Processes

How to get a protocol open to accrual in OnCore

Step 1:

 

A request for protocol build is received through one of three channel:

Step 2:

 

The UCDenver Portal Administrator builds the protocol shell in the ​OnCore PC Console (OnCore Path: Menu->Protocols->PC Console)

Step 3:

 

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:

Process Step
Instructions
Regulatory Admin Signoff
  • Notification to person listed in the PC Console -> Staff tab with the role of 'Regulatory Coordinator' when IRB Approval is entered by study team in OnCore
  • Training Required: Protocols Management Course
Research Manager Signoff
  • Notification to person listed in the PC Console -> Staff tab with the role of 'Critical Research Manager'
  • Training Required: Protocol and Subject Managements Courses
Open to Accrual
  • Notification to OnCore Support

 

Step 4:

 

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
      • ​​For an overview of the UCHealth Startup process click here.
      • For an overview of the CHCO Startup process click here.
  • 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.
Process StepInstructions
Calendar Review
  • Notification via Zendesk to person listed as doing the 'initial calendar' on the HSR Portal Protocol Assessment Form
  • Training Required: System Access Required. Review can be done by anyone with a pre-award, post-award, Financial Manager, View only, Initial Calendar Review or Financial View Only role.
Pre-Award Signoff
  • Notification to person listed in the PC Console -> Staff tab with the role of 'Finance Specialist' or 'Budget Specialist'.
  • Training Required: Pre-Award Course
Research Manager Signoff
  • Notification to person listed in the PC Console -> Staff tab with the role of 'Clinical Research Manager'
  • Training Required: Protocol and Subject Managements Courses
Compliance Signoff
  • Compliance signoff is assigned to different individuals depending on where the study is being conducted and the source of funding.
PI Signoff
  • Notification to person listed in the PC Console -> Staff tab with the role of 'Principal Investigator', cc to 'Clinical Research Manager'
  • Training Required: None
Release
  • Notifications to people listed in the PC Console -> Staff tab with the roles of 'Calendar Builder' and 'Clinical Research Manager'

Step 5:

 

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.