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:.

Process	Choose this process 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:.

Process	Choose this process 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:.

Process	Choose this process 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 process 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 process 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:.

Process	Choose this process 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:.

Process	Choose this process 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 process. Refer to the table below for guidance.

Process	Choose this process 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 will be 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:.

Process	Choose this process 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
Define Risk Threshold Data Set	Defines a new risk threshold data set used to 1) define the risk levels for individual variables for RBM analyses, and 2) specify the contribution of each variable to overall indicators of site risk.
Manage Risk Threshold Data Sets	Deletes risk threshold data sets that are no longer valid or useful for risk based monitoring of your study
Map Geocoding Help	Opens a JMP table listing the latitude and longitude of more than 750,000 geographical locations worldwide, spread over either1) U.S. Cities , or 2) Non-U.S. Cities to help individuals customize geographic information in Update Study Risk Data Set in order to geocode clinical trial sites.

Standard Reports

Reports are described in the table below:

Process	Choose this process 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

Subject Utilities

Utilities are described in the table below:

Note : Some processes require that a JMP table be open and in focus, with desired patients selected, prior to execution.

Process	Choose this process for...
Profile Selected Subjects	Generating a comprehensive graphical summary for each selected patient in a study 1
Profile All Subjects	Generating a comprehensive graphical summary for all patients in the current study
Cluster Subjects	Performing a subject-level clustering of patients with each of the domain indicators 1
Create Subject Filter	Generating a subject filter that is applied to all subsequent processes run on the data for a study 1
Manage Subject Filters	Removing a subject filter from the current study

Pharmacovigilance

Click the Disproportionality Analysis button to open the Disproportionality Analysis process, which screens an adverse event data set and performs data mining analyses for pharmacovigilance and signal detection.

Send

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

Process	Choose this process for...
Animal Profile	Compares distributions of demographic variables across treatment arms via a one-way ANOVA or contingency analysis.
Findings Incidence Report	Compares distributions of demographic variables across treatment arms via a one-way ANOVA or contingency analysis **SAME AS ABOVE
Trial Design	Visualizes findings measurements for each subject across the time line of the study.

Data Management

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

Process	Choose this process for...
Review Status Distribution	Aids in the review of study domains.
Review Status Distribution	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.