Skip Headers
Oracle® Health Sciences Adverse Event Integration Pack for Oracle Health Sciences InForm and Oracle Argus Safety Installation Guide for On-Premise Deployment
Release 1.0.1
E36158-02
Go to Table of Contents
Contents		 Go to Feedback page
Contact Us
Go to previous page
Previous		 Go to next page
Next
PDF · Mobi · ePub

8 Performing Post-Installation Configurations

This section discusses post-installation configurations for the InForm - Argus Safety integration, which includes:

Note:

Before you use the integration for a trial, follow the trial setup steps provided in the Oracle Health Sciences Adverse Event Integration Pack for Oracle Health Sciences InForm and Oracle Argus Safety Implementation Guide.

Note:

Ensure to install the patch set 1.0.1 for the integration. You can download it from MOS as patch 16523094.

8.1 Creating a User in Oracle WebLogic Server

InForm Publisher sends user name and password credentials to the SOA server. The user name and password that you create here must be entered as the endpoint user name and password in the InForm Publisher configuration screen. For more information, see InForm Publisher Installation Guide.

To create a user, perform the following:

  1. Navigate to WebLogic console.

  2. Under Domain Structure of soa_domain, select Security Realms, then select myrealm.

  3. Select the Users and Groups tab, and then select the Users tab.

  4. Click New.

  5. In the Name field, enter the user name the InForm Publisher sends.

  6. In the Password field, enter the password.

  7. In the Provider list, select the default authentication provider for the user.

  8. Click OK.

8.2 Creating File Adapter Control Directory in Oracle WebLogic Server

When a Read File Adapter is deployed on multiple SOA servers, multiple composite instances are created for a single file. It is required to create a control directory for File Adapter high availability when integration SOA server is clustered. This control directory ensures that all Read File Adapters do not read the same file simultaneously.

For example, when ReportDrugSafetyReportReadFileAdapter is deployed on a two-node SOA server cluster, control directory ensures that there is only one composite instance per incoming file.

  1. Log in to Oracle WebLogic Server Administration Console.

    To access the console, navigate to http://servername:portnumber/console.

  2. Click Deployments in the left pane for Domain Structure.

  3. Click File Adapter under Summary of Deployments on the right pane.

  4. Click the Configuration tab.

  5. Click the Outbound Connection Pools tab, and expand javax.resource.cci.ConnectionFactory to view the configured connection factories.

  6. Click eis/HAFileAdapter.

    The Outbound Connection Properties for the connection factory corresponding to high availability is displayed.

  7. Update the controlDir property:

    • Set the property to the directory structure where the control files can be stored.

      This must be set to a shared location if multiple WebLogic Server instances run in a cluster. The directory specified must be write accessible to all WebLogic server instances.

    • Specify the directory path in the controlDir property.

    • Press Enter after updating the controlDir property.

    Figure 8-1 Outbound Connection Properties

    Description of Figure 8-1 follows
    Description of "Figure 8-1 Outbound Connection Properties"

  8. Click Save. Save the deployment plan when prompted.

For more information, see Oracle® Fusion Middleware User Guide for Technology Adapters 11g Release 1.

8.3 Enabling Customization

For information about enabling customization, see Oracle® Health Sciences Adverse Event Integration Pack for Oracle Health Sciences InForm and Oracle Argus Safety Implementation Guide.

8.4 Installing Patch Set

You must install the following patch set for the integration before proceeding with post-installation steps: Patch 16523094. The patch is available on My Oracle Support (https://support.oracle.com). For information on how to install the patch set, see Oracle® Health Sciences Adverse Event Integration Pack for Oracle Health Sciences InForm and Oracle Argus Safety 1.0.1 Patch Set Readme.

For any questions or problems, contact Oracle Support for AIA.

8.5 Setting Up Argus E2B Profile

Argus Interchange server is used for this integration.

If you are using the Multi-tenant feature of Argus Safety, create the following:

For information about directories, see Chapter 5. Ensure that the following setup is completed on the Argus Interchange server.

Note:

Ensure to install the Adverse Event: InForm and Argus Safety integration patch set 1.0.1 before setting up the Argus E2B profile. Check MOS for the most recent patches.

To set up Argus E2B Profile, perform the following:

  1. Navigate to the SOA_Server directory <AIA_HOME>/data/AEInFormandArgus/sql/ArgusProfile and copy the ich-icsr-v2.1-FDA-PIP.dtd file to the Interchange server folder <Oracle_Home>\Argus\InterchangeService\DTDFiles\.

    Note:

    Argus DTD is updated to have more extension fields to support custom extensions and non-custom, non-E2B fields.

  2. Copy all the files from the SOA_Server directory <AIA_HOME>/data/AEInFormandArgus/sql/ArgusProfile to a folder on Argus ESM server (for example, C:\Temp_config_folder).

