Clean Progress Tracking in Data Central

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Clean Progress Tracking (CPT), integrated within Data Central, helps users monitor subject status and data cleaning progress with a pre-defined workspace and visualizations. This workspace features out-of-the-box visualizations and an enhanced Subjects listing. Enabling Clean Participant Tracking in the Subjects listing allows users to create a configurable Clean Status column, linking EDC metrics to cleaning in elluminate.

Important: While elluminate metrics for review and issues are automatically displayed in the workspace visualizations, enabling Queries is required to populate Queries-related visualizations. Similarly, enabling Clean Participant Tracking in the Data Central Subjects Listing configuration is necessary to populate Clean Status-related visualizations. Finally, the Subject Status Field and Group Assignment Field must be included in the Clean Participant Tracker for those dimensions to be included in the visualizations. 

Use the Subjects Listing as a Clean Participant Tracker

Enabling the Clean Participant Tracker in the Data Central Subjects Listing configuration determines which metrics contribute to the clean status. These metrics may include elluminate's cleanliness tracking functionality such as open/in-progress and answered issues; open and answered queries (if enabled); and records to review for each reviewer role with at least one user assigned and at least one Data Review responsibility assigned. EDC metrics can also be added by connecting a mapping containing numeric fields such as missing pages, outstanding SDV, uncoded MedDRA / WHODrug terms, and unfrozen / unlocked eCRFs. Fields selected to be included as part of the Clean Status will contribute to an 'Unclean' status for a subject if its value is greater than 1 in that column for a subject. Once configured, the Clean Status column will populate in the Data Central Subjects listing.

Subject Status Listing.png

Clean Status: The column's icon indicates whether a subject is clean or unclean. A checkmark indicates a clean subject; the absence of a checkmark indicates an unclean subject. Hover over the icon to see a tooltip describing the columns contributing to the unclean status. 
Unclean tooltip.png

Even if Clean Participant Tracking is disabled, the Subjects listing includes links for each subject to Records to Review (for users with reviewer roles), Open/In Progress Issues, Answered Issues, Open Queries, and Answered Queries (if a query table exists for the study) to assist in initiating the data cleaning workflow.

  • [Role] Records to Review: The hyperlinked number in this column indicates the number of records a role needs to review ('New' (not yet reviewed) plus 'Updated Since Reviewed' statuses). Click the number to open the Records Review Summary panel, filtered to show only Domains that contain that subject's records requiring review applicable to the user's role. In the image above, the Data Manager (DM) has 9 records to review for the second subject in the listing.
  • Open / In Progress Issues & Answered Issues: These columns display hyperlinked numbers indicating the count of open / in-progress and answered issues, respectively. Click the number to open the Issues panel, filtered to show only issues with the selected status for that subject.
  • Open Queries & Answered Queries: These columns display hyperlinked numbers indicating the count of open and answered queries, respectively. Click the number to open the Queries panel, filtered to show only queries with the selected status for that subject.

Users can also customize their Subjects listing view using existing Data Central functionality; for example, they can click the Subjects Settings icon in the panel toolbar to hide unwanted columns and toggle domain highlighting (color-coding). Columns and rows may be color-coded to indicate risk levels.

Access the Clean Progress Tracking Workspace

Access the Clean Progress Tracking workspace from within a Data Central study.

The Clean Progress Tracking workspace is available regardless of Clean Participant Tracking's enabled status. If Clean Participant Tracking is disabled, the workspace's pre-defined visualizations are limited to the Subjects: Data Cleaning sheet, displaying review, issue, and query status (if enabled). The Subjects listing retains links in the Records to Review (for users with reviewer roles), Open/In Progress Issues, Answered Issues, Open Queries, and Answered Queries columns.

Access Clean Progress Tracking workspace.png

  1. From the Workspace drop-down in the master header, select the Clean Progress Tracking workspace. 
  2. The Subjects: Data Cleaning sheet is displayed by default. Click the Subjects: Status tab in the bottom left to view the status sheet.
  3. Optionally, open and dock other visualizations or data listings from the left navigation, add sheets, and save the revised workspace with a new name. 
    Subjects Data Cleaning sheet.png

Subjects: Data Cleaning Sheet

The four panels on the Subjects: Data Cleaning sheet include:

  • Subjects Listing
  • Visualizations: View charts by Study (default). Click the bottom pill to switch to Site or Subject views.
    • Subjects: Review - View the number of records to review by study, site, or subject, using different colors for each Data Central reviewer role.
    • Subjects: Issues - View the number of issues by study, site, or subject, using different colors for each review status.
    • Subjects: Queries - View the number of queries by study, site, or subject, using different colors for each review status.

Subjects: Status Sheet

Subjects Status Sheet.png

The four panels on the Subjects: Status sheet include:

  • Subjects Listing
  • Visualizations:
    • Subjects: Population Breakdown - View the number of subjects by Subject Status (default). Click the bottom pill to switch to Site or Group Assignment.
    • Subjects: Clean Status - View the number of clean and unclean subjects by study (default). Click the bottom pill to switch to Site. 
    • Subjects: Unclean Status Contributors - View the number of unclean subjects by contributor (e.g., DM Role, Open Queries, Answered Queries, Answered Issues, Open Issues).

Chart Functionality

  • Zoom: Click and drag to zoom into a chart section; click the Zoom Out icon to reset the chart.
  • Export: Click the Export icon to Print, Export to PDF, Export to PNG, or Export to JPG.
  • Maximize / Restore: Click the Maximize icon for full-screen view; click the Restore icon to return to the default size.
  • Filtering:
    • The Filters icon highlights when filters are applied. Applied filters appear in the Filter Panel and global filters in the master header's filter pill.
    • Click a chart segment to filter the chart and all charts on the workspace.
    • Right-click a chart segment to Filter Subjects (global filter) or Filter To Selected Records (filters all charts on the workspace and panels with the same underlying data).
    • Click an item in a legend to filter all panels on the workspace.

Access Clean Progress Tracking Visualizations

Have your own workspace and want to add the out-of-the-box visualizations or access them ad-hoc while working in Data Central? Simply select them from the Visualizations subpanel in the left navigation under the elluminate > Subjects folder. Then, dock them to the sheet.

CPT Visualizations Access.png

 

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