Clinical Data Analytics (CDA) facilitates data exploration across domains and studies. This app is used to identify trends and outliers while providing traditional line listings, descriptive statistics, and visual patient profiles. It pulls data from your Reporting Data Mart, and always includes the most recent data integrated into elluminate.
CDA can be grouped by compound, therapeutic area, or program. If the CDA app is configured to be grouped at the URL level, the name will reflect the grouped app.
Note: Studies with the Therapeutic Area designated as Oncology will also include additional oncology sheets.
CDA, like all Analytics apps, has several common features such as filtering, selection tools, bookmarks, etc. For details on all Analytics functionality, please refer to the Analytics section or the Analytics courses in the Learning Portal.
In this article, you will find information on all the available out-of-the-box CDA sheets. Use the Table of Contents at the right to navigate to the sheets of interest.
Important: The list of sheets does not include custom sheets specific to your team.
CDA Home Page
The Home Page sheet displays key performance indicators (KPIs) on the status of the subjects across all studies (or the selected studies), group assignment details, screened subjects by country, adverse event metrics, and coding metrics.
Double-click on a KPI to go to the sheet containing visualizations related to that KPI. For example, if you click on the Screen Failure KPI, the Inclusion/Exclusion Criteria Not Met sheet opens in a new browser tab.
Tip: Any applied filters (shown in the Selections toolbar) will remain when you navigate to another sheet. Remove a filter by clicking the 'x' next to the filter in the Selections toolbar.
Adverse Events (12 Sheets)
Adverse Events Bubble
Use the Adverse Events Bubble sheet to track the number of AEs along with the time to onset by System Organ Class or Preferred Term.
- Use the buttons on the left to view by System Organ Class (default) or Preferred Term.
- Click SAE (red text) to view the results of SAEs only.
- To adjust the x-axis, click the Study Day drop-down and select Study Day (default), Study Week, or Study Month.
Adverse Event Comparison
Use the Adverse Event Comparison sheet to view a side-by-side graphical comparison of AE data using filters and variable buttons and evaluate differences in response to a therapy.
- Use each set of filters to identify the data you wish to compare for the related chart.
- Use the buttons at the top left to view all charts by Subject % by Subcategory (default) or Unique Subjects %.
- Use the 8-button group to view all charts by Toxicity (or Severity) (default), Highest Toxicity (or Highest Severity), Seriousness, Action Taken, Outcome, Causality, Group Assignment, or Trt Emergent.
- Use the 3-button group to view all charts by System Organ Class (default), Preferred Term, or Reported Term.
Note: This sheet is not linked to global filters or selections made in other CDA sheets. Filters applied elsewhere will not impact the data or visualizations in the Adverse Event Comparison sheet.
Adverse Events Cross Tabulation
Use the Adverse Events Cross Tabulation sheet to examine AEs for all subjects by system organ class, high-level group term, high-level term, preferred term, or reported term.
- Enter a number in the Highlight proportions where the highest and lowest values in a row differ by at least (n%) field, 1 is entered by default. Fields will be highlighted in yellow that meet the criteria and the text will be either red or green, indicating the highest and lowest proportion in each row.
- At the top of the table, click the plus sign to expand the table and see the highlighting.
- Click the drop-down on the left to select from System Organ Class (default), High-Level Group Term, High-Level Term, Preferred Term, or Reported Term.
- Use the 4-button group to view by Study (default), Country, Site, or Group Assignment.
- Use the 7-button group to view by Toxicity (or Severity) (default), Highest Toxicity (or Highest Severity), Seriousness, Action Taken, Outcome, Causality, or AE Duration.
- Click the Adverse Event Summary button to navigate to that sheet.
Adverse Events Duration
Use the Adverse Events Duration sheet to identify the abnormal durations with respect to adverse events.
To populate the AE Duration Distribution by PTs (Preferred Terms), select one Preferred Term from the Preferred Term filter in the top right.
