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

Within Data Central, there are two types of Patient Profiles available: Graphical and Workbook. They are both configured from 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 (the plus sign) 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's default subject field is different (e.g., SubjID).

Subjects Domain

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

Subject Header Fields

Select the fields from the drop-down multi-select list. The selected fields will 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 will be 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 that will be used for the earliest date shown on the slider of the x-axis. Selections include:

• Automatic (default): The earliest date on the x-axis will be the date of the earliest point in all of the charts.
• Fixed Date: A Fixed date field opens, enter a date, or click the calendar picker to select a date. The fixed date will display as the earliest date on the x-axis. This option is unavailable if Timeline Type of Study Day is selected.
• From Field: Additional fields open, Start Date Domain, Start Date Field, and optionally Start Date Subject Id Field Override. Click the drop-down in the Start Date Domain and select a domain; then click in the Start Date Field drop-down and select the desired field (i.e., if the selected Start Date Domain is DM and the Start Date Field is Birthdate, the earliest date on the x-axis will be the earliest date in the DM / Birthdate fields).

Click the Save icon in the panel toolbar.

Define the Graphical Patient Profile Groups

Depending on whether building a profile as new, or copying an existing profile, Groups can be modified or added, as needed. Click the Add Group icon in the panel toolbar and then define the group, such as Adverse Events (new groups are added at the bottom of the profile; use the scrollbar to see a newly added group).

To the right of the Group Name, click the plus sign to Add Chart, or the trashcan to Delete 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. In the Name field, the default is New Chart. This can be renamed and will display as a sub-name for the chart. Choose a name based on how the data is viewed: AEs by AE Term, for example.
3. Select Chart Type. The default is Events. For Adverse Events, this is the correct selection. Depending on the data, select between Events or Findings.
4. In the Domain field, select the domain that contains the data related to the group. For Adverse Events, this should be the domain that holds the AE data, typically from the Clinical Staging Area. This is a required field.
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 identifies what to display on the Y-axis. For example, if AETERM is selected, the Adverse Event terms would be listed down the Y-axis. If AESER is selected, Yes and No will display on the Y-axis, grouping AEs by whether they were serious or not.
10. Check the Additional Filter box to add an additional filter to the patient profile. For example, to only see SAEs, check the Additional Filter box, select the Serious field from the drop-down, and then type in the filter. AEs will only display if they are serious.
11. In the Legend Grouping Field, select the option for grouping the data, which will be displayed with a legend. For example, if the goal is to analyze Adverse Events by severity or toxicity grade, selecting that field will color code the AEs accordingly.
    
12. The Tooltip Format field is used to specify what should be included in the tooltip when hovering over a data point. By default, the tooltips show the date and the value of the item on the Y-axis. If this is changed, those will not display by default; selection will be required to include them as well.
    

    To change the default tooltip display, type @. A drop-down will appear with the domain fields; select the field to be displayed in the tooltip. To add another, type the @ symbol again.
    To have the two variables on separate lines, add <br> to break the line. Note that the fields are not displayed in the tooltip, just the values. In this example we use the Vital Signs domain and want the tooltip to show two lines. PULSE:, the value, then a break in the line, then RATE:, the value.  

    To add the field name to the tooltip, type it into the field before the @ symbol, such as PULSE: @[VSPULSE]<br>RATE: @VSRATE]. Consider using a dash or colon before the field name to help identify each item.
    
    The result should look like this:
    

    Important: Adding extra spaces in the entered code will cause 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 for the graphical patient profile that would be captured as a Finding, use the following steps. Note that these steps describe adding information to the Labs group. There are two different ways that this can be done, depending on the data. The same principles apply to other Findings groups. Regardless of which method is chosen, the first steps are the same, and the chart for both methods will look similar to:

1. Click Add Group icon from 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, a new window opens, Chart Configuration. In the Name field, the default is New Chart. This can be renamed, as appropriate and will display as a sub-name for the chart. For Labs, each lab may be displayed separately by naming the lab test here. These can be set up to focus on labs of specific interest to the study, such as AST. The graph displays to the right of the configuration items. 
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 is a required field.
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. Check the Additional Filter box to identify that a filter will be used, such as the name of the test.
    From the drop-down list, select the field that identifies the lab name.
    In the free form field, enter the lab name. This must be entered as the term displays in the field selected from the drop-down list.
    In this example a legend is not needed, therefore no updates have been made in the Legend Grouping Field.  
12. The Tooltip Format field is used to identify what should be included in the tooltip when hovering over a data point. By default, the tooltips show the date and the value of the item on the Y-axis. If this is changed, those will not display by default; selection will be required to include them as well.
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. Once all charts have been added or modified, click the Save icon in the panel toolbar to save any changes made to the profile. If the window is closed before clicking the Save icon, a warning dialogue box will display. Click Cancel to return to edit mode, or click Discard Changes to undo the previous changes.  
17. Close the configuration window when finished by clicking the Close icon in the panel toolbar.

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. It will be blank if a WPP has not already been configured.
   
   
   • In the Header field, type a left bracket followed by the first letters of the field to add, and it will populate. The fields that can be added to the header are shown in the drop-down list that appears when a left bracket is typed.
     Any text can be entered anywhere in the header area. To display information before the field, type that in first, such as: 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 certain domains that should always be excluded, such as those that include YN. Use the wildcard to allow for text before or after, such as *YN*.
     Note that this should be set up before making selections from the Data Stores and Domains, as it will override any selections made. For example, if the setup is to exclude the AEYN domain and then all domains in the Clinical data store are checked for inclusion, the AEYN domain will appear checked, but will not be included in the export.
   • Use Exclude Variables to specify certain variables that should always be excluded. Use the wildcard to allow for text before or after, such as *YN*.
     Note that this should be set up before making selections from the Data Stores and Domains, as it will override any selections made from those areas. 
   • For the Column Order, select between Default (order of the eCRFs) vs Alphabetical.
   • For the Column Headers, select between Name (the default), such as AESTDT, and Label, such as Adverse Event Start Date.
4. Click Save when finished.