Processes

The Study Team should enter IRB Review Information in the PC Console (access and training required​). Entering IRB Approval will start the Protocol Signoffs​​ with an email notification to the Regulatory Coordinator:

The OnCore Support Calendar Builder begins building the protocol calendar with procedures (collectively called the 'Specifications').

• The Calendar Builder will reach out to the study team with questions during the build
• The status of this build can be viewed using these instructions
• If applicable the appropriate Hospital Research Specialist performs the Coverage Analysis in OnCore.
  • Hospital Research Specialist​ emails the study team when the Coverage Analysis is complete with instruction to review (1) Coverage Analysis and (2) calendar structure
    • ​​Overview of the UCHealth startup process.
    • Overview of the CHCO Startup process.
      
• The Calendar Builder enters financial and billing information
  • If applicable the fully executed contract and finalized internal budget should be sent to OnCoreSupport@UCDenver.edu when received.
• When all financials information has been entered the Calendar Builder 'completes' the specifications and starts the specification signoff process. Each signoff is triggered by completion of the previous signoff and the responsible person (notification sent to) receives and email with instructions on how to complete their signoff.

When both the PC Console Clinical Research Manager Signoff is complete and the Specifications have been released OnCore Support will open the protocol to accrual and Hospital Research Administration will Epic Activate. An email notification is automatically sent to the study team.