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Study Receives All Sign-off Approvals in OnCore

Sign-off approval in OnCore involves multiple individuals or offices confirming their review and agreement on protocol details before a study begins enrolling patients. This includes protocol details, visit schedule, billing designations, and financials as applicable. Team members who may need to sign off include the study coordinator, central administrator, regulatory personnel, and those creating the OnCore calendar and coverage analysis. 

The Office of Clinical Research provides the following Protocol Status Workflow documents to assist study teams in navigating the OnCore sign-off process. 

If you have questions about the OnCore Status Signoff process, please contact the OCR Research Systems team at oncore@iu.edu. 

Pre-Open to Accrual Status Information

New: This is the status automatically assigned when a protocol is initially entered into OnCore. 

SRC Approval: Applicable for all studies in the Cancer-center library. Status automatically populates when the review decision is processed by the SRC Coordinator after scientific review.

IRB Initial Approval: The study status will remain in ‘New’ status until the IRB Reviews tab within the PC Console is correctly completed, at which point it will change to ‘IRB Initial Approval.’ This includes IU IRB reviews not transferred from Kuali Protocols and External Reliance reviews which must be manually entered. For guidance on documenting your IRB approvals, see the Quick Reference Guides from the OCR Research Systems team.

OCR Signoff/Account Signoff: For studies that receive a Coverage Analysis and Billing Review by the OCR Financial Compliance team, the OCR Signoff or Account Signoff will be completed when the study is in IRB Initial Approval Status, and the coverage analysis final review has been completed. For more information about the Coverage Analysis and Billing Review process visit the OCR Financial Compliance coverage analysis website. 

Research Unit Signoff: Once a study has received OCR Signoff or Account Signoff, a Research Unit Signoff reminder is emailed to the study site contact, budget contact and central admin.

The Research Unit Signoff should be completed once all reviews are final, sponsor authorization is obtained, and the study team is prepared to see patients. Additionally, the OnCore calendar, coverage analysis, and financials should be finalized where applicable, with summary accrual requested if necessary. The signoff process also signifies that the Principal Investigator or their delegate has approved the coverage analysis summary.

To complete the Research Unit Signoff, locate your study in OnCore and then navigate to the Protocols > PC Console through the OnCore Menu. Select ‘Status’ from the left-hand menu to locate the Protocol Status Signoffs. 

Open To Accrual: Open to Accrual Date is the date on which the institution is open to accrual/enrollment. It is completed ASAP after Research Unit Signoff occurs. At the time of opening, the Office of Clinical Research integrates the study with Cerner PowerTrials, releases the OnCore Calendar for use, and completes a final OnCore QA.

IU Simon Comprehensive Cancer Center (IUSCCC) Additional Information

For Cancer Center Trials (studies involving cancer patients): 

  • For studies involving the Cancer Center’s Adult Clinical Trials Office (CTO), please reach out to cto-finance-l@list.iu.edu for support with the Study Sign-off process. 
  • For studies involving the Pediatric Hematology/Oncology/Stem Cell Clinical Research Team, please reach out to rileyphosresearchteam@iuhealth.org for support with the Study Sign-off process.

Contacts and Resources

Your study receiving all signoffs and approvals in OnCore is one of the major prerequisite milestones in the study activation process, but all additional requirements should be reviewed using the Clinical Research Roadmap.