Clinical Research Associate dashboard

The Clinical Research Associate Dashboard can highlight which monitoring reports require completion or approval, as well as display key data points related to a site's health.

About access and filters

To properly view corresponding data in the Clinical Research Associate (CRA) Dashboard, you must have access to the Subject dataset, Queries dataset, Subject Forms dataset, and Blinded Subject Events dataset. For more information see Permissions to access Oracle Clinical One Analytics datasets.

Note:

You must have access to both datasets to view all information. If you only have access to one of the required datasets, you can still view the dashboard, but data in the reports related to the datasets you don't have access to displays as not available.

Because a dashboard is interactive, it displays any study data you already have access to. You can select what information to display using the following filters:

  • IS_CURRENT
  • STUDY_MODE
  • STUDY_TITLE
  • COUNTRY_NAME
  • SITE_NAME
  • Date Range
  • Subject State
  • Query State (Default to Answered, Candidate and Opened)

Tip:

Select data to analyze from a study one by one. If multiple studies or sites are used in a dashboard's filters, there is a possibility that data doesn't appear in the different visualizations due to their default sizes.
Additionally, some charts can be used as filters. Look for the filter icon (filter icon) to the left of the visualization title. Click any element of the chart with filter interactivity to filter out the remaining visualizations according to the selected data. To reverse selection on the chart, click the white space within it or use the undo button (undo button) at the upper right corner of the screen.

Note:

If the selected filters point to data that isn't present on another chart, it displays a No Data Found message.

Reports

The Clinical Research Associate (CRA) Dashboard includes the following 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.
Study Overview

Use case: review overall enrollment performance to assess sites in relation to study performance.

Insights:
  • Overall enrollment key performance indicators.
Visualizations:
Title Description Interactivity
Study Overview Represents subject counts by study and by subject status.
  • Type: Horizontal stacked bar chart.
  • X-axis: Subject counts. Colored stacks represent counts by subject status.
  • Y-axis: Study titles.
This chart can be used as a filter.
KPI: Total Screened Key Performance Indicator of total screened subjects.
  • Type: Tile chart.
  • Count: Subjects with STATE=
    • Screening_Initiated
    • Active
    • Complete
    • Withdrawn
    • Enrolled
    • Screen_Failed
Filtered data.
KPI: Current Screen Count Key Performance Indicator of current screened subjects.
  • Type: Tile chart.
  • Count: Subjects with STATE=
    • Screening_Initiated
Filtered data.
KPI: Screen Failed Count Key Performance Indicator of subjects with screen failure.
  • Type: Tile chart.
  • Count: Subjects with STATE=
    • Screen_Failed
Filtered data.
KPI: Enrolled Key Performance Indicator of enrolled subjects.
  • Type: Tile chart.
  • Count: Subjects with STATE=
    • Enrolled
Filtered data.
KPI: Current Active Key Performance Indicator of current active subjects.
  • Type: Tile chart.
  • Count: Subjects with STATE=
    • Active
Filtered data.
KPI: Randomized Count Key Performance Indicator of randomized subjects.
  • Type: Tile chart.
  • Count: Subjects with STATE=
    • Randomized
Filtered data.
KPI: Completed Study Key Performance Indicator of complete subjects.
  • Type: Tile chart.
  • Count: Subjects with STATE=
    • Complete
Filtered data.
KPI: Early Terminations Key Performance Indicator of withdrawn subjects.
  • Type: Tile chart.
  • Count: Subjects with STATE=
    • Withdrawn
Filtered data.
Study Details Lists subject counts by status for every study, study version, phase and therapeutic area.
  • Type: Listing table.
  • Columns:
    • STUDY_TITLE
    • STUDY_VERSION
    • STUDY_PHASE
    • THERAPEUTIC_AREA
    • Current Active
    • Completed Study
    • Early Terminations
Filtered data.
Screening Overview

Use case: review screen failure volume and identify possible reasons, by study, country and site.

