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27Setting Up and Configuring Safety System Integration

Setting Up and Configuring Safety System Integration

This chapter covers setting up and configuring Siebel Medical for safety system integration with a third-party application. It includes the following topics:

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 the following table.

Table 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.

Customizing Safety System Integration Web Services

Siebel safety system integration Web services can be customized for integration with any third-party safety system, or for specific business requirements. The following Web services are provided for safety system integration:

  • SWI LS Medical Update Product Issue Inbound. Use this Web service to create inbox items to invoke a message to owners of a product issue. An external application invokes this Web service with a product issue ID number.

  • SWI LS Medical Product Issue Create Inbox Item Inbound. Use this Web service to update product issue information such as AE Case ID, Safety System Received Date, and Status. An external application invokes this Web service with the product issue ID, and updated data.

For more information on customizing Siebel Web services, see Siebel CRM Web Services Reference.

Activating Workflows for Safety System Integration

This task describes how to activate the workflows that are required for safety system integration. You can modify the workflows to suit your own business model, using Siebel Business Process Designer. For more information, see Siebel Business Process Framework: Workflow Guide.

This task is a step in Process of Setting Up Safety System Integration for Siebel Medical.

To activate workflows for safety system integration

  1. Navigate to the Administration - Business Process screen, then the Workflow Deployment view.

  2. Query for and activate each of the following workflows:

    • LS Medical Update Product Issue Inbound

    • LS Medical Product Issue Create Inbox Item Inbound

    • LS Medical Product Issue Validation Workflow

    • LS Medical Product Issue Send To Safety

    • LS Medical Product Issue Close

  3. Verify that each activated workflow is added to the Active Workflow Processes.

    Configuring Web Services for Safety System Integration

    This task describes how to configure the inbound Web services that are required for safety system integration.

    This task is a step in Process of Setting Up Safety System Integration for Siebel Medical.

    Note: It is recommended that you use HTTPS authentication. For information on configuring Secure Sockets Layer (SSL) for HTTPS authentication, see Siebel Security Guide.

    To configure Web services for safety system integration

    1. Navigate to the Administration - Web Services screen, then the Inbound Web Services view.

    2. Query for the SWI LS Medical Update Product Issue Inbound Web service.

    3. On the Service Ports applet, update the Address variable to point to your Web server.

    4. Query for the SWI LS Medical Product Issue Create Inbox Item Inbound Web service.

    5. On the Service Ports applet, update the Address variable to point to your Web server.

    6. Click Clear Cache on the Inbound Web Services applet.

    For more information on configuring Web Services, see Integration Platform Technologies: Siebel Enterprise Integration Manager Administration Guide on the Siebel Bookshelf.

      Enabling Siebel Server Component Groups for Safety System Integration

      This task describes how to activate the component groups that are required for safety system integration.

      This task is a step in Process of Setting Up Safety System Integration for Siebel Medical.

      To enable Siebel Server component groups for safety system integration

      1. Navigate to the Administration - Server Configuration screen, and then the Component Groups view.

      2. Query for the Workflow Management Component Group.

      3. On the Component Groups applet, click the Enable button.

      4. Query for the EAI Component Group.

      5. On the Component Groups applet, click the Enable button.

      6. Restart the Siebel Server.

      7. Navigate to the Administration - Server Management screen, then the Servers and Component Groups view.

      8. Verify that the State value for the Workflow Management and EAI Component Groups is set to Online.

        Creating the Directory Structure on the Siebel Server for Safety System Integration

        This task describes how to set up the directory structure required for JMS communication with the Oracle WebLogic Server.

        This task is a step in Process of Setting Up Safety System Integration for Siebel Medical.

        To create the directory structure on the Siebel Server for safety system integration

        1. Create the following directory for storing the JNDI properties file and JAR files on the Siebel Server: D:\WLSJMS.

        2. Create the following directory for storing the log file on the Siebel Server: D:\WLSJMS\log.

        3. Copy Siebel.jar and SiebelJI_enu.jar from the Siebel installation directory to D:\WLSJMS.

          Creating the Oracle WebLogic Full Client JAR for Safety System Integration

          This task describes how to create the Oracle WebLogic full client JAR required for safety system integration. You use the Oracle WebLogic JarBuilder tool to generate the full client JAR. The JAR file is then added to the classpath.

          This task is a step in Process of Setting Up Safety System Integration for Siebel Medical.

          To create the Oracle WebLogic full client JAR for safety system integration

          1. Log on to the Oracle WebLogic server.

          2. Change the directory to the server/lib directory, using the following command:

            cd WL_HOME/server/lib

          3. Create wlfullclient.jar in the server/lib directory, using one of the following commands.

            JDK Version Command

            Version 1.5

            		 
            java -jar wljarbuilder.jar -profile wlfullclient5

            Version 1.6

            		 
            java -jar wljarbuilder.jar

          4. To add the Oracle WebLogic full client JAR to the classpath, copy it to the D:\WLSJMS directory on the Siebel Server.

            Creating the JNDI Properties File for Safety System Integration

            This task describes how to create the JNDI properties file required for safety system integration.

