Reviews

Introduction

Using the Review Builder

Available Reports

Using the Review Viewer

Introduction

The Reviews tab (shown below) enables you to create a new review of the selected study, open an existing review, or use a template generated previously for another study to generate a review for the current study.

A Review consists of all of the reports ¹ generated during your analysis of trial data.

The Review Builder is used for creating a new review. It does this by first creating a template containing one or more reports that have been configured with specific options. This template can then be used for preliminary analysis and/or saved for use with subsequent analyses of the same or alternative studies

The Review Viewer is used

Click on the following links for more information:

Using the Review Builder

Creating a Review Template

Saving a Review Template

Using a Prior Template for a New Study

Available Reports

Using the Review Viewer

Using the Review Builder

Creating a Review Template

Click to open the Review Builder and Select Reports... windows (shown below).

The Select Reports... window lists all of the reports that are available for analyzing the specified study. This window is used to select the reports that are to be included in the review.

Note : Normally, only those reports whose domain/variable requirements are satisfied, and therefore can be run are shown. Check the Show reports unsatisfied by the current study check box to show all reports.

Select the report(s) that you want to run and click OK .

The Review Builder window contains all of the specified reports. There is a separate tab for each report. Initially, each tab lists the options for the analysis. You can accept the default settings or adjust them as desired. After the report(s) is run, results are shown in the tab.

The following action buttons ² are available on the Review Builder to enable you to add or delete reports and run, save, or change the review.

•	Add Report : Click to add a report to the review.

•	Open Review Template : Click to open an existing review template.

•	Save : Click to surface a drop-down menu that enables you to save either the template for the current review or the review itself.

•	Manage Tabs... Click to reorder, duplicate, or delete reports. You can also apply a saved subject filter 3 to all reports in the review.

•	Run All Reports : Click to run all of the specified reports.

•	Cancel Run : Click to stop a run that is in progress.

•	Generate Review : Click to generate the review. Note : You must run all of the reports before you can generate a review.

•	Create static report for Review : Click to create a PDF, RTF, or PPT version of the Review.

•	Clear all report results : Click to clear the results of all of the reports.

You can reports one at a time using the tab-specific action button or all at once using .

Additional options include the following:

•	Explore Subjects for this study : Click to open the Subject Explorer to explore data for individual subjects.

•	Check Variable Requirements : Click to open the Check Variable Requirement and Usage window.

Saving a Review Template

Once you have created a template for analyzing a study, you can save it for use in future analyses. This template can be reused either for the same study (when new data becomes available, for example) or for a different study, for which you want to use the same report options.

To save a study template:

Click the drop-down menu and select Save Template... , as shown below:

Name

The Save Template window (shown below) ⁴ appears.

Provide a name for your template and click OK to template with the reports and options specified

Using a Prior Template for a New Study

When you generate a review for a study, you can save the template (reports, option settings, and so on) for that review using the Save Review Template... action button (see above). Saved templates can be used again and again for new studies.

Make sure that the new study has been selected.

Click the drop-down menu and select Open Template... , as shown below:

The Open Review Template window (shown below) ⁵ appears.

Select the desired template and click OK to open the Review Builder window with the reports and options specified

Available Reports

Reports are grouped into functional categories, as listed below:

Cross Domain

Reports using data from across multiple domains are described in the table below:.

Report	Choose this report for...
Cluster Subjects Across Study Sites	Constructs a cross domain data set and computes a distance matrix and performs hierarchical clustering of subjects across all of the study centers to identify pairs of subjects with a very small distance. This could be an indication that these subjects are in fact the same individual who has enrolled at multiple sites.
Cluster Subjects within Study Sites	Constructs a cross domain data set and computes a distance matrix and performs hierarchical clustering of subjects within each study center to identify pairs of subjects with a very small distance. This could be an indication that these subject are slightly modified copies of one another.
Create Cross Domain Data	Adding data for various domains to the ADSL table corresponding to incidence of variables in the AE , CM , LB , and MH domains and a summary statistic for LB , EG , and VS domain values
Multivariate Inliers and Outliers	Calculating Mahalanobis distance based on available data to detect subject inliers and outliers in multivariate space, and generating results by site to see which sites are extreme

Demographics and Visits

Reports examining patient demographics and study visit attendance are described in the table below:.

