Release Notes (2022.12)

Flatiron EDC+ Release Notes [Release 2022.12]

The following features were added as part of the Flatiron EDC+ release on December 7, 2022.

Query Workflow Updates

User Interface

  • CRFs (visit and subject log) now support:
    • Multiple form level queries
    • Field level queries
  • Data Manager, Monitor (CRA) and Safety role types can add, update and close queries (see example screenshot below).
  • A new Query Listing tab is available at the protocol level which will display all queries that a user has access to with the ability to view the history of the query and respond to and/or close the query (see example screenshot below).
  • Query counts (site, subject, visit/log) have been updated to reflect total number of queries (form and field level).
  • The Query Flag included in the procedure pills on the visit screen is now present for:
    • Site Users and Principle Investigators when a query is open
    • Data Managers, Monitors and Safety users when a query is answered
  • The Query Flag included in the status column for subject logs is now present for:
    • Site Users and Principle Investigators when a query is open
    • Data Managers, Monitors and Safety users when a query is answered
  • Subject Log design updates:
    • Log entries will no longer be shown as pop-up modal windows and instead are shown as an embedded page view.
    • Certified Copy documents now include buttons for easier access to signature and upload details as well as for invalidation.
    • Due to system architecture changes, the Query Status filter was removed from the Subject Log summary screen. This filter will be added back in a future release.
  • Fields will no longer get highlighted for Data Management users if the field was changed after a query was opened on the form. 

Query Migration

  • All existing form level manual queries and automatic edit checks were migrated to the new query structure.
    • Queries on measurement type fields (e.g., Vital Signs, Labs) will automatically convert to field level queries.
    • All other queries will appear as form level queries.

Reporting

  • A Query Listing Report has been added and is available for download on the Query Listing screen. This report will include sub-reports for:
    • Manual Query ListingManual Query Counts - CRF
    • Manual Query Counts - Field
    • Query Aging - CRF
    • Query Aging - Subject
    • Query Aging - Site
    • Automatic Query Listing
    • Auto Query Counts
  • The following Query related worksheets in the Dashboard Report have been moved to the new Query Listing Report:
    • Manual Query Listing
    • Automatic Query Listing
    • Auto Query Counts
    • Manual Query Counts - CRF
    • Query Aging - CRF
    • Query Aging - Site

Additional Updates

Reporting

  • Clinical Listings updates
    • Column order and sorting will be consistent and not change over the course of a trial due to protocol updates.
    • Date and datetime fields are now treated as strings and not Excel date formats to allow for consistency in the displayed values.
    • Partial dates are now displayed in the main column instead of using an Excel comment.

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