New: Assigned when the protocol is created.
SRB Approval: Assigned when the CTO has approved of the ePRMS submission or for IITs, when the RBHS SRB committee has completed their review of a new IIT.
If you need to undo this status change, you can do so as long as the IRB review record is removed and the protocol status hasn't advanced beyond the IRB Initial Approval status.
CTO Signoff: Assigned when the CTO has completed their congruency check and all documents/approvals are complete.
Open to Accrual: Assigned when the Open button is selected and the date you received approval to begin enrollment is added. An Open button is displayed after IRB initial approval and CTO signoff has been completed. When a protocol has a status of Open to Accrual, an Undo Open button appears. This button is available until a subject is registered to the protocol.
On Hold: This status is typically assigned when a sponsor puts the protocol on hold prior to opening to accrual.
- The On Hold button is displayed until the protocol status becomes Open to Accrual.
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The Off Hold button is displayed when a protocol is On Hold.
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When a protocol is removed from On Hold status by clicking Off Hold, the protocol reverts to its previous status.
- When an approved Initial IRB Review or an approved Initial SRB Review is entered for a protocol having the status On Hold, OnCore updates the status of the protocol to IRB Initial Approval or SRB Approval and inserts an Off Hold status into the table.
An Undo On Hold button appears for protocols in On Hold status, and an Undo Off Hold button appears for protocols with an Off Hold status. Clicking either button reverses the protocol status to its previous state. Note that to access these buttons, you must have the Protocol > On Hold and Protocol > Off Hold permissions.
Abandoned: This status indicates no further action is expected for this protocol. 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 most recent valid status.
Suspended: This status indicates that a protocol is temporarily closed to accrual. OnCore does not allow you to place subjects On Study when a protocol is Suspended. A Suspend button is displayed after the protocol is marked Open to Accrual. When a protocol has a status of Suspended, an Undo Suspend button is displayed. Clicking the button reverts the protocol to its previous status.
Closed to Accrual: Indicates that a protocol is closed to accrual. The Close To Accrual button is displayed when the protocol has a status of Open to Accrual. After a protocol is marked as Closed to Accrual, an Undo Closed to Accrual button is displayed.
IRB Study Closure: Typically the final status for the protocol when the expected outcome is successfully completed. 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.
Protocol-related events that are tracked as payable and have an active IRB Study Closure trigger will create payables when the associated protocol is moved to a status of IRB Study Closure on the PC Console > Status tab.
Terminated: 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.
