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Oracle® Argus Insight Installation Guide
Release 7.0.1

E28479-01
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4 Configuring the Argus Insight Application

This chapter provides information about configuring the Argus Insight application and the Argus Insight scheduling service.

This chapter includes the following topics:

4.1 Logging In to Argus Insight for Configuration and Setup

To log in to the Argus Insight application:

  1. Log in with rights to a workstation from where you can access the Argus Insight application.

  2. Start Internet Explorer.

  3. Start the Argus Insight application by typing the following URL in the Address bar:

    http://Argus_Insight_WebServer_Name:port_number/default.asp

  4. Press Enter. The Argus Insight Login screen opens.

    Surrounding text describes homepage.gif.
  5. Log in to the Argus Insight application:

    1. In the User Name field, type admin.

    2. In the Password field, enter the password for the admin user. This password is the same as the password of the admin user in Argus Safety.

    3. Click Login.

    Note:

    If you are using a Single Sign On (SSO) environment, you must ensure that SSO tools such as OAM are disabled on the Argus Insight Web Server for initial configuration. The only administrator user in Argus Insight is a non-LDAP user. A non-LDAP user cannot log in to Argus Insight with SSO tools set to Enabled.

    Note:

    In case of a multi-tenant setup, you must ensure that all the configuration is done using the default enterprise.
    • This will help in copying the configuration to a different enterprise

    • All the global configuration is available in the default enterprise.

4.2 Configuring the Argus Insight Application Profile Switches

Profile switches are a collection of settings that let you configure the default behavior of the system. This section describes the profile switches that you must set to establish connectivity with your Business Intelligence tool and to be able to run the initial ETL.

For detailed information about all the profile switches, see the following documents:

4.2.1 Accessing and Modifying the Profile Switches

To access and modify the Argus Insight profile switches:

  1. Log in to the Argus Insight application.

  2. Click the Tools tab in the upper-right corner of the Argus Insight Home page. The ADMINISTRATION TOOLS page opens.

  3. Click the List Maintenance tab.

  4. Select Profile Switches from the List Maintenance Items group. The system updates the Attributes group with the profile switches that you can configure. See Figure 4-1.

Figure 4-1 List Maintenance Tab with the Profile Switches

Surrounding text describes Figure 4-1 .

4.2.2 Setting the Populate Data Attributes

To set the data attributes:

  1. Click the List Maintenance tab on the ADMINISTRATION TOOLS page.

  2. Select Profile Switches from the List Maintenance Items group.

  3. Select POPULATE AFFILIATE DATA from the Attributes group.

    1. Click Modify. The following Modify Attribute dialog box opens:

      Surrounding text describes pad.gif.
    2. Click the Value field, and enter one of the following numeric values:

      0 = Do not bring any affiliate data into the data mart.
      1 = Bring all affiliate data into the data mart.

    3. Click OK to save your changes and return to the List Maintenance tab.

  4. Select POPULATE INTERCHANGE DATA from the Attributes group.

    1. Click Modify. The following Modify Attribute dialog box opens:

      Surrounding text describes pid.gif.
    2. Click the Value field, and enter one of the following numeric values:

      0 = Do not bring any interchange data into the data mart.
      1 = Bring all interchange data into the data mart.
      2 = Bring only the SAFETYREPORT, MESSAGES, and EDI_INFO tables data into the data mart.

    3. Click OK to save your changes and return to the List Maintenance tab.

  5. Select POPULATE NARRATIVE LANGUAGES TABLE from the Attributes group.

    1. Click Modify.

    2. Click the Value field, and enter one of the following numeric values:

      0 = Do not populate the RPT_CNL_MLINGUAL and RPT_CNL_ENGLISH tables.
      1 = Populate the RPT_CNL_MLINGUAL and RPT_CNL_ENGLISH tables. Argus Insight uses the information in these tables in the following reports:
      • Case Narrative Listing - English

      • Serious Adverse Events Report (for BusinessObjects only)

      Set this value to 1 only if you these reports.


    3. Click OK to save your changes and return to the List Maintenance tab.

4.2.3 Setting the Email Attributes

The following attributes relate to sending and receiving email after an extract, transform, and load (ETL) operation has completed, as well as sending email for scheduled reports.

  • ETL EMAIL SETUP

  • ETL EMAIL RECEIVER ADDRESS

  • EMAIL SENDER ADDRESS

  • FAILED RECIPIENTS STATUS EMAIL ADDRESS

  • MAX EMAIL SIZE

Note:

In previous releases, the three attributes for report scheduling (that is, EMAIL SENDER ADDRESS, FAILED RECIPIENTS STATUS EMAIL ADDRESS, and MAX EMAIL SIZE) were part of the Mailconfig.xml file. Beginning with Argus Insight 7.0, these attributes were moved to the List Maintenance section.

To configure the attributes related to email messages and delivery:

  1. Click the List Maintenance tab on the ADMINISTRATION TOOLS page.

  2. Select Profile Switches from the List Maintenance Items group.

  3. Define whether to send email following the failure or success of an extract, transform, and load (ETL) operation.

    1. Select ETL EMAIL SETUP from the Attributes group.

    2. Click Modify. The following Modify Attribute dialog box opens:

      Surrounding text describes ees.gif.
    3. Click the Value field, and enter one of the following numeric values:

      0 = Send no email message after an ETL operation.
      1 = Send an email message only if an initial or incremental ETL fails.
      2 = Send an email message only if an initial or incremental ETL succeeds.
      3 = Send an email message after any initial or incremental ETL (failure or success).

