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, 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.

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 Yes.
> Click Continue on each form, and then click the Finish button on the final 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 (linked on the left of your Inbox page)

2. From the All Submissions or In Review tab, click the name of the study to open it.  See Accessing a 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  If a modification or continuing review on an approved study is being withdrawn, it will only withdraw that submission and will not affect the current status of the study.

4. (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.

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 The PI, any PI Proxy, the Primary Contact and IRB Coordinator will receive a notice that the submission has been withdrawn.

6. 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.

7. Exit the study. Choose one of these ways to exit: 
> Click the Exit link. If prompted to save the study, click Yes.
> Click Continue on each form, and then click the Finish button on the final form.

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

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.