Permissions: Users must have the Data Central Designer privilege to configure the Workbook or Graphical Patient Profiles.

Data Central includes two types of Patient Profiles: Graphical and Workbook. Both are configured within the study after the Data Central study configuration is completed and saved.

Graphical Patient Profiles

Access the Graphical Patient Profile (GPP) by selecting a record in the Subjects panel and clicking the Graphical Patient Profile icon. This icon is located in the panel toolbar, and also appears above Subjects in the left navigation. 

The Graphical Patient Profile opens for the selected subject. 

Multiple GPPs are indicated by a drop-down arrow next to the Profile Name; ensure the correct profile is selected when copying. To configure the GPP, click the Configure icon in the panel toolbar. Note that a study can have multiple GPPs.

The view updates to options available when configuring or managing Graphical Patient Profiles.  

From left to right the icon actions are:

• New Profile
• Copy Profile
• Delete Profile
• Add Group
• Reorder Groups
• Save Profile
• Configure
• Dock Item
• Maximize / Restore (window)
• Close (window)

Configure a Graphical Patient Profile

To create a new profile, click the New Profile icon in the panel toolbar.

A new window opens.  

Profile Name

'New Profile' is the default name for the first graphical patient profile created. This can be changed by entering a new name in the Profile Name field.

Default Subject Field

The Default Subject Field defaults to 'Subject' and typically should not be changed unless the study uses a different subject field, such as SubjID.

Subjects Domain

Select the Data Store and Domain from the drop-down list that contain the subject data, for example, Clinical: DM.

Subject Header Fields

Select the fields from the multi-select drop-down list. Selected fields display in the top section of the Patient Profile. 

Timeline Type

Select the radio button to define whether the calendar date or the study day is used for the timeline on the x-axis. This selection applies to all charts created in the GPP.

• Calendar Date (default)
• Study Day: When Study Day is selected, the Profile Earliest Date, Fixed Date option is unavailable.

Profile Earliest Date

Select the radio button to determine the date used as the earliest date on the x-axis slider. Available selections include:

• Automatic (default): The earliest date on the x-axis is the earliest data point across all charts.
• Fixed Date: A Fixed date field opens. Enter a date or use the calendar picker to select a date. The selected date displays as the earliest date on the x-axis. This option is unavailable when the Timeline Type is set to Study Day.
• From Field: Additional fields display, including Start Date Domain, Start Date Field, and optionally Start Date Subject Id Field Override. Select a domain from the Start Date Domain drop-down, then select a field from the Start Date Field drop-down. For example, if Start Date Domain is DM and Start Date Field is Birthdate, the earliest date on the x-axis is the earliest value in the DM Birthdate field.

Click the Save icon in the panel toolbar.

Define the Graphical Patient Profile Groups

Depending on whether a profile is created or copied, groups can be added or modified as needed. Click the Add Group icon in the panel toolbar and define the group, such as Adverse Events. New groups are added at the bottom of the profile. Use the scrollbar to view newly added groups.

To the right of the Group Name, click the plus icon to add a chart or the trash icon to delete the group.

Groups within a Graphical Patient Profile can either be added as an Event or as a Finding.

For example, Adverse Events would be captured as an Event. Domains such as Labs or Vitals would be captured as Findings.

Define an Events Group

1. Starting with Adverse Events, update the Group Name from New Group to Adverse Events, then click the Add Chart icon (screenshot above).
2. The Chart Configuration window opens. The default value in the Name field is New Chart. Rename the chart as needed. The name displays as a sub-name for the chart, for example, AEs by AE Term.
3. Select Chart Type. The default is Events, which is appropriate for Adverse Events. Depending on the data, select either Events or Findings.
4. In the Domain field, select the domain that contains the data for the group. For Adverse Events, this should be the domain that holds the AE data, typically from the Clinical Staging Area. This field is required.
5. In the Subject Field Override field, specify the subject field for the domain if it differs from the Default Subject Field in the above settings.
6. In the Start Date Field, select the start date field of the event such as AESTDAT if Calendar Date was selected for Timeline Type. If Study Day was selected for Timeline Type, then select the appropriate study day field. This is a required field.
7. In the End Date Field, select the end date field of the event, if applicable. Select the appropriate field based on the selected Timeline Type of Calendar Date or Study Day. 
8. In the Ongoing Flag Field, select the field that identifies if the event is ongoing.
9. In the Event Type Field, select the field that defines what displays on the Y-axis. For example, selecting AETERM lists Adverse Event terms on the Y-axis. Selecting AESER displays Yes and No, grouping events by seriousness.
10. Select the Additional Filter checkbox to apply an extra filter to the patient profile. For example, to display only serious adverse events, select the Serious field from the drop-down and enter the filter value. Only serious AEs display.
11. In the Legend Grouping Field, select the field used to group data in the legend. For example, selecting a severity or toxicity grade field color-codes adverse events by that grouping.
    

