How to Conduct a Modification Response Review in ARROW
Instructions for IRB Members
As an IRB Member, you may be asked to review a study team's response to requested modifications. The IRB Staff Reviewer will assign the study to you for review of modifications. To complete your modification response review, follow these steps:
Once you are ready to comment on the review or indicate your approval, click on "Submit Modification Response Notes" under My Activities.
- Login to ARROW at http://arrow.wisc.edu.
- Make sure you are in your IRB Member role.
- Click on your "Inbox: All" tab.
- Open the Modification Response you want to review by clicking on the study name.
- Once you are in the Submission Workspace, review the information in the History tab. The IRB Staff Reviewer who assigned the modification response to you will include a comment about whether they feel the study team has adequately addressed the IRB's requests for modification and any specific modifications they would like you to review.
- From the Submission Workspace, click the "Reviewer Notes" tab to review the IRB's request to the study team and their responses.
You have now completed your modification response review. You can logout of ARROW, or click "My Home" (upper right corner) to return to your inbox.
- In the new window that appears, fill out the activity form.
- Once you have completed the activity form, click "OK" in the bottom right corner to submit to the IRB.
- View Differences--Click here for a helpful note on using "View Differences"
- Click on the button labeled “View Differences” in the submission workspace to review the differences between the most current version of the application and a previous version of the application.
- PLEASE NOTE: The system automatically defaults to comparing the SAME version, please click the drop down menu to select a previous version of the application. For assistance in which version to select, contact the assigned staff reviewer.
- Once you have finished reviewing the application differences, you can exit the using the "Close" button near the top of the screen. This will take you back to the submission workspace.
- Change Log
- From the submission workspace, click on the "Change Log" tab to open the list of changes that were made, sorted in the order in which they were made.
- The most recent changes will be on top, and correspond to a page of the application. Click on the top line that says "Change Log" (next to the "i" icon).
- For example, the change log will show the following when a consent form is updated.
- To move to the change made before or after the information you are viewing, click "Previous" or "Next".
- To return to the submission workspace, click on the title of the study directly above the change information.
Notes on Reviewing a Modification Response
- The IRB Request Reviewer Notes should reflect what the IRB determined was needed from the study team in order to finalize approval of the study. Upon review of the Reviewer Notes and the study team’s responses to these notes, you should determine whether the modification requests have been adequately addressed.
- The “View Differences” feature is a helpful way to see exactly how the study team revised the IRB application in order to address the IRB’s requests for modification. Your role is to determine whether the study team has adequately addressed the modification requests or whether additional information and/or modifications are needed.
- In the “Submit Modification Response Notes” you will be asked whether you agree with the staff reviewer that the investigator has addressed the IRB’s requests. If you do not agree that all of the requests have been addressed, you must include a description of what additional information and/or modifications are needed. You will also need to determine whether any of the responses require full board review and whether the study is now approvable. If you have questions and/or concerns about the modification response, please call the IRB Staff Reviewer to discuss these questions and/or concerns prior to submitting the modification response notes.
WHO TO CONTACT
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