To submit an amendment or continuing review for a previously approved study:
- Log into I-Manager.
- Scroll to the “My Studies” section near the bottom of the page, and click on the study number.
- From the study home page, click “Start xForm” in the left side menu.
- Select “Amendment xForm” or “Continuing Review xForm”.
- Complete the xForm and attach the required documents.
Amendments: Use track changes, highlight, or otherwise clearly mark your changes in all relevant study documents (protocol form, consent forms, recruitment materials, etc.). Attach these revised documents will be attached to the amendment xForm.
Continuing Reviews: Attach the current approved versions of your protocol, consent form(s) and all recruitment materials.
- Enter your password to submit the form.
- If you are not the PI, the study PI will receive a link to the form. The PI will also need to electronically sign/submit the form.
- Once the PI submits the form, it will be routed to the IRB for review.
Click here for a video demonstration.
- Amendments: The majority of amendments are reviewed by IRB office staff, and you will receive either requests for revisions or an approval letter within 1 week. For major changes, your amendment may be sent to an IRB member for review. If this occurs, you will receive either requests for revisions or an approval letter within 2-3 weeks.
- Continuing Reviews: You’ll receive an automated notice when your continuing review is accepted for review. From then, if we have questions we’ll let you know within 1 week (or 3 weeks if your study is sent to an IRB member for review, but this is uncommon). If you don’t hear anything from us after the automated notice, this means we had no questions or concerns and you will receive your new approval letter on or just before the expiration date.