With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Clinical Operations data model. These data model updates are automatically included in all Clinical Operations Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see New in 24R3 Limited Release.

24R2.2

The following changes were made to support the Auto-Manage Number Expected on EDL Items feature:

  • Added the Auto-Manage # Expected (automanage_expected__v) field to the following objects:
    • Template Expected Document (edl_item_template__v
    • Expected Document (edl_item__v)

The following changes were made to support the Clinical Operations-EDC - Protocol Deviations Link to CDMS feature: 

  • Added the EDC Protocol Deviation Link (edc_pd_link__v) field to the Issue (pdv__ctms) object

The following changes were made to support the Safety-Clinical Operations Connection: CRO Support feature:

  • Added the Sponsor Organization (sponsor_organization__v) field to the Study (study__v) object.