1. Analytics User Guide
  2. Work with templates
  3. Dashboard templates descriptions
  4. Subject Data Analysis dashboard

Subject Data Analysis dashboard

The Subject Data Analysis dashboard offers you insights on a subject's journey through the different stages of a study by showcasing data related to demographics, events, adverse events, concomitant medications, as well as lab, and vitals data.

About access and filters

Tip:

Analyze data from your studies one by one. If multiple studies or sites are used in a dashboard filter there is a possibility that data doesn't appear in the different visualizations due to their default sizes.

Note:

If the selected filters point to data not present on another chart, it displays a message that states No Data Found .
  • To properly view corresponding data in the Subject Data Analysis dashboard, you must have access to the Subject Form Items dataset.
  • A dashboard is interactive so it displays any study data that you already have access to. To select what information to display you can use the following filters:
    • IS_CURRENT (by default, this filter is set to Y)
    • STUDY_MODE (by default, this filter is set to active)
    • STUDY_TITLE
    • COUNTRY_NAME
    • SITE_NAME
    • SUBJECT_NUMBER
    • Date range
  • You can use a chart as a filter, too. Click the Filter icon (filter icon) to the left of the visualization title. Click on any element of the chart with filter interactivity to filter out the remaining visualizations according to the selected data. To reverse the selection on the chart, click on any white space within the chart or use the Undo button (undo button) in the upper right corner of the browser window.

Reports

Note:

Data elements used in the visualizations are listed here with data element notation, upper cases with words separated by underscores. In contrast, custom calculation elements are listed using title case. These notations match with what you see in the dashboard template.
The Subject Data Analysis Dashboard includes the following reports:
Individual Subject Data
Use cases
  • A CRA who is interested in the data and finding the data in a study without difficulty.
  • A physician who is overseeing the clinical study and wants to see whether the united individual subject information gets to another level.
Insights
  • Get a centralized synopsis and particulars of an individual subject at a study and site level.
  • Identify key data such as ethnicity, age, gender as part of a subject's demography.
  • Review the visit schedule to help you monitor the progress of subjects in a clinical study or at a site.
  • Review medical history, record, and physical examination parameters that are very important to relate a subject's condition to faster medical conclusions.
  • Get access crucial information for sound decision making, such as a subject's vital signs.
Visualizations
Title Description Interactivity
Study Information (Listing Table)
  • Type: Table chart
  • Columns:
    • STUDY_TITLE
    • STUDY_PHASE
    • THERAPEUTIC_AREA
    • BLINDING_TYPE
    • STUDY_VERSION
 N/A.
Site Information (Listing Table)
  • Type: Table chart
  • Columns:
    • SITE_ID_NAME
    • SITE_NAME
    • SITE_STATUS
    • SITE_STUDY_VERSION
    • SDV_GROUP_NAME
    • ADDRESS_COUNTRY
    • ADDRESS_CITY
    • TIMEZONE
 N/A.
Subject Details (Listing Table)
  • Type: Table chart
  • Columns:
    • SUBJECT_NUMBER
    • STATE
    • Total Visits
    • Completed Visits
    • Total Forms
    • Completed Forms
 N/A.
Subject Information (Listing Table)
  • Type: Table chart
  • Columns:
    • SUBJECT_NUMBER
    • Gender
    • Race
    • Date of Birth
    • Age
    • Date of Informed Consent
 N/A.
Visit Schedule (Listing Table)
  • Type: Timeline chart
  • X-axis: VISIT_START_DATE
  • Y-axis: EVENT_TITLE
N/A.
Medical History (Listing Table)
  • Type: Table chart
  • Columns:
    • Visit Seq.
    • Visit Name
    • Item Label
    • Value
 N/A.
Medical History Records (Listing Table)
  • Type: Table chart
  • Columns:
    • Visit Seq.
    • Visit Name
    • # (serial number)
    • Condition
    • Ongoing?
    • Start date
    • Resolved date
 N/A
Physical Examination (Listing Table)
  • Type: Table chart
  • Columns:
    • Visit Seq.
    • Visit Name
    • # (serial number)
    • Body system
    • Evaluation
 N/A.
Vital Sign Detailed Report (Listing Table)
  • Type: Table chart
  • Columns:
    • SITE_NAME
    • Visit Seq.
    • Visit Name
    • Weight
    • Pulse
    • Respiratory rate
    • Temperature
    • Unit
    • Systolic
    • Diastolic
 N/A.
Vital Signs
  • Type: Line chart
  • X-axis: EVENT_TITLE.
  • Y-axis: Vital signs. All represented with a different color.
N/A.
AE (Adverse Event) & CM (Concomitant Medication) Data
Use cases
  • Physicians, medical reviewers, data monitors, and biostatisticians are engaged in analyzing safety data from clinical studies. They typically want to speed up the analysis of a subject's medical narrative when they experience a serious adverse event and they're on medication during the clinical study.
Insights
  • Identify if a subject has experienced an adverse event, its seriousness, and the duration of that event, as well as any other relevant details.
  • Identify whether a subject is on any concomitant medication and for how long they've been on a specific medication.
  • Cross-checking data related to a subject's adverse events, their occurences and the prescribed medication. This helps identify the efficacy of the investigational product.
Visualizations
Title Description Interactivity
Adverse Events (Listing Table)
  • Type: Table chart
  • Columns:
    • # (serial number)
    • Adverse Event
    • Severity
    • Start date
    • Ongoing?
    • End date
    • Any related medication?
    • Serious
    • Outcome
    • PT
    • SOC
 N/A.
Prior and Concomitant Medications (Listing Table)
  • Type: Table chart
  • Columns:
    • # (serial number)
    • Start date
    • Stop date
    • Route
    • Ongoing?
    • Medication name
    • Indication
    • Frequency
    • Form
    • Dose
    • Dose unit
    • ATC 1
    • ATC 4
 N/A.
Adverse Events
  • Type: Scatter chart
  • Y-axis: Event Term, AE#
  • X-axis: AE Days
N/A.
Prior and Concomitant Medications
  • Type: Scatter chart
  • Y-axis: Medication Name, CM#
  • X-axis: CM Days
N/A.
Lab Data
Use cases
  • Physicians, medical reviewers, and data monitors need to identify a subject's medical conditions and monitor the progression and efficacy of a treatment. This custom report can help us diagnose, monitor, screen, and research a subject's medical condition.
Insights
  • Identify signs or parameters of a subject's biochemistry, hematology, cardiac biomarkers, and more.
  • Track the efficacy or progression of a subject's treatment.
Visualizations
Title Description Interactivity
Cardiac Biomarkers (Central Labs) (Listing Table)
  • Type: Table chart
  • Columns:
    • Visit Seq.
    • Visit Name
    • # (serial number)
    • Lab Test
    • Lab Result
    • Lab Unit
    • High Range
    • Low Range
 N/A.
Biochemistry (Listing Table)
  • Type: Table chart
  • Columns:
    • Visit Seq.
    • Visit Name
    • # (serial number)
    • Lab Test
    • Lab Result
    • Lab Unit
    • High Range
    • Low Range
 N/A.
Hematology (Listing Table)
  • Type: Table chart
  • Columns:
    • Visit Seq.
    • Visit Name
    • # (serial number)
    • Lab Test
    • Lab Result
    • Lab Unit
    • High Range
    • Low Range
 N/A.
Cardiac Biomarkers (Central Labs)
  • Type: Stacked category chart
  • X-axis: EVENT_TITLE with different columns for each lab test number and name.
  • Y-axis: High Range, Low Range, Lab Result represented with different colors.
N/A.
Biochemistry
  • Type: Stacked category chart
  • X-axis: EVENT_TITLE with different columns for each lab test number and name.
  • Y-axis: High Range, Low Range, Lab Result represented with different colors.
N/A.
Hematology
  • Type: Stacked category chart
  • X-axis: EVENT_TITLE with different columns for each lab test number and name.
  • Y-axis: High Range, Low Range, Lab Result represented with different colors.
N/A.
  • Required configuration for the Subject Data Analysis dashboard
    The Subject Data Analysis dashboard is closely related to the design of a study. This means that special configurations are needed in a form's design for some visualizations to work properly. These configurations include specific form names (FORM_NAME) and question names (ITEM_NAME).

Parent topic: Dashboard templates descriptions