information is securely reported by the OCR to IU Health RCS each day, and a global charge hold is established for these patients.
• When participants visit clinical spaces, they should be registered as usual, providing their insurance information.
• Charges for procedures completed in clinical spaces are entered by IU Health clinical staff as standard charges and are not marked as “research” charges.
• For patients with a research charge hold, all RCS charges are reviewed by the IU Health Clinical Trial and Research Charge team using a special research charge review tool.
• Study coordinators must track each patient encounter in OnCore within 48 hours to document the date of the visit and any additional procedures performed on different dates. 
• The charge review team reviews all research participant charges based on the visit tracking dates entered and billing designations set during the coverage analysis process. These charges are directed in one of three ways:
  • To the research account, invoiced to the IU Health RCS PO# in OnCore, when the billing grid indicates payment by the study.
  • To the patient with the required research codes and modifiers when designated as billable to the patient within the billing grid.
  • To the patient as unrelated to the research study.

For more information on this process, see the IU OCR Coverage Analysis & Research Billing Policy.