- In the AE Duration by System Organ Class / High-Level Group Term / High-Level Term / Preferred Term chart, use the 4-button group to view by System Organ Class (default), High-Level Group Term, High-Level Term, or Preferred Term.
- In the listing, click on a Unique Subject Identifier to open the Graphical Patient Profile in Data Central (if you have permissions).
Adverse Events Overlay Labs
Use the Adverse Events Overlay Labs sheet to review adverse events (AEs) against the relevant lab tests per subject.
First select the adverse event and relevant lab tests from the Event filter, then select one subject from the Subject filter.
In the AE Listing or Lab Listing, click on a Unique Subject Identifier to open the Graphical Patient Profile in Data Central (if you have permissions).
Adverse Event Summary
Use the Adverse Event Summary sheet to identify AEs that are prevalent in the subject population, identify event prevalence that is not in alignment with the safety profile of a drug, examine all AEs that led to treatment discontinuation, and evaluate all reported events for potential safety signals and trends.
- Select the Subject Counts (default) or Event Counts button at the top right to adjust the view of the two charts at the top.
- Use the 5-button group above the chart on the top left to adjust the view of all three charts. Buttons include System Organ Class (default), High Level Group Term, High Level Term, Preferred Term, or Reported Term.
- Use the 8-button group above the chart on the top right to adjust the view of the chart directly below the buttons. Buttons include Toxicity (or Severity), Highest Toxicity (or Highest Severity), Seriousness, Action Taken, Outcome, Causality, AE Duration, or Group Assignment.
Note: The names of the charts will update based on the selected buttons.
AE/Prior and Concomitant Treatment Association
Use the AE/Prior and Concomitant Treatment Association sheet to review adverse events (AEs) that were treated in relation to the treatments used for those AEs. This process helps ensure that the treatment is clinically related to the AE and confirms that the date of treatment initiation matches the AE information.
Exposure and Adverse Events
Click on the name of sheet above to navigate to the sheet details.
Med Hist, AE and Prior and Concom Treatment
Use the Med Hist, AE and Prior and Concom Treatment sheet to ensure that the medical history, AE, and prior and concomitant treatments are consistent with logical data relationships. Users can review the information for a given treatment and verify that it corresponds to data entered on either the Medical History Listing (ongoing) or Adverse Events Listing.
MedDRA Comparison Analysis
Use the MedDRA Comparison Analysis sheet to review AE information by the levels of MedDRA classification. Review can be for a study, group of studies, or across a program. Tabulations are presented by group assignment.
- Enter a number in the 'Highlight proportions where the highest and lowest values in a row differ by at least (n%)' field; 1 is entered by default. Fields will be highlighted in yellow that meet the criteria and the text will be either red or green, indicating the highest and lowest proportion in each row.
- To expand or collapse the rows in the table, click the plus sign next to an item in the column on the left, or right-click anywhere in the table and select Expand / collapse in the context menu, then select Expand all or Collapse all.
SMQ Comparison Analysis
Use the SMQ Comparison Analysis sheet to review AE information by Standard MedDRA Queries (SMQ). Review can be for a study, group of studies, or across a program. Tabulations are presented by group assignment. This sheet uses a current version of MedDRA (view a list of versions here: https://www.meddra.org/how-to-use/support-documentation/english ).
- Use the buttons on the left to view by Broad SMQ (default) or Narrow SMQ button.
- Uncategorized is listed in both Broad and Narrow SMQs, when expanded it will include all AEs that do not fit into any of the Broad or Narrow SMQ terms.
- Enter a number in the 'Highlight proportions where the highest and lowest values in a row differ by at least (n%)' field; 1 is entered by default. Fields will be highlighted in yellow that meet the criteria and the text will be either red or green, indicating the highest and lowest proportion in each row.
- To expand or collapse the rows in the table, click the plus sign next to an item in the column on the left, or right-click anywhere in the table and select Expand / collapse in the context menu, then select Expand all or Collapse all.
