How to Conduct PRS Review

Instructions for IRB Members

The preliminary review session (PRS) involves reviewing all changes of protocol and continuing reviews scheduled for an IRB meeting. PRS is completed in ARROW by two IRB members approximately one week prior to the meeting. IRB members are assigned to conduct PRS approximately twice a year.

How to Conduct PRS:

  1. Login to ARROW at http://arrow.wisc.edu (using your NetID and password).
  2. Select your "IRB Member" role.
  3. PRSGuidance_SelectyourIRBMember.PNG

  4. Click on the second tab "HS/MR: Other" to view the items for review (see IRB Member Workspace Navigation Guide for IRB Members).
  5. PRSGuidance_CurrentWorkspace.PNG

  6. Click on the first item in the "HS/MR: Other" inbox to be taken to the change of protocol or continuing review submission workspace.
  7. PRSGuidance_PRSItem.PNG

  8. Once in the change of protocol or continuing review workspace, click on "Print Reviewer Checklist" (under My Activities) to open the staff reviewer's checklist. Please note that, by executing this activity, it will not physically print the staff reviewer’s checklist.
  9. PRSGuidance_PRSActivities.PNG

    1. In the screen that appears, click on the file name to open the checklist.
    2. PRSGuidance_PrintReviewerChecklist.PNG

    3. Once you review the checklist, close the document, and click "ok" in the Print Reviewer Checklist screen to log in the system that the checklist has been reviewed. You can re-open the checklist multiple times if you need to review it later. Please note that, even though the instructions state to print out and complete the reviewer checklist(s) and place them in the baskets at the meeting, this is not necessary.
    4. PRSGuidance_PrintReviewerChecklist-OK.PNG

  10. To view the Change/Continuing Review form, click on "View CR Form" or "View Change Form" in the upper left.
  11. PRSGuidance_ChangeForm.PNG

    1. Use the "Continue" button to scroll through the form.
    2. When finished reviewing the form, click "Exit."

  12. For changes of protocol: Click on “View Modified Application” after viewing the change form. This is the application with the proposed changes incorporated by the study team (e.g., revised protocol, risk language, consent documents).
  13. PRSGuidance_ModifiedApplication.PNG

    1. Use the "Continue" button or “Jump Around” button to navigate the form like an initial review.
    2. When finished reviewing the form, click "Exit."

  14. For continuing reviews: To look at the currently approved version of the application while reviewing a Continuing Review, you will need to go to the main study workspace. To do this, click on the study title in the gray bar near the top.

    PRSGuidance_TitleofStudy.PNG

    To view the currently approved version of the application, click on "View Application."

    PRSGuidance_ViewApplication.PNG

    1. Use the "Continue" button or “Jump Around” button to navigate the form.
    2. When finished reviewing the form, click "Exit."

    To return to the continuing review workspace, click on the "Continuing Reviews" tab, and then click on the continuing review on the top of the list.
  15. PRSGuidance_ContinuingReviewWorkspace.PNG

  16. Once you are ready to sign-off on a submission, click "Submit PRS Notes" (under My Activities).
  17. PRSGuidance_PRSActivities_SubmitNotes.PNG

    1. The window that comes up will ask you basic questions, such as whether you agree with the staff reviewer, and whether you have any concerns regarding the submission.
    2. Once answers are entered into the form, click "ok" to officially submit the notes.
    3. PRSGuidance_SubmitPRSNotes.PNG

  18. Your review is complete--to return to your PRS Inbox, click "My Home" in the upper right.
  19. PRSGuidance_MyHome.PNG

  20. Click on your "HS/MR: Other" tab to view the remaining items for review, and start back at step 4.

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Keywords:IRBM, IRB member, preliminary review session, PRS   Doc ID:20577
Owner:Faye L.Group:Health Sciences IRBs
Created:2011-10-10 14:45 CSTUpdated:2017-08-18 12:23 CST
Sites:Health Sciences IRBs
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