            This task is a step in Process of Setting Up Safety System Integration for Siebel Medical.

            To create the JNDI properties file for safety system integration

            1. Create the file, D:\WLSJMS\jndi.properties, on the Siebel Server.

            2. Add the following JNDI properties to the file:

              java.naming.factory.initial=weblogic.jndi.WLInitialContextFactory                                         
java.naming.provider.url=t3://Host IP Address:Port

              where:

              Host IP Address is the IP address of the AIA server.

              Port is the port where the Web server instance is listening for connections.

            Note: Make sure there are no spaces at the end of the lines in the file jndi.properties. Spaces will cause the connection to fail.

              Creating the JVM Subsystem for Safety System Integration

              This task describes how to create the JVM subsystem required for safety system integration.

              This task is a step in Process of Setting Up Safety System Integration for Siebel Medical.

              To create the JVM Subsystem for safety system integration

              1. In the Siebel application, navigate to the Administration - Server Configuration screen, then the Enterprises view.

              2. Select the Enterprise Server that you want to configure, and then click the Profile Configuration tab.

              3. Create a new enterprise profile record and complete the necessary fields.

                • Set the following parameters on the form that appears:

                  Name Value

                  Profile

                  JAVA

                  Alias

                  JAVA

                  Subsystem Type

                  JVMSubsys

                • Set the following parameters in the Profile Parameters list applet.

                  Name Alias Data Type Value

                  JVM Classpath

                  CLASSPATH

                  String

                  Set the classpath value as follows:

                  • Windows. The files in the classpath must be separated by semicolons (;) and end with a semicolon and period (;.), for example:

                  D:\WLSJMS;D:\WLSJMS\Siebel.jar;D:\
WLSJMS\SiebelJI_enu.jar;D:\WLSJMS\
wlfullclient.jar;.

                  • UNIX. The files in the classpath must be separated by colons (:) and end with a colon and period (:.), for example:

                  /usr/wlsjms:/usr/wlsjms/
Siebel.jar:/usr/wlsjms/
SiebelJI_enu.jar:/usr/wlsjms:.

                  JVM DLL Name

                  DLL

                  String

                  Set the path to the JVM library file, for example:

                  • Windows:

                  <JAVA_HOME>/jdk/jre/bin/server/
jvm.dll

                  • UNIX:

                  <JAVA_HOME>/jre/lib/sparc/client/
libjvm.so

                  JVM Options

                  VMOPTIONS

                  String

                  Set the JVM-specific options for the log file, for example:

                  • Windows:

                  -Djms.log=D:\WLSJMS\log\jms.log

                  • UNIX:

                  -Xusealtsigs -Xrs -Djms.log=/usr/
wlsjms/log/jms.log

                Configuring Java Message Service Parameters for Safety System Integration

                This task describes how to configure Java Message Service parameters required for safety system integration.

                This task is a step in Process of Setting Up Safety System Integration for Siebel Medical.

                To configure Java Message Service parameters for safety system integration

                1. In the Siebel client, navigate to the Administration - Server Configuration screen, then the Enterprises view.

                2. Select the Enterprise Server that you want to configure, and then click the Profile Configuration tab.

                3. Create a new enterprise profile record and complete the necessary fields.

                  • Set the following parameters on the form that appears:

                    Name Value

                    Profile

                    JMSParameters_SafetySystem

                    Alias

                    JMSParameters_SafetySystem

                    Subsystem Type

                    JMSSubsys

                  • Set the following parameters in the Profile Parameters list applet.

                    Name Value

                    ConnectionFactory

                    jms/aia/AIA_SEBLDrugSafetyReportJMSQueueCF

                    SendQueue

                    jms/aia/AIA_SEBLDrugSafetyReportJMSQueue

                    SendUsername

                    Set the value to the Oracle WebLogic user name.

                    Note: The Oracle WebLogic user must have access to the JMS queue.

                    SendPassword

                    Set the value to the Oracle WebLogic user password.

                    The password is visible in plain text until the profile is saved and refreshed.

                4. Restart the Siebel Server.

                  Configuring Siebel Medical for Safety System Integration

                  This task describes mapping a protocol in Siebel Clinical to a study in the safety system.

                  This task is a step in Process of Setting Up Safety System Integration for Siebel Medical.

                  To configure Siebel Medical for safety system integration

                  1. Navigate to the Administration Clinical screen, then the Protocol List view.

                  2. In the Protocols list, drill down on the protocol number (#) of the protocol that you want to send adverse event information about.

                  3. Click the More Info tab.

                  4. In the Integration applet, set the Safety Study ID to the ID of the study in the safety system.

                    Logging a Product Issue for Safety System Integration

                    This task describes how to create a product issue in the Product Issues screen. To create a product issue from a service request, see Capturing Adverse Events and Complaints as Service Requests.

                    This task is a step in Process of Setting Up Safety System Integration for Siebel Medical.

