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System-Wide and Library Specific Notifications for Users

Notification

Library

Notification Description

Recipients

Extending Visit

System-wide

This notice alerts recipients that a subject has been checked in for the last visit of the last budgeted cycle on an open-ended protocol (Financials Console > Parameters > No. of Cycles for Budget Calculations).  A New Budget Version may be needed to invoice for more cycles.

Financial Coordinator 

Invoicing Reminder

System-wide

This notice is a quarterly invoicing reminder sent on Jan 1, Apr 1, June 1, and Oct 1.  This will only send if the protocol has a Notification Frequency and Start Date entered in the Invoicing Reminder section of the Financial Console > Parameters tab.  Please note, this reminder will be quarterly regardless of the Notification Frequency entered in OnCore.

Financial Coordinator; Financial Billing Contact

Maximum Invoiceable Screening Failures Met

System-wide

This notice alerts recipients that the protocol has reached the Maximum Number of Invoiceable Screening Failures designated in the Financials Console > Parameters tab.  Future Screening Failure Milestones will not be invoiceable unless the budget is amended.

Financial Coordinator ; Financial Billing Contact

Protocol Specification Released Notice

System-wide

This notice alerts recipients that a protocol calendar has gone through all completed signoffs and is released.

BJC Coverage Analyst; Clinical Research Coordinator - Primary ; Regulatory Coordinator - Primary ; WU Coverage Analyst ; Financial Coordinator ; Program Coordinator

Protocol Specification (Budget Team) Reminder Notice

System-wide

This notice alerts recipients that the protocol is ready for budget entry (if applicable), calendar review and completion of the Budget Signoff.

Financial Coordinator

Protocol Specification [Budget Team Signoff] Notice

System-wide

This notice alerts recipients that the protocol has received Budget Signoff and is ready for Final MCA Review and Calendar Release.

WU Coverage Analyst

Protocol Status (IRB Initial Approval)

RC Total Accrual Goal (Lower) Met Notice

System-wide

This notice alerts recipients that

an initial IRB approval review was populated into the OnCore reviews tab, so the protocol status was updated to IRB Initial Approval

a protocol has reached the maximum number of subjects approved to be enrolled to the protocol at WashU.

Regulatory Coordinator - Primary ; Regulatory Coordinator -

Secondary; WU Coverage Analyst 

Secondary 

RC Total Accrual Goal (

Lower

Upper) Met Notice

System-wide

This notice alerts recipients that a protocol has reached the maximum number of subjects approved by the WashU IRB to be

enrolled

consented to the protocol at WashU or that the RC Total Accrual Goal (Upper) Met Notice field in the PC Console needs to be updated to match the number approved to be consented in myIRB.  The protocol status will automatically update to Closed to Accrual in OnCore.  

Regulatory Coordinator - Primary ; Regulatory Coordinator -

Secondary 

Secondary; Clinical Research Coordinator - Primary

ADE Messages

Oncology only

System-wide

This notice alerts recipients that subjects on an active protocol have been admitted, discharged or expired at BJC facilities. (This is only for protocols with certain specifications- contact oncore@wustl.edu for details).

Clinical Research Coordinator - Primary; Principal Investigator (only on patient expiration); Data Coordinator - Primary; Program Coordinator

DSM Approval

Oncology only

This notice alerts recipients of Data Safety Monitoring (DSM) reports that have been approved.

Clinical Research Coordinator - Primary; Regulatory Coordinator - Primary; Principal Investigator; Data Coordinator - Primary

DSM Notification

Oncology only

This notice alerts recipients a Data Safety Monitoring (DSM) report is due.

Clinical Research Coordinator - Primary; Regulatory Coordinator - Primary; Principal Investigator; Data Coordinator - Primary

PI Accrual Notifications

Oncology only

This notice alerts recipients of protocols that have had zero accruals entered in OnCore for the last 12 months.

