Safety Shift Plot: test evidence

SSP-CTRL-001 This drop-down menu is used to filter the lab variable that is displayed in the chart. The default measure is set to the first variable in the data set, but the default value can be adjusted to any measure upon the project team's request. Users can select any pre-defined measure in this filter. Selecting a measure will display the data points associated with that measure and will display the visits that the measure is collected at underneath the chart.

SSP-REQ-002 This drop-down menu is used to filter the visit data that will be displayed in the chart. The default measure is set to 0, but the default value can be adjusted to any visit(s) upon the project team's request. Users can select one of more pre-defined visit(s) in this filter to be used as the baseline visit(s) in the chart. These values will be displayed on the x-axis.

SSP-CTRL-002 This drop-down menu is used to filter the visit data that will be displayed in the chart. The default measure is set to all visits other than visit 0, but the default value can be adjusted to any visit(s) upon the project team's request. Users can select one of more pre-defined visit(s) in this filter to be used as comparison visit(s) in the chart. These values will be displayed on the y-axis.

SSP-CTRL-003 The chart can be configured to have any number of data filters. Each specified filter has a drop-down menu that is used to filter the visit data that is displayed in the chart.

SSP-CHART-002 Both axes carry one shared domain, so the dashed identity reference line marks y = x at 45° and a participant's shift is read as distance from that line.

SSP-SCALE-001 An Axis Type control switches both scatter axes between a linear and a logarithmic scale together; because the identity line requires one domain shared by both axes, the choice applies to the pair and never to one axis alone. The initial choice comes from the axis_type setting and defaults to linear.

SSP-SCALE-004 The dashed identity reference line still marks y = x under a logarithmic transform, and the participant counts reflect the pairs actually plotted.

SSP-COUNT-001 Displayed under the header, this statement provides the total number of participants in the data set in integers as well as the percentage of participants shown to one decimal place. In the default view, all participant data is included in the chart, or 100%, unless the project team requests otherwise. When filters are used, the data shown in the histogram is manipulated and the number of participant records shown at the top of the page may increase or decrease, depending on the variable selected.

SSP-REG-005 Confirm that the # of enrolled/randomized participants is visible at the top of the page

SSP-REG-020 Confirm that invalid results are removed from the data rather than measures with any invalid results. Invalid results include missing and non-numeric values. Then confirm that the number of removed results is noted in the console (You can confirm by downloading the data from CAT, updating the STRESN column so a few values are bad. When you reupload the edited data you will see that the number changes appropriately in the console).

SSP-REG-001 Confirm that measure filter is working as expected

SSP-REG-002 Confirm that baseline visit filter are working as expected

SSP-REG-003 Confirm that comparison visit filter are working as expected

SSP-CTRL-003 The chart can be configured to have any number of data filters. Each specified filter has a drop-down menu that is used to filter the visit data that is displayed in the chart.

SSP-REG-006 Confirm that hovering over a data point displays subject ID, baseline value, comparison value, change value, and percent of change

SSP-REQ-003 Clicking and dragging the mouse across the data points will open a table to the right of the chart that contains a detailed listing of participant records. This linked table contains the participant's subject ID, their baseline value for the selected measure, the comparison value for the selected measure, the difference between the baseline and comparison value using an integer and a percentage. When the table appears, the data points selected will appear in a gray box inside of the chart, lightening all of the data points not selected in the box. When a user clicks outside of the gray box, the gray box disappears along with the detailed table.

SSP-REQ-006 Create a gray box around the selected data points

SSP-REQ-007 Lighten all of the data points not contained in the table

SSP-REG-004 Confirm that detailed record can be viewed by clicking and dragging the mouse across a section of values

SSP-REG-012 Confirm that the detail listing isn't initially available but then does display when the chart is brushed

SSP-REG-011 Confirm that unselecting data points resets the detailed record at the bottom of the page

SSP-REG-008 Confirm that Search works to filter the data displayed in the listing

SSP-REG-009 Confirm that Sort works in the listing by clicking on column headers

SSP-REG-010 Confirm that you can export the displayed data to a csv via via the Export: CSV button

SSP-API-003 The custom participantsSelected event is dispatched on the shell root (bubbling, so wrapper/element-level listeners keep working) whenever the details for one or more participants are viewed (or cleared) by brushing the chart. The event has a custom data property holding an array of the selected IDs (["123-456-7"]) or an empty array when participant details are cleared.

SSP-API-001 A factory to create a custom webChart chart object.

SSP-REG-016 Confirm that the chart appears between controls and listing.

SSP-REG-018 Confirm that the controls appear to left of chart.