  3. On the Argus Interchange server, open a command prompt and navigate to the folder where you copied the scripts in step 2.

  4. Run the batch file Setup_Safety_Integration_Profile.bat. These scripts will import all custom extension fields, and non-custom or non E2B extension fields that are added to integration specific DTD.

    Note:

    Run the batch file Setup_Safety_Integration_Profile.bat for each enterprise separately.

  5. Enter the database name, enterprise short name, ESM owner's username (for example, esm_owner), password, and the log file path (C:\Temp_config_folder\profilecreationoutput.log).

    Note:

    If Argus Safety is installed in the Single-tenant mode, you do not have to provide the enterprise short name. Press Enter.

  6. Press Enter.

8.5.1 Updating an Existing Argus Profile

Note:

Please perform the following steps only if you have already created ICH-ICSR V2.1 MESSAGE TEMPLATE - FDA PIP Argus profile, before applying Patch set described in Section 8.4, "Installing Patch Set".

You must update the ICH-ICSR V2.1 MESSAGE TEMPLATE - FDA PIP Argus profile if you:

  • Create an Argus profile before applying the patch set

  • Upgrade Argus Safety from 7.0.1 to 7.0.2 after applying the patch set

You can update an existing Argus profile using the following steps:

  1. After the patch set is successfully installed on the SOA server, copy all Argus profile creation SQL scripts from $AIA_HOME/data/AEInFormandArgus/sql/ArgusProfile to a temporary directory on the Argus Interchange server.

  2. On the Argus Interchange Server, open ESM Mapping Utility.

    You must select a specific enterprise name for Multi-tenant Argus.

  3. Select Profile - ICH-ICSR V2.1 MESSAGE TEMPLATE - FDA PIP from the Profile drop-down list.

  4. Select Administrator and then Delete Profile.

    Note:

    If the Delete Profile option appears to be disabled, expand the profile element such as, SAFETYREPORT[A.1], and click on any child node (for example, SAFETYREPORTVERSION). Navigate to Administrator and then Delete Profile.

  5. Click Yes.

    The following error message is displayed on ESM Mapping Utility:

    Unhandled exception has occurred in your application. If you click Continue, the application will ignore this error and attempt to continue. If you click Quit, the application will close immediately. Contact your System Administrator - Continue, Quit.

    This error may be ignored by clicking on Continue, because you are deleting the profile that is being referred in the reporting destination configuration on Argus Console. In the next steps below, the profile is created again and hence reporting destination's reference to the profile will be intact.

  6. Click Continue.

  7. Open the command prompt and navigate to the temporary directory where the Argus 7.0.2 profile creation scripts are copied.

  8. Run Setup_Safety_Integration_Profile.bat.

    These scripts will import all custom extension fields, and non-custom or non E2B extension fields that are added to integration specific DTD.

  9. Enter the database name, enterprise short name, ESM owner's user name (for example, esm_owner), password, and the log file path (for example, C:\Temp_config_ folder\profilecreationoutput.log).

    Note:

    For Single-tenant Argus, you do not have to provide the enterprise short name. Press Enter.

  10. When the script runs, it generates unique constraint violation errors as follows:

    • ORA-00001: unique constraint (ESM_OWNER.PK_CFG_PROFILE) violated

    • ORA-00001: unique constraint (ESM_OWNER.PK_LM_ESM_ARGUS_MAPPING) violated

    These errors occur if a profile with the same name exists. While deleting the profile in step 4, data from LM_ESM_ARGUS_MAPPING and CFG_PROFILE tables are not deleted. However, you can ignore these errors because the profile scripts insert same data into these tables.

  11. After the script completes, the profile is updated for the Argus7.0.2 E2B import process.

8.6 Configuring Argus Safety for Using Extension Profile

To configure Argus Safety for using the extension profile, perform the following:

  1. Open the Argus Console.

  2. Navigate to the Reporting Destination folder from the Browser.

  3. Click Add New to create new agency details to serve as a reporting destination.

  4. Enter the agency information in the Agency Information pane. Table 8-1 provides field description and example values:

    Table 8-1 Agency Information Tab Field Description

    Fields Description

    Agency Name

    Enter INFORM-ARGUS-INTEGRATION.

    Note that this agency is being added for the integration only and should not be used for sending reports to any regulatory agencies.

    The E2B files received by this agency cannot be sent in the same format to the regulatory authorities such as FDA. You need to modify the sequence of standard E2B fields.

    For example, positions of companynumb element and primarysourcecountry element have been swapped to ensure that we have companynumb element in all acknowledgement files that are auto-generated by Argus due to M2 validation failure.

    Report for Marketed Licenses

    This field contains default value Always.

