4. Notifications Descriptions
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 |
| 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 |
| RC Total Accrual Goal (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 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; Clinical Research Coordinator - Primary |
| 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 | 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 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.), 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 |
Need more help? Contact the OnCore Support Team: oncore@wustl.edu