Reporting a Protocol Deviation
How to Submit a Protocol Deviation:
Please note that the Protocol Deviation Report is used to notify the IRB that the research has not been compliant or has deviated from the approved study. If a researcher is notifying the IRB of a proposed change to the study, the Renewal Application should be used.
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Log-in to IRBWise and open the study.
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The protocol should be open on the screen. In the middle of the page, on the left, you should see the heading “Protocol Deviations”. Click on the link that states, “Report Protocol Deviation”.
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This will open the Protocol Deviation Report.
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The report should be completed and saved.
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When the report is ready to be submitted, click on the “Continue >>>” button.
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In the endorsements, check the box to agree to the statements and type in your name.
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Select the option to submit the protocol directly to the IRB, then click the button that states, ‘Finish’.