Source Data Verification (SDV) Integration

This integration generates a cumulative list of subjects selected for Source Data Verification (SDV) in a Oracle Clinical One Platform study, as well as an incremental list of verified visits, and sends this data to CTMS.

Integration data flow details

Table 2-6 Integration data flow details

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

Integration overview

This integration generates a cumulative list of subjects selected for SDV in a Clinical One Platform study based on a customer-defined schedule. The integration also sends incremental information regarding SDV status changes at the visit level. The integration sends only the first SDV performed for a visit to CTMS.

Once the integration process completes,
  • In CTMS, the Subjects tab (Site Management—Subjects—SDV Required column) stores subject data from Oracle Clinical One Platform.
  • In CTMS, the CRF Tracking tab (Site Management—CRF Tracking tab—Source Verified and Source Verified Date columns) stores the subject visit verification data.

Integration limitations

  • Subject Data Verification 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:
        • Answer Queries
        • Integrate Subject Data
        • Perform Source Data Verification and Reconcile Inventory
    • 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 study versions for sites in CTMS and in Oracle Clinical One Platform match.
    • Confirm the source data verification setting in Oracle Clinical One Platform is configured to allow for source data verification in a study.
    • Create Credentials
    • Create an Integration Group
    • Download the integration templates
      For this integration download the following integration templates.
      • CTMS_SDVParentIntegration_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_SDVSubIntegration_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 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