Patch set release impact for other applications

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

Oracle Life Sciences Data Management Workbench

• As part of this release, a new dataset has been introduced to support changes in the Sign, Verify, Freeze, and Lock (SVFL) statuses for objects (visits, forms, or questions). The enhancements to clinical views or the additional operational tables in support of this new dataset will be added as part of an upcoming release. For more information, see New datasets to track sign, verify, freeze, and lock actions.
• The newly implemented lock status will be introduced as part of a future release. For more information, see New data element to track visit, form, and item level locks.
• The new data elements related to order type and forced randomization will be added as part of a future release. For more information, see Enhancements to Oracle Clinical One Analytics datasets.
• Clinical data extracts now support loading data for the STUDY column from the Study Identifier, found in the General tab of the Study Settings of a Oracle Clinical One Platform study. Previously, STUDY information would be loaded from the Study Version Name related to that study's clinical data. For more information, see Enhancements to Oracle DMW clinical data extracts.

ODM Extract

• Sign, Verify, Freeze, and Lock (SVFL) audit transactions are not included in the ODM extract as part of this release. For more information about this new feature, see New datasets to track sign, verify, freeze, and lock actions.
• The newly implemented lock status is not currently reflected in the ODM Extract. For more information, see New data element to track visit, form, and item level locks.