Clinical Research Coordinator - Primary; Regulatory Coordinator - Primary; Principal Investigator; Program Coordinator

Protocol Not Open to Accrual Notice

Oncology only

System-wide

This notice is a reminder to update the protocol status to Open to Accrual.  For Med Onc protocols, It is initially sent 30  days after the protocol has reached IRB Initial Approval.  For all other

oncology

protocols, it is sent immediately after the protocol has reached IRB Initial Approval.  After the initial notice, this notice is sent every 30 days for all protocols.

Clinical Research Coordinator - Primary; Regulatory Coordinator - Primary; Program Coordinator

IRB Review Expiration Notice

System-wide

This notice alerts regulatory coordinators of IRB expiration dates that need to be updated. Some studies may not have expiration dates (retrospective, etc.)

and therefore the common rule date of 12/31/2099 can be entered

, so the Review Expires Setting on the review can be updated to No.

Regulatory Coordinator - Primary

QASM Audit Notifications

Oncology only

This notice alerts recipients of an upcoming QASM audit; it is sent 42 days prior to audit due date.

Clinical Research Coordinator - Primary; Regulatory Coordinator - Primary; Principal Investigator; Data Coordinator - Primary; Program Coordinator

QASMC First Enrollment Notification

Oncology only

This notice alerts recipients that the first patient has enrolled on a protocol.

Clinical Research Coordinator - Primary; Regulatory Coordinator - Primary; Principal Investigator; Data Coordinator - Primary

Submission on Agenda Notice

Oncology only

This notice alerts recipients that the PRMC submission for the protocol was added to a PRMC meeting agenda.

Submitter; Clinic Research Coordinator - Primary ; Principal Investigator ; Regulatory Coordinator - Primary ; Regulatory Coordinator - Secondary 

Submission Queried Notice

Oncology only

This notice alerts recipients that the PRMC submission for the protocol was queried by the PRMC team and requires follow-up by the submitter. 

Submitter; Regulatory Coordinator - Primary ; Regulatory Coordinator - Secondary 

Submission Reviewed Notice

Oncology only

This notice alerts recipients that a review decision was made on the PRMC submission for the protocol, along with the Action Date and any Review Summary. This notification is used even for decisions that result in a Queried status requiring further follow-up by the submitter.

Submitter; Regulatory Coordinator - Primary ; Regulatory Coordinator - Secondary 

Summary Accrual

Oncology only

This notice is a reminder to recipients to enter protocol summary accrual data.

Clinical Research Coordinator - Primary; Regulatory Coordinator - Primary; Principal Investigator

Protocol Status Abandoned Notice

Non-Oncology

This notice alerts recipients that a protocol they are on the staff list for, had a status change to abandoned.

Regulatory Coordinator - Primary

Adding Notifications to Protocols

Adding notifications within a protocol is useful to remind members of the study team of important milestones in a protocol's life cycle. It can also be used to alert study team members of steps they need to take in OnCore. Only users with the Regulatory access role in OnCore can add protocol notifications.

  1. From the Home Page > Protocols menu > PC Console

  2. Type in the protocol number in the Select Protocol field

  3. Select Notifications vertical tab

  4. Scroll to the specific notification you would like to set

    1. Move the radio button of your notification to the middle, "Custom" column

      1. All notifications are automatically set to the Default radio button

    2. Once you move the radio button to the middle column, a message saying "Not Configured" will appear

    3. Click on the Notification Hyperlink to set the notification details

      1. Once you click on the hyperlink you will be taken to the notification configuration page

      2. Click "Update" at the bottom right corner of the page

      3. Add "no_reply_oncore@wustl.edu" in the Reply To field 

      4. Add the Email Address in the "To" field of where you would like the notification to go

        1. If you wish to add additional recipients by staff role or protocol role, you can add them in the Additional Recipients section

      5. The Subject field is automatically filled with the title of the notification

      6. Add the intended email body message to the "Text" field

    4. Click Submit

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