Regulatory Management: IRB Staff - Approve Repository Application

Overview

Newly submitted Repository Applications display on the Unassigned tab of the IRB Staff Home Workspace. IRB Staff complete an initial review of newly submitted Repository Applications, including requesting any required changes to the application from the Repository Director, before the application is routed for IRB Committee review.

Contents

• Assign Owner
• Select Committee
• Submit Staff Review
• Select Review Type
• (Optional) Request Changes

Navigation

Role: Core Committee Staff > Home Workspace

Step-by-Step Process

Assign Owner

Assigning an IRB Staff Primary Owner moves the application from the Unassigned tab to the Inbox tab of the assigned owner.

1. Click Unassigned.
   
2. Click the application Name under the Unassigned Repository Applications list.
3. Click the Assign Owner activity.
   
4. Enter a new Primary owner’s name, or click Browse  to select one.
   Note If applicable, enter the following:
   • Secondary Core Staff Owner
   • Other IRB Owners
   • Inbox Staff Notes

​

5. Click OK.
   Note The application now displays in the Primary Core Staff Owner’s Inbox tab under Repository Application Reviews.

Select Committee

After a primary owner has been assigned, the Repository Application must then be assigned to the applicable review committee

1. Click the Select Committee activity.
   
2. Select the applicable Assigned Committee radio button.
   
3. Click OK.

Submit Staff Review

The Submit Staff Review activity can be executed multiple times as needed. This activity is not available until a Committee has been assigned.

1. Click the Submit Staff Review activity.
   
2. Review the Identified Issues Assigned to You. For each identified issue, answer the following:
   • Issue Resolved?
   • Require Repository Team Action?

Notes

• If desired, enter Related Reviewer Comments.
• If desired, edit the text of an Identified Issue.
• Assign Identified Issues to another reviewer via the Edit All Issues activity in the Repository Application Workspace.

3. If applicable, click Add to add any new issues. If not adding a new issue, then go to step 10.
   Note If new issues are added, you will need to notify the Repository Director of required changes.
4. Select the most relevant option from the Section drop-down list.
   
5. Select a role from the Assigned To drop-down list.
6. Enter a Description.
7. Select the Yes/No Require Repository Team Action radio button.
   Note Yes will publish the Description text to the repository team.
8. If desired, enter Related Review Comments.
   Note This text is not published to the repository team.
9. Click OK or OK and Add Another. If adding another, repeat steps 4-9.
10. If you are ready to indicate a Motion, select the applicable radio button.
    Note To save your review for completion at a later time, do not select a motion.
    
11. If applicable, enter Inbox Staff Notes.
12. Click OK.
    Note You can view Submitted Reviews and All Issues on the IRB tab in the Repository Application Workspace.

Select Review Type

Once IRB Staff review is complete, select the appropriate review type to route the application to the applicable party.

1. Click the desired review type from the Activities menu.
   Note In this example, we will select Full Committee. The following steps may differ slightly for other review types.
   
2. Click Add to assign Reviewers and select the applicable Reviewer Roles.
   Note The list of reviewers available for selection is limited to active members of the assigned committee only.
   
3. Select the applicable Meeting date radio button.
4. If applicable, enter Comments to Reviewers.
5. Click OK.
   Notes
   • The state of the application will change according to the selected review type.
   • The application routes to the assigned reviewer/committee.
   • Once IRB Committee review is complete, IRB Staff must validate the committee decision.

(Optional) Request Changes

If new issues are added or changes are required, IRB Staff can use the Changes Required by IRB Staff activity to notify the Repository Director of required changes.

1. Click the Changes Required by IRB Staff activity.
   
2. Enter Comments.
   
3. If applicable, click Add to attach related documents.
4. Click OK.
   Note The state of the application changes to Changes Required by IRB Staff.
5. Once the application has been resubmitted, IRB Staff can click View Differences to review the changes.
   Note Alternatively, click Edit Submission to view the entire application.
   
6. Review the changes made to the Repository Application using the following:
   • Show Changes drop-down list to display changes made between versions.
   • Changed Steps drop-down list to display the sections of the Repository Application that have been updated.

7. Click Close.