Subject Deviations

The Subject Deviations tab displays the list of all deviations for the current subject. This tab will be hidden for those users who do not have permission for Protocol Deviations. Those with access can add a deviation by clicking the Add New Deviation button or edit a deviation by clicking , which opens the Deviation module. The caption for this tab section is defined in the Protocol Deviation Caption Plural Configuration variable. The default caption is Deviations.

 

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Field

Description

Date

This column lists dates of the deviations by most current first.

Class

This column indicates whether the deviation is classified as a Protocol Deviation, Minor Protocol Deviation, or Major Protocol Deviation. 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.

Src

This field will be hidden if the Enable Protocol Deviation Class configuration variable under the Protocol Deviation configuration group under the Protocol Deviation configuration group is set to false. If visible, these icons will appear:

 

= Auto-generated

= User entered

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 Date

This column displays the date that action has been taken.

Action Taken

This column displays the action that has been taken.

CAPA

A check in the box indicates that a CAPA (Corrective Action / Preventative Action) flag was set to Yes.