Chapter 19: Data
Visualization For Clinical Trials Data Management And
Operations By Ted Snyder
Guidance for the creation of figures using Spotfire.
These are all variations of the
same visualizations. Column selection for axes and color is configured to
use properties controlled by Select Lists in the Text Area on left side of
screen. This allows the end user to configure multiple versions of the
visualization with a click.
Visualization
type: Scatter Plot
Dataset
description: One row per lab value, with standard SDTM LB domain
structure.
Properties:
x-axis: Subject
ID or Days from First Dose or Visit # and Name or Actual
Lab Date
y-axis: Lab
Value in Std. Units or Lab Grades (CTCAE) or ULN Multiple or
Original Results
Colors:
In/Out-of-Range or Original Unit or Laboratory Name
Line
Connection: Subject ID (Figure 19.4 and 19.5)
Trellis:
Lab Test. y-axis scaled per trellis panel
Horizontal
Reference Lines: Reference High and Low for each lab test
Vertical
Reference Lines: Day 0 or day of first dose (Figure. 19.5 only)
Visualization
type: Scatter Plot (with Cross Table above)
Dataset
description: One row per subject per specific type of event (First dose, last
dose, discontinuation, efficacy assessment, etc).
Events are categorized by type and given a common timeline of days from first
dose.
Properties:
x-axis: Days
from First Dose
y-axis: Event
Category
Colors:
Event Details
Shape:
Event Type
Line
Connection: Event Category
Visualization
type: Combination Chart (Bar and Line)
Dataset
description: One row per Subject
Properties:
x-axis:
Enrollment Date with Hierarchy of Year > Month
Bars:
Enrollment in Month. Expression: UniqueCount([SUBJECT_ID])
Lines:
Cumulative Enrollment. Expression: UniqueCount([SUBJECT_ID]) OVER (AllPrevious([Axis.X]))
Series:
Column Names
Visualization
Type: Line Chart
Dataset
description: One row per Subject
Properties:
x-axis:
Enrollment Date with Hierarchy of Year > Month
y-axis:
Cumulative Enrollment. Expression: UniqueCount([SUBJECT_ID]) OVER (AllPrevious([Axis.X]))
Colors:
Study Name
Visualization
Type: Line Chart
Dataset
description: One row per Subject
Properties:
x-axis: Days
from First Patient Dosed
y-axis:
Cumulative Enrollment. Expression: UniqueCount([SUBJECT_ID]) OVER (AllPrevious([Axis.X]))
Colors:
Study Name
Visualization
Type: Bar Chart
The
select lists in the Text Area on the left control 2 properties that are used
for x-axis and color axis.
Dataset
description: One row per datapoint from EDC system (1
datapoint = 1 value entered on eCRF)
with current status and most recent time from audit trail for each status
including entry, verification, freezing, and locking.
Properties:
x-axis: Study
Name or Site Name or Subject ID or CRF or CRF Field
y-axis: Number
of Data Points. Expression: UniqueCount([DATAPOINT_ID])
Colors:
Verified Status or Frozen Status
Visualization
Type: Bar Chart (with Table below showing marked data from bar chart)
Dataset
description: One row per query from EDC system
Properties:
x-axis: Study
Name or Site Name or Subject ID or CRF or CRF Field
y-axis: Number
of Open Queries. UniqueCount([QUERY_ID])
Colors:
System Query
Visualization
Type: Scatter Plot
Dataset
description: One row per subject with continuous column for Number of AEs
Reported and categorical columns for Subject ID, Site ID, etc.
x-axis: Median
Days on Treatment. Expression: Median([DAYS_ON_TREATMENT])
y-axis: Median
number of AEs Reported. Expression: Median([#
AEs Reported])
Markers:
Site Number
Lines:
Straight line fit, Custom line using expression for historical program-level
rate
Visualization
Type: Bar Chart
Dataset
description: One row per data point from EDC with column for Days Until Data Entry calculated as timestamp of entry in EDC -
actual date (Visit Date).
x-axis: Binned
Days Until Entry
case
when [Days Until Data Entry]<0 then
"<0 Days"
when [Days Until Data Entry]<=14 then
"<=14 Days"
when [Days Until Data Entry]<=30 then
"<=30 Days"
when [Days Until Data Entry]<=60 then
"<=60 Days"
when [Days Until Data Entry]<=90 then
"<=90 Days"
when [Days Until Data Entry]>120 then
">90 Days" else
null end
y-axis: Number
of Data Points. Expression: UniqueCount([DATAPOINT_ID])
Trellis:
Site Number
Colors:
Binned Days Until Entry