Site Integration

This cumulative integration runs on a schedule to retrieve a list of sites from CTMS (based on their status) and then imports applicable data into Oracle Clinical One Platform.

Integration data flow details

Table 2-2 Integration data flow details

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

Integration overview

  1. The integration makes an outbound call to CTMS to retrieve a list of sites and their associated details based on status.

    Table 2-3 Site statuses available for import

    Site status in CTMS Site status in Oracle Clinical One Platform after import
    Initiated New
    Enrolling Active
    Terminated Retired
  2. The CTMS response includes contact information for the Principal Investigator (Role), as defined in CTMS on the Contacts tab (Site Management – Contacts). The integration uses these details to create a Oracle Clinical One Platform Contact. If the contact already exists, the integration doesn't make any changes.
  3. The response also includes information about the Site Primary account type (account type is configurable for the integration) defined in CTMS on the Accounts tab (Site Management – Accounts). The integration uses these details to create the Oracle Clinical One Platform Organization (Institution). If the organization already exists, the integration doesn't make any changes.
    • The integration uses the Site Primary address, defined in CTMS on the Accounts tab (Site Management – Accounts), to create the Primary Address for the contact and the organization created in Oracle Clinical One Platform.
    • The integration uses the ship address (address is configurable for the integration), defined on the Addresses tab (Site Management – Addresses), to create the Shipping Address for the contact and the organization created in Oracle Clinical One Platform.

      Note:

      If a ship address is not defined in CTMS the Site Primary address is used as the shipping address for the contact and organization created in Oracle Clinical One Platform.
  4. The integration creates the study site using the protocol name, which is also included in the CTMS response. The study site in Oracle Clinical One Platform reflects the site ID in the CTMS system, using the organization address as the primary address and the institution shipping address as the study site shipping address.
  5. The following Contact and Organization details are used by Oracle Clinical One Platform to determine uniqueness when creating the study site:
    • Contact First Name, Last Name, Address Line 1, City, State, Country, and Zip/Postal Code. In addition to these, it is recommended that the Email and/or Phone should also match to ensure uniqueness.
    • The Organization Phone must also match.
  6. The Upsert functionality (enabled by default) uses the unique site IDs from Oracle Clinical One Platform to determine what action to take on each site.
    • If a site does not exist, the integration creates it.
    • If a site does exist, then the information for the site is updated.
    • If an existing (already imported) site ID is updated in CTMS, a new site is created in Oracle Clinical One Platform.

Monitoring the integration

The Site integration includes the following monitoring features:
  • Jobs are created and monitored at the site level.

Integration limitations

  • The integration creates a job for each site it retrieves from CTMS, regardless of whether the site details have changed. The process of retrieving all sites ensures that updates to addresses and PI contacts, which CTMS does not consider to be updates in the same manner as Oracle Clinical One Platform does, get processed.
  • If shipping information was not defined in CTMS, the integration uses the site address and contact information defined in Oracle Clinical One Platform for the shipping information.
  • If a site's time zone is not defined in CTMS, the value in Oracle Clinical One Platform defaults to UTC, as the time zone is a required site field.

    Note:

    Time Zone can be found on the Site Info tab ( Site Management—Target Site—More Info—Site Info) in CTMS.
  • It is not possible to clear Prefix or Time Zone information of an existing Oracle Clinical One Platform Contact or Organization. It is only possible to update these fields after the initial import.

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
        • Create and Manage Sites
        • View Sites
    • 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.
    • Ensure that the values in the Oracle Clinical One Platform template codelist are accurately mapped to the full country names in CTMS. If the mappings are incorrect, the job fails with a country not found error.
    • Confirm the site numbers in CTMS match the site IDs in Oracle Clinical One Platform.
    • Create Credentials
    • Create an Integration Group
    • Download the integration templates
      For this integration download the following integration templates.
      • CTMS_TenantSiteParentIntegration_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_TenantSiteSubIntegration_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