6. Protocol Staff Roles
Description | Use | System-wide Notifications | Oncology Specific Notifications |
|---|---|---|---|
| Ancillary Personnel | Assign this role to any peripheral staff who do not have access to the protocol, but will require access. Example: Laboratory Staff, External Monitors. | None | None |
| BJC Coverage Analyst | Only OnCore admin are to assign/adjust this role. Role is assigned when BJC is required to review the protocol for billing compliance. | Protocol Specification (Released) Notice; Budget Release Notice | None |
| Clinical Research Coordinator - Primary | Assign to the primary coordinator responsible for subject tracking in OnCore. Limit to one. Along with the Clinical Team access role, this provides access for subject tracking. Staff assigned this role will appear as Study Contact in Epic. This role is required to be assigned if individual subject tracking will occur in OnCore. | Protocol Specification (Released) Notice; Protocol Not Open to Accrual Notice; RC Total Accrual Goal (Upper) Met Notice | Submission on Agenda Notice (PRMC); Response Required Reminder Notice (PRMC); DSM Approval; DSM Notification; ADE Messages; PI Accrual Notifications; QASM Audit Notifications; QASMC First Enrollment Notification |
| Clinical Research Coordinator - Secondary | Assign to all coordinators, aside from the primary, who need to perform subject tracking in OnCore. Multiple secondary can be assigned. Along with the Clinical Team access role, this provides access for subject tracking. | None | None |
| Clinical Research Nurse | Use if your team wants to separately track Clinical Research Coordinators who are Nurses. Along with the Clinical Team access role, this provides access for subject tracking. | None | None |
| CRBS Admin | Only OnCore admin are to assign/adjust this role. Role is assigned when the WashU Clinical Research Billing Support is required to review the protocol for billing risk. | None | None |
| Data Coordinator - Primary | Use if your team wants to separately track who is responsible for data coordination in OnCore. Limit to one primary. Along with the Clinical Team access role, this provides access for subject-level information. | None | DSM Approval; DSM Notification; ADE Messages; QASM Audit Notifications; QASMC First Enrollment Notification |
| Data Coordinator - Secondary | Use if your team wants to separately track who is responsible for data coordination in OnCore. Multiple secondary can be assigned. Along with the Clinical Team access role, this provides access for subject-level information. | None | None |
| Financial Billing Contact | Assign to the contact person for billing inquiries, as this contact’s name, email and phone number will appear on all OnCore generated invoices for the protocol. Limit to one or invoices will not generate. This role is required to be assigned if the study team will be generating invoices in OnCore. | Invoicing Reminder (if configured for protocol); Maximum Invoiceable Screening Failures Met | None |
| Financial Coordinator | Assign to staff who need to do budget entry, budget review and/or Budget Team Signoff for the calendar in OnCore. Multiple can be assigned, but teams will need to establish who is responsible for Budget Team Signoff and budget entry. This role is required to be assigned if there will be a calendar for the study. | Invoicing Reminder (if configured); Maximum Invoiceable Screening Failures Met; Protocol Specification (Budget Team Signoff) Reminder Notice; Protocol Specification (Released) Notice; Extending Visit (if configured) | None |
| Legal Contracts Office Contact | Use this role if you want to track your contact person from the Joint Research Office for Contracts. This role does not control access or receive notifications. | None | None |
| Pharmacy Personnel | Use this role if you want to track your pharmacy contact person for the study. | None | None |
| Principal Investigator | Assign to the PI of the protocol. Limit to one. This role is required. | Submission on Agenda Notice; Response Required Reminder Notice (both PRMC) | Submission on Agenda Notice (PRMC); Response Required Reminder Notice (PRMC); DSM Notification, DSM Approval, Patient Expiration (if at BJC facility), upcoming QASM audit |
| Program Coordinator | For Oncology protocols, this is assigned to managers of disease groups so they receive QASM Audit Notifications. Limit to one. For Non-Oncology protocols, teams can develop an internal use for this role, if desired. | Protocol Specification (Released) Notice; Protocol Not Open to Accrual Notice | PI Accrual Notifications; QASM Audit Notifications |
| Protocol Creator | Auto assigned to the user that created the protocol in OnCore. | None | None |
| Registering Coordinator | This role should not be assigned to the protocol, as it is only for assignment to individual subjects. | None | None |
| Registering Investigator | This role should not be assigned to the protocol, as it is only for assignment to individual subjects. | None | None |
| Regulatory Coordinator - Primary | The primary staff member responsible for regulatory tasks for the protocol. Limit to one. If your protocol shell is created by the Coverage Analysis admin, this role will be assigned to the person who submitted the protocol to HRPO and the assignee will be emailed Instructions for Newly Submitted Studies. This role is required. | New Protocol Specification (Released) Notice; Protocol Status (IRB Initial Approval) Notice; RC Total Accrual Goal (Lower) Met Notice; RC Total Accrual Goal (Upper) Met Notice; Protocol Not Open to Accrual Notice; | Submission Reviewed Notice (PRMC); Submission Queried Notice (PRMC); Submission on Agenda Notice (PRMC); Response Required Reminder Notice (PRMC); Non-Submitted PRMC Review Pending (PRMC); DSM Approval; DSM Notification; QASM Audit Notifications; QASMC First Enrollment Notification |
| Regulatory Coordinator - Secondary | Assign to all staff, aside from the primary, who need to perform regulatory task for the protocol. | Protocol Status (IRB Initial Approval) Notice; RC Total Accrual Goal (Lower) Met Notice; RC Total Accrual Goal (Upper) Met Notice | Submission Reviewed Notice (PRMC); Submission Queried Notice (PRMC); Submission on Agenda Notice (PRMC); Response Required Reminder Notice (PRMC) |
| Statistician | Assign to the statistician(s) for the protocol. Along with the Statistician access role, this will grant access to the Biostat console. | None | None |
| Sub-Investigator | Use this role if you want to track Sub-Investigators on the protocol. This role does not control access or receive notifications. | None | None |
| Treating Physician | This role should not be assigned to the protocol, as it is only for assignment to individual subjects. | None | None |
| WU Coverage Analyst | Only OnCore admin are to assign/adjust this role. Role is assigned when the WashU Clinical Research Billing Support is required to review the protocol for billing compliance. | Protocol Status (IRB Initial Approval) Notice; Protocol Specification [Budget Team Signoff] Notice; Protocol Specification (Released) Notice | None |
| Submitter | Oncology library only. Auto assigned to any user creating a submission through ePRMS. Can not be manually assigned. | None | Submission Reviewed Notice (PRMC); Submission Queried Notice (PRMC); Submission on Agenda Notice (PRMC); Response Required Reminder Notice (PRMC) |
Need more help? Contact the OnCore Support Team: oncore@wustl.edu