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How to Submit a Protocol Deviation Form

If at any point during your research activities you deviate from your approved study protocol/design, you will need to submit a Protocol Deviation Form. Please see the instructions below for submitting this form.

  1. Log into iRIS (
  2. Click on "View and Manage My Studies" on the left (under Featured Study Operations) and open your study.
  3. Click on the link to the left of the screen for “Protocol Deviation/Violation Form”.
  4. Select “Add a 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 deviation.
  6. At the end of the form, you should select the “Signoff and Submit” button.
  7. Select “Approve”, input your 4x4 and password, and select “Save Signoff”.

Please refer to SOP 407: Protocol Deviations and Unanticipated Problems for more information regarding the processing of these submissions.