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.
- Log into iRIS (https://iris.ou.edu).
- Click on "View and Manage My Studies" on the left (under Featured Study Operations) and open your study.
- Click on the link to the left of the screen for “Protocol Deviation/Violation Form”.
- Select “Add a New Form”.
- 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.
- At the end of the form, you should select the “Signoff and Submit” button.
- 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.