SAP Supply Management System

This workflow applies to shipments that involve an integration with the SAP Supply Management system and a study utilizing either a non-drug-pooling or drug-pooling supply strategy.

The SAP Supply Management integration includes the following components and can be configured for studies with either non-drug-pooling or drug-pooling supply strategies.

  • Stock Report Integration
  • Shipment Request Integration
  • Advanced Shipment Notification Integration
  • Proof of Delivery Integration
  • Shipment Rejection Integration
  • Actual Enrollment Integration

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.

Prerequisites

  • Pooled kit types need to be defined in Oracle Clinical One Platform and must match the pack types in SAP.
  • Plant, Storage, and Shipping locations must be defined for the depot.

Integration user details

Integration setup includes the creation of study-level-integration user accounts. They are assigned to a custom study role that includes the permissions assigned to the Clinical supply manager - Unblinded template study role, plus the following permission.
  • Receive Shipments and Update Site Inventory

The SAP Supply Management integration can be configured in one of two ways. Use the credentials of a single user account in all of the configuration files, or have user accounts created for each integration component.

The integration user account is created using the email address of one of your organization's clinical supply managers. The email address associated with the integration user receives integration notifications, which can include content resulting in unblinding.

WARNING:

Make sure the appropriate email address is configured for the integration user account to avoid unblinding issues.

Integration overview

  • SAP generates the stock report and posts it on the Oracle sFTP server. The Stock Report Integration retrieves the file and updates the study drug inventory details in Oracle Clinical One Platform.
  • A shipment request, raised in Oracle Clinical One Platform, triggers the Shipment Request Integration, which communicates the supply request from a site to SAP.
  • SAP posts a shipment notification file on the Oracle sFTP server, which is retrieved by the Shipment Notification Integration. The file notifies the requester about the fulfillment and shipment of their request. The file also includes courier and tracking details.

    This integration also imports kit information for the kits included in the shipment and updates the inventory in Oracle Clinical One Platform with the corresponding lot and site/depot information.

  • After the site confirms the shipment by changing the status to Completed, the Proof of Delivery Integration generates a file (one per shipment), which is posted on the Oracle sFTP server. The file includes confirmation of the quantity of kits received, the kit numbers, and an indication of the quantity expected but not received.
  • SAP posts a shipment rejection file on the Oracle sFTP server (when applicable). The Shipment Rejection Integration retrieves the file. The file includes the shipment number and other details from the shipment request file. The integration uses these details to update the shipment's status to Invalid in Oracle Clinical One Platform.
  • The Actual Enrollment Integration, used for supply forecasting and planning, generates a cumulative file that is posted on the Oracle sFTP server. The file contains information about completed study visits and the number of subjects that completed them. The file also includes the subject's site and treatment group details.

Integration monitoring and notifications

Monitoring:

Job monitoring is performed by the Oracle Clinical One Digital Gateway.

Notifications:

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

Use the links below to learn more about each integration.

  • Stock Report Integration
    This integration maintains the study drug inventory in your Oracle Clinical One Platform studies.
  • Shipment Request Integration
    This integration sends shipment requests, generated in Oracle Clinical One Platform, to SAP.
  • Shipment Notification Integration
    This integration notifies Oracle Clinical One Platform users that a requested shipment has shipped and provides the courier and tracking information for it.
  • Proof of Delivery Integration
    This integration provides confirmation to SAP that a site has confirmed receipt of a shipment and has changed the status to Completed in Oracle Clinical One Platform.
  • Shipment Rejection Integration
    If SAP rejects a shipment request, this integration changes the shipment status in Oracle Clinical One Platform to Invalid.
  • Actual Enrollment Integration
    This integration, used for depot material forecasting and planning, provides information to SAP about completed visits and the number of subjects who completed them.

Parent topic: Supply Systems