Clinical One Digital Gateway integrations support rescreen visits

Integrations that process screening data now support the use of rescreen visits if configured in your Clinical One Cloud Service studies.

Rescreen refers to the ability to screen subjects who initially did not meet protocol requirements but then qualified at a later date. This process is different from the Undo Screen Failure action, which occurs when a subject is incorrectly marked as screen failed. For more information about this feature, see Limit subject rescreening.

Supported inbound to Clinical One Cloud Service integrations

You can find additional information in the Digital Gateway User Guide after the Release Assessment Environment (RAE) upgrade.

Table 2-1 Impact to inbound integrations

Integration Details
These integrations can now send rescreening data to Clinical One Cloud Service studies for subjects in a screen-failed status and trigger events if applicable.
  • After the rescreen data is successfully processed, the vendor can make another API call instructing the integration to trigger the appropriate event—Screen or Screen Fail—based on the submitted data.

    Note: The ObvioHealth integration can import rescreening data, but it does not make additional API calls to trigger events.

  • Previous screen failure instances cannot be updated. Only the most recent instance of Screen Fail Date and Screen Fail Reason can be modified.

    Note: The ability to update these values is only applicable to the Multi-IWR and Medrio integrations. The ObvioHealth integration cannot update these values.

There is no impact to existing integrations. If you want to take advantage of this enhancement:
  • Reach out to your Oracle point of contact to request a change to the integration template.
  • Contact your integration vendor to request that they update the integration to send rescreen data and to make an additional API call to trigger the events after the rescreening data has been successfully integrated.

Supported outbound from Clinical One Cloud Service integrations

You can find additional information in the Digital Gateway User Guide after the Release Assessment Environment (RAE) upgrade.

Table 2-2 Impact to outbound integrations

Integrations Details
The following details are relevant for the Outbound subject data and Clinical One Cloud Service to Oracle InForm integrations.
  • Multiple instances of rescreening are supported.
  • Screen and screen failure events triggered by a rescreen visit are propagated downstream to the configured target, which includes third-party EDC systems or Oracle InForm studies.
    • Data sent by the Outbound subject data integration to a third-party system can be mapped to update initial screening data or as individual scheduled visits. Unscheduled visit mapping is not supported.
    • Data transmitted to Oracle InForm studies can be mapped to update initial screening information on a flat form within an existing visit or added as unscheduled visits.
  • Updates to the Screen Fail Date or Reason for Screen Fail overwrite the corresponding values in the target system.
  • The audit trail in the target system captures changes made to the visit date, form items, screen fail date, and screen fail reason and includes the rescreening instance number if multiple instances are triggered.
  • Updates are integrated downstream in the order in which they occur in Clinical One Cloud Service.

Note: There is no impact to existing integrations. If you want to integrate data from a rescreen visit with a third-party EDC system or with Oracle InForm studies, reach out to your Oracle point of contact and request that they update the integration template to support this.

Parent topic: Integrations