    4. Click OK to save your changes and return to the List Maintenance tab.

  4. Specify the email address of each administrator who should receive email status messages of the ETL process.

    1. Select ETL EMAIL RECEIVER ADDRESS from the Attributes group.

    2. Click Modify. The following Modify Attribute dialog box opens:

      Surrounding text describes ps-etlerad-mod.gif.
    3. Click the Value field, and enter the email address of each administrator who should receive email status messages of the ETL process. Use a semi-colon to separate each entry.

      If you leave the Value field blank, then Argus Insight sends no email messages.

    4. Click OK to save your changes and return to the List Maintenance tab.

  5. Specify the email address of the person who will send all the Argus Insight email messages.

    1. Select EMAIL SENDER ADDRESS from the Attributes group.

    2. Click Modify. The following Modify Attribute dialog box opens:

      Surrounding text describes ps-etlesad-mod.gif.
    3. Click the Value field, and enter the email address of the person on whose behalf Argus Insight sends all email messages.

      If you leave the Value field blank, then Argus Insight sends no email messages.

    4. Click OK to save your changes and return to the List Maintenance tab.

  6. Specify the email address of the user who will receive information about undeliverable emails:

    1. Select FAILED RECIPIENTS STATUS EMAIL ADDRESS from the Attributes group.

    2. Click Modify. The following Modify Attribute dialog box opens:

      Surrounding text describes frsea.gif.
    3. Click the Value field, and enter the email address of the user who will receive information about undeliverable emails.

    4. Click OK to save your changes and return to the List Maintenance tab.

  7. Specify the maximum size of an email message sent from the Argus Insight Web Server:

    1. Select MAX EMAIL SIZE from the Attributes group.

    2. Click Modify. The following Modify Attribute dialog box opens:

      Surrounding text describes maxemail.gif.
    3. Click the Value field, and enter a numeric value that defines the maximum attachment size limit (in KB) of the mail server in the organization.

    4. Click OK to save your changes and return to the List Maintenance tab.

4.2.4 Specifying the URL for Reports Exceeding Mail Size

Depending on the value set in the MAX EMAIL SIZE attribute, some reports may be too large to send by email. For such reports, users can view the reports at a specified URL.

To define the URL where users can access reports that cannot be sent by email:

  1. Click the List Maintenance tab on the ADMINISTRATION TOOLS page.

  2. Select Profile Switches from the List Maintenance Items group.

  3. Select ARGUS INSIGHT REPORTS URL from the Attributes group.

  4. Click Modify. The following Modify Attribute dialog box opens:

    Surrounding text describes airurl.gif.
  5. Click the Value field, and enter the URL for the Argus Insight application for accessing scheduled reports that cannot be sent to the configured email ID, due to mail size limit. For more information on mail size limit, see Section 4.2.3, "Setting the Email Attributes."

  6. Click OK to save your changes and return to the List Maintenance tab.

4.2.5 Specifying the Images for Company Logos

You can specify the image to use for the following logos:

  • LOGO IMAGE. This image is used in the following reports:

    — CIOMS report

    — CIOMS II Line Listing report

    — US FDA MedWatch 3500A report

    These reports are called the Argus Reports. By default, a logo does not print on these reports.

  • COMPANY LOGO PATH. This image is used in the header of reports generated using your Business Intelligence tool.

4.2.5.1 Specifying the Logo Image for the Argus Reports

To specify the image for the logo used in the Argus Reports:

  1. Click the List Maintenance tab on the ADMINISTRATION TOOLS page.

  2. Select Profile Switches from the List Maintenance Items group.

  3. Select LOGO IMAGE from the Attributes group.

  4. Click Modify. The following Modify Attribute dialog box opens:

    Surrounding text describes ps-li-mod.gif.
  5. Click the Value field, and enter the complete path to the GIF image on the Argus Insight Web Server that you want to use as the logo for the Argus Reports. For example:

    C:\apr_logo.gif

    To ensure the logo fits in the report layout, the size of the image must be 155 pixels (width) by 53 pixels (height).

  6. Click OK to save your changes and return to the List Maintenance tab.

4.2.5.2 Specifying the Image for Your Company Logo

To specify the logo image the prints in the header of an Argus Insight report:

  1. Click the List Maintenance tab on the ADMINISTRATION TOOLS page.

  2. Select Profile Switches from the List Maintenance Items group.

  3. Select COMPANY LOGO PATH from the Attributes group.

  4. Click Modify. The following Modify Attribute dialog box opens:

    Surrounding text describes clp.gif.
  5. Click the Value field and enter the image location for your company logo. The specified logo prints in the header of reports.

