OnCore: Protocol Statuses
Common Statuses
New
New - A "pending" status.
When to use - This status appears when the protocol has been created or is in the process of being created.
PRMC/UROC Approval
PRMC/UROC Approval - A "pending" status.
When to use - This status is set automatically when PRMC or UROC reviewers document the Initial Review Approval. This will appear in the PC Console > Reviews > PRMC/UROC tab.
IRB Initial Approval
IRB Initial Approval - A "pending" status. The IRB initial application has been approved.
When to use - This status is set automatically when users document the Initial Application Approval in the PC Console > Reviews > IRB Tab. This entry must have an IRB Review Reason of "Initial Review", a Type of "Full", and an Action of "Approved". Note that "Approved with Administrative Hold" does not trigger this status.
SMPH Review Request Signoff
SMPH Review Request Signoff - A "pending" status. The protocol is ready to submit for approval.
When to use - Click the SMPH Review Request Signoff button when the OnCore protocol is ready for review and approval. See SMPH Review Process for more details.
An "Undo SMPH Review Request Signoff" button becomes available in case you click it by accident. Click the Undo button if necessary.
When the SMPH Review has been completed, the Protocol Status will update to SMPH Review Complete Signoff, and you will be able to open the protocol to accrual.
Open to Accrual
Open to Accrual - An "active" status. The protocol has an Open to Accrual date entered and participants can be entered and enrolled in the study on or after that date.
When to use - Once the protocol has been through Study Registration, protocol staff can change the status by clicking "Open" in PC Console > Status when ready to start enrolling participants.
An "Undo Open" button becomes available in case you click it by accident. Click the Undo button if necessary and it will be listed in the History. However, the Undo button will not be available if subjects have already been accrued.
Closed to Accrual
Closed to Accrual - An "active" status. The protocol has a Closed to Accrual date entered.
When to use - This status is an indication that no additional participants will be recruited or enrolled.
Participants may be active in treatment or follow-up; however, no additional participants may be placed On Study. The Financials Console is still active and available for fiscal work in the study. Protocol staff can close the protocol to accrual under PC Console > Status.
The Accrual Information in the PC Console > Main > Details tab should be updated at the same time the protocol is CLOSED TO ACCRUAL. See Documenting Protocol Accrual Information and Completion Dates for more details.
Terminated
Terminated - A "complete" status.
When to use - Protocol has gone through its entire life cycle, no more participants are in treatment or on follow-up and the IRB considers the study to be completed. The Financials Console is still active and available for fiscal work in the study. Includes when protocols have a shorter than expected life cycle due to SAEs, low accrual, etc. Protocol staff can terminate the protocol under PC Console > Status. Setting this status will generate a notification to patient billing to deactivate the study in Health Link.
If you receive a Warning: N accrued participants are still active message when you press the Terminate button, make sure you communicate with your study team to inactivate these participants. OnCore will allow you to proceed with entering Terminate, but it is important that all participants have inactive status when the study is closed with Terminated in OnCore. When a participant no longer needs to be associated with a study or have study related charges billed to the study account, study staff should change the participant's status in the OnCore protocol to one of the Inactive statuses. See "Attach Subject to the Health Link Research Record" in OnCore: Adding UW-Madison Subjects (Epic MRNs) to OnCore Protocol for more details.
Other Statuses
Abandoned
Abandoned - A "complete" status.
When to use - A status for protocols that are ended prior to being Open to Accrual. The Financials Console is still active and available for fiscal work in the study. Protocol staff can abandon the protocol under PC Console > Status.
Suspended
Suspended - An "active" status.
When to use - A status for protocols that had been Open to Accrual but currently should not accrue any more participants until issues are resolved. Protocols are often re-opened after having been in a suspended status. Protocol staff can suspend and re-open the protocol under PC Console > Status.
When you are ready to re-open to accrual, you have two options in OnCore:
- Undo Suspend: This will remove the SUSPEND from the Protocol Status List. It will still be visible in the History.
- Open (preferred): The SUSPEND status detail will be retained in both the Protocol Status List and History.
On Hold
On Hold - An "active" status.
When to use - Used during the process of opening to accrual to indicated that the process is stopped due to outside influences.
An "Undo On Hold" button becomes available in case you click it by accident. Click the Undo button if necessary and it will be listed in the History. 
Off Hold
Off Hold - An "active" status.
When to use - Used during the process of opening to accrual to indicate that the protocol is no longer On Hold.
An "Undo Off Hold" button becomes available in case you click it by accident. Click the Undo button if necessary and it will be listed in the History.
