Master User List (MUL)—Site Tenant Integration

This integration is responsible for creating new sites and updating existing ones in Oracle Clinical One Platform.

Overview

The MUL Site Tenant Integration retrieves files placed on the Oracle sFTP server, creates new sites (institutions) and contacts, and updates existing ones at the tenant level in Oracle Clinical One Platform.

The integration then creates sites (with their associated institutions and contacts) in the corresponding study.

Configuration Service details

B92664: Oracle Life Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.

For more information, see Oracle Life Sciences Cloud Consulting Professional Services, Service Descriptions and Metrics.

Reach out to your Oracle point of contact if more information is needed.

Workflow

Below is the standard data flow for the MUL Site Tenant integration.
  1. The integration runs on a schedule to pick up and read files placed on the Oracle sFTP server.
  2. The integration then sorts them in ascending order based on the timestamp in the file name.

    File naming convention: IVRS_PROTOCOLNAME-EE_MUL_DD-Mmm-YYYY-HH-MM-SS.xml. For example, ORS_ABCStudy-00_MUL_09-Sep-2020-04-10-03.xml.

  3. Files are validated, data is analyzed, and then split by site number. The files are then deleted from the Oracle sFTP server.
  4. An integration job is created for each file (based on site number) in Oracle Clinical One Digital Gateway.
  5. Site data is then converted to match the site format requirements defined for the Oracle Clinical One Platform study.
  6. Sites are created or updated based on the data included in the file.
    • Newly created sites are marked as New.
    • Sites to be deleted are marked as Retired.
  7. Principal Investigator (PI) details, if included in the file, are used to create a contact of type Investigator.

    If the contact already exists, no updates are applied, and if it does not exist, a new tenant-level contact is created.

    For more information, see Create a contact at your organization.

  8. Patient treatment details, if included in the file, are used to create an organization of type Institution.

    The patient treatment address is used as the primary address for the organization, and the drug shipment details are used as the shipping address associated with the organization.

    If the organization already exists, no updates are applied, and if it does not exist, a new tenant-level organization is created.

    For more information, see Create an organization (Institution)

    The contact and organization are associated when the study-level site is created.

    The following contact and organization details are used 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 number also match to ensure uniqueness.
    • The Organization phone must also match.

Import validation checks

  • The file cannot contain blank rows. If blank rows exist, the file is considered invalid, and the integration job fails.
  • The protocol name in the file is not validated. Instead, the integration matches the configured protocol name with the protocol in the file name and only picks up the files that match the naming convention.
  • If one of the records in the incoming file is for an UPDATE but the site does not exist in Oracle Clinical One Platform, the corresponding integration job fails.

Notification

If errors occur during any phase of the integration, the Oracle Clinical One Digital Gateway sends notifications to users configured for the integration.

Monitoring

Oracle Clinical One Digital Gateway jobs are searchable and displayed by site number. If a specific site experiences errors leading to an incomplete job, the system blocks subsequent jobs for that site.

Parent topic: Study Administration