Subject Visit (SV) Integration

This incremental integration, based on subject number, runs on a customer-defined schedule to identify Oracle Clinical One Platform subject visit, subject and visit status, and visit schedule details and imports them into CTMS.

Integration data flow details

Table 2-4 Integration data flow details

Type of integration Data flow Frequency
Multiple file One-way, from Oracle Clinical One Platform to CTMS. Scheduled

Integration overview

The integration makes a call to Oracle Clinical One Platform to retrieve a list of events that occurred in a study since the integration was last processed. The integration then sends all completed forms, questions, and subject status transitions for any subject event that occurred to CTMS. This also includes information about planned visits.
  • Subject data is imported into CTMS under each site on the Subjects tab (Site Management—Subjects).
  • Completed subject visit details are visible in CTMS on the Visits tab (Subject—Visits).
  • All question data is visible in CTMS on the Activities tab for each visit (Subjects—Activities).

If the integration job fails to process an event, future jobs for the subject are blocked until the current job is fixed or canceled. This ensures that data stays in sync in the target system. A failed job for one subject does not block event processing for other subjects.

The integration supports the following Oracle Clinical One Platform events. The integration processes the data corresponding to these events in the order of occurrence.

Note:

The first row in the table below is the parent template; all others are sub-integration templates.

Table 2-5 Oracle Clinical One Platform Supported events

Event Integration Template Details
N/A ClinicalOneParent.xml

This is the parent integration template. All others below are sub integration templates.

Note: Only one parent file is required, regardless of the number of sub-integration templates used.

Pre-screening

NewSubjectIntegration_CTMS_SV_Std.xml

After a subject completes the pre-screening visit in Oracle Clinical One Platform, the integration sends subject information to CTMS, including the visit complete date.

Note: The Visit Complete date in Oracle Clinical One Platform is equivalent to the Encounter Date in CTMS.

After screening, the integration updates the encounter date in CTMS to the screening date.

Screening

Screen fail

Undo Screen fail

ScreeningIntegration_CTMS_SV.xml

After a subject is screened in Oracle Clinical One Platform, the subject number and the status of Screening are sent to CTMS.

Note: Undo events restore subjects to their previous status.

Oracle Clinical One Platform sends screening data to CTMS based on one of two screening events:
  • Integrate data at visit complete: The screening visit is considered complete when a user answers all the required questions included in it. When this condition is met and the Screen button is selected, data is integrated.
  • Integrate data before visit complete: In this scenario, the screening visit does not need to be complete before data can be integrated. If a user answers all of the questions that are tagged as Required for Screening, the Screen button is enabled, and when selected, the data is integrated.

    For more information about this option, see Define required visits.

    Prerequisites to integrate data before visit complete.
    • You can integrate the visit start date with the screen event—not just with visit complete. The visit start date must be designed as a required question so the integration can uniquely identify cycles and unscheduled visits in the downstream system.
    • The study design must include the Informed Consent Date as a required question in order to integrate it with the screening event.

Enrolling

EnrollIntegration_CTMS_SV.xml

This is for your non-randomization studies. Once a subject completes the screening visit in Oracle Clinical One Platform, CTMS receives the Enrolled status.

Change Subject Number

ChangeSubjectNumberIntegration_CTMS_SV.xml

After you update a subject number in Oracle Clinical One Platform, the integration sends the new subject number to CTMS.

Randomization
RandomizationIntegration_CTMS_SV.xml
  • This template must include the randomization visit ID.
  • For a study with multiple randomization visits, you must create one template per visit.

After a subject is randomized in Oracle Clinical One Platform, the integration sends the updated status and randomization details to CTMS, which include the randomization date, randomization number, and cohort name.

Oracle Clinical One Platform sends randomization data to CTMS based on one of two randomization events.
  • Integrate data at visit complete: The randomization visit is considered complete when a user answers all the required questions included in it. When this condition is met and the Randomize button is selected, data is integrated.
  • Integrate data before visit complete: In this scenario, the randomization visit does not need to be complete before data can be integrated. If a user answers all of the questions that are tagged as Required for Randomization, the Randomize button is enabled, and when selected, the data is integrated.

    For more information about this option, see, Define required visits.

    Prerequisites to integrate data before visit complete.
    • You can integrate the visit start date with the randomize event—not just with visit complete. The visit start date must be designed as a required question so the integration can uniquely identify cycles and unscheduled visits in the downstream system.

Subject Withdrawal

Undo Withdrawal

SubjectWithdrawIntegration_CTMS_SV.xml

When you withdraw or undo a withdrawal for a subject in Oracle Clinical One Platform, the integration sends the updated status to CTMS.

Subject Completion

Undo Completion

SubjectCompleteIntegration_CTMS_SV.xml

When you mark a subject complete or undo subject completion in Oracle Clinical One Platform, the integration sends the updated status to CTMS.

Subject Transfer

SubjectTransferIntegration_CTMS_SV.xml

After you transfer a subject in Oracle Clinical One Platform, the integration sends the updated status to CTMS.

You can send this event to CTMS either before or after a subject has undergone screening in Oracle Clinical One Platform.