Treatment Emergent AE Analysis
Use the Treatment Emergent AE Analysis sheet to review the instances of AEs that started on or after the first dose of study medication. Tabulations present the number of events and subjects by various demographic parameters.
- Enter a number in the 'Highlight proportions where the highest and lowest values in a row differ by at least (n%)' field; 1 is entered by default. Fields will be highlighted in yellow that meet the criteria and the text will be either red or green, indicating the highest and lowest proportion in each row.
- Select up to two ages to define a specific age or age range.
Con. Meds (5 Sheets)
AE/Prior and Concomitant Treatment Association
Click on the name of sheet above to navigate to the sheet details.
Con-Med Cross Tabulation
Use the Con-Med Cross Tabulation sheet to examine prior and concomitant treatments for all subjects by medication class and the standardized medication name.
- Use the buttons on the left to view by Subject Counts (default) or Medication Counts.
- In the tabulation chart, use the 6-button group to view by Occurrence (default), Route, CM Duration, Race, Sex, or Ethnicity.
- To expand or collapse the rows in the table, click the plus sign next to an item in the column on the left, or right-click anywhere in the table and select Expand / collapse in the context menu, then select Expand all or Collapse all.
Con-Med Group
Use the Con-Med Group sheet to identify and review subjects who received specific combinations of non-study treatments.
For the sheet to work properly, make selections from the Standardized Medication Name filter or column.
Med Hist, AE and Prior and Concom Treatment
Click on the name of sheet above to navigate to the sheet details.
Prior and Concomitant Treatment Summary
Use the Prior and Concomitant Treatment Summary sheet to review non-study treatments in relation to inclusion and exclusion criteria, as well as use of prohibited medications and per-protocol use of required non-study treatments. Additionally, it can be used to evaluate whether certain medications are recorded on the proper CRF page per instructions based on treatment type, indication for use, or date.
- Use the buttons on the left to view by Subject Counts (default) or Medication Counts.
- For the chart on the right, use the top two buttons to view by Standardized Medication (default) or ATC 2 Text.
- Use the 6-button group to view by Occurrence, Route, CM Duration, Race, Sex, or Ethnicity.
Death Summary
Use the Death Summary sheet to view the primary cause of death and examine the relationship between death and adverse events for the identification of potential safety signals.
Demographics
Use the Demographics sheet to view counts and percentages for screened subjects.
- In the Subject Counts by Group Assignment / Sex / Race / Ethnicity / Age Range chart, use the buttons above the chart to view by Group Assignment (default), Sex, Race, Ethnicity, or Age Range.
- In the Subject Counts by Site / Country chart, use the buttons above the chart to view by Site (default) or Country.
- In the Subject Count by Age and Sex / Cohort / Country / Site / Race / Ethnicity chart, use the buttons above the chart to view by age and Sex (default), Cohort, Country, Site, Race, or Ethnicity.
Disposition Summary
Use the Disposition Summary sheet to review disposition / status events for all subjects and the period in which they occurred. Examine all events or only the latest.
To expand or collapse the rows in the table on the right, click the plus sign next to an item in the column on the left, or right-click anywhere in the table and select Expand / collapse in the context menu, then select Expand all or Collapse all.
ECG (2 Sheets)
ECG - Descriptive Stats
Use the ECG - Descriptive Stats sheet to view the distribution of ECG results for each test by various parameters. The box-and-whisker chart beneath the summary tabulations can be used to identify potential trends or outliers in a test requiring further investigation.
To populate the ECG Results box-and-whisker chart, select one test.
Use the buttons above the table to view results by Visit Name (default), Visit Number, Study Day, Study Week, Study Month, Age Range, Sex, Ethnicity, Race, Site, or Group Assignment.
ECG Results Over Time
Use the ECG Results Over Time sheet to examine changes in ECG over time to detect proarrhythmic effects. Review reported results, change, and percent change from either baseline or the previous visit.
One test must be selected.
- Enter values in the Low Limit Value and High Limit Value fields to apply reference lines to the chart.
