Details for integration managers

Starting with Oracle Clinical One Platform 25.2, studies can now be designed so that site users can screen, randomize, and dispense subjects without first needing to answer all of the required questions in the visit. This can result in data being integrated with downstream systems before a visit is considered complete.

To allow for this, study designers apply one of the following tags to form questions during the study design phase: Required for Screening, Required for Randomization, or Required for Dispensation. After a user answers all of the tagged questions, the action associated with the visit is enabled. This occurs even if all of the required questions have not been answered. For more information about the new study design feature, see Improved data entry workflows for Data Collection and Randomization and Trial Supply Management (RTSM).

Once an event is triggered, the associated data is sent to any integrated downstream system; the integration no longer waits for the visit to be considered complete.

If your organization intends to implement this new feature for existing or future studies, make sure all questions that are to be integrated are tagged as required for the given event. This will ensure that the event (screening, randomization, or dispensation) is only allowed after all of the necessary information, being sent to a downstream system, has been collected. Doing this may limit integration failures caused by missing data or lead to the possibility of events being integrated out of logical order. For example, the randomization event could be integrated before the screening visit.

What integrations could this enhancement impact?

• Oracle's Siebel Clinical Trial Management System—Subject Visit (SV) Integration
  • Only subject status changes for screening and randomization can be sent to CTMS prior to visit completion. All other event data is integrated once a visit is considered complete.
• Outbound subject data integration
  • For studies with this design, integration template updates are required to ensure the tagged questions are integrated when the event is triggered and not when the visit is complete. For more information, reach out to your Oracle point of contact.
• Clinical One to Oracle InForm
  • For studies with this design, integration template updates are required to ensure the tagged questions are integrated when the event is triggered and not when the visit is complete. For more information, reach out to your Oracle point of contact.

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