Descriptions of 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) 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.	Regulatory Coordinator - Primary ; Regulatory Coordinator - Secondary; WU Coverage Analyst
RC Total Accrual Goal (Lower) Met Notice	System-wide	This notice alerts recipients that a protocol has reached the maximum number of subjects approved to be enrolled to the protocol at WashU.	Regulatory Coordinator - Primary ; Regulatory Coordinator - Secondary
ADE Messages	Oncology only	This notice alerts recipients that subjects on an active protocol have been admitted, discharged or expired at BJC facilities.	Clinical Research Coordinator - Primary; Principal Investigator (only on patient expiration); Data Coordinator - Primary
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	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.	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.

From the Home Page > Protocols menu > PC Console
Type in the protocol number in the Select Protocol field
Select Notifications vertical tab
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.
5. If you are setting up a Subject Status Rule, there are additional steps.
  1. At the bottom right of the PC Console > Notifications page. click on the “Subject Status Rules” hyperlink .
  2. You will see the below screen (if not, click Update).
  3. Select the Status that corresponds to the Notification you selected in Step 4 above.
  4. Enter the number of subjects at which you want to be notified. (Ex: Enter 10 if you want to know when 10 subjects have reached the Status you selected).
  5. Enter whether you want it to never repeat, repeat for each additional subject who reaches that status or for each X subjects (number entered for subject threshold) that reach that status.
  6. Press Add.

Descriptions of Notifications for Users

Notification

Library

Notification Description

Recipients

Adding Notifications to Protocols

From the Home Page > Protocols menu > PC Console

Type in the protocol number in the Select Protocol field

Select Notifications vertical tab

Scroll to the specific notification you would like to set

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

All notifications are automatically set to the Default radio button

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

Click on the Notification Hyperlink to set the notification details

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

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

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

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

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

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

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

Click Submit.

If you are setting up a Subject Status Rule, there are additional steps.

At the bottom right of the PC Console > Notifications page. click on the “Subject Status Rules” hyperlink .

You will see the below screen (if not, click Update).

Select the Status that corresponds to the Notification you selected in Step 4 above.

Enter the number of subjects at which you want to be notified. (Ex: Enter 10 if you want to know when 10 subjects have reached the Status you selected).

Enter whether you want it to never repeat, repeat for each additional subject who reaches that status or for each X subjects (number entered for subject threshold) that reach that status.

Press Add.

4. Notifications Descriptions & Adding Custom Notifications

Descriptions of Notifications for Users

Notification

Library

Notification Description

Recipients

Adding Notifications to Protocols

From the Home Page > Protocols menu > PC Console

Type in the protocol number in the Select Protocol field

Select Notifications vertical tab

Scroll to the specific notification you would like to set

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

All notifications are automatically set to the Default radio button

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

Click on the Notification Hyperlink to set the notification details

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

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

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

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

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

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

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

Click Submit.

If you are setting up a Subject Status Rule, there are additional steps.

At the bottom right of the PC Console > Notifications page. click on the “Subject Status Rules” hyperlink .

You will see the below screen (if not, click Update).

Select the Status that corresponds to the Notification you selected in Step 4 above.

Enter the number of subjects at which you want to be notified. (Ex: Enter 10 if you want to know when 10 subjects have reached the Status you selected).

Enter whether you want it to never repeat, repeat for each additional subject who reaches that status or for each X subjects (number entered for subject threshold) that reach that status.

Press Add.