#  Editing a Submission 

 



You can continue to make changes to a study until you submit it for IRB review. You can also make changes if the IRB requests clarifications (except during committee review) or modifications.

**Note:** steps indicated here can also be completed for Modifications/Updates, Sites, Continuing Review and RNI submissions.

**To edit a study before it has been submitted:**

1\. From My Inbox, click the name of the study to open it. Note: If the study does not appear in your inbox, see [Accessing a Submission](/accessing-submission).

2\. Click **Edit Study** on the left. For Modifications or Continuing Reviews, click Edit Submission.

3\. Make changes as appropriate. When updating a study document previously submitted to the IRB, revise it in tracked-changes format and replace the original document with the tracked-changes version. When the IRB approves the document, all tracked changes will be accepted and comments removed in the final version.

4\. Exit the study. Choose one of these ways to exit:  
> Click the **Exit** link. If prompted to save the study, click **Save Changes & Exit.**  
> Click **Continue** on each form, and then click the **Save & Exit** button on the Next Steps page of the form.

If you have submitted the study and you need to make edits, or edits are requested from an Ancillary Reviewer, you can still make edits to the study without having to make a special request to the IRB to open the study record.

**To edit a study after it has been submitted:**

1\. Go to the Submissions page (click “IRB” on the menu at the top of the page)

2\. From the All Submissions or In Review tab, click the name of the study to open it. See [Accessing a Submission](/accessing-submission) for more instructions.

3\. Click **Withdraw** on the left. Completing the Withdraw activity only affects the submission. If a modification or continuing review on an approved study is being withdrawn, it will only withdraw that submission and will not affect the current status of the study.

(Optional) Use the comment box space, or document upload, to provide additional information. Do not upload any study documents here; study document should be uploaded to the SmartForm.

4\. Click **OK**. The PI, any PI Proxy, the Primary Contact and IRB Coordinator will receive a notice that the submission has been withdrawn.

5\. Make changes as appropriate. When updating a study document previously submitted to the IRB, revise it in tracked-changes format and replace the original document with the tracked-changes version. When the IRB approves the document, all tracked changes will be accepted and comments removed in the final version.

6\. Exit the study. Choose one of these ways to exit:   
> Click the **Exit** link. If prompted to save the study, click **Save Changes & Exit.**  
> Click **Continue** on each form, and then click the **Save & Exit** button on the Next Steps page of the form.

7\. After edits are completed, the PI or PI Proxy must complete the **Submit** activity again, to send it back to the IRB for review.

Sort**TIP**

When the submission is in pre-submission or clarifications requested, click **Discard** to completely remove a submission from further consideration by the IRB. Completing the Discard activity only affects the submission. If a modification or continuing review on an approved study is being discarded, it will only discard that submission and will not affect the current status of the study.







 

- [Logging In](/logging-in "Logging In")
- [Creating a New Study](/creating-new-study "Creating a New Study")
    - [Study SmartForm](/study-smartform "What to Include in a Study SmartForm")
    - [Site SmartForm](/site-smartform "What to Include in a Site SmartForm")
    - [SmartForm Attachments](/checklist-study-smartform-attachments "Checklist of SmartForm Attachments")
    - [External IRB Submission](/ExternalIRB "Requesting External IRB Review")
- [Editing a Submission](/editing-submission "Editing a Submission")
- [Checking for Errors](/check-submission-errors "Checking a Submission for Errors")
- [Submitting a Study](/submitting-a-study "Submitting a Study for Review")
- [Checking the Status](/check-the-status "Checking the Status of a Submission")
- [Accessing a Submission](/accessing-submission "Accessing a Submission")
- [Responding to the IRB](/responding-to-irb "Responding to a Request for Clarifications or Modifications")
- [Changing Study Documents](/changing-study-documents "Changing Documents on a Study")
- [Communicating with Staff](/communicating-with-staff "Communicating with Staff During Review")
- [Managing Related Projects](/managing-related-projects "Managing Related Projects")
- [Finding the IRB Decision](/finding-IRB-determination "Finding Determination Letters and Approved Documents")
- [Managing PI Proxy](/about-pi-proxy "Managing Principal Investigator (PI) Proxy")
- [Changing a Primary Contact](/change-primary-contact "Changing the Study Primary Contact")
- [Managing Guests](/about-study-guests "Managing Guests with View-Only Permissions to the Study")
- [Copying a Study](/copy-submission "Copying a Study")
- [Creating a Follow On](/create-followon "Creating a Follow-On Submission after Study Approval")
    - [Modification SmartForm](/mod-smartform "What to Include in a Modification SmartForm")
    - [Renewal(CR) SmartForm](/cr-smartform "What to Include in a Continuing Review SmartForm")
    - [RNI SmartForm](/rni-smartform "What to Include in a Reportable New Information SmartForm")
    - [Site Modification (for External IRB Update)](/ExternalIRB "Requesting External IRB Review")
- [Closing a Study](/study-closure "Closing a Study")
- [Generating Reports](/generating-reports "Generating Standard Reports")