    Report for Investigational Licenses

    This field contains default value Always.

  5. Click the Local Company Contact tab and enter the contact details. Table 8-2 provides field description and example values:

    Table 8-2 Local Company Contact Tab Field Description

    Fields Description

    Company Name

    Enter the company name. This is a mandatory field.

    For example, INTEGRATIONS.

  6. Click the EDI tab and enter the values in the fields. Table 8-3 provides field description and example values:

    Table 8-3 EDI Tab Field Description

    Fields Description

    SGML or XML

    Select XML.

    This field represents the format of incoming E2B and outgoing acknowledgement files.

    Agency Identifier

    Enter INFORM_01. This value should match sender identifier in E2B file.

    Company Identifier

    Enter ARGUS_01. This value should match receiver identifier in E2B file.

    Method

    Select E2B-XML transmission from the list.

    Message Profile

    Select the ICH ISCR V2.1 MESSAGE - TEMPLATE - FDA PIP extension profile from the Message Profile list.

    ACK Profile

    Select the ICH-ICSR V 1.1 ACKNOWLEDGMENT TEMPLATE - FDA acknowledgment profile from the ACK Profile list.

    File Name

    Enter Safety######.xml as the file name pattern of the incoming file.

    URL of Message DTD

    Enter the extension DTD file path in the URL of Message DTD field.

    For example, C:\Program Files\Oracle\Argus\InterchangeService\DTDFiles\ich-icsr-v2.1-FDA-PIP.dtd

    URL of ACK DTD

    Enter the acknowledgment DTD file path in the URL of ACK DTD field.

    For example, C:\Program Files\Oracle\Argus\InterchangeService\DTDFiles\FDA-icsrack-v1.1.dtd

  7. Click Save. The Argus Console dialog box is displayed.

  8. Click OK. Oracle Argus Safety is configured for E2B extension for the selected agency.

    Note:

    In Multi-tenant Argus Safety, different enterprises can have same agency and company identifier values. For configuring E2B folder, see "Configuring Folders for XML File Sharing".

8.7 Configuring Folders for XML File Sharing

For the exchange of E2B and acknowledgement files between Argus Safety and SOA Server, you must create folders and configure them. For folders' details, see Chapter 5.

Note:

If you are using Multi-tenant Argus Safety, you will need to create folders and configure each enterprise separately.

To configure the folders, perform the following:

  1. On Argus ESM Server, open ESM Mapping Utility. To open the ESM Mapping Utility, click Start, select All Programs, select Oracle, then select ESM Mapping.

  2. Enter the user name, password, and database name to run the mapping tool.

  3. For Multi-tenant Argus Safety installation, select the enterprise name from the drop-down list.

  4. In the ESM Mapping Utility, navigate to Administrator, and select setup.ini.

  5. In the Multiple Database section, double-click on the database name to set up system directories for E2B exchange.

    Note:

    If Argus Database is new, you may not see a database name. To create a database, select Add New Process and double click. This opens the Service DB Setup screen.

    For entering the values in the Service DB Setup screen, see Table 8-4.

  6. Select the database name (for example, AS70xx). This opens the Service DB Setup screen.

  7. In the System Directories pane, select INFORM-ARGUS-INTEGRATION from the list.

    Table 8-4 Field Description of Service DB Setup Screen

    Fields Description

    Database Section

    Enterprise Short Name

    Select the enterprise short name.

    For example, ent1

    Database Name

    Enter the database name.

    For example, AS70xx

    Unique Database ID

    Enter unique database ID.

    For example, 123

    User ID

    Enter the database user name.

    Password

    Enter the database password.

    Process

    Enter C:\Program Files\Oracle\Argus\InterchangeService\EsmProc.exe.

    Receive Process

    Enter C:\Program Files\Oracle\Argus\InterchangeService\E2BReceive.exe.

    Archive Folder

    Select the folder for archiving the files.

    You had created this folder as one of the Prerequisites listed.

    For example, C:\INF-ARG-INTEGRATION\Archive.

    Receive Processes

    Enter the value as 1.

    Process Elapse Time

    Enter the value of 1 minute.

    Time Out Section

    EDI Transmit Time Out value (File is not picked up by Gateway)

    Enter time out value as 10 minutes.

    Physical Media Transmit Time Out value (File is not picked up manually)

    Enter time out value as 10 minutes.

    Receive ACK Time Out value (ACK is due for transmitted reports)

    Enter time out value as 10 minutes.

    Processing Time Out value (E2B Report not Processed by User)

    Enter time out value as 10 minutes.

    XML Transmit Time Out value (File is not picked up by Gateway)

    Enter time out value as 10 minutes.

    Binary Transmit Time Out value (File is not picked up by Gateway)

    Enter time out value as 10 minutes.

