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SAEs (Report Tool)

The purpose of this page is to display the list of Serious Adverse Events for the current Site. Users can click to add one event at a time or   to edit the desired event in the SAE module.

This tab will be hidden if:

• the user does not have permission for the Serious Adverse Events feature
• the Show SAEs check box on the Tabs module of the current Site Visit Report Template is not checked
• the Enable Subject Detail Configuration Variable under the Enrollment configuration group is set to False

• the Enable Serious Adverse Events configuration variable under the Enrollment configuration group is set to False

• the current user does not have permission for the SVR Process

The other tabs are Overview, Panels, Monitoring, Narrative, Attachments, Documents, Subjects, Consents, Deviations, Issues, 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.