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Working with Reviewer Notes

Working with Reviewer Notes

What are reviewer notes?

Reviewer notes are what the HS-IRBs Office uses to request revisions or ask questions about the application. You could see reviewer notes at two times during the submission process: during IRB pre-review and after formal IRB review.

NOTE: For Changes of Protocol, there may be additional reviewer notes in the Modified Application. As of March 25, 2017, click "Modified App Reviewer Notes" in the change workspace to view these reviewer notes. See below for additional details.

How do I respond to reviewer notes?

There are two ways you can respond to reviewer notes.

  1. Within the application:

    1. Your reviewed study will be in your inbox for review. Select the study and click “Edit Application” on the left-hand side of the screen.
    2. EditApplication.JPG

    3. Next, click on the arrow next to "Reviewer Notes" (near the top) to hide/display the reviewer notes as necessary.

      ReviewerNotes.JPG
    4. You can move from reviewer note to reviewer note by clicking “next” next to the reviewer note panel.

      ReviewerNotes-Next.JPG
    5. Responding to the reviewer notes is a two-step process. You may need to revise the page per the reviewer note. You will also be required to respond directly to the reviewer note by clicking “Click here to respond."

      ClickHeretoRespond.JPG
    6. When you click on the reviewer note, a pop-up window will appear. You should respond to the review note by explaining what changes, if any, you made and why.

      Response(2).JPG
    7. If you make a change to the application itself, make sure to click “Continue” or “Save” to ensure your changes are saved.

  2. From the “reviewer notes” tab:

    1. Your reviewed study will be in your inbox for review. Select the study. Once you are within the study’s workspace, select the “Reviewer Notes” tab.

      ReviewerNotesTab.JPG
    2. You will see a list of reviewer notes.

      List.JPG
    3. Responding to the reviewer notes is a two-step process. You may need to revise the page per the reviewer note by clicking on the link to the page with the note.

      You will also be required to respond directly to the reviewer note by clicking “Click here to respond." You should respond to the reviewer note by explaining what changes, if any, you made and why.

      Response(2).JPG
    4. If you make a change to the application itself, make sure to click “continue” or “save” to ensure your changes are saved.

What do I do when I'm done responding to the reviewer notes?

When you are done responding to reviewer notes, exit the application. Within the study’s workspace, select “SUBMIT” under My Activities on the menu on the left, and verify that you would like to submit by clicking "ok" at the bottom of the pop-up window. This step must be completed for the IRB to receive the submission back.

Submit_IssuesPending.JPG

For changes, how do I tell if a reviewer note is in the modified application or the change form?

Completing a change requires study teams to fill out a change form and then modify the application to incorporate those changes. Staff reviewers assigned to changes may have notes in both places, and when a change is sent back to a study team, ARROW will specify the question location.

Changenotes.JPG

As of March 25, 2017, click on the appropriate tab to view the reviewer notes in the change of protocol cover letter.

ChangeFormReviewerNotes.JPG

As of March 25, 2017, click on the appropriate tab to view the reviewer notes in the modified application.

ModifiedAppReviewerNotes.JPG

If you miss the questions in one tab, you will be prompted to complete these before the change can be submitted back to the HS IRBs Office. Use the live links under "Jump To" to go immediately to the questions not yet addressed.

ErrorMessage.JPG

How do I edit my response to a reviewer note?

After you have responded to a reviewer note, you can edit your response by clicking on the IRB Question link, in the upper left hand corner, for that reviewer note. This will open the note and allow you to edit your response. Please note that you cannot edit your responses to the reviewer notes after the application has been submitted back to the IRB office.

Link.JPG




Keywords:notes, issues pending, pre-review, questions, responding, reviewer comments, submit   Doc ID:17341
Owner:Faye L.Group:Health Sciences IRBs
Created:2011-03-16 19:00 CDTUpdated:2017-03-16 12:18 CDT
Sites:Health Sciences IRBs
Feedback:  11   10