    • For Cognos, enter the full URL to the location of your company logo on the local server. Cognos supports JPG, GIF, and BMP images. For example:

      http://argusinsightwebserver:8084/apr_logo.jpg

    • For BusinessObjects, enter the full directory path to the location of your company logo on the BusinessObjects Server. BusinessObjects supports TIFF and BMP images. For example:

      C:\Logo\logo.bmp

    Note:

    The recommendations for the logo image are as follows:
    • The preferred size of the logo file is 10 KB. Because this logo appears on every page of the reports generated in Argus Insight, Oracle recommends that you limit the size of the logo file.

    • The dimensions of the logo should be approximately 300 (width) by 100 (height) pixels to fit in the space provided for the logo in the reports.

  6. Click OK to save your changes and return to the List Maintenance tab.

4.2.6 Setting the DAYS TO LOCK Attribute

To define the DAYS TO LOCK attribute:

  1. Click the List Maintenance tab on the ADMINISTRATION TOOLS page.

  2. Select Profile Switches from the List Maintenance Items group.

  3. Select DAYS TO LOCK from the Attributes group.

  4. Click Modify. The following Modify Attribute dialog box opens:

    Surrounding text describes ps-dtl-mod.gif.
  5. Click the Value field, and enter the number of days per your business needs or configuration.

  6. Click OK to save your changes and return to the List Maintenance tab.

4.2.7 Setting the Follow-up Attribute

To define the FOLLOW UP ACTION CODE attribute:

  1. Click the List Maintenance tab on the ADMINISTRATION TOOLS page.

  2. Select Profile Switches from the List Maintenance Items group.

  3. Select FOLLOW-UP ACTION CODE from the Attributes group.

  4. Click Modify. The following Modify Attribute dialog box opens:

    Surrounding text describes ps-fuac-mod.gif.
  5. Click the Value field, and select the appropriate choice for your business needs or configuration.

  6. Click OK to save your changes and return to the List Maintenance tab.

4.2.8 Setting the Attributes Specific ONLY to Cognos

If you are using Cognos as your Business Intelligence tool with Argus Insight, you need to set the following Cognos-specific attributes:

  • COGNOS AUTHENTICATION ENTERPRISE

  • COGNOS SERVER

  • POPULATE DLL SLL REPORTS TABLE DATA

Note:

You must configure the COGNOS AUTHENTICATION ENTERPRISE profile switch for Cognos integration. The default value of this switch is Null.

To define the attributes required for Cognos:

  1. Click the List Maintenance tab on the ADMINISTRATION TOOLS page.

  2. Select Profile Switches from the List Maintenance Items group.

  3. Select COGNOS AUTHENTICATION ENTERPRISE from the Attributes group.

    1. Click Modify. The following Modify Attribute dialog box opens:

      Surrounding text describes cas.gif.
    2. Click the Value field, and select the Enterprise Short Name from which all users are authenticated for Cognos login.

    3. Click OK to save your changes and return to the List Maintenance tab.

  4. Select COGNOS SERVER from the Attributes group. Argus Insight uses this attribute to identify which Cognos 8 Web Server to use.

    1. Click Modify. The following Modify Attribute dialog box opens:

      Surrounding text describes cs.gif.
    2. Click the Value field, and enter the name of the Cognos 8 Server and the port number. Use the following format:

      Cognos8_Server_Name:Port_Number

      For example: srv001:9300

      Port 9300 is the default port for the Cognos 8 application.

    3. Click OK to save your changes and return to the List Maintenance tab.

  5. Select POPULATE DLL SLL REPORTS TABLE DATA from the Attributes group.

    1. Click Modify. The following Modify Attribute dialog box opens:

      Surrounding text describes pdsrtd.gif.
    2. Click the Value field, and enter one of the following numeric values:

      0 = Do not populate the RPT_CASE_EVENT_PRODUCT table, which is required for DLL and SLL reports
      1 = Populate the RPT_CASE_EVENT_PRODUCT table, which is required for DLL and SLL reports

    3. Click OK to save your changes and return to the List Maintenance tab.

4.2.9 Setting the Attributes Specific ONLY to BusinessObjects

If you are using BusinessObjects as your Business Intelligence tool with Argus Insight, you need to complete the following tasks to define those attributes that are required for BusinessObjects configurations only:

4.2.9.1 Setting the Attributes for the BusinessObjects Servers

To define the attributes required for the BusinessObjects Servers:

  1. Click the List Maintenance tab on the ADMINISTRATION TOOLS page.

  2. Select Profile Switches from the List Maintenance Items group.

  3. Define the BusinessObjects Server that Argus Insight uses:

    1. Select BO SERVER from the Attributes group.

    2. Click Modify.

      Surrounding text describes ps-bos-mod.gif.
    3. Click the Value field, and enter either the IP address or the host name of the BusinessObjects Server.

      In addition, specify the cluster name if you are using the BusinessObjects clustering feature.

      Note:

      In the case of a single-server environment (that is, Argus Insight and BusinessObjects are hosted on the same server), you must enter the IP address to avoid problems when accessing the Report Writer. These problems may be caused due to the session interference of Argus Insight and BusinessObjects web application.
    4. Click OK to save your changes and return to the List Maintenance tab.

  4. Define the BusinessObjects port number that InfoView uses:

    1. Select BO PORT NUMBER from the Attributes group.

    2. Click Modify.

      Surrounding text describes ps-bop-mod.gif.
    3. Click the Value field, and enter the port number used by InfoView.

