Workflow and supported events

1. Events completed in the external Medrio system trigger calls to a REST API-enabled web service, exposed by the Clinical One Platform Digital Gateway Builder.
   The supported events are:

   Note:

   Events depend on the source system design. The integration needs to be configured based on how the source system bundles and sends the data.

   • Create a subject
   • Screen a subject
   • Update the status for a subject
   • Insert, update and delete data in Visits-Form-Items (static repeating, flat and two-section forms).
     • Supported item types include text, date, check box (single and multi-select), radio control, and dropdown.
   • Update the status of a visit
   • Update visit date (all visit types are supported).
     • For cycle visits, the visit date should not be used as a repeat key if updates are expected.
   • Visit completion
   • Withdrawal or completion of a subject
   • Create Adverse Event entries
2. The web service validates the data, then triggers the parent integration (a specific integration configuration), which controls the entire integration process.
3. The parent integration calls the appropriate event processing sub-integration configuration.
   The available sub-integration configuration templates are:

   Sub-integration	Description
   Screening	Handles the creation of a subject, subject screening activities, and data updates for the screening visit.
   Visit completion	Handles the creation and completion of scheduled and unscheduled visits and data upserts for visits.
   Subject Withdrawal or Completion	Handles subject state updates.
   Adverse event	Handles the creation of log entries in an Adverse event.
   Subject number update	Handles updates to a subject number after the subject is created.
   Clear data	Supports the Clear Data feature for Oracle Clinical One Platform.

4. The triggered sub-integration reads the data, then groups it by subject and visits, allowing the integration to process data for multiple subjects in parallel.
5. Subject data is transformed per the Oracle Clinical One Platform study design.
6. Clinical One API calls are made to update the subject status and insert or update the data in the respective visit, form, and item.