Study Version Template (SVT) Integration

This incremental integration runs on a schedule to identify study versions created in Oracle Clinical One Platform since the integration was last processed; it then creates corresponding templates in CTMS.

Integration data flow details

Table 2-1 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 SVT integration runs on a customer-defined schedule to identify study versions that have been created (for a configured study mode) since the integration was last processed. It retrieves study design metadata from Oracle Clinical One Platform, then sends the information to CTMS. The integration then imports visits, forms, and questions of type date/time and Boolean and creates a corresponding subject visit template.
  • Each study version gets imported in CTMS as a subject visit template and includes an Integrated flag, which is set by the integration.
  • For cycle visits and unscheduled visits, only one instance of each cycle or unscheduled visit is created in CTMS.

Monitoring the integration

The SVT integration includes the following monitoring features:
  • Job monitoring is done at the study version level.

    Note:

    The integration monitors study version changes for one study mode at a time.
  • Data received for multiple study versions is processed in parallel.
  • Data is processed in the order the requests are received.

Integration limitations

  • The forecasting information and lead days calculation (for cycle and unscheduled visits) are not included with study version details. These details can be included in the Subject Visit Schedule sub-integration, which is part of the Subject Visit (SV) Integration.
  • The integration does not provide a delta (a list of changes) between study versions. It sends the entire study design metadata that corresponds to a study version.
  • The integration does not recognize Advanced Study Version (ASV) changes applied to previous study versions and does not send them to CTMS.

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 View Design permission.
    • 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.
    • Verify with the study designer that they have defined the visit schedule for the scheduled visits.
    • Confirm the protocol exists in CTMS, and the study name matches the study title in Oracle Clinical One Platform.
    • Create Credentials
    • Create an Integration Group
    • Download the integration templates
      For this integration download the following integration templates.
      • CTMS_SVTParentIntegration_Std.xml

        Tenant-level integration: You can configure multiple studies to use the same integration. The parent file controls this ability. For more information, see Configure a tenant-level integration.

      • CTMS_SVTSubIntegration_Std.xml
  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 test integration file you configured 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