Insights:
  • High screen failure may indicate a site is screening the wrong patient population, or existing issues with the inclusion/ exclusion criteria. In this case, contact site to review protocol and screening population.
  • Review screen failure reasons to identify issues with protocol, raise with your study manager.
  • In case of rapid screening and enrollment of subjects, schedule monitoring visits.
Visualizations:
Title Description Interactivity
KPI: Total Screened Key Performance Indicator of total screened subjects.
  • Type: Tile chart.
  • Count: Subjects with STATE=
    • Screening_Initiated
    • Active
    • Complete
    • Withdrawn
    • Enrolled
    • Screen_Failed
Filtered data.
KPI: Current Screen Count Key Performance Indicator of current screened subjects.
  • Type: Tile chart.
  • Count: Subjects with STATE=
    • Screening_Initiated
Filtered data.
KPI: Screened Failed Count Key Performance Indicator of subjects with screen failure.
  • Type: Tile chart.
  • Count: Subjects with STATE=
    • Screen_Failed
Filtered data.
KPI: Enrollment Count Key Performance Indicator of enrolled subjects.
  • Type: Tile chart.
  • Count: Subjects with STATE=
    • Active
    • Complete
    • Withdrawn
    • Enrolled
Filtered data.
Screening vs. Enrollment by Country Represents subject counts by subject status.
  • Type: Bar chart.
  • X-axis: Country name.
  • Y-axis: Subject counts. Different colored bars represent counts by subject status:
    • Total Screened
    • Screen Failed Count
    • Enrollment Count
    • Current Screen Count
This chart can be used as a filter.
Screen Failure Reason by Site Represents counts of subject with screen failure by reason.
  • Type: Horizontal stacked bar chart.
  • X-axis: Count of subjects with screen failure. Colored stacks represent different screen failure reasons.
  • Y-axis: Reasons of screen failure.
Filtered data.
Screening Overview Lists subject details by country and site, including reason of screen failure when applicable.
  • Type: Listing table.
  • Columns:
    • COUNTRY_NAME
    • SITE_NAME
    • SITE_ID_NAME
    • SIBJUECT_NUMBER
    • STATE
    • Screen Failure Reason
Filtered data.
Enrollment Report

Use case: review and analyze the enrollment volume for different sites and countries.

Insights:
  • Contact the site for the reason of low enrollment to provide guidance on protocol training, patient population, prompts to enter data, etc.
Visualizations:
Title Description Interactivity
Subjects’ enrollment Counts by Site/Country Represents the enrollment count and respective percent by site for all countries.
  • Type: Donut chart.

    Note:

    There is a different donut chart for each country.
  • Data: Subject enrollment count by site. Total count is displayed at the center of the Donut.
This chart can be used as a filter.
Month-wise Enrollment Trend Represents total screened subjects count vs. enrollment count by month.
  • Type: Bar chart with reference line.
  • X-axis: Enrollment month.
  • Y-axis: Total screened and enrolled subjects count. Different colored bars represent screening and enrollment respectively.
  • Reference line: Average total screened subject count.
Filtered data.
Subject Enrollment Details Lists screening and enrollment counts by site, study and country.
  • Type: Listing table.
  • Columns:
    • COUNTRY_NAME
    • STUDY_TITLE
    • SITE_NAME
    • SITE_ID_NAME
    • Total Screened
    • Current Screen Count
    • Enrollment Count
    • Current Active
    • Completed Study
    • Dropout Count
Filtered data.
Subject Dropout Count by Reason

Use case: review subject dropout trend volume and reasons, for the overall study and by site and country.

Insights:
  • High dropout volume may indicate a site is screening the wrong patient population. In this case contact site to review protocol and screening population.
  • High dropout volume may indicate existing issues with the inclusion/ exclusion criteria, the drug itself, adverse events, protocol design or site conduct of the protocol. In this case, contact site to review protocol.
  • Review dropout reasons to identify issues with protocol, raise with your study manager.
  • In case of rapid screening and enrollment of subjects, schedule monitoring visits.
Visualizations:
Title Description Interactivity
Total Dropout Counts by Reason Represents subject dropout counts by reason.
  • Type: Horizontal bar chart.
  • X-axis: Dropout count.
  • Y-axis: Dropout reason.
This chart can be used as a filter.
Total Dropouts by Site/Country Represents subject dropout counts by country and by site.
  • Type: Horizontal stacked chart.
  • X-axis: Dropout counts.
  • Y-axis: Country name. Colored stacks represent counts by site.
This chart can be used as a filter.
Total Dropouts by Study Represents total subject dropout counts by study.
  • Type: Donut chart.
  • Data: Total dropout counts by study. Total count is displayed at the center of the Donut.
This chart can be used as a filter.
Subject Dropout Count by Reason Details Lists subject dropout count by reason for every site in all countries.
  • Type: Listing table.
  • Columns:
    • COUNTRY_NAME
    • SITE_NAME
    • STATE
    • REASON
    • Dropout count
Filtered data.
Outstanding Queries by Site and Visit

Use case: to review high volume of queries by status at a site and to compare with other sites.

