Note
: You should refer to
How does JMP Clinical define various terms for risk-based monitoring?
for information about how terms used in risk-based monitoring are defined.
Running
Risk Based Monitoring
for the
Nicardipine
study generates the
Results
shown below. Output from the report is organized into sections. Each section contains one or more plots, data panels, data filters, or other elements that facilitate your analysis.
The
Report
contains the following elements:
Contains a series of
Histogram
s for risk indicators from the site-level risk indicators data table.
The
Site-Level Distributions
section contains the following elements:
|
•
|
The color of outliers is based on the risk indicator selected from the
Risk Indicators
down.
|
•
|
A
Local Data Filter
to subset histograms to data of interest, for example, to data for a particular set of study monitors.
|
Contains global and, depending on the countries present in the data, country maps detailing the location of the clinical sites based on geocoding. Site colors are based on the selected risk indicator.
Note
; This section is present only with geocoded sites.
|
•
|
Maps
: A global map is provided detailing the location of clinical sites based on the available geocoding. The colors of the site markers are based on the risk indicator selected from the
Risk Indicators
down. These colors enable you to identify if a risk is attributable to specific locations. Maps at the country level are available for the United States, Canada, France, Germany, Great Britain, Italy, Spain, China, and Japan.
Note
: Maps are provided only for these countries if they are present in the study database.
|
|
•
|
A
Local Data Filter
to subset histograms to data of interest, for example, to data for a particular set of study monitors.
|
Contains a series of
Histogram
s for risk indicators from the country-level risk indicators data table.
|
•
|
This section enables you to view the
distribution
of risk indicators across countries, possibly identifying any outliers. The color of outliers is based on the risk indicator selected from the Risk Indicators down.
See
Distributions
in the JMP documentation for more information.
|
•
|
A
Local Data Filter
to subset histograms to data of interest (for example, to data for a particular region).
|
The
Country-Level Map
section contains the following elements:
|
•
|
Maps
: A global map is provided detailing risk indicators at the country level. The color of country is based on the risk indicator selected from the
Risk Indicators
down. These colors enable you to identify if a risk is attributable to specific locations.
|
|
•
|
A
Local Data Filter
to subset histograms to data of interest (for example, to data for a particular set of study monitors).
|
Click to highlight risk-indicator colors on data table row markers, histogram outliers, and map points.
Note:
This option is for use with indicators having defined thresholds,
Note
: Cells with missing values do not display
|
•
|
Site-Level Data
: This data table displays risk indicators derived using the study database as well data included in the supplemental data set. Updated disk indicators can be supplies either by using the
Update Study Risk Data Set
option or supplemental data sets (See
How Supplemental Data Sets are Used by JMP Clinical.
for more information.). Risk indicators with defined thresholds are colored in green, yellow, or red.
Note
: The
Signal
column is the Risk Score for that particular Risk Indicator.
|
|
•
|
Country-Level Data
: This data table displays risk indicators summarized at the country level. Risk indicators with defined thresholds are colored in green, yellow, or red.
Note
: The
Signal
column is the Risk Score for that particular Risk Indicator.
|
|
•
|
Subject Summary Data
: This data table summarizes the status of the study subjects.
|
|
•
|
Show Subjects
: Select subjects and click
to open a data table of subjects from the sites selected from the site-level data table for review.
|
|
•
|
Report Actions
: Click
to open a set of
distributions
for selected rows listing recommended actions for selected study sites.
|
|
•
|
Open Edit Checks
: Click
to open a document of consistency checks performed on the risk indicators. The findings might suggest queries to one or more sites.
|
|
•
|
Select Rows Using Risk Indicators
: Click
to select rows based on the color of the selected Risk Indicator for both the site- and country-level risk indicator data tables.
|
|
•
|
Select Sites Using Subgroup Selection
: Click
to select rows in the site-level data table for sites within the countries selected in the country-level data table.
|
|
•
|
Click
to view the associated data tables. Refer to
View Data
for more information.
|
|
•
|
Click
to generate a standardized
pdf
- or
rtf
-formatted report containing the plots and charts of selected sections.
|
|
•
|
Click
to take notes, and store them in a central location. Refer to
Add Notes
for more information.
|
|
•
|
Click
to read user-generated notes. Refer to
View Notes
for more information.
|
|
•
|
Click the
arrow to reopen the completed report dialog used to generate this output.
|
|
•
|
Click the gray border to the left of the
Options
tab to open a dynamic report navigator that lists all of the reports in the review. Refer to
Report Navigator
for more information.
|
|
•
|
Click the gray border to the left of the
Options
tab to open a dynamic report navigator that lists all of the reports in the review. Refer to
Report Navigator
for more information.
|
|
•
|
with
.
|
•
|
with
.
where
is the mean, median or user-supplied center value, and
x
ij
is the value of the
i
th site (or country, vendor, monitor) for the
j
th risk indicator. The quantity c
ij
= |x
ij
-
μ
ij
|, (x
ij
-
μ
ij
, or -(x
ij
- m
ij
) for Direction equal to B, U, or L, respectively.
is the mean, median or user-supplied center value, and
x
ij
is the value of the
i
th site (or country, vendor, monitor) for the
j
th risk indicator. The quantity c
ij
= |x
ij
-
μ
ij
|, (x
ij
-
μ
ij
, or -(x
ij
- m
ij
) for Direction equal to B, U, or L, respectively.
.
.
Overall risk indicators are calculated as
, where
,
, or
for Direction equal to B, U, or L, respectively.The
w
j
are weights for the overall risk indicator; 1 by default.
, where
,
, or
for Direction equal to B, U, or L, respectively.The
w
j
are weights for the overall risk indicator; 1 by default.
Refer to
How are risk thresholds defined?
for more information.