Release impact on downstream applications

This document describes the known impact and limitations that new features introduced in Clinical One Cloud Service 26.3 may have on Oracle Clinical One Analytics, Clinical One Digital Gateway, and other downstream systems.

Note:

Only the features with direct impact on other downstream applications are listed in this document.

For additional information about the features in this release and the potential impact on your studies, Download the Release Implementation Assessment document.

Review the following after the assessment environment upgrade for more information about the impacts that are listed in this document:

• For Oracle Clinical One Analytics see the Analytics User Guide.
• For Oracle CRF Submit see the Reporting Guide.
• For Clinical One Digital Gateway see the Digital Gateway User Guide.

New enrollment visit type (CLINONE-132321)

The following table describes this feature's impact to reports and downstream applications:

Downstream system	Impact
Oracle Clinical One Analytics and Data Hub	Existing Oracle Clinical One Analytics datasets that already have VISIT_TYPE data element, are updated to include the Enrollment visit type as one of the possible values. These datasets are: Blinded Kits dataset Blinded Subject Event dataset Kits and Randomization Design dataset Queries dataset Study Codelist dataset Study Design dataset Subject Event SVFL dataset Subject Forms dataset Subject Form Items dataset Subject Form SVFL dataset Subject Item SVFL dataset Unblinded Kits dataset Unblinded Subject Event dataset
Clinical One Digital Gateway configured integrations	The new enrollment visit type is supported. CTMS integrations process the enrollment event for non-randomized studies. See Integration support for the Enrollment visit type.
Oracle CRF Submit	Supports the new enrollment event as part of the subject history.
Oracle Life Sciences Data Management Workbench (DMW)	No impact.
Oracle Central Coding	No impact.

For more information on this new feature, see New enrollment visit type.

Enter data in the next visit before current visit completion (CLINONE-129236)

The following table describes this feature's impact to reports and downstream applications:

Downstream system	Impact
Oracle Clinical One Analytics and Data Hub	A new data element NEXT_VISIT_WITHOUT_COMPLETION for the visit level setting Allow Next Visit Without Completion is added to the Study Design dataset in the Event folder.
Clinical One Digital Gateway configured integrations	No impact.
Oracle CRF Submit	No impact.
Oracle Life Sciences Data Management Workbench (DMW)	New Data Hub views are created to support this feature, introduced with this Clinical One Cloud Service release, but they will be available in Oracle DMW as part of a future release.
Oracle Central Coding	No impact.

For more information on this new feature, see Enter data in the next visit before current visit completion.

Enhancements to signature configuration and management (CLINONE-132398, CLINONE-129916, CLINONE-116134)

The following table describes this feature's impact to reports and downstream applications:

Downstream system	Impact
Oracle Clinical One Analytics and Data Hub	A new data element ALLSIGNED is added in Oracle Clinical One Analytics datasets to provide the overall signed status at all levels: At the visit level in the Event folder of the Blinded and Unblinded Subject Event datasets. At the form level in the Form folder of the Subject Forms dataset. At the item level in the Item folder of the Subject Form Items dataset.
Clinical One Digital Gateway configured integrations	No impact.
Oracle CRF Submit	No impact.
Oracle Life Sciences Data Management Workbench (DMW)	No impact.
Oracle Central Coding	No impact.

For more information on this new feature, see Enhancements to signature configuration and management.

Dispensation rollback (CLINONE-58239)

The following table describes this feature's impact to reports and downstream applications:

Downstream system	Impact
Oracle Clinical One Analytics and Data Hub	Oracle Clinical One Analytics supports this feature in the following ways: The Blinded and Unblinded Kits datasets properly reflect the kit status if dispensation rollback occurs. When dispensation rollback occurs, the kit is no longer associated to the visit in the Blinded and Unblinded Subject Events datasets and EVENT_TYPE becomes Dispensation_Rollback. The reason for change provided when dispensation rollback occurs flows to the following datasets: Blinded Subject Events dataset Unblinded Subject Events dataset Blinded Kits dataset Unblinded Kits dataset
Clinical One Digital Gateway configured integrations	Dispensation rollback events and kit updates are indicated in outbound transfers. See Dispensation rollback events are supported by outbound integrations.
Oracle CRF Submit	This new feature is supported in Oracle CRF Submit. See Dispensation rollback actions are reflected in Oracle CRF Submit PDFs.
Oracle Life Sciences Data Management Workbench (DMW)	No impact.
Oracle Central Coding	No impact.

For more information on this new feature, see Define dispensation rollback.

Combine kit dosages (CLINONE-131923)

The following table describes this feature's impact to reports and downstream applications:

Downstream system	Impact
Oracle Clinical One Analytics and Data Hub	The following data elements are added to the Kits and Randomization Design dataset, in the kit folder, to support this feature: COMBINATION_KIT COMBINATION_KIT_TYPES Additionally, when using this feature, the information flows properly to Blinded and Unblinded Kits datasets.
Clinical One Digital Gateway configured integrations	Whenever there are kit replacements, with this feature it may happen that multiple kits replace a single kit. All kit replacements will integrate appropriately downstream: When mapped to a repeating form item each replacement shows on its own row. For example, 123&456 replaced 444 in a row, and if there is a replacement on another kit, there would be another row showing 777 replaced 123. When mapped to a flat form item the replacements are concatenated in that single item. For example, 123&456 replaced 444, 777 replaced 123 showing in a single row. For non-serialized kits, if multiple lot numbers are replacing a single lot then they are concatenated in the same manner as serialized kits do. If only the inventory ID is different for the replacement, the quantity will be cumulative, since inventory ID is not mapped downstream. No configuration updates are required to support this.
Oracle CRF Submit	No impact.
Oracle Life Sciences Data Management Workbench (DMW)	No impact.
Oracle Central Coding	No impact.

For more information on this new feature, see Combine kit dosages.

Define partial dispensation and dose holds simultaneously (CLINONE-126182)

The following table describes this feature's impact to reports and downstream applications:

Downstream system	Impact
Oracle Clinical One Analytics and Data Hub	To support this feature, the Blinded and Unblinded Subject Events datasets now show Dose Hold in the KIT_NUMBERS data element if a dose hold is created on a visit.
Clinical One Digital Gateway configured integrations	No impact.
Oracle CRF Submit	No impact.
Oracle Life Sciences Data Management Workbench (DMW)	No impact.
Oracle Central Coding	No impact.

For more information on this new feature, see Define partial dispensation and dose holds simultaneously.