Regulatory Management: IRB Committee - Review Participating Site Application

Overview

Participating Site Applications assigned to an IRB Committee member for review display under Participating Sites to Review on the Inbox tab of the Home Workspace.

Navigation

Role: Committee Member > Home Workspace

Step-by-Step Process

1. Click the Participating Site Name from the Participating Sites to Review list on the Inbox tab.
2. To post comments or communicate with other reviewers, you have two options in the Activities list:
   • Post Correspondence posts comments visible to all individuals with access to the Participating Site workspace.
   • For Reviewers and IRB Office Staff posts comments visible only to other Reviewers and IRB Office Staff.
3. Click the Submit Review activity.
   Notes

• This activity can be executed multiple times as needed.
• Changes made in this activity are only recorded when you click OK at the end of the screens (steps 11 & 13).

4. Click the All Issues link to review any issues/comments for this submission.
   
5. If applicable, click to Add any new issues. If not adding a new issue, then go to step 11.
6. Select the applicable option from the Section drop-down list.
   
7. Select a role from the Assigned To drop-down list.
8. Enter a Description.
9. Select the applicable Require Site Team Action radio button.
   Note Yes will publish the Description text to the site team.
10. If desired, enter Related Reviewer Comments.
    Note This text is not published to the site team.
11. Click OK or OK and Add Another. If adding another issue, repeat steps 6-11.
12. Select the applicable Motion radio button.
    Note To save your review for completion at a later time, do not select a motion.
    
13. Click OK to save updated/new issues and (if selected) the motion.
    Note The site application will use the parent application’s expiration date, unless a different date is selected via Edit Approval Date activity.