Visit Dump

VisitDataDumpIntegration_CTMS_SV.xml

Use this template to send visit details and question data for all forms in a completed visit from Oracle Clinical One Platform to CTMS.

You can configure the visit dump sub-integration to send clinical items imported via the Study Version Template (SVT) integration, which are enabled for integration in the CTMS item library. These items are marked in CTMS with a completion date.

When question data or a visit date are cleared or deleted for a completed Oracle Clinical One Platform visit, the corresponding visits should also be cleared in CTMS. This ensures activities corresponding to an incomplete visit are updated in CTMS and the completed date is cleared. This should be done so that the payment cannot be done for such questions and visits. When subsequent updates are made in Oracle Clinical One Platform, the integration will send the visit dump payload for all activities within a visit.

This template also processes Oracle Clinical One Platform visit date changes and sends the updated visit date to CTMS. The integration updates both the visit's completed date and the completion date of the Boolean items, which are part of the CTMS item library, when a visit date changes.

Visit Schedule

VisitScheduleIntegration_CTMS_SV_Std.xml

A subject's visit schedule can change based on previous visits, the treatment arm assigned, or completion of a form question by selecting a specific answer.

The sub-integration retrieves:
  • The VisitComplete date for the configured visits.
  • Data updates for a configured visit, form, or question.

    Note: You can configure a generic visit ID, such as "0000000000000000000000000000", for a form question. In this case, the integration processes the visit complete event and data update event from all of the visits where this form question exists. Configure the corresponding event IDs in the integration template if you need to process events from specific visits.

  • The data that pertains to Screen Fail / Undo Screen Fail, Withdraw / Undo Withdraw, and Subject Complete / Undo Subject Complete events.
Once received, the integration sends the projected visit dates and matching visit names to CTMS. The integration also sends the information required for planning and forecasting and marks them as planned in CTMS.
  • For cycle visits, the integration sends the visit name concatenated with the branch name and the event instance number.
  • Due to the dynamic nature of the branch visits, which control how a subject progresses in a Oracle Clinical One Platform study, CTMS creates branch visit instances on the fly when the data is received.
  • For unscheduled visits, the integration includes the event instance number from Oracle Clinical One Platform. CTMS dynamically creates these visits.

Integration limitations

  • The integration cannot be configured at the tenant level.
  • All dates are in UTC time zone.
  • The sub integration generates a list of future visits based on the subject's current state in the study. The list of future visits is not based on the current event that the integration is handling.

    For example, if a subject was screened, randomized, and completed Visit1 and all the events were picked in a single job, only the next visits from Visit1 would be selected as Planned in CTMS and the Screening, Rand, and Visit1 visits would show as Completed in CTMS.

  • If the question used to determine a branch or treatment arm for a subject is changed after the initial branch has started, the integration returns data from both branches.

    For example, if the user initially selects Branch1 and enters data, then subsequently changes the option to Branch2, the integration returns started visits from Branch1 and Branch2.

  • Subject Visit information for Adverse Events is not sent.

Configure the integration

  1. Prerequisites
    The following prerequisites must be completed before you can configure and test the integration:
    • Get access to Oracle Clinical One Digital Gateway.
    • Be sure to capture your configuration decisions so you have a record of the specifications defined for this integration.
    • Ask your user administrator to create the Oracle Clinical One Platform integration user:
      1. They need to create a global user and assign them to the Integration Manager and Integration Builder Global Roles.

        Tip:

        Later in the process, you will need to provide the user name and password for this user when you Create Credentials. Make sure to create the user with an email address that allows you to retrieve the password.
      2. Next, the user needs to be added to the study and assigned to a study role that includes the following permissions:
        • Edit Supply Settings, Blinded Groups, Label Groups and Resupply Strategies (Unblind)
        • Integrate Subject Data
        • View Form Data for Subjects
    • The integration requires the creation of two (2) CTMS integration users, whose credentials are needed when you create credentials in Oracle Clinical One Digital Gateway and when updating the integration templates.
      • This step is a one-time setup task. You do not need to do this for each integration; two users are needed for the CTMS integration group regardless of the number of integrations you configure (SVT, SV, Site, and SDV). You can use the same credentials to configure one or all four CTMS integrations.
      • For step-by-step instructions, see Change Request (CR) creation details.
    • Confirm the sites in CTMS are active and are associated with an approved study version.
    • Confirm the study version for the site in CTMS and the site in Oracle Clinical One Platform match.
    • Create Credentials
    • Create an Integration Group
    • Download the integration templates
      For this integration download the following integration templates.
      • ClinicalOneParent.xml
      • Refer to the table above for a list of available sub-integration templates.
  2. Create the test integration
    After downloading the necessary integration templates, follow these steps to configure and test the integration before using it with a production study.
  3. Create the production integration

    To accomplish this, you're going to download the integration file you set up and tested, update it for production use, and then use it to create the production integration.

    For step-by-step instructions, see Configure the production integration.

Manage an integration

Here are some common tasks associated with managing integrations.

Parent topic: Oracle Siebel CTMS