      You can enter any whole number from 10 to 65535 for the port number. The default value is 8080.

      Note:

      If the port number is incorrect, you will not be able to access InfoView from Argus Insight.
    4. Click OK to save your changes and return to the List Maintenance tab.

  5. Define the BusinessObjects WEBI Server that the system uses to access the Report Writer and InfoView from Argus Insight:

    1. Select BO WEBI SERVER from the Attributes group.

    2. Click Modify.

      Surrounding text describes ps-bows-mod.gif.
    3. Click the Value field, and enter either the host name or the IP address of the BusinessObjects WEBI Server. The system uses this value to access the Report Writer and InfoView from Argus Insight.

    4. Click OK to save your changes and return to the List Maintenance tab.

4.2.9.2 Setting the Attributes for the BusinessObjects Users

To define the attributes required for the BusinessObjects users:

  1. Click the List Maintenance tab on the ADMINISTRATION TOOLS page.

  2. Select Profile Switches from the List Maintenance Items group.

  3. Define the BusinessObjects administrator user:

    1. Select BO ADMIN USER from the Attributes group.

    2. Click Modify.

      Surrounding text describes ps-boa-mod.gif.
    3. Click the Value field, and enter the name of the BusinessObjects user that has administrator privileges to create, update, and delete users in the BusinessObjects repository. This user is a BusinessObjects user, but not necessarily an Argus Insight user.

    4. Click OK to save your changes and return to the List Maintenance tab.

  4. Define the password for the BusinessObjects administrator user:

    1. Select BO ADMIN PASSWORD from the Attributes group.

    2. Click Modify.

      Surrounding text describes ps-boapwd-mod.gif.
    3. Click the Value field, and enter the password for the BusinessObjects administrator user (BO ADMIN USER) that you defined in the previous step.

    4. Click OK to save your changes and return to the List Maintenance tab.

    Note:

    Ensure that you update this password whenever you change the password for the BusinessObjects administrator user on the BusinessObjects Server.
  5. Define a name for the BusinessObjects user group:

    1. Select BO USER GROUP NAME from the Attributes group.

    2. Click Modify.

      Surrounding text describes ps-bougn-mod.gif.
    3. Click the Value field, and enter a name for the BusinessObjects User Group under which all users will be created in the BusinessObjects repository.

    4. Click OK to save your changes and return to the List Maintenance tab.

4.2.9.3 Setting the Attributes for BusinessObjects Reports

To define the attributes related to the reports you use in BusinessObjects:

  1. Click the List Maintenance tab on the ADMINISTRATION TOOLS page.

  2. Select Profile Switches from the List Maintenance Items group.

  3. Define the name for the BusinessObjects report folder:

    1. Select BO REPORT FOLDER NAME from the Attributes group.

    2. Click Modify.

      Surrounding text describes ps-borfn-mod.gif.
    3. Click the Value field, and enter a name for the report folder that will contain all the objects from Argus Insight.

      The maximum length of the folder name is 255 characters. If the folder name does not match the name of the BusinessObjects Reports root folder, then the report listing will not be visible in Argus Insight.

    4. Click OK to save your changes and return to the List Maintenance tab.

  4. Define the column number that contains the supplier name:

    1. Select UDN Column for SUPPLIER NAME from the Attributes group.

    2. Click Modify.

      Surrounding text describes ps-udn-mod.gif.
    3. Click the Value field, and enter the number of the column in the Argus Insight CASE_MASTER table that contains the SUPPLIER NAME value.

      Note:

      You need to configure the UDN Column for SUPPLIER NAME attribute only if you use the Supplier Performance Report.
    4. Click OK to save your changes and return to the List Maintenance tab.

  5. Define the CASE REFERENCE TYPE ID attribute.

    1. Select CASE REFERENCE TYPE ID from the Attributes group.

    2. Click Modify.

      Surrounding text describes ps-crt-mod.gif.
    3. Click the Value field, and enter the number of your Case Reference Type ID, as per your business requirements. Argus Insight uses this value to populate the RPT_CASE.FIRST_REF_NO column.

      Note:

      You need to configure the CASE REFERENCE TYPE ID attribute only if you use the Monthly Manufacturing Report.
    4. Click OK to save your changes and return to the List Maintenance tab.

4.2.9.4 Setting the Populating Data Attributes Required for BusinessObjects Only

This section describes how to configure the POPULATE RPT_REG_REPORTS COLUMNS attribute required for BusinessObjects only.

For information about the other populating data attributes that are used by both BusinessObjects and Cognos, see Section 4.2.2, "Setting the Populate Data Attributes."

To define the POPULATE RPT_REG_REPORTS COLUMNS attribute:

  1. Click the List Maintenance tab on the ADMINISTRATION TOOLS page.

  2. Select Profile Switches from the List Maintenance Items group.

  3. Define the POPULATE RPT_REG_REPORTS COLUMNS attribute.

    1. Select POPULATE RPT_REG_REPORTS COLUMNS from the Attributes group.

    2. Click Modify.

    3. Click the Value field, and enter one of the following numeric values:

      0 = Do not populate the extra columns of the RPT_REG_REPORTS table.
      1 = Populate the extra columns of the RPT_REG_REPORTS table, which is required by the BusinessObjects version of the Regulatory Submission and Distribution Compliance report. Set this value to 1 only if you use this Argus Insight report and BusinessObjects.