- Click on the y-axis drop-down arrow to select from Results (beats/min) (default), % Change from Previous Visit, % Change from Baseline, Change from Previous Visit, or Change from Baseline.
- Click on the x-axis drop-down arrows to select from Visit Name (default), Study Month, Visit Number, Date of Collection, Study Day, Study Week, or Visit & Timepoint, and Subject (default) Study Month, Visit Number, Date of Collection, Study Day, Study Week, or Visit & Timepoint.
Exposure Data (3 Sheets)
Exposure and Adverse Events
Use the Exposure and Adverse Events sheet to identify safety signals in AEs and dosing data, as well as correlate changes to dosing based on AEs.
Select one Subject or one Reason for Dose Adjustment.
Exposure Data
Use the Exposure Data sheet to review exposure data and explore dosing trends over time for each subject, along with any dose adjustment reasons.
To populate the Dosing Trend Over Time per Subject chart, select one subject.
In the Dosing Trend Over Time per Subject chart, click on the x-axis drop-down arrows to select Study Day of Start of Treatment (default) or Name of Treatment, and Start Date of Treatment (default) or Name of Treatment.
Exposure Summary
Use the Exposure Summary sheet to view dosing profiles and monitor the duration of subjects' treatment, identify instances where subjects on combination treatments stop one medication before the other, and understand the impact of dosing on subject participation in the study.
Graphical Patient Profile
Use the Graphical Patient Profile (GPP) sheet to review selected subject data over time in graphical form. Users can review AEs, Exposure, Laboratory Data, and Concomitant Medications by date, with symbols color-coded to identify outliers.
One subject must be selected.
- Use the buttons above the chart to view by Study Day (default), Study Week, Study Month, or Event Date.
- To scroll along the y-axis, hold and drag up or down.
- To zoom in or out, place your mouse pointer anywhere on the graph and scroll.
I/E Criteria Not Met
Use the Inclusion/Exclusion Criteria Not Met sheet to identify specific inclusion / exclusion criteria that may be preventing enrollment.
In the treemap chart, the size of the box is proportional to the count.
Labs (11 Sheets)
Adverse Events Overlay Labs
Click on the sheet name above to navigate to that sheet's details.
Comparative Lab Results
Use the Comparative Lab Results sheet to compare two lab tests against each other, displayed as a scatter plot.
Select two lab tests from the Test filter.
- Select a Vendor Name to display reference lines.
- By default, the scatter plot displays the average test result score for the selected tests. Click on the drop-down arrow next to Average to select from Minimum, Maximum, or Median.
- The table displays all the test results for the selected tests.
eDISH Plot
Use the eDISH Plot sheet to identify subjects of interest who show evidence of potential drug-induced liver injury based on liver function tests using established criteria such as Hy's Law.
- For the eDISH Plot, use the buttons on the left to adjust the X-axis from ALT (default) to AST.
- By default, all ALP results display; click the drop-down to select from ALP<2xULN, or ALP>=2xULN.
- By default, No Window is selected (the max values can fall at any point within the study); click the drop-down to select from Window 30 days or Less (the max values must fall within 30 days of each other), or Window Same Day (the max values must fall on the same day).
- For the four charts on the right, use the buttons above the charts view by Study Week (default) or Study Day.
Lab - Descriptive Stats
Use the Lab - Descriptive Stats sheet to view the distribution of lab test results for each test by various parameters. The box-and-whisker chart beneath the summary tabulations can be used to identify potential trends or outliers in a test requiring further investigation.
To populate the box-and-whisker chart, select only one test.
- Use the buttons across the top to view by Visit Name (default), Vendor Name, Study Day, Study Week, Study Month, Age Range, Sex, Ethnicity, Race, Site, or Group Assignment.
- To expand or collapse the rows in the table, click the plus sign next to an item in the column on the left, or right-click anywhere in the table and select Expand / collapse in the context menu, then select Expand all or Collapse all.