12. Use the Tooltip Format field to define the content displayed when hovering over a data point. By default, tooltips display the date and the Y-axis value. If the format is changed, those values no longer display unless explicitly added.

    To customize the tooltip, type the @ symbol. A drop-down list of domain fields displays. Select a field to include it in the tooltip. To add additional fields, type @ again.
    To display values on separate lines, add <br> to insert a line break. Field names do not display in the tooltip, only values. For example, when using the Vital Signs domain, the tooltip can display the PULSE value on one line and the RATE value on the next line.

    To include the field name in the tooltip, enter the text before the @ symbol, for example, PULSE: @[VSPULSE]<br>RATE: @VSRATE]. Use a dash or colon before the field name to clearly identify each value.
    
    The result should look like this:
    

    Important: Adding extra spaces in the code causes an error.  

13. The Legend Color overrides is used to change the default colors in a legend. This only displays when a Legend Grouping Field has been selected. To change the default colors in the legend:
    1. Click in the Facet field. A drop-down with the available facets opens.  
    2. Select a Facet.
    3. Click in the Override Color field. Click the drop-down and a color palate window opens. Select the color by using options in the color window.
    4. Click Apply.
    5. Continue to select a color for each facet of the legend.
    6. To delete a facet / color selection right-click and select Delete Color Override.
       
14. Click the Done button in the right corner.

Define a Findings Group

To define data captured as a Finding in the Graphical Patient Profile, follow these steps. The steps describe adding data to the Labs group. Two methods are available, depending on the data. The same principles apply to other Findings groups. Regardless of the method used, the initial steps are the same, and the resulting charts appear similar to the following example.

1. Click Add Group icon in the panel toolbar.
2. Scroll to the lower section of the screen to see the new group and update the New Group name (in the screenshot below the New Group name is updated to Labs). 
3. Click the Add Chart icon to begin the chart configuration process, or click Delete Group to remove the group from the graphical patient profile.
   
4. When Add Chart is selected, the Chart Configuration window opens. The default value in the Name field is New Chart. Rename the chart as needed. The name displays as a sub-name for the chart. For Labs, name the chart by lab test to display each test separately, such as AST. The graph displays to the right of the configuration options.
5. In Chart Type, the default is Events. For Labs, select Findings.
6. In the Domain field, select the domain that contains the data related to the group. For Labs, this should be the domain that holds the Lab results. This is a required field.
7. In the Subject Field Override field, specify the subject field for the domain if it differs from the Default Subject Field in the above settings.
8. In the Start Date Field, select the field for the date of the finding. This field is required.
9. In the Value Field, select the field that identifies the lab result value.
10. Click in the Use Normals checkbox to define ranges for the test.
    Ranges can be identified by a specific value, so it is the same range for all patients, or by the value in a specified field, so the value would be patient-specific.
    1. For the same range for all patients, click in the Value radio button and enter the number for the Normal Min field and the number for the Normal Max field.
    2. For a patient-specific range, click in the Field radio button and then select the field that holds the low value for the Normal Min field and the field that holds the high value for the Normal Max field.
11. Select the Additional Filter checkbox to apply a filter, such as by test name. 
    From the drop-down list, select the field that identifies the lab name. 
    In the free-form field, enter the lab name exactly as it appears in the selected field.
    In this example a legend is not required, so no selection is made in the Legend Grouping Field.  
12. Use the Tooltip Format field to define what displays in the tooltip when hovering over a data point. By default, tooltips display the date and the Y-axis value. If the format is changed, those values no longer display unless explicitly included.
13. To change the tooltip display, type @. A drop-down with the domain fields displays; select the field to display in the tooltip. To add another, type the @ symbol again. Note that the fields are not displayed in the tooltip, just the value.
    To add the field name to the tooltip, type it into the field before the @ symbol, such as ‘Site: @[Site]’. Consider using a dash before the field name to help identify each item.
    
