Release impact for other applications

This document describes the known impact and limitations that new features and enhancements introduced in this release may have on downstream applications.

Oracle Clinical One Analytics also known as Data Hub

  • Updates to a signature's status are included in the application's reports and datasets. Information related to affidavits is not included in the application's reports and datasets. This capability will be introduced in a future release.
  • Data associated with the new Temperature Excursion Number field is not displayed in any reports or datasets. This capability will be introduced in a future release.
  • Data related to screen failure visits is displayed in the application's reports and datasets, as expected. Failure dates specified by a user and updates to the Reason for Change field (for screen failures) will not be displayed in any reports or datasets. Instead, if Screen Failure Visit is enabled, the system date specified when a screen failure occurs will be displayed.

Oracle Life Sciences Data Management Workbench

  • Data associated with the new Temperature Excursion Number field is not displayed in Oracle DMW. This capability will be introduced in a future release.
  • Data associated with the new screen failure visit is displayed in Oracle DMW, as expected. Failure dates specified by a user and updates to the Reason for Change field (for screen failures) will not be displayed in the application. Instead, the system date specified when a screen failure occurs will be integrated.

Expected metadata changes in Oracle Life Sciences Data Management Workbench

The following updates to metadata in Oracle DMW are introduced in this release:
View/Table Column Variation Details
DHVW_SUBJECT_VISITS_V1 ADDRESS_COUNTRY Attribute differences: Length (100:4000)

Oracle Clinical One Digital Gateway

  • Data associated with the new Temperature Excursion Number field is currently not supported in Oracle Clinical One Digital Gateway. This capability will be introduced in a future release.
  • Screen failure visit dates entered by users are currently not supported and will not be integrated. Only system generated failure dates are integrated.
  • While you can include screen failure visits in the new study design, data related to these visits for integration configurations is not supported at this time. This capability will be introduced in a future release.