Subjects

Subject data can be stored in BSI on databases that have Study Level Security enabled and data can only be defined and stored for studies that require authorization. Only users that have been authorized for a study can enter, view, or print labels on subject data.

There are two types of Subject data fields: common and study-specific fields. Common subject data is stored in fields that are available across studies. This information does not change depending on the study and can include items such as First Name, Last Name, and Date of Birth. Study-specific data is stored in fields which only pertain to a given study.

Subject Attributes for a specific Study ID are defined in the Subject Attributes submanager. Once these fields have been defined, they can be entered by users in the Subject Manager and Editor or via Data Entry.

The Subject Editor is used to add new subject data and to edit existing subject data and can be opened from the Subject Manager or through a data entry add batch.  A new subject record is created based on the Subject ID and Study ID.  

Users must have permission to access the Subjects manager. Users who can access the Subjects manager but have not been authorized for a study, can view default subject fields for any database subject, including: Study ID, Subject ID, Date Created, Created By, Date Last , and any common subject level fields.

Add New Subject Data

Subject data can be added through the Subject Manager.  It can also be added through a data entry add batch.

To add new subject data:

1. On the Subject Manager, press the New button.  The Select Study ID dialog will open.
2. Select the study for the new subject.
   • Enter the study name or ID directly into the Study ID field.
   • Press the Ellipsis (...) button to open the Select Codes dialog and select the desired study from the code list.
3. Press OK to open the Subject Editor or press Cancel to exit without opening the editor.
4. Enter the new subject data in the Subject Editor.
   • Enter subject data directly into the editor.
   • Import a text file with the Import Wizard by selecting File > Import.
   • Press the Toggle Form/Table button to open a dialog that displays all of the subject attribute fields in form layout.
5. Save the editor to save the subject data by selecting File > Save or pressing the Save button.  All errors must be resolved before the new subject data can be successfully saved.

Add Subjects

When the Subject Editor is opened to add new data, it contains one empty row.  

To add data to this row:

1. Select a field and begin typing in it.  

2. Press the Tab key to move to the next field.  Some fields offer a code list from which to choose values.  To open this list simply double click in a field and press the ellipsis (...) button that appears.  To add a value to the field, click on a value in the list to highlight it and then press the OK button.  

3. When the end of a row is reached, pressing the Tab key will create a new row. Rows may also be added by selecting Insert from the Edit menu or pressing the Insert button.  The new row will be inserted above the row where the cursor is located. Rows can also be added by pressing the down arrow key from anywhere in the last row.

Rows may be deleted by selecting Delete from the Edit menu or pressing the Delete button.  Subject data can only be deleted if the subject ID does not exist for specimens in the database.

Users can also import data into the editor from a text or Excel file by selecting Import from the File menu.

After subject data has been entered, saving the editor will enter the data in the database.

View Subject Data

When the Subject Editor is opened in view mode, no changes can be made to the data displayed.

To view subject data:

1. Highlight the subject(s) to view in the manager.

   • Click anywhere in the subject row to highlight it.

   • Click and drag to select multiple rows.

   • Use Shift + Click or Ctrl + Click to select multiple rows.

2. Press the View button on the manager.  The Subject Editor will open with the selected subjects displayed.

Edit Subject Data

It is possible to edit existing subject data by opening selected subjects in the editor, making changes and saving.

To edit subject data:

1. Highlight the subject(s) to edit in the manager.

   • Click anywhere in the subject row to highlight it.

   • Click and drag to select multiple rows.

   • Use Shift + Click or Ctrl + Click to select multiple rows.

2. Press the Edit button on the manager.  The Subject Editor will open with the selected subjects displayed.

3. Make any desired changes.  Users can change multiple fields within a column via the Mass Change and Find and Replace options.

4. Changes will appear in bold in the editor.

5. Select File > Save or press the Save button to save changes.  All errors must be resolved before changes can be saved.

Edit Subjects

When the Subject Editor is opened containing existing subject data, data can be edited as in other tables in BSI.  Navigate to the data to be changed by clicking in the cell or using tab, enter, or the keyboard arrow keys.  Some fields offer a code list from which to choose values.  To open this list simply double click in a field and press the ellipsis (...) button that appears.  To add a value to the field, click on a value in the list to highlight it and then press the OK button.

Rows may also be added by selecting Insert from the Edit menu or pressing the Insert button.  The new row will be inserted above the row where the cursor is located.

