A protocol deviation occurs when, without significant consequences, the activities on a study diverge from the Institutional Review Board-approved protocol, e.g., missing a visit window because the subject is traveling.

-Norman M. Goldfarb Journal of Clinical Research Best Practices Nov 2005

The Deviation Log tab is located on the main trial page, as shown below.

Click on the tab to open the list of previously submitted deviations, and to add new deviations. The + Add Deviation button will show in the header bar above the list of deviations.

When recording new deviations, you'll need to add the relevant information based on whether it's a Site Level or Subject Level Deviation. Review the Loom below to see the process of submitting a Site level deviation. All fields with a red asterisk are required in order to save the deviation.

Some information may not be available at the time of the deviation, or previously submitted information may need to be updated. Once a deviation is submitted, you can click the deviation to open the details in a pane to the right of the screen. If a detail can be edited, an Edit option will appear when you hover your cursor over the field.

Subject level deviations can be submitted from the trial page, but can also be submitted at the individual subject level.

When submitting a protocol deviation at the subject level, the Deviation Type, Site, and Subject will auto-populate based on the subject profile you are on, and can not be changed.

The table below outlines which roles can submit/edit, view, or sign protocol deviations.