Release Notes (2022.05)

Protocol First Enhanced Functionality Release Notes - Release 2022.05

The following features were added as part of the Protocol First production upgrade release on May 24, 2022.

User Interface

• To help avoid confusion when users are logged into non-production environments, a banner is now  displayed at the top of the screen with a message reminding them to not upload clinical trial data or any data containing PHI.
• A defect was resolved that caused projected visit dates to be displayed one day prior to the specified date when the user was located in certain time zones.

CRF Design

• For RECIST style forms, the system now supports multiple grids on the visit level assessments. This allows for capturing fields like “Sum of Diameters” in addition to individual tumor specific measurements on the same form while ensuring proper SDTM export.

Reporting

• The protocol number is now included in the filename when the Dashboard Report is generated.
• The following updates have been made to the Dashboard Report for locked subjects:
  • TRUE will be displayed on the Visit Listing tab for all of the subject's visits.
  • A count of log lines that have been locked will be displayed on the Subject Log Listing tab.

System/Protocol Administration

• A defect has been corrected that was preventing sites from being ordered properly when sorting by country on the Site List in the admin section.

SDTM Export

• A new feature has been added to allow SAS Transport Format (XPT) versions of the SDTM export to be available both from the Export Listing screen and via API.

API

• The ODM Get Study Site List has been updated to include the site’s country in the response.
• The ODM Get Study User List has been updated to include the country for all associated sites in the response.