Report	Choose this report for...
Birthdays and Initials	Identifying subjects that might be identical based on birthdays or initials.
DM Distribution	Compares distributions of demographic variables across treatment arms via a one-way ANOVA or contingency analysis.
Enrollment Patterns	Generates uniformly weighted moving average plots to determine whether enrollment patterns within each site appear unusual.
Perfect Scheduled Attendance	Compares the distributions of study visit days for each center compared to all other centers combined, and identifies unusual differences.
Study Visits	Generating a graphical display and tabulation of study visit attendance.
Visit Order	Determines whether visit dates are unusual for subjects when ordering dates according to visit number.
Weekdays and Holidays	Identifying the weekday of study dates and determining whether these dates fall on major holidays.

Events

Reports examining patient study events are described in the table below:.

Report	Choose this report for...
Adverse Events Report	Generates SAS reports of adverse events counts and percentages by treatment arms, sex, and race.
AE Bayesian Hierarchical Model	Fitting Bayesian hierarchical models for adverse events, while taking into account a grouping variable
AE Distribution	Comparing Distribution s of adverse events and demographic variables across treatment arms
AE Incidence Screen	Screening adverse events by performing a Cochran-Mantel-Haenszel exact test on all 2x2 tables constructed from incidence and treatment arm
AE Narrative	Generating adverse event narratives for clinical study reports
AE Resolution Screen	Screening adverse events by performing a Cochran-Mantel-Haenszel test on all 2x2 tables constructed from event resolution and treatment arm
AE Severity ANOVA	Screening adverse events by performing a mixed-model analysis of variance , with average ranked severity score as the dependent variable and customizable fixed and random effects
AE Time to Event	Screening adverse events by performing log-rank and Wilcoxon tests between treatment groups
Discontinuation Time to Event	Creating Kaplan-Meier Survival Curves for time to study discontinuation and associated statistics, grouped by treatment arm
Events Distribution	Comparing Distribution s of events from a domain and demographic variables across treatment arms Note : This report should be considered as two : DS Distribution and MH Distribution , depending on which domain is specified in the dialog .
Events Incidence Screen	Screening events from a domain by performing a Cochran-Mantel-Haenszel test on all 2x2 tables constructed from event incidence and treatment arm Note : This report should be considered as two : DS Incidence Screen and MH Incidence Screen , depending on which domain is specified in the dialog.
Mortality Time to Event	Grouping clinical mortality results by treatment arm and generating Kaplan-Meier Survival Curves with associated statistics
Standardized MedDRA Queries Distribution	Compares distributions of SMQs across treatment arms.
Standardized MedDRA Queries Incidence Screen	Screens SMQ terms by performing a Cochran-Mantel-Haenszel test on all 2 x 2 tables constructed from event incidence and treatment arm.
Treatment Emergent AE Summary	Creating a tabular and graphical overview of treatment emergent adverse events for the safety population by actual treatment arm

Findings

Reports examining patient findings are described in the table below:.

Report	Choose this report for...
Constant Findings	Identifying tests from findings domains that have the same result for the entire study
Correlated Findings	Calculates pairwise correlations between tests within each findings domain and identifies unusual results at specific study sites.
Digit Preference	Assesses the use of terminal digits by study sites when reporting their clinical findings to identify those sites that might exhibit biases in rounding issues or other problems with how they report data.
Duplicate Records	Identifying sets of records that have identical values on more than one occasion within a subject or between subjects within a study site
Findings ANOVA	Screening findings measurements for a specified domain one at a time by performing a repeated-measures analysis of variance
Findings Box Plots	Displaying Box Plot s by treatment group representing the change from baseline in measurements for each test for a specified findings domain across various time windows or points in a study
Findings Bubble Plot	Tracking a pair of findings measurements over time with an animated Bubble Plot
Events Distribution	Comparing Distribution s of findings and demographic variables across treatment arms
Findings Shift Plots	Displaying Shift Plot s to compare test measurements for a specified findings domain at baseline versus on-therapy values, and performing a matched pairs analysis on average score during baseline and a summary score during the trial
Findings Time to Event	Defining events using one or more findings tests to be analyzed in a time-to-event analysis
Findings Time Trends	Visualizing findings measurements across the timeline of a study
Findings Waterfall Plots	Creating waterfall plots to show the distribution of changes in test measurements for a given Findings domain across subjects
Frequencies	Identifies unusual frequencies by study visit.
Hy’s Law Screening	Visualizing peak values for lab measurements pertaining to Hy’s Law for detecting potential liver toxicity for all subjects across treatment arms
Missing Findings	Determines whether individuals are missing data for all test codes across all Findings domains, based on data available at each visit number and time point number.
Outliers	Identifies outliers and identifies sites with excessive outliers.
Screening Bias	Identifies within-site mean differences between two selected visits for continuous endpoints to identify regression to the mean in assessing study entry criteria.
Summary Statistics	Identifies unusual summary statistics by study visit.