Insights:
  • Plan workload distribution and additional resources implementation to handle high volume of queries.
  • Work along with Clinical team and schedule monitoring visits to pro-actively provide training for site users to conduct a particular visit.
Visualizations:
Title Description Interactivity
Outstanding queries by Site Represents the total count of queries as well as the count of queries grouped by state for each site.
  • Type: Vertical stacked bar chart.
  • X-axis: Site name.
  • Y-axis: Queries count. Colored stacks represent counts by query status.
This chart can be used as a filter.
Count and duration of Open Queries by Site Represents open queries count by age range for every site.
  • Type: Vertical stacked bar chart.
  • X-axis: Site name.
  • Y-axis: Open queries count. Colored stacks represent age ranges:
    • 6 to 10 days
    • 11 to 30 days
    • 31 to 60 days
    • greater than 60 days
This chart can be used as a filter.
Count and duration of Open Queries by Visit Short description
  • Type: Bar chart.
  • X-axis: Visit.
  • Y-axis: Open queries count. Different colored bars represent age ranges:
    • 6 to 10 days
    • 11 to 30 days
    • 31 to 60 days
    • greater than 60 days
This chart can be used as a filter.
Outstanding Queries by Site and Visit Details Lists the total count of queries as well as the count of queries grouped by state in every visit for every subject in all sites.
  • Type: Listing table
  • Columns:
    • COUNTRY_NAME
    • SITE_NAME
    • SUBJECT_NUMBER
    • Visit
    • Open Queries Count
    • Answered Queries Count
    • Candidate Queries Count
    • Total queries count
    • 0-5 Days Opened
    • 6-10 Days Opened
    • 11-30 Days Opened
    • 31-60 Days Opened
    • >60 Days Opened
Filtered data.
Query Aging by Site

Use case: review high volume of open queries and query age at a site as compared to other sites.

Insights:
  • Plan workload distribution and additional resources implementation to handle high volume of queries.
  • Work along with Clinical team and schedule monitoring visits to pro-actively provide training for site users to conduct a particular visit.
Visualizations:
Title Description Interactivity
Count and Duration of Open Queries by Site Represents open queries count by age ranges for every site.
  • Type: Vertical bar chart.
  • X-axis: Site name.
  • Y-axis: Open queries count. Different colored bars represent age ranges:
    • 0 to 5 days
    • 6 to 10 days
    • 11 to 30 days
    • 31 to 60 days
    • greater than 60 days
This chart can be used as a filter.
Outstanding Queries by Site and Visit Details Lists queries counts by query state, by age range for open queries and by visit, for every subject in all sites.
  • Type: Listing table.
  • Columns:
    • COUNTRY_NAME
    • SITE_NAME
    • SUBJECT_NUMBER
    • Visit
    • Open Queries Count
    • Answered Queries Count
    • Candidate Queries Count
    • 0-5 Days Opened
    • 6-10 Days Opened
    • 11-30 Days Opened
    • 31-60 Days Opened
    • >60 Days Opened
Filtered data.
Query Status by Site and Subject

Use case: review specific query volume by Subject, Country and Site

Insights:
  • In case of high query volume, contact site for workload prioritization based on open queries
  • Identify the need of additional training for a site.
Visualizations:
Title Description Interactivity
Query Count by Country Heat map of queries counts by country.
  • Type: Map chart. Countries appear in heat map colors.

    Tip:

    Hover on a country to view country name and total queries count.
This chart can be used as a filter
Query Count by Country and state Lists countries upon selection along with queries count, in total and by query state.
  • Type: Pivot table.
  • Columns:
    • COUNTRY_NAME
    • COUNT

      Note:

      One COUNT column for each query state.
    • Grand Total
Filtered data.
Query Count by Study and Site Represents total queries count vs. open queries count by site. Study name details appear on hover.
  • Type: Horizontal bar chart.
  • X-axis: Queries count. Different colored bars represent total queries count and open queries count respectively.
  • Y-axis: Site name.
This chart can be used as a filter.
Query Status by Site and Subject Details Lists counts of queries by state for every subject in all sites.
  • Type: Listing table.
  • Columns:
    • COUNTRY_NAME
    • SITE_NAME
    • SUBJECT_NUMBER
    • SUBJECT_STATE
    • Open Query Count
    • Answered Query Count
    • Candidate Query Count
    • Closed Query Count
    • Deleted Query Count
    • Started Visits Count
    • % of Queries within Country
Filtered data.
Query Volume by Month

Use case: review specific query volume by month, for every site and country and by Subject.

