Subject Attributes

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Subject specific data for a study is defined on the Subject Attributes Manager. Attributes are defined by study. A study must have the Requires Authorization property set to True/Yes to define attributes and store subject data. Subject attributes can be defined by the PI for the study or by BSI administrators. Once attributes have been defined, subject data can be entered through the Subject Manager or through Data Entry.

The Subject Attributes Editor is where the subject fields stored for a study are defined. Subject attributes can only be defined for studies that require authorization on databases that have Study Level Security enabled.

The Subject Attributes Editor displays the subject fields in a tree format. Users will be able to see the properties of a Subject Attribute field in the preview panel when they click on the field name in the Subject Attributes tree. Users will also be able to add verifiers to a study’s subject attributes through this editor.

Example: Dr. Pascal needs to enter information on diagnosis for specimens in his HR23 study. Using the Subject Attributes submanager, he creates a new field called “Diagnosis” which is specific to that study. He creates a code list associated with the field and adds 20 new possible diagnoses to choose among for each subject.

Add New Subject Attributes

If subject attributes have not yet been defined for a study, they can be created through the Subject Attributes Manager. If attributes have already been defined for a study they can be modified by filtering for the study on the manager and editing the study attributes.

To create new subject attributes:

On the Subject Attributes Manager, select New. A Select Study dialog will open.
Select the study.
- Press the ellipsis (...) button and select the study from the Select Codes dialog.

Type the Study ID directly into the text box.

Press OK on the Select Study dialog. The Subject Attribute Editor will open for the selected Study.
Define the fields that will store the subject data by Adding Subject Attribute Fields.
Select Save from the File menu or press the Save button to save the attributes.

View Subject Attributes

Subject attributes cannot be edited when opened for viewing.

To view subject attributes:

On the Subject Attributes Manager, find the study that corresponds to the subject attributes to view.
Highlight the study by clicking anywhere in the row.
Press the View button. The Subject Attribute Editor will open for the selected Study in View mode.

Edit Subject Attributes

To edit subject attributes:

On the Subject Attributes Manager, find the study that corresponds to the subject attributes to edit.
Highlight the study by clicking anywhere in the row.
Press the Edit button. The Subject Attributes Editor will open for the selected Study.

Delete Subject Attributes

Subject attributes for a study cannot be deleted if data has been entered in the database that references the defined attributes.

To delete subject attributes:

On the Subject Attributes Manager, find the study that corresponds to the subject attributes to delete.
Highlight the study by clicking anywhere in the row.
Press the Delete button. A confirmation dialog will be displayed.
Press Yes to delete the subject attributes or No to cancel.

Duplicate Subject Attributes

The Duplicate button on the Subject Attributes manager allows users to create a new subject attribute entry with the same fields and verifiers as an existing set of subject attributes.

To duplicate a consent form:

Highlight the subject attributes to be duplicated in the Subject Attributes manager.
Press the Duplicate button on the right side of the manager.
The Specify Identification for Definition dialog will open. Choose a Study ID to associate with the subject attributes.
Press the OK button. The Subject Attributes editor will open with a duplicate of the selected subject attributes.