    4. Click OK to save your changes and return to the List Maintenance tab.

4.3 Mapping Case Workflow States

Workflow is company-specific and your company may not use all the Workflow states.

To configure workflow management for the Argus Insight application:

  1. Click the Tools tab in the upper-right corner of the Argus Insight Home page. The ADMINISTRATION TOOLS page opens.

  2. Click the List Maintenance tab.

  3. Select Workflow Management from the List Maintenance Items group.

    The system updates the Attributes group with the following entries that you can modify:

    • Archiving States

    • Data Entry Complete

    • Assessment Complete

    • Approval Complete

    Surrounding text describes lm-wm.gif.
  4. Select Archiving States from the Attributes group, and click Modify. The following dialog box opens:

    Surrounding text describes lm-wfm-as.gif.
    1. Select Germany Expediting Reporting, Japan Reporting, and US-Reporting from the list on the left.

    2. Click the right arrow (>) to add them as Archiving States.

    3. Click OK to save your changes and return to the List Maintenance tab.

  5. Select Data Entry Complete from the Attributes group, and click Modify.

    1. Select Germany Data Validation, Japan Validation, and US-Validation from the list on the left.

    2. Click the right arrow (>) to add them as Data Entry Complete.

    3. Select Closed from the list on the right.

    4. Click the left arrow (<) to remove the Closed entry.

    5. Click OK to save your changes and return to the List Maintenance tab.

  6. Select Assessment Complete from the Attributes group, and click Modify.

    1. Select Germany Medical Review, Japan Medical Review, and US Medical Review from the list on the left.

    2. Click the right arrow (>) to add them as Assessment Complete.

    3. Select Closed from the list on the right.

    4. Click the left arrow (<) to remove the Closed entry.

    5. Click OK to save your changes and return to the List Maintenance tab.

  7. Select Approval Complete from the Attributes group, and click Modify.

    1. Select Germany Medical Review, Japan Medical Review, and US Medical Review from the list on the left.

    2. Click the right arrow (>) to add them as Approval Complete.

    3. Select Closed from the list on the right.

    4. Click the left arrow (<) to remove the Closed entry.

    5. Click OK to save your changes and return to the List Maintenance tab.

4.4 Configuring Duration Value Bands

In Argus Insight, you can map the following time values (entered in Argus Safety) to specific ranges called Duration Value Bands:

You set the value of these fields in Argus Safety by navigating to Product Tab, Drug Duration of Administration, and Events Tab.

By mapping the time values to Duration Value Bands in Argus Insight, you can specify query criteria based on ranges instead of specific values for the Time to Onset fields listed above.

Using the Duration Value Bands item on the List Maintenance tab, you can configure duration value bands in hours, days, weeks, months, and years. For each band, you can specify multiple ranges by entering minimum and maximum values for each range item. Any value that falls within a configured range will map to that range.

Note:

Duration Value Band configuration must be done before running the Initial ETL.

If Duration Value Bands are modified after Initial ETL, you must re-run the Initial ETL.

To modify a duration value band:

  1. Click the Tools tab in the upper-right corner of the Argus Insight Home page. The ADMINISTRATION TOOLS page opens.

  2. Click the List Maintenance tab.

  3. Select Duration Value Bands from the List Maintenance Items group. The Attributes group displays the valid bands (Hours, Days, Weeks, Months, and Years). You can modify the values of these bands. You cannot, however, add more bands or delete an existing band.

    Surrounding text describes lm-dvb.gif.
  4. Select the duration value band (Hours, Days, Weeks, Months, Years) you want to change, and click Modify. The Duration Value Bands Configuration dialog box displays the factory-configured ranges.

    Note that:

    • The Label column represents the name of the range.

    • The Lower Range (>=) and Higher Range (<) columns contain the minimum and maximum values, respectively.

    • The highest value band includes all values that are greater than the highest range value specified.

    Surrounding text describes dvb.gif.
  5. Modify the values, as appropriate:

    • To modify an existing range, edit the values in the Lower Range (>=) and Higher Range (<) fields.

    • To add a range, scroll to the current highest range and click in the blank Higher Range (<) field. Enter a value greater than the current highest range and press Tab to add a new row.

    • To delete an existing range, click the Delete icon next to the row. Note that you cannot delete the lowest band.

      If you delete an intermediate range, the system automatically converts the highest value of the deleted range to the lowest value in the next range. However, the system does not change the range labels.

  6. Click OK to save your changes.

4.5 Configuring Derivation Functions

Argus Insight lets you create a new List Maintenance item and derive specific cases to this item based on case attributes. These attributes are supplied to the system as SQL.

For example, you can create a new List Maintenance item called Report Type 1 and derive to this item all the cases that have the Report Type attribute defined as Spontaneous, Literature, or Compassionate Use. As a result, Report Type 1 appears as an option in the query tool interface corresponding to the Report Type attribute. When you select Report Type 1 from the Report Type list and execute your query, the system returns only those cases that have the Report Type attribute specified as Spontaneous, Literature, or Compassionate Use.

