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version v5.5.3

Release Notes

With this release to the Modernized PRS (available in the PRS Test system), several important fixes were made in response to user feedback. These include updates to make the behavior of several validations in the Protocol Section consistent with the classic system.

Improvements

  • Protocol Section:
    • Various modules
      • Corrected validations for Human Subjects Protection Review Board Status fields to be more consistent with regulatory requirements
      • Removed an error message that incorrectly appeared when the correct citation format was entered in the References module
      • Removed an error that was incorrectly shown for an anticipated Study Start Date displayed using the month and year
    • Contacts and Locations
      • U.S. phone numbers for a study's central contact are now recognized and no warning message appears
      • Validations for the Investigator's last name and role are now displayed
      • A validation error no longer appears for Location cards that have been removed from the Contacts and Locations module
    • Observational Studies
      • Added a missing validation rule for the Target Duration Follow Up field for observational studies
      • Fixed an incorrect error that appeared when no intervention was entered for an observational study
  • Record Summary:
    • People menu
      • Updated the Change Record Owner and Record Access lists on the People menu to include the appropriate user
      • When the Record Owner is updated using the People menu, the change is now reflected in the Status Details and Record Owner section of the Record Summary page

With this release to PRS Test, several important bug fixes were made in response to user feedback and improvements were made to the record access list. In addition, two new demonstration videos were posted on Fast Forward from ClinicalTrials.gov that show how to use some of the features in the Modernized PRS. These videos can be accessed through the About menu in the Modernized PRS.

Improvements

  • Record Summary:
    • Enhancements to and remodeling of the record access list.
      • Redesigned the search feature so users can search by name or username.
      • Column headers have been relabeled as "No Access" and "Access List" to clearly indicate which users have access to the record. Each user appears in a single column and can be moved to the other column as needed.

Completed or Coming Soon

  • Links Accessible from About Menu:
    • Additional Fast Forward videos
  • Bug Fixes to the Protocol Section:
    • The Unique Protocol ID will no longer trigger an error unless it is duplicated in an active record within the user's organization.
    • Deleting or renaming an arm or group in the Modernized PRS will no longer create cross-referencing errors in the Classic PRS.
    • An error message will no longer be shown when an organization's preferred name or partners of an organization are entered in the Sponsor field.
    • Errors shown for actual and anticipated study dates will be consistent with how these errors are handled in the classic system.
    • No error will be generated when the URL field for an IPD Sharing Statement has not been filled in.
    • Active user accounts will no longer produce an error in the Responsible Party field indicating that the account has been disabled.