Issues (Report Tool)

The purpose of this page is to display the list of Site Issues for the current Site. Users can click to add one issue at a time or to edit the desired issue in the Issue module. If the Site Visit Report Template includes a sub-report of issues, only the issues that have a start date on or before the last day of the visit will be included. A closed issue will appear on the subsequent report, but not after.

This tab will be hidden if:

the user does not have permission for the Site Management feature
the Show Issues check box on the Tabs module of the current Site Visit Report Template is not checked
the current user does not have permission for the SVR Process

The other tabs that can be available are Overview, Panels, Monitoring, Narrative, Attachments, Documents, Subjects, Consents, Deviations, SAEs, Review, and History.

To view the report as it will print, click , which opens the report as a PDF file with the report status as Current Version Preview and the signature section is left blank. This button will be hidden if the current Site Visit Report does not have a Site Visit Report Template assigned, or if the Site Visit Report Status is Approved or higher.

The responses and data fields on the report will represent the current values at the time the button was clicked, except for any sub-report sections, which will reflect the current data up to the time the Site Visit Report Status is changed to First Draft. This prevents changes in sub-report data made after the First Draft from inadvertently updating the Site Visit Report.

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

Field	Description
Issue Date	This column displays the date that the issue was reported.
Closed Date	This column displays the date 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.
Type	This column displays the issue's type, based on the selections entered in the Site Issue Types system table.
Responsibility	This column displays the role of the person who is held accountable for this issue.
Subject	This column lists the subject who is connected to the issue. If this issue does not apply to a subject, then N/A will display.
Description	This column lists the issue as described in the Issue module.
Action Icon	This column indicates whether Action Taken has been entered. Action Taken has not been entered Action Taken has been entered
Action Date	This column lists the issue's date as entered in the Issue module.
Action Taken	This column lists the action that was taken for the issue as described in the Issue module.
Site Visit Report	This column displays the Site Visit Date of the Approved Site Visit Report where this issue first appeared with a status of Closed at the time the First Draft was submitted.
CAPA	This column will be hidden if the Enable Site Issue CAPA Configuration Variable on the Site configuration group is set to False.