You can specify more than one attribute. For example, you can create a further specialized List Maintenance item called Report Type 1 US and derive to this item all the cases that have the Report Type attribute defined as Spontaneous, Literature, or Compassionate Use, and the Country of Incidence attribute defined as United States.

Note:

There can be situations where two different List Maintenance items you create contain similar attributes in the SQL criteria. In this case, you can assign a priority level to individual List Maintenance items. The priority level determines which List Maintenance item SQL executes first.

4.5.1 Opening the Derivation Fields Dialog Box

To open the Derivation Fields dialog box and configure derivation functions:

  1. Click the Tools tab in the upper-right corner of the Argus Insight Home page. The ADMINISTRATION TOOLS page opens.

  2. Click the List Maintenance tab.

  3. Select Derivation Functions from the List Maintenance Items group.

    Surrounding text describes lm-df.gif.
  4. Select All Derivations from the Attributes group, and click Modify. The Derivation Fields dialog box opens.

    Surrounding text describes drvflds.gif.

4.5.2 Icons in the Derivation Fields Dialog Box

Table 4-1 describes the icons in the Derivation Fields dialog box that you can use to add, delete, and reorder derivation field elements (rows).

Table 4-1 Icons in the Derivation Fields Dialog Box

Click… To…
Add Row Above icon

Add a derivation field element (row) above the currently selected row

Add Row Below icon

Add a derivation field element (row) below the currently selected row

Delete Row icon

Delete the currently selected derivation field element (row)

Move Row Up icon

Move the selected row up

Move Row Down icon

Move the selected row down


4.5.3 Field Mapping Derivation Rules

Table 4-2 lists the available field mapping derivation rules for Argus Insight.

Table 4-2 Field Mapping Derivation Rules

Function Category Function Sub-category Argus Insight Field

ANALYSIS

BfArM Information

Causality

ANALYSIS

Case Assessment

Case Outcome Case Serious Listedness Determination

EVENTS

Event Information

Lack of Efficacy

GENERAL

General Information

Report Type Derived Pregnancy

PATIENT

Patient Information

Age Group Gender Patient weight BMI desc

PRODUCTS

Product Drug

Derived Drug Abuse Derived Drug Interaction Derived Overdose Last daily dose


Note:

Causality, Report Type, Age Group, and Last daily dose are comma-separated derivation rules.

4.5.4 Fields and Check Boxes in the Derivation Fields Dialog Box

This section describes the fields and check boxes in the Derivation Fields dialog box.

4.5.4.1 LM Table

The LM Table field is the table name of the selected Argus field (that is, automatically populated).

4.5.4.2 Suppress

The Suppress check box is available for fields associated with the list maintenance data. When suppress is enabled for a field, the corresponding list maintenance values that are not present in any case are deleted and thus not available for querying.

Note:

The Suppress check box is applicable only if the condition specified in the SQL text box covers all the cases having the selected List Maintenance field.

4.5.4.3 Value

The Value field captures the value for the new derivation field. For the following four rules, you must enter the new value for the rule as a comma-separated value:

  • Causality

  • Report Type

  • Age Group

  • Last Daily Dose

Note:

Make sure that you enter the values for these rules as defined in the following sections. Unexpected results and/or ETL errors may result if the values are not entered as specified.

Causality Rule

Parameters: VALUE, REPORTABILITY

where:

       VALUE = New value for the rule

       REPORTABILITY = Lower value of the group

Example: NewCausality,1

Report Type Rule

Parameters: VALUE, INC_LIT, INC_TRIAL, ABRV

where:

       VALUE = New value for the rule

       INC_LIT = 1 if Literature Report Type else 0

       INC_TRIAL = 1 if Clinical Trial Report Type else 0

       ABRV = A 3-letter abbreviation for the Report Type

Example: NewReportType,0,1,NRT

Age Group Rule

Parameters: VALUE, GROUP_LOW, GROUP_HIGH

where:

       VALUE = New value for the rule

       GROUP_LOW = Lowest value of the age group

       GROUP_HIGH = Highest value of the age group

Example: NewAgeGroup,25,50

If you do not want to specify the High Value, then the comma is mandatory in the end.

Example: Unknown,70,

Last Daily Dose Rule

Parameters: VALUE, DAILY_DOSE_SORTING_ORDER

where:

       VALUE = New value for the rule

       DAILY_DOSE_SORTING_ORDER = 1 or 2 or 3 and so on to define the sorting order if there is more than 1 rule for the Last Daily Dose field

Examples: 1 -> 0to1,1;     2 -> 2to3,2     3 -> 5to8,3

4.5.4.4 Priority

The Priority field captures the priority for a list of derivation rules applied to a single List Maintenance field. The value should be from 1 to 255.

Note:

The priority for derivation rules applicable to a single List Maintenance field should be unique.

4.5.4.5 SQL

The SQL field specifies the SQL statement to capture the cases for which the derivation rule is applicable.

Note:

The SQL statement must follow the correct syntax.

The system does not validate the length of the new values against the database. Make sure that new values being inserted into the data mart do not exceed the limit defined in the database.