Rows may be deleted by selecting Delete from the Edit menu or pressing the Delete button.  Subject data can only be deleted if the Subject ID does not exist for specimens in the database.

Users can also import data into the editor from a text or Excel file by selecting Import from the File menu.

After subject data has been modified, saving the editor will enter the data in the database.

Delete Subject Data

Subject data can only be deleted through the Subject Manager if the data does not link to a subject ID and study that exists as specimen data in the database.

To delete subject data:

1. Highlight the subject(s) to be deleted in the manager.

   • Click anywhere in the subject row to highlight it.

   • Click and drag to select multiple rows.

   • Use Shift + Click or Ctrl + Click to select multiple rows.

2. Press the Delete button on the manager.  A confirmation dialog will open.

3. Select Yes to delete the selected subjects.  Select No to close the confirmation dialog without deleting.

4. If the Subject ID is linked to existing sample data, the Subject cannot be deleted.

Switch to Form Editor

The form editor is available in the Subject Editor to provide a different interface for entering data or editing existing data.  When the form is opened from the Subject Editor, it will contain only the fields which are shown in the Table view.

To use the Form Editor:

1. Select the row(s) to be edited in the Form view.
2. Select Toggle Form/Table from the Tools menu or press the Toggle Form/Table button.  The Subject editor switch to Form View.
3. Enter or update the subject data in the form.
4. Use the navigation tools at the bottom of the form to continue to add data as needed:
   • Next - Advances the current form to the next subject row in the Subject Editor.
   • Previous - Changes the current form to the previous subject row in the Subject Editor.
   • Go To Record - Changes the current form to the row number entered in the Current Record field.

5. When the subject data has been entered, press the Save button on the toolbar to save the new subject data.

Filtering to Find Subject Data

The standard Filter button at the bottom left of the manager will open the Standard Search dialog that allows users to filter on several criterion.  In addition to the standard manager filter, there is a quick Study ID filter in the bottom right of the manager.

Press the Ellipsis (...) button next to the Study ID field to open the Select Codes dialog.  Select the appropriate study and press OK to filter the manager.  Users can also enter the study name or ID directly into the field.

Universal Subjects

Universal Subject IDs are used to link general data from a single subject across multiple studies. A single person may participate in multiple studies and have their records from each one stored with multiple Subject IDs in BSI which are connected via the Universal Subject ID.

When enabled, Universal Subject IDs are required for each Subject ID. All general subject fields, usually demographic fields, such as First Name, Last Name, DOB, and Sex that are created via the Customization module, will be tied to the Universal Subject ID, which is entered a single time, then connected to any corresponding Subject IDs in another study. Study-specific data, such as cancer type or whether or not the subject smokes, will remain tied to only the study. Users who have study permissions for at least one study which a particular subject is part of, will have access to view study-specific data on that subject for the study/studies for which they have permission.

All users with permissions to access the Subjects module will have access to view general subject data on specimens.

A system preference must be enabled by administrators to enforce Universal Subject IDs across a database. There are three other optional system preferences related to Universal Subjects: one which will delete Universal Subjects which are no longer tied to a study/subject, another which requires a separate role permission (Edit Universal Subject) to be assigned for users to edit universal subject data, and one which is required before users can use the Generate Universal Subject IDs tool that determines the format that the ID will be generated in.

Creating a new Universal Subject

1. From the Subjects manager, select New.
2. Select the Study which the subjects will be entered for and select OK.
3. Enter general subject data for any number of subjects and assign Subjects IDs to them.
4. Enter a Universal Subject ID for each new subject created in one of two ways:
   • Manually enter the IDs, only if you are sure they have not been used before.
   • Highlight all of the subjects and select the Generate Universal Subject IDs tool from the Tools menu or the menu bar.

Linking a new Subject to an existing Universal Subject ID

1. From the Subjects manager, select New.
2. Select the Study which the subjects will be entered for and select OK.
3. Use one of the following methods to enter pre-existing Universal Subject IDs which match the subjects being entered:
   • Import – use the import wizard to import the Universal Subject IDs
   • Find Universal Subject IDs tool –
     • Highlight an empty row and select Find Universal Subject IDs from the Tools menu.
4. A dialog will open. Enter some general subject data belonging to the subject you are entering in the fields provided.
5. Select the Report button.
6. A list of Universal Subjects matching the entered criteria will open.
7. Locate and select the correct Universal Subject, then select OK. General subject data will be added to the row and the Universal Subject ID will be assigned to the subject.