Configure Patient Profiles for Data Central

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

The Graphical Patient Profile (GPP) can be accessed from the Subjects panel, or from the GPP icon just below Subjects in the left Navigation pane, after a record has been selected.

From the Subjects, select a record and then click the Graphical Patient Profile icon located in the panel toolbar. This is the same icon that would display below Subjects in the Navigation pane.

The Graphical Patient Profile opens for the selected subject.

If more than one Graphical Patient Profile exists, there will be a drop-down arrow on the right-hand side of the Profile Name field. If you are copying a GPP, you will want to make sure the correct profile has been selected.

With the Profile open, 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
Maximize / Restore (window)
Close (window)

Configure a Graphical Patient Profile

To create a new profile click the New Profile icon (plus sign) from the panel toolbar.

A new window opens.

Profile Name

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

Default Subject Field

The Default Subject Field auto-populates to Subject. This should typically not be changed. If the default subject field for your study is something other than Subject, such as SubjID, this should then be updated.

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 that you want displayed in the top portion of the Patient Profile. The selected fields will display for each patient within the selected Data Central Patient Profile. In the drop-down, selections will be highlighted in blue with a check mark when it has been selected.

Timeline Type

Select the radio button to define if calendar date or the study day will be used to for the 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 to save your selections.

Define the Graphical Patient Profile Groups

Depending if you are 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 garbage can 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

Starting with Adverse Events, update the Group Name from New Group to Adverse Events, then click the Add Chart icon (screenshot above).
The Chart Configuration window opens. In the Name field, the default is New Chart. This can be renamed. This is what displays as a sub-name for the chart. You may choose to name it based on how you view the data: AEs by AE Term, for example.
Select Chart Type. The default is Events. For Adverse Events, this is the correct selection. Depending on the data, you can select between Events or Findings.
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.
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.
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.
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.
In the Ongoing Flag Field, select the field that identifies if the event is ongoing.
In the Event Type Field, select the field that identifies what you want displayed on the Y-axis. For example, if you select AETERM, the Adverse Event terms would be listed down the Y-axis. If you select AESER, Yes and No would display on the Y-axis and AEs would be grouped by whether they were serious or not.
Check the Additional Filter box if you want to add an additional filter to the patient profile. For example, if you only wanted to 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.
In the Legend Grouping Field, select the field you want the data grouped by with a legend displayed. For example, if you want to look at the Adverse Events by severity or toxicity grade, you could select that field and the AEs would display with that color coding.
The Tooltip Format field is used to identify what should be included in the tooltip when you hover over a data point. By default, the tooltips show the date and the value of the item on the Y-axis. If you change this, those will not display by default; you would have to select them to also display.

To change the default tooltip display, type @. A drop-down with the domain fields display; select the field you want 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.
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.
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 you choose, the first steps are the same, and your chart for both methods will look similar to:

Click Add Group icon from the panel toolbar.
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).
Click the Add Chart icon to begin the chart configuration process, or click Delete Group to remove the group from the graphical patient profile.
When you select Add Chart, a new window opens, Chart Configuration. In the Name field, the default is New Chart. This can be renamed, as appropriate. This displays as a sub-name for the chart. For Labs, you may choose to display each lab separately, naming the lab test here. These can be set up so as to focus in on labs that are of specific interest to the study, such as AST. The graph displays to the right of the configuration items.
In Chart Type, the default is Events. For Labs, select Findings.
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.
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.
In the Start Date Field, select the field for the date of the finding. This is a required field.
In the Value Field, select the field that identifies the lab result value.
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.
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.
The Tooltip Format field is used to identify what should be included in the tooltip when you hover over a data point. By default, the tooltips show the date and the value of the item on the Y-axis. If you change this, those will not display by default; you would have to select them to also display.
To change the tooltip display, type @. A dropdown with the domain fields display; select the field you want displayed 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.
Click the Done button in the bottom right corner.
To add another Lab to the patient profile, click the Add Chart icon and repeat the steps.
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 you try to close the window before clicking the Save icon, a warning dialogue box displays. Click Cancel to return to edit mode, click Discard Changes to undo the previous changes.
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 you delete a group or chart in error, click the Undo Delete Group or Undo Delete Chart icon.

Reorder a Graphical Patient Profile

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

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 (you can dock this to the dashboard).
Click the Configure icon in the panel toolbar (this changes the panel toolbar icons).
Click the Reorder icon in the panel toolbar.
The Reorder Groups window opens. Simply drag the groups to the desired order.
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):

Click on the Workbook icon in the panel toolbar.
Click Configure.
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, the first letters of the field you want to add, and then it will populate. The fields that can be added to the header are shown in the drop-down list that appears when you type a left bracket.
  Any text can be entered anywhere in the header area. If you want information to display before the field, type that in first, such as: Patient Profile Workbook for: [Subject]
- In Data Stores and Domains, expand the data store that has the domains you want to include. 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. You can use the arrows to deselect any variables you do not want to display in the workbook.
  
  You can move variables individually by selecting them and using the single arrow icons. Or you can move the entire list at once by using the double arrow icons.
  
  You may not want all variables included in your profile, first remove the entire list and select only the ones you want included. 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 you can select the variables you want to include in your Patient Profile. Click on each variable and use the right arrow icon to move it to the Selected list. You can also select multiple variables at once by using the control key. Or you can just double-click each variable to move them automatically. Use the scrollbar on the right to see all available variables.
- Use Sort Fields to identify by which field you want 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 identify certain domains that you always want to have excluded, such as any 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 your selections from the Data Stores and Domains and will override any selections you make from Data Stores and Domains. If, for example, you set up to exclude the AEYN domain, and then check to include all domains in the Clinical data store, the AEYN domain will appear checked, but will not be included in the export.
- Use Exclude Variables to identify certain variables that you always want to have excluded. Use the wildcard to allow for text before or after, such as *YN*.
  Note that this should be set up before making your selections from the Data Stores and Domains and will override any selections you make from Data Stores and Domains.
- 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.
Click Save when finished.