Insights:
  • Identify which Sites have more or less queries in particular month or visit.
  • In case of high query volume,contact site for workload prioritization based on queries.
  • Identify the need of additional training for a site.
Visualizations:
Title Description Interactivity
Query Count by Status Represents the evolution of query volume by month.
  • Type: Line chart.
  • X-axis: Year-month to evaluate for active queries.
  • Y-axis: Total queries count. Different colored lines represent different query states.
This chart can be used as a filter.
Query Volume by Month by Site Lists queries count by state by month for each site.
  • Type: Pivot table.
  • Columns:
    • COUNTRY_NAME
    • SITE_ID_NAME
    • SITE_NAME
    • Month
    • COUNT

      Note:

      One COUNT column for each query state.
    Subtotal counts per site appear in red.
Filtered data.
Query Count by Subject by Month Lists queries count and state by month for every subject in all sites.
  • Type: Listing table.
  • Columns:
    • SITE_NAME
    • SUBJECT_NUMBER
    • Total Queries Count
    • Month
    • Query State
Filtered data.
Query Management Detail Report

Use case: review query details for total query volume or by query state, for all subjects or by site. Use this information to indicate a problem with certain visit or the data collection forms.

Insights:
  • In case of high query volume, contact site for workload prioritization based on open queries
  • Identify the need of additional training for a site.
Visualizations:
Title Description Interactivity
Unresolved Queries by Site Represents the total count of queries as well as the count of queries grouped by state for each site.
  • Type: Vertical stacked chart.
  • X-axis: SITE_ID_NAME.
  • Y-axis: Total queries count. Colored stacks represent counts by query status.
This chart can be used as a filter
Query Management Detail Report Lists query details for every subject in every site.
  • Type: Listing table.
  • Columns:
    • COUNTRY_NAME
    • STUDY_TITLE
    • SITE_ID
    • SITE_NAME
    • SUBJECT_NUMBER
    • Visit
    • FORM_NAME
    • ITEM_NAME
    • QUERY_COMMENT
    • STATE
    • QUERY_AGE
    • VERSION_START
    • USER_NAME
Filtered data.
Query Volume by Form

Use case: identify issues on specific forms causing high query volume. Use this information to indicate a problem with certain visit or the data collection forms.

Insights:
  • In case of high query volume, contact site for workload prioritization based on open queries
  • Identify the need of additional training for a site.
Visualizations:
Title Description Interactivity
Query Volume by Form Represents total queries count, as well as queries count by status, by form.
  • Type: Horizontal stacked bar chart.
  • X-axis: Queries count. Colored stacks represent counts by query status.
  • Y-axis: Form name.
This chart can be used as a filter.
Query Volume by Form Lists queries count, total and by status, by form, grouped by visit and by site.
  • Type: Pivot table.
  • Columns:
    • SITE_NAME
    • Visit
    • FORM_NAME
    • Open Query Count
    • Answered Query Count
    • Candidate Query Count
    • Grand Total
Filtered data.
Subject Counts with Outstanding Queries

Use case: review specific query volume by subject, country and site.

Insights:
  • In case of high query volume, contact site for workload prioritization based on open queries
  • Identify the need of additional training for a site.
Visualizations:
Title Description Interactivity
Subject Count with Query Status by Site Represents the subject count with opened, answered and candidate queries, as well as the total, by site.
  • Type: Vertical stacked bar chart.
  • X-axis: SITE_ID_NAME.
  • Y-axis: Subject count. Colored stacks represent subject counts with specific query status.
This chart can be used as a filter.
Avg. Age of Queries Open by Site/Study Represents the average age of open queries by site.
  • Type: Vertical stacked bar chart with reference line.
  • X-Axis: SITE_ID_NAME.
  • Y-Axis: Average age of open queries for each site.
  • Reference line: Average age of queries across all sites.
This chart can be used as a filter.
Subject Counts with Outstanding Queries Lists queries count by state for every subject by site and country.
  • Type: Listing table.
  • Columns:
    • COUNTRY_NAME
    • SITE_NAME
    • SITE_ID_NAME
    • SUBJECT_NUMBER
    • STATE
    • COUNT
Filtered data.
Missing Forms Report
Use case: Measure study performance by analyzing the forms that have not yet been entered.

Note:

