PRMC and BSS Reviews

PRMC-R

In order to complete these tasks, you must have the PRMC-R access role assigned to you in OnCore.

Who to Contact

For submission questions: Contact PRMC staff at protocoloffice@wudosis.wustl.edu

For OnCore questions: Contact the OnCore support team at 314-747-0347 or oncore@wustl.edu.

From the Menu, navigate to ePRMS > Reviewer Console.

Click the Active vertical tab.

In the Active Submissions box, filter by Review Type for Admin reviews, locate the submission you wish to review, and click on the hyperlinked Submission No. to access the submission.

Submission details will display, including the following sections:

  1. Review Detail: protocol info, all assigned reviewers (click Query Detail to see ongoing query information)
    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 and attach the completed Review Form.
    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 to the protocol at WashU.
    2. RC Total Accrual Goal (Lower): maximum number approved to be enrolled to the protocol at WashU.
  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: Financials Coordinator, PI, Protocol Creator, and Regulatory Coordinator will be listed.
  13. Signoffs: will show timeline of study sign-offs, leading to Activation.

Need more help? Contact the OnCore Support Team: oncore@wustl.edu