Subject

The Subject tab allows the user to add a single Subject record. After entering the required fields (*) on this tab clicking Save, the following tabs become available when the user has proper authorization: Enrollment, Consent, Import (if enabled), Visits, Deviations (user must have permission for Protocol Deviations feature), Budget, Payments (user must have permission for Site Payments feature), Custom Fields (if defined), and Attachments.

A user will be prevented from inactivating a record if any of the following conditions are true:

There is at least one completed subject visit for this subject
There is at least one subject event or subject visit that has been invoiced
There is at least one inventory transaction for this subject

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

Adding a Subject from Enrollment Page

An error message will display if the user attempts to add a new Subject to a Site that has a Site Status of Startup or Not Used.

When the configuration variable for the Subject Consent configuration group is set to Subject Consent Page (multiple per Subject), the Consent Date field will not be editable. Consent forms can be entered on the Consent tab.

When the configuration variable for the Subject Consent configuration group is set to Subject Consent Page (multiple per Subject), the Consent Date field will be editable.

Adding a Subject from Project Page

An error message will display if the user attempts to add a new Subject to a Site that has a Site Status of Startup or Not Used. Select a Site and the image above will appear. Select the Site and the image above will appear.

Editing a Subject - more tabs become available

Field	Description
Site	The field is read only.
Subject	This field will be hidden when adding a new record and read only when editing.
IDENTIFICATION
Initials	This field is restricted to three characters, all must be either letters or a hyphen. The value entered by the user will be converted to upper case when saved. This field will be hidden if the Enable Subject Initials configuration variable under the Enrollment configuration group under the Enrollment configuration group is set to False, otherwise it is required.
Screen Number	If the Enable Screening configuration variable under the Enrollment configuration group is set to True, then other configuration variables can be considered including: Enable Screen Number Enable Screen Number Auto-Assign Enable Screen Number Override Require Screen Number Screen Number Length (# of digits) Screen Number Prefix
Subject Number	If the Enable Subject Number configuration variable under the Enrollment configuration group is set to True, then other configuration variables can be considered including: Assign Subject Number at Status Enable Subject Number Auto-Assign Enable Subject Number Override Include Site Number in Subject Number Require Subject Number Subject Number Length (# of digits) Subject Number Prefix
Comment	The user can enter up to 200 characters. The field is visible when editing an existing record.
PROTOCOL
Protocol version	This field is required and restricted to the list of Protocol Versions defined on the Project Tables page for the current project.
Subject group	This field is required and restricted to the list of Subject Groups defined on the Project Tables page for the current project. If no subject groups are defined, then this field will be hidden.
Consent Date	When the configuration variable for the Subject Consent configuration group is set to Subject Consent Date Field (one per Subject), then this field is editable. When the configuration variable for the Subject Consent configuration group is set to Subject Consent Page (multiple per Subject), then this field is not editable. Consent forms can be entered on the Consent tab.
DEMOGRAPHICS
Date of Birth	This field will not be restricted to the project dates, but will be hidden if the Enable Subject Date of Birth configuration variable under the Enrollment configuration group is set to False.
Age (years)	The user can enter up to three digit integers between zero and 130. This field will be hidden if the Enable Subject Age configuration variable under the Enrollment configuration group is set to False.
Gender	This field will be hidden if the Enable Subject Gender configuration variable is set to False, otherwise it is required and the choices are: Female Male Unknown (this choice will be hidden if the Enable Subject Gender Unknown configuration variable under the Enrollment configuration group is set to False)