Forms form Cycle Visits and Branch Visits are not included.
Insights:
  • Identify key performance indicators related to missing forms.
Visualizations:
Title Description Interactivity
KPI: Forms Completed Count Key Performance Indicator of completed forms.
  • Type: Tile chart.
  • Count: Forms with FORM_STATUS=
    • Completed
Filtered data.
KPI: Forms Partially Completed Count Key Performance Indicator of partially completed forms.
  • Type: Tile chart.
  • Count: Forms with FORM_STATUS=
    • Incomplete
    • In_progress
Filtered data.
KPI: Forms Missing Count Key Performance Indicator of missing forms.
  • Type: Tile chart.
  • Count: Forms with IS_MISSING_FORM=
    • Yes
Filtered data.
KPI: Forms Overdue Count Key Performance Indicator of overdue forms.
  • Type: Tile chart.
  • Count: Forms with FORM_STATUS=
    • Incomplete
    • Invalid
    • In_progress
    • Scheduled
    • Valid
    and VISIT_STATUS=
    • In progress
    • Incomplete
Filtered data.
Missing Forms by Site Represents missing and completed forms count by site and study.
  • Type: Horizontal bar chart.
  • X-Axis: Form counts. Different colored bars represent the completed and the missing forms count.
  • Y-Axis: Study titles and Sites.
This chart can be used as a filter.
Missing Forms by Subject Represents missing and completed forms for each subject by study.
  • Type: Horizontal bar chart.
  • X-Axis: Form counts. Different colored bars represent the completed and the missing forms count.
  • Y-Axis: Study titles and Subjects.
This chart can be used as a filter.
Missing Forms by Visit Represents missing and completed forms for each visit by study.
  • Type: Horizontal bar chart.
  • X-Axis: Form counts. Different colored bars represent the completed and the missing forms counts.
  • Y-Axis: Study titles and Visits.
This chart can be used as a filter.
Missing Forms Timeline Represents missing and completed forms for each subject by study.
  • Type: Line chart with two lines.
  • X-Axis: Visit date or projected visit date for the completed or missing forms respectively.
  • Y-Axis: Form counts. Different colored lines represent the completed and the missing forms counts.
This chart can be used as a filter.
Missing Forms Details Lists forms count by status (completed, partially completed, missing or overdue) for every subject by site and country.
  • Type: Listing table.
  • Columns:
    • STUDY_TITLE
    • SITE_NAME
    • COUNTRY_NAME
    • SUBJECT_NUMBER
    • EVENT_TITLE
    • VISIT_START_DATE
    • FORM_NAME
    • Completed Forms Count
    • Forms Partially Completed Count
    • Forms Missing Count
    • Forms Overdue Count
Filtered data.
Missing Visits Report
Use case: Measure study performance by analyzing the visits that have not yet been started.

Note:

Cycle Visits and Branch Visits are not included.
Insights:
  • Identify key performance indicators related to missing visits.
Visualizations:
Title Description Interactivity
KPI: Visits Completed Count Key Performance Indicator of completed visits.
  • Type: Tile chart.
  • Count: Visits with VISIT_STATUS=
    • Completed
Filtered data.
KPI: Visits Partially Completed Count Key Performance Indicator of partially completed visits.
  • Type: Tile chart.
  • Count: Visits with VISIT_STATUS=
    • Incomplete
    • Incomplete_Err
    • Inprogress
    • Complete_Err
Filtered data.
KPI: Visits Skipped Count Key Performance Indicator of skipped visits.
  • Type: Tile chart.
  • Count: Visits with VISIT_STATUS=
    • Skipped
Filtered data.
KPI: Visits Missed Count Key Performance Indicator of missing visits.
  • Type: Tile chart.
  • Count: Visits with IS_MISSING_VISIT=
    • Yes
Filtered data.
KPI: Visits Overdue Count Key Performance Indicator of overdue visits.
  • Type: Tile chart.
  • Count: Visits with IS_OVERDUE_VISIT=
    • Yes
Filtered data.
Missing Visits by Site Represents missing and completed visits count by site and study.
  • Type: Horizontal bar chart.
  • X-Axis: Visit counts. Different colored bars represent the completed and the missing visits counts.
  • Y-Axis: Study titles and Sites.
This chart can be used as a filter.
Missing Visits by Subject Represents missing and completed visits for each subject by study.
  • Type: Horizontal bar chart.
  • X-Axis: Visit counts. Different colored bars represent the completed and the missing visits counts.
  • Y-Axis: Study titles and Subjects.
This chart can be used as a filter.
Missing Visits Timeline Represents missing and completed forms for each subject by study.
  • Type: Line chart with two lines.
  • X-Axis: Visit date or projected visit date for the completed or missing visits respectively.
  • Y-Axis: Visit counts. Different colored lines represent the completed and the missing visits counts.
This chart can be used as a filter.
Missing Visits Details Lists visits count by status (completed, partially completed, skipped, missing or overdue) for every subject by site and country.
  • Type: Listing table.
  • Columns:
    • STUDY_TITLE
    • SITE_NAME
    • COUNTRY_NAME
    • SUBJECT_NUMBER
    • EVENT_TITLE
    • VISIT_START_DATE
    • Visits Completed Count
    • Visits Partially Completed Count
    • Visits Skipped Count
    • Visits Missing Count
    • Visits Overdue Count
Filtered data.