Interventions

Reports describing interventions are described in the table below:.

Report	Choose this report for...
Exposure Summary	Generating an exposure summary and plot for all subjects in a study of an investigational product, by dose and exposure time for the safety population , by treatment
Interventions Distribution	Comparing Distribution s of interventions and demographic variables across treatment arms
Interventions Incidence Screen	Screening interventions by performing a Cochran-Mantel-Haenszel exact test on all 2x2 tables constructed from event incidence and treatment arm

Patient Recruitment

Click on a button corresponding to an interventions report. Refer to the table below for guidance.

Report	Choose this report for...
Patient Recruitment	Estimates patient recruitment parameters and uses these estimates to predicts future enrollment pattern. If the target time will be missed by a user-defined probability, adaptive adjustment launched by predicting the number of new centers necessary for the target enrollment to be reached by the deadline.

Risk-Based Monitoring

Reports are described in the table below:.

Report	Choose this report for...
Risk Based Monitoring	Generates a dashboard for risk-based monitoring of clinical trials
Update Study Risk Data Set	Manually enter site-specific descriptive information as well as risk indicator information
Manage Risk Threshold Data Sets...	Enables you to modify or delete risk threshold data sets.

Standard Reports

Reports are described in the table below:

Report	Choose this report for...
Study Visit Report	Generating a report of total subject clinic attendance over the course of a study
Standard Safety Reports	Generating standard safety tabular reports
Comment Report	Generating a document of study comments obtained from source data pertaining to each subject.
Adverse Events Report	Generating reports of adverse event counts and percentages by treatment arms , sex, and race

Data Management

Click on a button corresponding to a subject utility . Refer to the table below for guidance..

Report	Choose this report for...
Domain Viewer	Aids in the review of study domains.
Notes Viewer	Enables you to review notes for a selected study.
Required Domain Report	Checks SAS data sets in the SDTM and ADaM folders that have been specified for the selected study, for all variables required for various JMP Clinical reports.
Review Status Distribution	Displaying the distribution of the review status of subjects in a study
Variable Report	Launches the JMP Clinical Study Variable Report.

Using the Review Viewer

This option enables you to open and view an existing, saved review.

Note : You cannot update or otherwise alter the review.

Click the drop-down menu and select Open Review... , as shown below:

The Review Viewer and the Open Review windows (shown below) appear.

Select the desired review and click Open .

The Review Viewer opens, as shown below:

The Review Viewer enables you to interactively explore all of the reports in the saved Review . The Data Filter and all -down options for each report are available and fully functional. You can filter the observations and view subjects by demographic and other groupings. However, you cannot change. alter or update the initial options or conditions of any of the reports.

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1

See Available Reports for a list and descriptions for all of the JMP Clinical reports.

2

Note : Action buttons are active only when the requirements for their function are met.

3

Use the Data Filter any report to generate a filter. Click to name and save the filter. clicking

4

Note : By default, review templates are saved to C:\Users\username\AppData\Roaming\SAS\JMPClinical\12\JMPC\ReviewTemplates . If you want to save your templates elsewhere, simply navigate to the correct location before clicking Save .

5

Note : By default, review templates are saved to C:\Users\username\AppData\Roaming\SAS\JMPClinical\12\JMPC\ReviewTemplates and the Open Review Template window automatically opens to this folder. If your templates are located elsewhere, simply navigate to the correct location.