Deviations

The Deviations tab provides the ability to view and edit a deviation record for the current subject. This tab will be hidden if the user does not have permission for the Protocol Deviations feature. Users can add an item by clicking Add New Subject Deviation or edit an item by clicking , which opens the Deviation module.

The caption for this tab is defined in the Protocol Deviation Caption Plural configuration variable. The default caption is Deviations. Other tabs are available to track additional information including Subject, Enrollment, Consent, Import (if enabled), Visits, Budget, Payments, Custom Fields (if defined), and Attachments.

Click Common Buttons for a description of the buttons found throughout the system and their uses.

Field	Description
Date	This column lists dates of the deviations.
Class	This column indicates whether the deviation is classified as a Protocol Deviation, Minor Protocol Violation, or Major Protocol Violation. This field will be hidden if the Enable Protocol Deviation Class Configuration variable under the Protocol Deviation configuration group is set to false.
Type	This column indicates the Protocol Deviation Type from the System Tables Page. This field will be hidden if the Enable Protocol Deviation Class Configuration variable under the Protocol Deviation configuration group is set to false.
Auto Check box	This column will be checked if the deviation has been auto-generated.
Description	This column lists a brief explanation of the deviation. This field will be hidden if the Enable Protocol Deviation Class Configuration variable under the Protocol Deviation configuration group is set to false.
Action Check box	This column has no caption. The column will have a check mark if the Action Taken has been provided.
Action Date	This column indicates the action taken date.
Action Taken	This column contains a sub-set of what was entered into the Action Taken field within Corrective Action tab.
CAPA	This column will be checked if the Corrective Action/Preventative Action flag on the Deviation module has been selected.