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Overview of Safety System Integration

Reporting of adverse events can be integrated with a third-party safety system. Adverse events are logged as product issues in Siebel Medical. The following integration processes are provided:

  • Reviewing a product issue. Siebel Medical product issue records with a status of Open can be reviewed for adverse event criteria.
  • Sending a product issue to the safety system. The Siebel Medical product issue data can be sent to a third-party safety system for processing and reporting.
  • Sending follow-up information about the product issue to the safety system. The submitted product issue record can be updated with follow-up information.
  • Verifying case acceptance by the safety system. The AE Case ID and Safety System Received Date fields are automatically populated when the product issue has been accepted as an adverse event by the safety system.
  • Verifying case rejection by the safety system. Rejection reasons for cases rejected by the safety system are posted to the inboxes of users listed in the product issue Owners field.
  • Voiding a product issue in Siebel Medical. A product issue that has been accepted by the safety system can be voided in Siebel Medical.

The product issue status values for the integration between Siebel Medical and the third-party safety system are described in Table 40.

Table 40. Product Issue Status for Safety System Integration
Status
Description
Status Bar

Open

The product issue has been created and is ready to be reviewed or submitted to the third-party safety system.

The status bar is set to 25% complete.

Review Complete

The product issue has been reviewed by the call center agent or the quality manager. The Status field updates to Review Complete when the user clicks the Review Complete button.

The status bar is set to 50% complete.

Closed

The product issue has been resolved and closed. The Status field updates to Closed when the user clicks the Close button. You can set to Closed a product issue that has a status of Open, Review Complete, Submitted, Rejected, or Reopened.

The status bar is set to 100% complete.

Reopened

This value is automatically populated when the product issue has been reopened by the user.

A product issue that has a status of Closed can be reopened.

The status bar is set to 25% complete.

Pending

The Status field for the product issue is automatically updated to Pending when the product issue has been written to the Java Message Service (JMS) queue, and it is pending acceptance by the safety system.

The status bar is set to 75% complete.

Submitted

This value is automatically populated when the product issue has been successfully delivered to the safety system from the Java Message Service (JMS) queue and has been accepted as a case by the safety system. The AE Case ID and Safety System Received Date fields in Siebel Medical are populated by the safety system.

The status bar is set to 75% complete.

Failed

This value is automatically populated when writing to the JMS queue fails.

The status bar is set to 50% complete.

Rejected

This value is automatically populated when the safety system has rejected the product issue.

The status bar is set to 100% complete.
      
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