5 Release impact on downstream systems
This document describes the known impact and limitations that new features introduced in Oracle Clinical One Platform 25.3 may have on downstream systems, specifically Oracle Clinical One Analytics and Oracle Clinical One Digital Gateway integrations.
For additional information about the features in this release and the potential impact on your studies, Download the Release Implementation Assessment document
Oracle Clinical One Analytics also known as Data Hub
| Release feature | Analytics impact |
|---|---|
| Configure advanced dispensation for your study | This feature is not supported in Oracle Clinical One Analytics and will be implemented in a future release. |
| Support for compounding shipments | A new data element that helps differentiate shipments with compounding kits from shipments without compounding kits is now part of a Oracle Clinical One Analytics dataset. |
| Choose when subject numbers are assigned | When subject numbers are assigned upon screening, data related to subject numbers and subjects only flows to the applicable datasets as soon as a subject's screening forms are successfully submitted. This happens whether the subject fails or passes screening. |
| New adaptive randomization schemes | The new adaptive randomization feature is now reflected in Oracle Clinical One Analytics datasets. |
Oracle Clinical One Digital Gateway configured integrations
| Release feature | Impacted integration | Impact details |
|---|---|---|
| Subject data can now be unverified | CTMS Source Data Verification (SDV) | The ability to integrate unverified subject data is not supported. |
| Limit the number of times a subject can be rescreened |
Outbound subject data integration Oracle Clinical One Platform to Oracle InForm SAP Supply Management System—Actual Enrollment Integration Note: For a list integrations that support this feature, see Oracle Clinical One Digital Gateway integrations support rescreen visits. |
Multi-IWR Does not support integrating data into rescreening visits and does not trigger any rescreen actions. Integrating rescreen data using the Oracle Clinical One Platform to Oracle InForm integration and the Outbound Subject Data integration is not currently supported. Rescreen visits are not included in the extract for the SAP Actual Enrollment Integration. |
| Support for compounding shipments |
Oracle Siebel CTMS Site Integration Supply Systems: Almac, Fisher, Catalent, SmartSupplies PMD, and Sharp ERP Shipment Note: This feature is only supported by the Master User List (MUL) - Site Tenant Integration and the SAP Supply Management System integration. |
The Oracle Siebel CTMS Site integration cannot create compounding sites, and the following supply-management integrations cannot ship to them: Almac, Fisher, Catalent, SmartSupplies PMD, and Sharp ERP Shipment. |