Huron IRB - Create and Submit a Modification

Navigation

1. Make sure you are on the IRB tab.
2. Select “Submissions” in the sub-navigator to see your IRB submissions.
3. Select the “Active” tab.
4. Find and select the study related to your Modification.  

Study Workspace

1. Once inside the study workspace, you will select “Create Modifications/CR” to open the Modifications and Continuing Review SmartForm. 

Modifications SmartForm

Selection Page

1. Identify the purpose of the submission
   • Continuing Review: Select Continuing Review if you want to extend the approval period or close the study. Refer to the “Create and Submit a Continuing Review” tipsheet. 
   • Modification/Update:  Select Modification/Update to make a change to the study. 
   • Modification and Continuing Review. Combined Modifications and Continuing Reviews are limited to changes involving study team updates. More significant modifications should be submitted separately. 
2. Modification scope: This question will only appear if you select “Modification/Update” for question 1. You can edit study team information, other parts of the study, or both.  

Modification Summary Page

1. Study Enrollment Status:  Select the best option to describe the study enrollment status for this study. 
2. Notification of Subjects: Select the best option to describe the notification of subjects. You can select both items, if applicable. If you are notifying subjects, please add a description of how they will be notified to the “Other Attachments” section of the “Local Site Documents” page. 
3. Summarize the Modification: Write a brief summary of the modification.  

Make Changes

Your changes will vary depending on the modification you intend to make. You will see a page related to the modification you selected. For instance, if you select “edit the study team membership,” the Local Study Team page will appear. If you select another part of the study, you will see those pages instead. 

Final Page

1. After you have completed the Continuing Review /Study Closure SmartForm, you will come to the Final Page. You can check your submission for errors using the validate and compare features at the top of the left navigator. 
2. After you have corrected any errors, click finish and exit the SmartForm. 

Modification Workspace

Before entering the Modification, you were in the Study Workspace. After completing the Modification SmartForm, a new Modification workspace has been created as a follow-on to the original study. You can use the breadcrumb trail at the top of the page to navigate back to the Study Workspace. 

Submit Modification

1. After exiting the Continuing Review SmartForm, you are now in the Modification Workspace. Your Modification is completed, but not yet submitted. You will notice that the current status is “Pre-Submission.” Click on “Submit” in the left navigator, and a pop-up window will appear. 
2. Read the information in the pop-up window and click “OK” if you agree. 
3. Your modification has now been submitted. You will notice that the status is now “Pre-Review.”   
    

Article ID: 97
Created: March 17, 2025
Last Updated: March 17, 2025

Online URL: https://ohiostateresearch.knowledgebase.co/article/huron-irb-create-and-submit-a-modification-97.html