7. Completing Administrative PRMC/BSS Reviews

1. In order to complete these tasks, you must have the PRMC-R role
2. Begin on Home Page > ePRMS > Select "Reviewer Console"
   1. Click the "Active" vertical tab
      1. In the "Active Submissions" box, filter "Review Type" for "Admin" review, click on the blue hyperlink in the "Submission No." column to access the submission.
      2. Submission details are visible. Including the following sections:
         1. Review Detail: - protocol info, all assigned reviewers, may click "Query detail" to see ongoing.
            1. In "Review Detail" block, open the reviewer form next to your name.
            2. Complete the form as appropriate
            3. In "Reviewer's Notes/Evaluation" box, click "Choose File", attach completed Review Form (from b above).
            4. Click "Add" and "Submit".
            5. Repeat for all assigned reviews.
            6. Notify Protocol Office when reviews are completed.
         2. Reviewer's Notes/Evaluation -  where completed review sheet will be attached.
         3. Documents - all required documents will be attached.
         4. Initial Review - basic protocol information from the initial submission.
         5. Accrual Information - accrual breakdown for study. 
            1. "RC Total Accrual Goal (Upper)" = maximum number approved to consent for trial.
            2. "RC Total Accrual Goal (Lower)" = maximum number approved to be enrolled at WUSTL
         6. Completion Dates - anticipated
         7. Administrative Groups - 
            1. Program Area: NCI Designated 
            2. Oncology Group: Focus Group(s)
            3. Management Group: team responsible for managing patients and/or collecting data
         8. Disease Sites - all applicable disease sites will be listed
         9. Institutions - any institution that is/will be involved in trial.
         10. Sponsors - all will be listed
         11. Competing Protocols - any applicable competing protocols will be listed.
         12. Protocol Staff - at minimum, PI, Protocol Creator, and Regulatory CRC will be listed.
         13. Signoffs - will show timeline of study sign-offs, leading to Activation

Contact PRMC staff at protocoloffice@wudosis.wustl.edu for submission questions, or the OnCore support team (at 314-747-0347 or oncore.wustl.edu) with any OnCore questions.