Enhancements to Oracle Clinical One Analytics datasets

To help clinical supply managers gain a better understanding of investigational product dispensation, multiple (existing) datasets have been enriched with new data elements.

Clinical supply managers and other Oracle Clinical One Analytics users can now generate reports and dashboards that include the following new elements:

• ORDER_TYPE: Provides detailed information about how a shipment was initiated in Oracle Clinical One Platform.

  This data element is now available in the Blinded Kit dataset and the Unblinded Kits dataset.

• FORCED_RAND: Indicates if subjects underwent forced randomization. This helps track how many times forced randomization has been used over the course of the study, which can occur due to a lack of kits for at least one treatment arm in the study at the time of randomization.

  This data element is now available in the Unblinded Kits dataset and the Unblinded Subject Event dataset.

Impact on datasets

The following dataset changes are introduced for this enhancement:

Dataset	Type of change	Description
Blinded Kit dataset	New data element	The ORDER_TYPE data element has been added to the Shipment folder. This data element can have the following values: INITIAL, MANUAL, and RESUPPLY.
Unblinded Kit dataset	New data element	The FORCED_RAND data element has been added to the Randomization folder. This data element can have the following values: Y: indicates that a subject underwent forced randomization. N: indicates that a subject was randomized normally. NULL: indicates that a subject has not yet been randomized. The ORDER_TYPE data element has been added to the Shipment folder. This data element can have the following values: INITIAL, MANUAL, and RESUPPLY.
Unblinded Subject Event dataset	New data element	The FORCED_RAND data element has been added to the Kits folder. This data element can have the following values: Y: indicates that a subject underwent forced randomization. N: indicates that a subject was randomized normally. NULL: indicates that a subject has not yet been randomized.

Already working in a live study?

For subjects that were randomized and the shipments that were triggered before the introduction of this feature, these new data elements are populated based on historical data.

You can find additional information about the new data elements in the Analytics User Guide after the Release Assessment Environment (RAE) upgrade.