Lab Result Review Over Time
Use the Lab Result Review Over Time sheet to review up to four lab tests over time at once. Review for potential safety signals, inclusion/exclusion violation criteria, or situations where study therapy should be modified.
Select up to four tests.
- By default, the charts display the Visit Name on the x-axis. Click on the drop-down arrow next to Visit Name in the top right corner to select from Visit Number, Study Day, Study Week, Study Month, Date of Collection, or Visit & Timepoint.
- In all the charts, click on the y-axis drop-down to select from Results (<missing>) (IU/L) (default), % Change from Baseline, % Change from Previous Visit, Change from Baseline, or Change from Previous Visit.
Lab Result Trends
Use the Lab Result Trends sheet to review lab data by test through various combinations of comparison to identify potential safety signals. Additionally, this sheet allows for the identification of inclusion/exclusion criteria violations through the evaluation of baseline values.
Select only one test.
- In the middle chart, click on the y-axis drop-down arrow to select from average Post Baseline (multiple) (default), Min Post Baseline (multiple), or Max Post Baseline (multiple).
- Click on the x-axis drop-down arrow to select from Baseline (multiple) (default), Min Post Baseline (multiple), or Max Post Baseline (multiple).
Lab Vendor Details
Use the Lab Vendor Details sheet to track lab results by vendor to aid in follow-up when there are subjects with missing lab test results.
- Use the buttons on the left to view Lab Test or Examination Name (default) or Lab Test or Examination Short Name.
- By default, the cross tabulation displays by Visit Name. Click on the drop-down arrow next to Visit Name in the top right corner to select from Visit Number, Study Day, Study Week, or Study Month.
- To expand or collapse the rows in the table, click the plus sign next to an item in the column on the left, or right-click anywhere in the table and select Expand / collapse in the context menu, then select Expand all or Collapse all.
Labs Summary
Use the Labs Summary sheet to examine summary lab test results for each test collected, based on any applied filters.
- By default, the table displays the average test result score across all the test results. Click on the drop-down arrow next to Average to select from Minimum, Maximum, or Median.
- Use the 6-button group to view by Visit Name (default), Vendor Name, Group Assignment, Site, Sex, or Toxicity.
- To expand or collapse the rows in the table, click the plus sign next to an item in the column on the left, or right-click anywhere in the table and select Expand / collapse in the context menu, then select Expand all or Collapse all.
Labs Summary - Distribution Plot
Use the Labs Summary - Distribution Plot sheet to explore differences in test results by group assignment, which may identify safety issues. The distance between the dots indicates the magnitude of differences in the test results between the group assignments based on the selected parameter (average, minimum, maximum, and median).
- By default, the plot displays the average test result score across all the test results. Click on the drop-down arrow next to Average to select from Minimum, Maximum, or Median.
- Use the buttons on the left to view Lab Test or Examination Name (default) or Lab Test or Examination Short Name.
LB and VS Listings
Use the LB and VS Listings sheet to review lab data and vital signs together.
- Within the Lab Listing, when the Result in Standard Units is less than the lower limit, the background color of the cell will be yellow.
- If the Result in Standard Units is greater than the upper limit, the background color of the cell will be red.
Liver Lab Test Analysis
Use the Liver Lab Test Analysis sheet to review liver function test abnormalities and to detect possible Hy's Law subjects.
Medical History (3 Sheets)
Med Hist, AE and Prior and Concom Treatment
Click on the sheet name above to navigate to the sheet details.
Medical History Cross Tabulation
Use the Medical History Cross Tabulation sheet to examine the medical history for all subjects by system organ class and preferred terms.
- Use the buttons on the left to view by Subject Counts (default) or Event Counts.
- In the cross tabulation, use the 8-button group to view by Category (default), MH Duration, Race, Sex, Ethnicity, SubCategory, Occurrence, or Completion Status.
- To expand or collapse the rows in the table, click the plus sign next to an item in the column on the left, or right-click anywhere in the table and select Expand / collapse in the context menu, then select Expand all or Collapse all.