                    To log a product issue for safety system integration

                    1. Navigate to the Product Issues screen, then the Product Issue view.

                    2. In the Product Issue List, create a new record and complete the necessary fields for the integration.

                      Some fields are described in the following table.

                      Name Description Required

                      AE Case ID

                      This field is populated with the adverse event case ID when the case is accepted by the safety system.

                      No

                      Awareness Date

                      The date the company was made aware of the event.

                      Yes

                      Country of Incidence

                      This list of values displays the countries that are configured in Siebel CRM.

                      Yes

                      Description

                      Detailed description of the adverse event.

                      Yes

                      Event Type

                      Describes the type of event, such as adverse drug event or adverse, medical-device event.

                      Yes

                      Event Severity

                      This field captures the severity of the product issue. The following list of values is provided:

                      • Mild

                      • Moderate
                      • Severe

                      No

                      Last Follow Up Date

                      This field displays the date that follow-up information on the adverse event was last recorded.

                      No

                      Product

                      The name of the product associated with the adverse event.

                      Yes

                      Received Date

                      The date when a company representative became aware of the event.

                      No

                      Reportable

                      Set this field to one of the following values:

                      • Yes

                      • No

                      • Potential

                      • Follow Up

                      • Void

                      Yes

                      Reported Outcome

                      This field captures the reported outcome for the product issue. The following list of values is provided:

                      • Recovered

                      • Recovering

                      • Not Recovered

                      • Resolved with Sequelae

                      • Fatal

                      • Unknown

                      No

                      Reporter Qualification

                      This field captures whether the reporter is a health professional, lawyer, or consumer. The following list of values is provided:

                      • Physician

                      • Pharmacist

                      • Other Health Professional

                      • Lawyer

                      • Consumer or Non-Health Professional

                      No

                      Report Type

                      This field captures whether or not the product issue was reported during a study. The following list of values is provided:

                      • Spontaneous

                      • Study

                      • Other

                      • Not available to Sender

                      Yes

                      Safety System Received Date

                      This field is populated with the date when the case was accepted by the safety system.

                      No

                    3. (System) The product issue Status field is set to Open by default.

                    Reviewing a Product Issue for Safety System Integration

                    You can review Siebel Medical product issue records with a status of Open for adverse event criteria.

                    This task is a step in Process of Setting Up Safety System Integration for Siebel Medical.

                    To review a product issue for safety system integration

                    1. Navigate to the Product Issues screen, then the Product Issue view.

                    2. In the Product Issue List, review the product issue for adverse event or product complaint criteria.

                    3. (Optional) In the Reportable field, select Yes, No, or Potential.

                    4. Click Review Complete.

                      The product issue Status field updates to Review Complete.

                    Sending a Product Issue to the Safety System

                    You can send the Siebel Medical product issue data to a third-party safety system for processing and reporting.

                    This task is a step in Process of Setting Up Safety System Integration for Siebel Medical.

                    To send a product issue to the safety system

                    1. Navigate to the Product Issues screen, the Product Issue view.

                    2. In the Reportable field, select Yes or Potential.

                    3. Click Send to Safety.

                      The User Authentication screen is displayed.

                    4. Enter user name and password.

                    5. Click Verify.

                      The Status field for the product issue updates 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.

                    Sending Product Issue Follow-Up Information to the Safety System

                    You can update the submitted product issue record with follow-up information.

                    This task is a step in Process of Setting Up Safety System Integration for Siebel Medical.

                    To send product issue follow-up information to the safety system

                    1. Navigate to the Product Issues screen, then the Product Issue view.

                    2. In the Product Issue List, drill down on the record (in the PI# field) for which follow-up information must be sent.

                    3. Update the Product Issue record with the follow-up information.

                    4. In the Reportable field, select Follow Up.

                    5. Click Send to Safety.

                    Verifying Case Acceptance by the Safety System

                    The safety system populates the AE (Adverse Event) Case ID and Safety System Received Date fields when the adverse event has been accepted.

                    To verify case acceptance by the safety system

                    1. Navigate to the Product Issues Screen, the Product Issue view.

                    2. In the Product Issue List, drill down on the record (in the PI# field) for the case that you want to verify.

                    3. Verify that the following fields have been populated:

                      • AE Case ID. This field is populated with the case ID that the safety system assigns.

                      • Safety System Received Date. This field is populated with the time and date on which the case was accepted in the safety system.

                      • Status. This field is set to Submitted when the case has been accepted 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.

                    To verify case rejection by the safety system

                    1. Log in to Siebel Medical.

                    2. Navigate to the Inbox applet.

                      Rejected cases are listed in the Inbox applet by product issue number in the Name column.

                    Voiding a Product Issue in Siebel Medical

                    You can void a product issue that has been accepted by the safety system. The AE Case ID field must have been populated by the safety system before you can void the product issue.

                    To void a product issue in Siebel Medical

                    1. Navigate to the Product Issues Screen, then the Product Issue List.

                    2. In the Product Issue List, select the product issue record that you want to void.

                    3. In the Reportable field, select Void.

                    4. Click Send to Safety.

                      A nullification message is sent to the safety system.