Enhancements to Randomization and Trial Supply Management reports

Improvements have been made to some of the reports related to Randomization and Trial Supply Management (RTSM).

Certain edge cases are also addressed through this update, primarily in the context of replacement kits.

Details for clinical supply managers

The following improvements have been brought to reports:

Report Enhancements
Shipment Order Summary report
  • A new Received By column has been added.
  • Users can now schedule the report.
Kit Dispensation report In addition to .html and .pdf, this report is now available in CSV format.
  • These reports have been updated to include kit replacement data, in order for sponsor users to be able to determine which kits have been replaced in a study.
  • This includes new columns for dispensation dates, replacement kit numbers, as well as reasons for replacement.
  • These reports now include kit replacement data, in order for sponsor users to be able to determine which kits have been replaced in a study.
  • This includes new columns for dispensation dates, replacement kit numbers, and reasons for replacement.
  • Users can now filter on projected window dates.

    Tip:

    as a sponsor user, use this new feature to preview potential upcoming kit dispensations within a particular window of time.
Kit Inventory (Blinded) report New Blinded Lot ID and Blinded Lot Expiry Date columns have been added for better supply management.
Kit Inventory (Unblinded) report New Manufacturing Lot Expiry Date, Blinded Lot ID, and Blinded Lot Expiry Date columns have been added for better supply management.
Study Design report
  • The following column names from the Signature Configuration section have been updated:
    • Required Forms to Required Form(s)
    • Required Visits to Required Visit(s)
    • Effective Scope to Required on Selected Visits
    • Target Date to Target
  • The visit summary of the report has been updated to display the visit branch, in order for users to differentiate between visits when these are named identically.
Study Enrollment report
  • This report has been updated to feature the following site enrollment audit data categories:
    • Screening Limit
    • Randomization Limit
    • Last Modified
    • Last Modified By
  • A new Site ID column has been added.
  • The name of the Site column has been updated to Site Name.
  • This report can now be exported in CSV format, part of which each report section will have its own sheet.