How to Submit a Modification/Notification Form

To make changes to the study after approval, you must submit a Modification/Notification form. Please follow the instructions below to complete this form.

  1. Log into iRIS (
  2. Click on the “My Studies” tab on the left (under Study Assistant) and open your study.
  3. Click on the link to the left of the screen for “Modification/Notification”.
  4. Select “Add New Form”.
  5. Respond to the questions and click the “Save and Continue” button in the top right to move through the various sections. Be sure to provide a detailed description of the proposed changes.
  6. The last section will give you an opportunity to revise your application and/or study documents and attach them to the modification form. Use the gray bars provided for this purpose. Note—you may need to click the “Add Revision” button to make changes to the previously approved forms.
  7. Once these documents have been attached, click the “Save and Continue” button once more and select the “Signoff and Submit” button.
  8. Select “Approve”, input your 4x4 and password, and select “Save Signoff”.