Protocol Statuses in OnCore

OnCore protocol statuses are assigned (and unassigned) in a predetermined order. The PC Console > Status page displays the protocol's status history. Users with the appropriate permissions will see buttons that can be used to assign the next status, undo the current status, or update the order of the protocol's approval statuses.

Updating Study Statuses

1. From the Menu, navigate to Protocols > PC Console and enter the Protocol No. in the Select Protocol field. 
2. Once you select the protocol, the protocol information will display in the banner, including the current Protocol Status.
3. Click Status in the vertical toolbar.
4. In the Protocol Status block, the status history will display, indicating which statuses the protocol has gone through and when. The History button in the top right corner will open additional audit trail information.
5. To update study statuses, you should NOT be in Update mode. Status options will display at the bottom of the Protocol Status block. Available options depend on the current study status, as certain statuses are prerequisites for others.
   
6. Click the appropriate status button and enter the status date.  You may back-date if the status took effect prior to today.
7. Click Submit.  The Protocol Status that displays in the banner will be updated to the status sign off you just completed.

Open to Accrual

Opening a study to accrual requires a multi-step protocol sign off process. For industry sponsored studies, be sure to communicate with the Financial Coordinator assigned to the study to make sure the study is ready to be Open to Accrual.  Once the study is IRB approved and is ready for accrual, the following status sign offs must be completed before the Open to Accrual signoff will be available:

• CRC Signoff (Oncology library studies only)
• Team Lead Signoff
• Regulatory Signoff (Oncology library studies only)

The protocol signoff status buttons only display for users with the permissions required to complete the specific signoff. Any of these status signoffs can be undone if necessary.

For Oncology library studies, some study teams have a different staff member complete each signoff, while other teams have one staff member complete all three. Regardless your team structure, these three signoffs are global to all Oncology library protocols and must all be completed before the study can be marked as Open to Accrual.

Additionally data collection and retrospective chart review studies will still need to be opened to accrual even if patient enrollments will not be logged. This is to ensure that the study can be closed at a later date. 

Closed to Accrual

As described in the Auto-Closer section of IRB Initial Submission and Renewals, protocols are automatically placed in the Closed to Accrual status when the accrual goal for the protocol is met, as indicated in the protocol shell. If/When the accrual goal is updated with the IRB, the Regulatory Coordinator must manually reopen the protocol to accrual.

If you need to manually update a protocol status to Closed to Accrual, the Closed to Accrual status button will become available only after the study has been in the Open to Accrual status. If a protocol closed before it opens, the Abandoned or Terminate status will be more appropriate (see definitions below).

IRB Study Closure

Once the protocol has been closed with IRB, the protocol status in OnCore will need to be manually updated to IRB Study Closure. The IRB Study Closure button is displayed after the protocol is marked Closed to Accrual. When a protocol is assigned the status of IRB Study Closure, an Undo IRB Study Closure button is displayed. If you update the status to IRB Study Closure while the protocol still has active subject (accrued subjects without Off Study dates), a warning appears but does not prevent you from updating the status.

Definitions

• New: Automatic status upon creating a new protocol shell; the Last Changed By field will auto-populate with the name of the staff who created the protocol shell.
• PRMC Approval: (Oncology library only) Assigned when a PRMC Initial Review is completed for the protocol; this status may not be required if PRMC Review is not required for the protocol.
• IRB Initial Approval: Assigned when an IRB Initial Review is completed for the protocol.
• Protocol Signoffs: see Open to Accrual section above for more details
  • CRC Signoff: (Oncology library only): Clinical research coordinator
  • Team Lead Signoff: Manager or Team lead
  • Regulatory Signoff:  (Oncology library only) Regulatory coordinator
• On Hold: This status is typically assigned when a sponsor puts the protocol on hold prior to opening to accrual.  When a protocol is removed from On Hold status by clicking Off Hold, the protocol reverts to its previous status. 
• Abandoned: This status indicates that no further action is expected for this protocol prior to Open to Accrual. An Abandon button is displayed until a protocol is Open to Accrual. When a protocol has the status of Abandoned, an Undo Abandon button is displayed. Clicking the button reverts the protocol to its previous status.
  
• Open to Accrual: Protocol has been approved, is open, and is actively enrolling subjects. Open to Accrual signoff is not available until all protocol signoffs have occurred.
• Closed to Accrual: Protocol is not actively enrolling subjects.  For studies that require PRMC Review, the study should not be closed to accrual until the PRMC Closure review has been submitted. 
  The following fields are required:
  • Initiator: Choose the party that initiated the closed to accrual status change.
  • Reason: Records the reason for the status change.
• Suspended: This status indicates that a protocol is temporarily Closed to Accrual but may reopen. OnCore does not allow you to place subjects On Study when a protocol is Suspended.
• IRB Study Closure: Typically the final status for the protocol when the expected outcome is successfully completed and comes after Closed to Accrual.
• Terminate: This status is typically used when a protocol ends prior to completing the expected outcome, and indicates that no further protocol action is required. The Terminate button is displayed after the protocol is Closed to Accrual or after IRB Study Closure. When a protocol is marked as Terminated, an Undo Terminate button is available. If you update the status to Terminated while the protocol still has active subject (accrued subjects without Off Study dates), a warning appears but does not prevent you from updating the status.
• Undo: Whenever an Undo status option is available, this will remove the status from the Protocol Status block. (It will still appear in the History.)
  • User Undo if a signoff was completed erroneously and should be removed.
  • Do NOT use Undo if the status was active at one time but has since changed.