Medical History Summary
Use the Medical History Summary sheet to review the medical history for all subjects and examine medical history events in relation to study protocol's inclusion and exclusion criteria.
- Use the buttons on the left to view by Subject Counts (default) or Event Counts.
- In the MH Subject / Event Counts by System Organ Class / Preferred Term and Category chart, use the buttons above the chart to view by System Organ Class (default) or Preferred Term.
Oncology (11 Sheets)
ECOG Performance Status
Use the ECOG Performance Status sheet to view data that indicates the ability of subjects to tolerate serious illness(es), specifically for chemotherapy. The Eastern Cooperative Oncology Group (ECOG) performance assesses how a disease affects the daily living abilities of the subject.
- In the ECOG Performance Score chart, click on the x-axis drop-down arrows to select Visit Name (default) or Study Day of Assessment, and Score (default) or Study Day of Assessment.
- In the ECOG Performance Score Over Time chart, click on the x-axis drop-down arrows to select Visit Name (default) or Study Day of Assessment, and Subject (default) or Study Day of Assessment.
Objective Response Rate
Use the Objective Response Rate sheet to view the drug efficacy (reviewing the objective response rate) over the study duration.
Response Duration
Use the Response Duration sheet to examine the timeline of response relative to participation in the study for each subject.
Survival Summary
Use the Survival Summary sheet to examine the duration of subject's participation in the treatment and follow-up phases, as well as their overall duration in the study.
- In the Subject Duration chart, use the tabs to view the Subject Duration - Months (default), or Subject Duration - Days.
- In the Survival Days by Group Assignment chart, click on the y-axis drop-down arrows to select from Group Assignment (default), Overall Survival, or Progression Free Survival, and Study Free Survival (default), Overall Survival, or Progression Free Survival.
Note: Subjects with a status of 'Screen Failed' or 'In Screening' have been removed from this sheet as they have not received treatment and therefore should not be part of the analysis.
Swimmers Plot with Subjects' Overall Response
Use the Swimmers Plot with Subjects' Overall Response sheet to view subjects' overall response over time for each subject in a clinical trial.
Select one Study and one Response Type.
Use the buttons on the left to view by Group Assignment (default) or Disease Type.
Use the buttons at the top center to view results by all subjects (default) or only those who are on treatment or off treatment.
Tumor Identification
Use the Tumor Identification sheet to examine the prevalence of tumors present among subjects in a study or studies.
In the chart on the right, use the tabs to view the New Lesion Counts (default), or the Subjects Counts.
Tumor Measurement Spider Plot
Use the Tumor Measurement Spider Plot sheet to view tumor measurement percentage change from baseline by Subject and Group Assignment, Disease Type, Best Overall Response, Sex, or Race.
- By default, RECIST evaluation is selected, click the down arrow next to RECIST to select from RANOTR or LUGANO.
- Use the buttons to view by Group Assignment (default), Disease Type, Best Overall Response, Sex, or Race.
- Select between All Study Days (default) or Study Days >=0.
- Enter the Low Limit Value and High Limit Value to add reference lines.
- Click the x-axis drop-down arrows to select from Study Day of Tumor Measurement (default), Study Month of Tumor Measurement, or Study Week of Tumor Measurement, and Subject (default), Study Month of Tumor Measurement, or Study Week of Tumor Measurement.
Tumor Response
Use the Tumor Response sheet to review of a summary of the response, and drill down to view individual subject response over time for subjects of interest.
To populate the RECIST Response Trend Over Study Day chart, select one subject.
Tumor Results
Use the Tumor Results sheet to explore tumor measurement results over time. The sum of lesions and the change from baseline in the sum of lesions presented.
- In the Sum of Lesions Over Time (mm) chart, click on the x-axis drop-down arrows to select Visit Name (default) or Study Day of Tumor Measurement, and Subject (default) or Study Day of Tumor Measurement.
