Patch set impact on other applications

This document describes the known impact and limitations that new features and enhancements introduced in Oracle Clinical One Platform 25.1.1 may have on downstream applications.

Oracle Clinical One Analytics also known as Data Hub

Some new features and enhancements in this release impact datasets in Oracle Clinical One Analytics as follows:
  • For this release, Oracle Clinical One Analytics is enhanced with a new architecture, using a new data processing model that refreshes data more frequently in Oracle Clinical One Analytics than before. Besides the improved performance, we have brought other enhancements that may impact your workflow if you are working with Oracle Clinical One Analytics datasets. For more information, see Improved performance in Oracle Clinical One Analytics with new data elements to track data reliability.
  • EHR data and any configurations related to this new feature are displayed in Oracle Clinical One Analytics datasets, as expected. For more information on the new feature, see Import Electronic Health Record (EHR) data.
  • With the improved workflow for withdrawal, completion, and screen fail visits, related data is displayed in both Oracle Clinical One Analytics datasets and standard reports. For more information on this new enhancement, see Manage subject event related data and visits better.
    The following data points will be introduced in a future release in the Oracle Clinical One Analytics datasets:
    • WITHDRAWAL_REASON
    • WITHDRAWAL_COMMENT
    • SCREEN_FAILURE_COMMENT
    • SCREEN_FAILURE_DATE
    Moreover, whereas this new feature allows users to capture and update events such as a subject's study completion or withdrawal date, along with the reasons for making these updates, these reasons will only be propagated to downstream systems in a future release.
  • You can now exclude or include screen failed subjects from the Source Data Verification (SDV) pool. Data related to included or excluded subjects from the SDV pool is refreshed in the appropriate Oracle Clinical One Analytics datasets. For more information on this new enhancement, see Include or exclude screen failed subjects from Source Data Verification.
  • You can now make Advanced Study Version changes to forms with label questions. Changes you make in your tabular forms are now reflected reflected appropriately in Oracle Clinical One Analytics. For more information on this new enhancement, see Update tabular forms included in live studies.
  • Should your study use a SAP integration to ship pooled kits, data related to the Material ID is sent to Oracle Clinical One Analytics, as expected. For more information on this new enhancement, see Enhanced kits pooling for the quantum shipment model.

Oracle Clinical One Digital Gateway configured integrations

Some new features and enhancements in this release impact Oracle Clinical One Digital Gateway integrations as follows:
  • Data related to a subject's Withdrawal, Screen Failure, and Study Completion events, as well as updates to these events, is now supported by the integrations with Oracle InForm, Medidata Rave, and Oracle's Siebel Clinical Trial Management System (CTMS). For more information, see Support for undoing subject events.
  • With this release, should your study use a SAP integration to ship pooled kits, you may need to perform certain updates on your integration configuration file. For more information, see Enhanced kits pooling for the quantum shipment model.

Oracle Life Sciences Data Management Workbench integrations

Some new features and enhancements in this release impact Oracle DMW integrations as follows:

  • Electronic Health Record (EHR) data imported into your study is now supported in Oracle DMW. For more information on this new feature, see Import Electronic Health Record (EHR) data.
  • With the improved workflow for withdrawal, completion, and screen fail visits, related data is displayed in Oracle DMW. For more information on this new enhancement, see Manage subject event related data and visits better.
    The following data points will be introduced in a future release in Oracle DMW:
    • WITHDRAWAL_REASON
    • WITHDRAWAL_COMMENT
    • SCREEN_FAILURE_COMMENT
    • SCREEN_FAILURE_DATE
    Moreover, whereas this new feature allows users to capture and update events such as a subject's study completion or withdrawal date, along with the reasons for making these updates, these reasons will only be propagated to downstream systems in a future release.
  • Numeric ordering tags for queries will not be reflected in Oracle DMW. For more information on this enhancement, see Trace queries for a target question.
  • Data related to included or excluded subjects from the SDV pool is supported in Oracle DMW. For more information on this new enhancement, see Include or exclude screen failed subjects from Source Data Verification.

Parent topic: Release impact on other applications