SSP-CFG-004 an object that defines the baseline value

SSP-CFG-005 an object that defines the comparison (or post-baseline) value

SSP-CFG-006 an array of filter variables and associated metadata

SSP-REQ-005 Display the raw data records, including the subject identifier, baseline value, comparison value, change, and percent change

SSP-REG-020 Confirm that invalid results are removed from the data rather than measures with any invalid results. Invalid results include missing and non-numeric values. Then confirm that the number of removed results is noted in the console (You can confirm by downloading the data from CAT, updating the STRESN column so a few values are bad. When you reupload the edited data you will see that the number changes appropriately in the console).

SSP-DATA-001 Safety Shift Plot is initialized with JSON data files that match the format created by d3.csv(). The chart expects an ADaM-esque data structure by default, but can be customized to work with any dataset that contains one row per participant per time point per measure and includes the required columns specified below.

SSP-REG-013 Confirm that the User can specify visit_order_col that names a variable that orders the visits.

SSP-REG-014 Confirm that Visit ordering can be set two ways: {"visit_col":"VISIT","visit_order_col":"VISITNUM"} to order visits sequentially and {"visit_col":"VISIT","visit_order_col":"VISIT"} to order visits alphanumerically.

SSP-CHART-001 The chart plots one point per participant: their baseline-visit value on the x-axis against their comparison-visit value on the y-axis for the selected measure.

SSP-REQ-005 Display the raw data records, including the subject identifier, baseline value, comparison value, change, and percent change

SSP-REG-019 Confirm that when a measure contains fewer than five unique values it isn't removed from the data (edit the dataset ADBDS so that it contains at least two results for the same measure from the same USUBJID. The shift plot is plotting the baseline value on the x-axis and the comparison value on the y-axis which requires at least two results).

SSP-CFG-005 an object that defines the comparison (or post-baseline) value

SSP-CTRL-001 This drop-down menu is used to filter the lab variable that is displayed in the chart. The default measure is set to the first variable in the data set, but the default value can be adjusted to any measure upon the project team's request. Users can select any pre-defined measure in this filter. Selecting a measure will display the data points associated with that measure and will display the visits that the measure is collected at underneath the chart.

SSP-CTRL-003 The chart can be configured to have any number of data filters. Each specified filter has a drop-down menu that is used to filter the visit data that is displayed in the chart.

SSP-CHART-002 Both axes carry one shared domain, so the dashed identity reference line marks y = x at 45° and a participant's shift is read as distance from that line.

SSP-SCALE-001 An Axis Type control switches both scatter axes between a linear and a logarithmic scale together; because the identity line requires one domain shared by both axes, the choice applies to the pair and never to one axis alone. The initial choice comes from the axis_type setting and defaults to linear.

SSP-SCALE-002 On a logarithmic scale the shared domain is derived from the strictly positive values only and padded multiplicatively rather than additively, so the lower bound is always greater than zero and no point sits on the frame.

SSP-SCALE-003 A participant pair whose baseline or comparison value is zero or negative cannot be placed on a logarithmic axis; the pair is removed rather than clamped or imputed, the shown-of-total participant count reflects the removal, and the number of pairs removed is reported in the note above the chart alongside the invalid-result count.

SSP-DATA-001 Safety Shift Plot is initialized with JSON data files that match the format created by d3.csv(). The chart expects an ADaM-esque data structure by default, but can be customized to work with any dataset that contains one row per participant per time point per measure and includes the required columns specified below.

SSP-DATA-003 No customization is needed to initialize a chart when the data object contains all default variables above. Just pass an empty object ({}) for settings and initialize the chart like so: safetyShiftPlot('body', {}).init(data).

SSP-FILT-001 A filter spec accepts start, all and multiple alongside value_col and label, and means the same thing here as in every other renderer. A spec that declares only value_col and label behaves exactly as it did before: a single-value dropdown whose first option is "All".

SSP-FILT-002 start names the value the filter opens on, and suppresses the "All" option unless the spec also passes all: true. A start of 0 or false is a real column value, not an absent start.

SSP-FILT-003 all: false removes the "All" option so a value is always selected. The key is read as written and is never truthiness-tested, because false is the value that does something.

SSP-FILT-004 multiple: true renders a checkbox multiselect instead of a dropdown, and the rows shown are those matching ANY selected value. Its state is null (everything selected, no restriction) or an array of values.

SSP-MEAS-001 The measures setting is an ordered whitelist: the Measure control offers exactly the listed measures, in the listed order. Entries match the label the control shows, falling back to the bare measure name. When the setting is unset the control offers every measure in the data, alphabetically.

SSP-MEAS-002 A configured measure absent from the data is dropped from the Measure control with a console warning naming it; when none of the configured measures is present the control falls back to every measure in the data rather than rendering empty.

SSP-CTRL-004 A "Reset chart" control at the foot of the control panel restores every settings-derived control to its configured default (measure, axis type, baseline/comparison visits and their statistics, filters), re-derives the data-driven defaults the settings do not carry — the opening measure and the baseline/comparison visit resolution of SSP-CFG-004/005, all three of which the settings leave null — clears the brush selection, the linked listing and the railed profile, and re-renders.