Site Issues

The Site Issues tab displays a list of issues for the current site that are either open or closed. The open issues will show on subsequent reports until the issue is closed. The issues can be linked to the integrated Site Visit Report.

 

This tab will be hidden if the user does not have permission for the Site Management feature (see Roles). Users can add a record by clicking or edit a record by clicking , which opens the Site Issue module.

 

Additional information is available on the Overview, Documents, and Subjects tabs.

 

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

 

 

Field

Description

Issue Date

This column lists the dates of the issues.

Closed Date

This column lists the dates that the issue was closed.

Days

This column displays the number of calendar days between the Issue Date and the Closed Date. If the Closed Date has not been provided, the current date will be used instead.

Type

This column lists the type of issue, which is brought forward from a list of Site Issue Types from the System Tables page.

Responsibility

This column lists the person who is held accountable for the resolution of the issue.

Subject

This column lists the subject who is connected to the issue, if any. This column will be visible when the Enable Subject Detail Configuration Variable under the Enrollment configuration group is set to True.

Description

This column provides details about the issue.

Action Icon

= Action Taken has not been entered

= Action Taken has been entered

Action Date

This column displays the date that action was taken.

Action Taken

This column displays the action that was taken.

Site Visit Report

This column lists the Site Visit Date of the Approved Site Visit Report that this Issue first appeared with a status of Closed at the time the First Draft was submitted.

CAPA

This column will be visible when the Enable Site Issue CAPA Configuration Variable under the Site configuration group is set to True.

Attachments

This column displays the number of documents attached to the record using X of Y, where Y is the total number of attachments, and X is the number that have been linked/uploaded. A check in front of the display indicates that all attachments have been linked or uploaded.