Subjects (Report Tool)

The purpose of this page is to provide access to the list of enrolled Subjects for the current Site. Subjects that have a status of Screening or Screen Failure will not be displayed. Users can click to add one subject at a time or to edit the desired subject in the Subject module.

This tab will be hidden if

the user does not have permission for the Subject Management feature or the SVR Process
the Enable Subject Detail Configuration Variable under the Enrollment configuration group is set to False
the Show Subjects check box on the Tabs tab of the current Site Visit Report Template is not checked

The other tabs that can be available are Overview, Panels, Monitoring, Narrative, Attachments, Documents, Consents, Deviations, 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.

Field	Description
Subject	The number and initials of the patient will be displayed.
Status Icon	= Enrolled = Completed = Discontinued
Status	The level of completion of the patient through the study is displayed. If the status is Discontinued, then the code for the subject's discontinuation reason also will be displayed in parentheses.
Enrollment Date	The subjects date of enrollment is displayed.
Gender	This field will be hidden if the Enable Subject Gender Configuration Variable under the Enrollment configuration group is set to False.
Protocol Version	The version of the protocol is displayed.
Subject Group	The subject's group will display if the project does has Subject Groups defined in the Project Tables.
Budget	This column will be hidden if the Enable Site Budgets Configuration Variable under the Finance and Budgets configuration group is set to False. If a budget is not listed, then the site budget may not be assigned to the site (see Site Budgets) or the subject does not fit under a site budget, perhaps because the subject consent date is before the site budget date.
Comment	Any additional information recorded will be displayed.