- In the Change from Baseline-Sum of Lesions chart, click on the y-axis drop-down arrow to select Change from Baseline-Sum of Lesions (default) or % Change from Baseline-Sum of Lesions.
- Click on the x-axis drop-down arrows to select from Visit Name (default), Days from Baseline, or Study Day of Tumor Measurement, and Subject (default), Days from Baseline, or Study Day of Tumor Measurement.
Tumor Results - RANO
Use the Tumor Results - RANO sheet to explore tumor measurements over time. The sum of the lesions and the change from baseline in the sum of lesions is presented.
- In the Sum of the Products of Lesion Diameters Over Time (mm) chart, click on the x-axis drop-down arrows to select Visit Name (default) or Study Day of Tumor Measurement, and Subject (default) or Study Day of Tumor Measurement.
- In the % Change from Baseline-Sum of the Products of Lesion Diameters chart, click on the y-axis drop-down arrow to select % Change from Baseline-Sum of the Products of Lesion Diameters (default) or Change from Baseline-Sum of the Products of Lesion Diameters.
- Click on the x-axis drop-down arrows to select from Visit Name (default), Days from Baseline, or Study Day of Tumor Measurement, and Subject (default), Days from Baseline, or Study Day of Tumor Measurement.
Waterfall Plot
Use the Waterfall Plot sheet to view the best percentage change in tumor size from baseline by your choice of evaluation criteria.
- Enter the Low Limit Value and High Limit Value to add reference lines.
- By default, RECIST evaluation is selected, click the down arrow next to RECIST to select from RANOTR or LUGANO.
Physical Exam Results
Use the Physical Exam Results sheet to review the results of physical exams. Identify subjects with abnormal findings for patterns in the subject population and compare findings against medical history and adverse events.
Subject Status
Use the Subject Status sheet to review a subject's current progress in a study.
If the study is configured in Data Central, click the link in the Graphical Profile Link column for a subject to access the subject's Graphical Patient Profile in Data Central.
Vital Signs (4 Sheets)
LB and VS Listings
Click on the name of sheet above to navigate to the sheet details.
Vital Signs - Descriptive Stats
Use the Vital Signs - Descriptive Stats sheet to view the distribution of vital signs data for each test by various parameters. The box-and-whisker chart beneath the summary tabulations can be used to identify potential trends or outliers in a test requiring further investigation.
To populate the box-and-whisker chart, select only one test.
- Use the buttons to view by Visit Name (default), Visit Number, Study Day, Study Week, Study Month, Age Range, Sex, Ethnicity, Race, Site, or Group Assignment.
- To expand or collapse the rows in the table, click the plus sign next to an item in the column on the left, or right-click anywhere in the table and select Expand / collapse in the context menu, then select Expand all or Collapse all.
Vital Signs Result Trends
Use the Vital Signs Result Trends sheet to review vital signs data by test to identify outliers for potential safety signals. Identify inclusion/exclusion criteria violations based on average, minimum, and maximum baseline values. Review vital signs test results distribution by frequency.
Select one test.
- For the chart on the left, enter lower and upper limits to add or adjust the reference lines.
- Click on the y-axis drop-down arrow to select Average Post Baseline (default), Min Post Baseline , or Max Post Baseline.
- Click on the x-axis drop-down arrow to select Baseline (default), Min Post Baseline, or Max Post Baseline.
Vital Signs Results Over Time
Use the Vital Signs Results Over Time sheet to review vital signs results over time, identify potential safety signals, and inclusion/exclusion criteria violations.
Select one test.
- For the chart on the left, enter the Low Limit Value and High Limit Value to add reference lines.
- Click on the y-axis drop-down arrow to select Results (default), % Change from Previous Visit, or % Change from Baseline.
Application Information
Use the Application Information sheet to view application information, such as what's new in CDA for the version you are using, when the data was last refreshed broken out by domain, a list of special interest adverse events and prohibited meds, and a glossary of terms used in CDA.
Download Sheet Descriptions
Click the links below to Download the PDF with full sheet descriptions.