14. Click the Done button in the bottom right corner. 
15. To add another Lab to the patient profile, click the Add Chart icon and repeat the steps.
16. After all charts are added or updated, click the Save icon in the panel toolbar to save the changes. If the window is closed before saving, a warning dialog box displays. Click Cancel to return to edit mode, or click Discard Changes to undo the changes.  
17. When finished, click the Close icon in the panel toolbar to close the configuration window.

Modify Existing Charts

The icons on the right-hand side of the chart allow you to delete or edit a chart, and view data.

Click the Edit icon to edit an existing chart.  See sections Defining an Events Group and Defining a Findings Group for details.

Click the View Data icon to see data listed as defined in the chart.

Delete a Chart (Event or Finding)

To delete a chart (event or finding), such as a specific lab test or vital sign, rather than the entire group, click the Delete Chart icon. 

Undo Delete Group / Undo Delete Chart

Delete groups and charts are highlighted in pink. If a group or chart is deleted in error, click the Undo Delete Group or Undo Delete Chart icon.

Reorder a Graphical Patient Profile

If the GPP is not already open in Configuration mode, start with step 1. If the GPP is open in Configuration mode, start with step 3.

1. From the Subjects panel, highlight a subject and click the Graphical Patient Profile icon in the panel toolbar. This opens the profile in a separate window (This can be docked to the sheet).
2. Click the Configure icon in the panel toolbar (this changes the panel toolbar icons).
3. Click the Reorder icon in the panel toolbar.
4. The Reorder Groups window opens. Simply drag the groups to the desired order.
   
5. Click the Done button in the right-hand corner.

Configure a Workbook Patient Profile

Workbook Patient Profiles can be configured by anyone with the Data Central Designer privilege.

Each study can have one Workbook Patient Profile.

To configure the Workbook Patient Profile (WPP):

1. Click the Workbook icon in the panel toolbar.
2. Click Configure.
3. The Export Patient Profile Workbook window opens. The window is blank if a WPP has not been configured.
   
   • In the Header field, type a left bracket followed by the first letters of the field to add. A drop-down list displays available fields. Select a field to insert it into the header.
     Text can be entered anywhere in the header. To display text before a field, enter the text first, for example: Patient Profile Workbook for: [Subject].
     

   • In Data Stores and Domains, expand the data store that contains the desired domains. In this example we expand the data store Clinical. Click the checkbox next to 'Clinical' to select all domains in that data store, or select individual domains from the list by checking the box(es) for each domain. In the example the domain Adverse Events is selected. 

     Once selected, the domain is highlighted in blue, and all its variables are listed in the Selected column by default. Use the arrows to deselect any variables that should not be displayed in the workbook.

     Variables can be moved individually by selecting them and using the single arrow icons. Alternatively, the entire list can be moved at once using the double arrow icons.

     If not all variables are needed in the profile, first remove the entire list and select only the desired ones. Click the left double arrows to move all variables from the Selected column to the Available column.

     

     All variables are now listed in the Available column.
     

     From here, select the variables to include in the Patient Profile. Click each variable and use the right arrow icon to move it to the Selected list. Multiple variables can also be selected at once by holding the control key, or each variable can be double-clicked to move them automatically. Use the scrollbar on the right to view all available variables.

   • Use Sort Fields to specify the field by which to sort the data. For example: AETERM
   • Select between a Horizontal (the default) and Vertical layout. Horizontal displays as the records would in a table or listing; vertical is a useful selection when there are only a few records, or when it is desirable to compare several records over time.
   • Use Exclude Domains to specify domains that should always be excluded, such as those containing YN. Use a wildcard to match text before or after the value, for example, *YN*.
     Configure excluded domains before selecting Data Stores and Domains, as exclusions override inclusion selections. For example, if AEYN is excluded and all domains in the Clinical data store are selected, AEYN appears selected but is not included in the export.
   • Use Exclude Variables to specify variables that should always be excluded. Use a wildcard to match text before or after the value, *YN*.
     Configure excluded variables before selecting Data Stores and Domains, as exclusions override any selections made in those areas.
   • For the Column Order, select Default, which follows the eCRF order, or Alphabetical.
   • For the Column Headers, select Name, such as AESTDT, or Label, such as Adverse Event Start Date.
4. Click Save when finished.