    MDN Time Out Value (For E2B Reports which have received Bus ACK)

    Enter the value 0 hours.

    System Directories Section

    Agency Name

    Select INFORM-ARGUS INTEGRATION agency configured in the Argus Console, Reporting Destination.

    Local Company

    This value is displayed based on Reporting Destination Configuration.

    Incoming Folder

    Specify the folder path for incoming files.

    You had created this folder as one of the Prerequisites listed.

    For example,

    For Multi-tenant Argus, agencies from two different enterprises cannot share the same folder for incoming E2B files. Therefore, it is necessary to have the following folder structure in the file system:

    Incoming files

    C:\<FILE_EXCHANGE_DIR_ROOT>\in\<enterprise_name_1>

    C:\<FILE_EXCHANGE_DIR_ROOT>\in\<enterprise_name_2>

    For Single-tenant Argus, the folder structure is as follows:

    Incoming files

    C:\<FILE_EXCHANGE_DIR_ROOT>\in

    Outgoing Folder

    Specify folder path for outgoing files.

    You had created this folder as one of the Prerequisites listed.

    For example,

    For Multi-tenant Argus, the folder structure is as follows:

    Outgoing files

    C:\<FILE_EXCHANGE_DIR_ROOT>\out\<enterprise_name_1>

    C:\<FILE_EXCHANGE_DIR_ROOT>\out\<enterprise_name_2>

    For Single-tenant Argus, the folder structure is as follows:

    Outgoing files

    C:\<FILE_EXCHANGE_DIR_ROOT>\out

  8. Enter the values in the corresponding fields and click Save.

  9. Click OK.

  10. Click OK on Service INI File Setup screen.

8.8 Changing Parameters on the SOA Server

8.8.1 Changing Parameters to Increase Performance

To change parameters on the SOA server to increase the performance of the integration, perform the following:

  1. Navigate to the Enterprise Manager (EM) Console:

    http://<server name>:<port number>/em/

  2. Navigate to farm_soa_domain, select SOA, then right-click soa-infra.

  3. Select SOA Administration and then select Mediator Properties.

  4. Change the default value of ResequencerLockerThreadSleep from 10 to 1.

8.8.2 Changing Default Values of Transaction Timeout

To change the transaction timeout values on the SOA server to suit your environment, perform the following:

  1. Log in to the WebLogic Console.

  2. Navigate to soa_domain and then Services.

  3. Click the JTA tab.

  4. Increase the default value of Java Transaction API (JTA) timeout as the default JTA transaction timeout value may not be enough to complete transaction.

    Ensure to increase this value to be large enough to complete your transactions but not so large that it will impact performance.

  5. Oracle recommends you to increase the Extended Architecture (XA) Transaction timeout for XA data source as mentioned in http://docs.oracle.com/cd/E28271_01/admin.1111/e10226/soainfra_config.htm#BHCDIBCE.

In the clustered SOA server environment, perform the following configurations to ensure all composites in a flow participate in one global transaction:

  1. Navigate to the EM Console:

    http://<server name>:<port number>/em/

    1. Navigate to farm_soa_domain, select SOA, then right-click soa-infra.

    2. Select SOA Administration and then select Common Properties.

    3. In the property named Server URL, enter load-balancer URL for your server cluster (for example, http(s)://lbhost:lbport/).

      Note:

      Ensure to use the ending backslash (/), otherwise the function will not work correctly.

  2. Open the WebLogic Console.

    1. Navigate to Domain Structure/<domain name>/environment/Clusters page.

    2. Select the cluster name.

    3. Click the Configuration/HTTP tab.

    4. Enter values in the following fields:

      Frontend Host: Specify the host DNS address of the load balancer.

      Frontend HTTP Port: Specify the port number of the load balancer.

      Frontend HTTPS Port: If SSL communication is enabled, use this field instead of Frontend HTTP Port.

  3. Restart node manager, admin, and SOA servers.

8.9 Disabling Acknowledgment Flow

The Acknowledgement flow requires InForm Adapter. If you do not have InForm Adapter and/or not using it, you can disable the Acknowledgement flow by shutting down the following services through Enterprise Manager (EM).

8.9.1 Shutting Down the Services

To shut down the services, perform the following:

  1. Navigate to the EM Console:

    http://<server name>:<port number>/em/

  2. Log in with the server admin user name.

  3. Navigate to soa-infra/services/default.

    The list of services will be displayed.

  4. Click on the service you want to shut down and click Shut Down.

  5. Click Yes in the confirmation window.

    Note:

    To restart a service, click Start Up.
Go to previous page
Previous		 Go to next page
Next
Go to Table of Contents
Contents		 Go to Feedback page
Contact Us