Deviations (Report Tool)

The purpose of this page will be to display the list of all Deviation records for the current Site in descending date order. Records will be grouped based on the Subject. If a deviation is not linked to a specific subject, then it will be displayed at the top of the list and not in a group.

The caption for this tab is defined in the Protocol Deviation Caption Plural configuration variable under the Protocol Deviation configuration group with a default caption of Deviations. Users can click to add one deviation at a time or   to edit the desired deviation in the Deviation module.

This tab will be hidden if:

• the user does not have permission for the Protocol Deviations feature
• the Show Deviations 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, Issues, 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.