Regulatory Management: Assign Designated Reviewer for Contingency Review

Overview

If a submission was approved with contingencies, and the contingencies addressed by the Study Team require a review by the committee members prior to final approval, then IRB staff can send the submission to a Designated Reviewer to complete the contingency review.

Navigation

Role: Core Committee Staff > Home Workspace

Step-by-Step Process

1. Click the Submission ID.
   Note The submission is in the Core Committee Staff Contingency Review State.
   
2. Click the Refer to Designated Reviewer activity.
   
3. To assign a current reviewer, check the box next to the Reviewer’s name and go to step 8.
   OR
   To add other reviewers, click Select in a blank row.
   
4. Enter a search term for the Reviewer you wish to add, then click Go.
   Note Use the Filter by drop-down list to search by Last name, First name, Uniqname or Project ID.
   
5. Click the radio button next to the person's name.
6. Click OK.
7. Select the appropriate role from the Reviewer Role drop-down list.
   
8. If applicable, enter Inbox Staff Notes and Comments for Reviewers.
9. Click OK.
   Notes
   • The Designated Reviewer receives an email notification informing them that they have been added as a reviewer to the submission. It also contains any Comments for Reviewers that were entered. The submission displays in the Designated Reviewer(s) Inbox and includes any Inbox Staff Notes that were entered.
   • The submission displays on the In Progress tab of the Core Committee Staff Home Workspace.
   • The submission is in the Designated Reviewer Contingency Review State.

Study Workspace - IRB Tab

Notes

• Information related to all reviews on the submission display on the IRB tab.
• The IRB Staff Review is in the Contingencies Under Review State.
• Reviews assigned to Designated Reviewers are in the Review Contingencies State.
• A reviewer may enter their recommendation at any time, but the review will remain in the Review Contingencies State until the review has been submitted. Once submitted, the designated review changes to the Submitted State.
• A yes in the Staff Can Review Contingencies column displays if the Reviewer indicates that IRB Staff can review the contingencies. If not, the column is blank.
• When all contingency reviews have been submitted, the submission will change to the Core Committee Staff Contingency Review State, and it will display in the Core Committee Staff Inbox.