Guidelines for correct syntax:

  • The SQL query configured against a rule should not contain the table name. It should contain only the primary key column name(s) of the field in the SELECT clause. For example:

    Correct: SELECT CASE_ID FROM RPT_CASE WHERE…

    Incorrect: SELECT RPT_CASE.CASE_ID FROM RPT_CASE WHERE…

  • Make sure that there is only one space after the SELECT clause in the SQL query. For example:

    Correct: SELECT CASE_ID, SEQ_NUM FROM RPT_PRODUCT WHERE…

    Incorrect: SELECT     CASE_ID, SEQ_NUM FROM RPT_PRODUCT WHERE…

  • Make sure that no Oracle keyword (such as DISTINCT) is used after the SELECT clause in the SQL query. For example:

    Correct: SELECT CASE_ID, SEQ_NUM FROM RPT_PRODUCT WHERE…

    Incorrect: SELECT DISTINCT CASE_ID, SEQ_NUM FROM RPT_PRODUCT WHERE…

4.6 Configuring the Product Datasheet

To configure the product datasheet:

  1. Click the Tools tab in the upper-right corner of the Argus Insight Home page. The ADMINISTRATION TOOLS page opens.

  2. Click the List Maintenance tab.

  3. Select Profile Switches from the List Maintenance Items group.

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  4. Select and modify the following profile switches in the Attributes group:

    • DATASHEET BPI

    • DATASHEET EMEA

    • DATASHEET IB

    • DATASHEET PI

    These profile switches let you configure the user-defined fields for assessment of each datasheet on the Product tab.

4.7 Configuring the Argus Insight Scheduling Service

To configure the Argus Insight scheduling service:

  1. Log in to the Argus Insight Web Server.

  2. Click Start and then select Run.

  3. Type services.msc in the text box and click OK. The Services window opens.

  4. Right-click Argus Insight Service and then select Properties. The Argus Insight Service Properties dialog box opens.

  5. Set the value of the Startup type field to Automatic.

  6. Click Start to start the Argus Insight Service.

  7. Click OK to apply your changes and close the dialog box.

    Note:

    To change the interval of different service tasks, modify the entries in the Service.config file located in the Bin folder of Argus Insight. All the times in the Service.config file are specified in seconds.

IMPORTANT! Ensure that the user who runs this service has administrator privileges. If the user does not have administrator privileges, either the Scheduled CIOMS Reports might not return or an LDAP user might not be able to log in to the Argus Insight application.

4.8 Configuring the CIOMS and MedWatch Reports

These are required settings because PwReports.exe file is responsible for LDAP authentication along with CIOMS and MedWatch reports.

  1. Log in to the Argus Insight Web Server.

  2. Click Start and then select Run.

  3. Type dcomcnfg in the text box and click OK. The Component Services window opens.

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  4. Navigate to Console Root, Component Services, Computers, My Computer, and then select DCOM Config.

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  5. Right-click PwReports and select Properties. The PwReports Properties dialog box opens.

  6. Click the Security tab.

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  7. Look in the Launch and Activation Permissions group, select Customize, and then click Edit. The Launch Permission dialog box opens.

  8. Click Add. The Select Users or Groups dialog box opens.

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    1. In the Enter the object names to select field, add the following information:

      machine_name\IUSR

    2. Click OK. The system returns to the Launch Permission dialog box:

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  9. Complete the Launch Permission dialog box as follows:

    1. Select the newly created Internet Guest Account.

    2. Grant the listed permissions to the account by selecting all the check boxes in the Allow column.

    3. Click OK.

  10. Exit the Component Services program.

4.9 Configuring the IIS File Download Limit

To configure the IIS file download limit for Windows 2008:

  1. Go to the Internet Information Services (IIS) Manager.

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  2. Double-click ASP in the right pane. The ASP dialog box opens.

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  3. Expand Limit Properties and change the Response Buffering Limit from its default value of 4 MB to a large value such as 200000000 (200 MB).

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  4. Click Apply to save the changed value.

  5. Restart the IIS service.

    1. Click Start and select Run.

    2. Type iisreset -start in the text box.

    3. Click OK.

4.9.1 Configuring the ASPMaxRequestEntityAllowed Value

Defining a value for the ASPMaxRequestEntityAllowed setting is optional.

You may need to set this value only if you use custom SQL scripts in advanced conditions and only if the scripts have more than 70,000 characters.

If you receive AJAX errors when saving your custom SQL scripts that have more than 70,000 characters, you can increase the value of the ASPMaxRequestEntityAllowed setting in the MetaBase.xml file. Increasing the setting ensures that the ASP can post that much data onto the server.

To change the value of the ASPMaxRequestEntityAllowed setting:

  1. Stop the Internet Information Services (IIS):

    iisreset /stop

  2. Navigate to the following folder:

    \WINDOWS\system32\inetsrv

  3. Open the MetaBase.xml file for editing.

  4. Find the following line in the file:

    ASPMaxRequestEntityAllowed=

  5. Set this value to the lowest possible value that allows for the functionality you need. A common value is 500000. The maximum value is 1,073,741,824 bytes.

  6. Save the file.

  7. Restart the Internet Information Services (IIS):

    iisreset /start

Alternatively, you can use DOS commands to change the value of the ASPMaxRequestEntityAllowed setting:

  1. Open the DOS command prompt.

  2. Change to the following directory:

    cd drive:\inetpub\adminscripts

    where drive is the hard disk where IIS is installed.

