Oracle Clinical One Digital Gateway integrations support rescreen visits

Integrations that process screening data now support the use of rescreening visits if configured in your Oracle Clinical One Platform studies.

Rescreen refers to the ability to screen subjects who initially did not meet protocol requirements but then qualified at a later date. For more information about this new feature, see Limit the number of times a subject can be rescreened.

Supported inbound to Oracle Clinical One Platform integrations

Integration	Details
Data Intake integration	This integration supports the import of data to a rescreen visit, provided that the visit is not locked. For existing integrations, a new mapping needs to be added to the Visits section in the integration template. Note: If assistance is needed, reach out to your Oracle point of contact.

Supported outbound from Oracle Clinical One Platform integrations

Screening data is usually integrated after the completion of a screening visit, but now it can also be integrated following the completion of a rescreen visit. Once a rescreen visit is completed, Oracle Clinical One Platform triggers either the screening event or the screen fail event, and the corresponding data is integrated into configured downstream systems.

Integration	Details
Oracle's Siebel CTMS Subject Visit (SV) integration	If the rescreen results in screening, the screening date and status are reflected in CTMS. If the rescreen results in a screen fail, the new screen fail date and reason are sent to CTMS. The screen fail date and reason for screen fail are overwritten if they were previously captured. Note: Updates to the integration template are not required to support rescreen visits.
CTMS Study Version Template (SVT) integration	For existing integrations, the ReScreeningEvent needs to be added to the VisitType codelist mappings in the SVT integration template, so that rescreening visits can be added to the CTMS system and marked as completed. <Entry Source="ReScreeningEvent" Description="" Target="UnScheduleable"/> For new studies, the newest version of the integration template should be used, as it includes this new mapping.
Oracle's Siebel CTMS Source Data Verification (SDV)	After source data verification (SDV) for a rescreening visit is complete, the data are integrated into the clinical trial management system (CTMS).

For a list of integrations that do not support this feature, see Release impact on downstream systems.

Additional information will be available in the Digital Gateway User Guide after the Release Assessment Environment (RAE) upgrade completes.