Regulatory Management: PRC Committee Member Review

Overview

This document details how to complete PRC Committee Member review.

Navigation

Role: Committee Member > Home Workspace > Review Workspace

Step-by-Step Process

1. Click the Committee Member role or verify it is selected on the Home Workspace.
   
2. Click the review Name in My Reviews to access the review.
3. Click Edit Reviewer Checklist.
   
4. Optional: Click one of the following to open available views/reports:
   • All Issues displays all identified issues related to the study.
   • View PRC Summary Report displays PRC-related information for the submission.
   • Print Version of Submission opens a printable version of the submission in a new window.
   • Change Log for Submission displays a history of modifications made to the submission.
     
5. Optional: Click the Review Checklist Section link to open that section of the submission in a new window.
   
6. Select the applicable Condition Met radio button.
7. Enter any Comments related to the Checklist Item/Condition in the field provided.
   Notes
   • Comments are optional when Condition Met = Yes.
   • Comments are required when Condition Met = No.
   • Comments will be converted to an identified issue upon submission of the review.
8. If applicable, enter any additional identified issues for the study team in the Additional Issues field.
   
9. Optional: enter any personal notes (e.g., presentation notes, visible only to committee members) about the review in the Notepad field.
10. If applicable, click Add and upload Supporting Review Documents.
11. Select the applicable Review Recommendation radio button.
12. Check the box if you wish to auto populate any responses in the Condition Met column that have been completed.
13. Click Continue.
14. If applicable, check the Check here if core committee staff can review ALL identified issues box.
    
15. Select the applicable Are you ready to submit your review? radio button.
16. Click Finish to exit the Submit Review page and save your work.
    Notes
    • The submission is now ready to be reviewed at the assigned Committee meeting.
    • You may edit and resubmit the review at any time until the determination for the submission is processed and the study team is notified.
    • You can find the review under the In Progress tab on your Home Workspace.