  3. Enter the following command:

    cscript adsutil.vbs set w3svc/ASPMaxRequestEntityAllowed value

    where value is the lowest possible value that allows for the functionality you need. A common value is 500000. The maximum value is 1,073,741,824 bytes.

  4. Restart the Internet Information Services (IIS):

    iisreset /start

4.10 Using Export and Import to Copy Configuration Data

Before configuring export and import functions, be aware of the following:

4.10.1 Exporting Data

To export data:

  1. Start the Argus Insight Schema Creation Tool.

  2. Click Export Data. The Export Utility dialog box opens.

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  3. Enter the name of the schema owner, the schema password, and the name of database.

  4. Enter the complete directory path and file name for the export dump file. You can choose to:

    • Keep the default file location and name as specified.

    • Click the ... button next to the Export Dump File Name field. When the Export Dump File dialog box opens, navigate to the appropriate location, enter the file name in the File name field, and then click Save. The system returns to the Export Utility dialog box.

  5. Enter the complete directory path and file name for the log file. You can choose to:

    • Keep the default file location and name as specified.

    • Click the ... button next to the Log File Name field. When the Log File dialog box opens, navigate to the appropriate location, enter the file name in the File name field, and then click Save. The system returns to the Export Utility dialog box.

  6. Click Export to continue with the data export. The system displays a series of command screens. For example:

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  7. Follow the instructions on the command screen to continue with the export. When the export is done, the following dialog box opens:

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  8. Click OK. The system displays a message when the Argus Insight configuration data has been exported:

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  9. Click OK to close the dialog box. Be sure to review the log files for information about the export as well as export errors, if any.

    Log files are in the following folder:

    \Program Files\Oracle\ArgusInsight\Database\DBInstaller\Copy_Config_Data

4.10.2 Importing Data

To import data:

  1. Start the Argus Insight Schema Creation Tool.

  2. Click Import Data. The Import Utility dialog box opens.

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  3. Enter the name of the schema owner, the schema password, and the name of database.

  4. Enter the complete directory path and file name for the dump file. You can choose to:

    • Keep the default file location and name as specified.

    • Click the ... button next to the Dump File Name field. When the Import Dump File dialog box opens, navigate to the appropriate location, enter the file name in the File name field, and then click Open. The system returns to the Import Utility dialog box.

  5. Enter the complete directory path and file name for the log file. You can choose to:

    • Keep the default file location and name as specified.

    • Click the ... button next to the Log File Name field. When the Log File dialog box opens, navigate to the appropriate location, enter the file name in the File name field, and then click Open. The system returns to the Import Utility dialog box.

  6. Click Import to continue with the data import.

    The system opens a dialog box that lists the prerequisites to importing data.

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  7. Review the prerequisites and verify that your system complies with the requirements.

    • If you have not met all the prerequisites, click Cancel to stop the data import. Complete all prerequisites before restarting the data import process.

    • If you have met all the prerequisites, click OK. The system displays a series of command screens. For example:

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  8. Follow the instructions on the command screen to continue with the import.

    When the Argus Insight configuration data has been imported, the system displays the following message:

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  10. Click OK to close the dialog box. Be sure to review the log files for information about the import as well as import errors, if any.

    Log files are in the following folder:

    \Program Files\ArgusInsight\DBInstaller\Copy_Config_Data\Log

4.11 Using Argus Safety to Configure Enterprises for Argus Insight

Using Argus Safety to configure enterprises for Argus Insight is supported in multi-tenant installations only.

In addition, you must be a valid LDAP user and you must have access to the Argus Safety global home page. See the Global Enterprise Management section of the Argus Safety Installation Guide for detailed steps on logging and accessing Argus Safety global home page.

To create an enterprise in Argus Insight:

  1. Log in to the Global Enterprise Management portlet.

  2. Select an enterprise from the Enterprises folder in the left pane. The Enterprises folder includes only those enterprises that you have privilege to access:

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  3. Click Copy Enterprise to Insight to initiate the creation of the selected enterprise in Argus Insight.

    Note that the Copy Enterprise to Insight button:

    • Is disabled if the selected enterprise already exists in Argus Insight.

    • Is enabled if you have Copy Configuration role in any of the listed enterprises.

    The system opens the following screen:

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  4. Use the Copy Enterprise Configuration From field to select the source enterprise from which the information will be copied.

    Note that the drop-down list includes only those enterprises that meet the following two conditions:

    • The enterprise has already been created in Argus Insight.

    • You have been assigned Copy Configuration privileges for the enterprise.

  5. Click Setup. The system begins to copy the configuration and displays status information throughout the process:

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  6. Click Finish to complete the creation of the enterprise in Argus Insight.

4.12 Securing Sensitive Configuration and Operational Data

For security reasons, you should configure permission settings for certain files and folders on the Argus Insight Web Server. The permission settings ensure that only the IIS user can access these files. Local system login accounts that are not part of the Administrators group cannot make changes to the files.

Windows Directory File

For the user under which IIS is running, the ai.ini file requires a permission of Full Control.

Shared Folders

For the user under which IIS is running, the following folders require a permission of Full Control: