Oracle® Argus Insight

User's Guide

Release 8.1.1

E88249-01

September 2017

Oracle Argus Insight User’s Guide, Release 8.1.1

E88249-01

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Contents

Preface

- Where to Find More Information

- Documentation Accessibility

1 Introduction

- 1.1 Generating Reports in Argus Insight

- 1.2 Argus Insight Components

- 1.3 Argus Insight Process Flow

- 1.4 Product Compatibility and Upgrade Options

- 1.4.1 Compatibility of Argus Insight with Argus Safety

- 1.4.2 Compatibility of Argus Insight with Reporting Tools

- 1.4.3 Upgrade Paths to Argus Insight 8.1.1

- 1.4.4 Copy Configuration Utility

2 Getting Started

- 2.1 About Login Accounts and Access

- 2.1.1 System Administrator Account

- 2.1.2 Single Sign-On Accounts

- 2.2 Logging In to the Argus Insight Application

- 2.3 Setting Your Personal Options

- 2.3.1 Changing the Default Home Page

- 2.3.2 Changing Your Preferences for Overwrite Confirmation

- 2.3.3 Viewing Group Memberships

- 2.4 Entering Dates in Argus Insight Date Fields

- 2.5 Viewing the Database Name and Argus Insight Release

- 2.6 Viewing the Online Help

- 2.7 Extending Argus Insight Features

3 Creating Queries by Example

- 3.1 Overview of the Query by Example Tool

- 3.1.1 QUERY BY EXAMPLE Page—Tab Description

- 3.1.2 Example of a QBE

- 3.1.3 Using the Type-Ahead Feature in Input Fields

- 3.2 Starting a New QBE

- 3.2.1 Entering Your Search Criteria and Executing the QBE

- 3.2.2 Reviewing the Results of Your QBE

- 3.2.3 Reviewing and Modifying the Criteria for an Executed QBE

- 3.2.4 Saving the QBE

- 3.3 Query By Example Page—Input Fields

- 3.3.1 General Tab

- 3.3.1.1 Selecting the Study Information

- 3.3.2 Patient Tab

- 3.3.2.1 Patient View

- 3.3.2.2 Parent View

- 3.3.2.3 Selecting a Lab Test

- 3.3.2.4 Using the MedDRA Browser

- 3.3.3 Products Tab

- 3.3.3.1 Using the Product Browser

- 3.3.3.2 Using the WHO Drug Browser

- 3.3.3.3 Using the Study Drug Lookup

- 3.3.4 Events Tab

- 3.3.5 Analysis Tab

- 3.3.6 Activities Tab

- 3.3.7 Additional Info Tab

- 3.4 Assigning Group-Level Permissions to a Saved QBE

- 3.5 Working with the Last Modified or Executed QBE

- 3.6 Working with Saved QBEs

- 3.6.1 Searching for a Saved QBE

- 3.6.2 Creating a New QBE

- 3.6.3 Modifying a Saved QBE

- 3.6.4 Deleting a Saved QBE

- 3.6.5 Executing a Saved QBE

- 3.6.6 Executing a Saved QBE on the Active Case Series

- 3.7 Using QBEs with Advanced Conditions

- 3.7.1 Converting a QBE to an Advanced Condition

- 3.7.2 Integrating a QBE with an Advanced Condition

4 Using Filters to Create Queries

- 4.1 About Filters

- 4.2 Using Predefined Filters

- 4.2.1 Selecting a Predefined Filter

- 4.2.2 Creating a Value Set for the Predefined Filter

- 4.2.3 Executing a Value Set

- 4.3 Creating Custom Filters

- 4.3.1 Creating a Value Set for a Custom Filter

- 4.4 Working with the Last Modified or Executed Value Set

- 4.5 Working with Saved Filters and Value Sets

- 4.5.1 Searching Saved Filters and Value Sets

- 4.5.2 Creating a New Filter

- 4.5.3 Creating a New Value Set

- 4.5.4 Modifying a Filter or Value Set

- 4.5.5 Deleting a Filter or Value Set

- 4.5.6 Executing a Value Set

- 4.5.7 Executing a Saved Value Set on the Active Case Series

- 4.6 Using Filters with Advanced Conditions

- 4.6.1 Converting a Value Set to an Advanced Condition

- 4.6.2 Integrating a Value Set with an Advanced Condition

5 Using Advanced Conditions to Create Queries on Insight Mart

- 5.1 Creating a New Advanced Condition

- 5.1.1 Returning to the Advanced Conditions Editor

- 5.1.2 Assigning a Category to an Advanced Condition

- 5.1.3 Using and Ordering Advanced Condition Operators

- 5.1.3.1 Advanced Condition Example

- 5.1.3.2 Sample SQL Generated

- 5.2 Working with the Last Modified or Saved Advanced Condition

- 5.3 Working with Saved Advanced Conditions

- 5.3.1 Searching Saved Advanced Conditions

- 5.3.2 Creating a New Advanced Condition

- 5.3.3 Modifying an Advanced Condition

- 5.3.4 Modifying the SQL of an Advanced Condition

- 5.3.5 Deleting an Advanced Condition

- 5.3.6 Executing an Advanced Condition

- 5.3.7 Executing a Saved Advanced Condition on the Active Case Series

6 Using Advanced Conditions to Create Point-in-Time Queries on Argus Mart

- 6.1 Creating a New Advanced Condition

- 6.1.1 Saving and Providing Point-in-Time Query Date

- 6.1.2 Returning to the Advanced Conditions Editor

- 6.1.3 Assigning a Category to an Advanced Condition

- 6.1.4 Using and Ordering Advanced Condition Operators

- 6.2 Working with the Last Modified or Saved Advanced Condition

- 6.3 Working with Saved Advanced Conditions

- 6.3.1 Searching Saved Advanced Conditions

- 6.3.2 Creating a New Advanced Condition

- 6.3.3 Modifying an Advanced Condition

- 6.3.4 Modifying the SQL of an Advanced Condition

- 6.3.5 Deleting an Advanced Condition

- 6.3.6 Executing an Advanced Condition

- 6.3.7 Executing a Saved Advanced Condition on the Active Case Series

7 Working with Case Series

- 7.1 Working with the Active Case Series

- 7.1.1 Viewing the Active Case Series

- 7.1.1.1 Active Case Series and Active Query Names

- 7.1.1.2 Sorting, Searching, and Navigating

- 7.1.2 Saving the Active Case Series

- 7.1.3 Viewing the Criteria that Generated the Active Case Series

- 7.1.4 Assigning Group-Level Access Permissions

- 7.1.5 Adding an Annotation to a Case

- 7.1.5.1 About Case Annotations

- 7.1.5.2 Annotations in the Active Case Series

- 7.1.5.3 Annotations in Advanced Conditions

- 7.1.6 Adding a Case to a Case Series

- 7.1.7 Deleting a Case from a Case Series

- 7.2 Working with Case Series Saved in the Library

- 7.2.1 Opening the CASE SERIES LIBRARY Page

- 7.2.2 Searching for a Saved Case Series in the Library

- 7.2.3 Making a Case Series Active

- 7.2.4 Modifying a Case Series

- 7.2.5 Merging Case Series

- 7.2.6 Importing a Case Series from an External Source

- 7.2.7 Deleting a Case Series from the Library

- 7.2.8 Viewing the Query Criteria that Generated the Case Series

- 7.3 Sharing Case Series with Argus Safety Web

- 7.4 Exporting a Case Series to Microsoft Excel

- 7.5 Freezing and Unfreezing Case Series Data

- 7.5.1 Freezing a Case Series

- 7.5.1.1 Recognizing a Frozen Case Series

- 7.5.1.2 Freezing and Saving Case Series

- 7.5.2 Unfreezing Case Series Data

- 7.6 Using the Link to Argus Safety Medical Review

8 Generating and Scheduling Standard Reports - BIP

- 8.1 About BIP Standard Reports

- 8.1.1 Case Series, ETL, and Association

- 8.1.2 Browser Configuration

- 8.1.3 Report Cover Page

- 8.1.3.1 Page Header

- 8.1.3.2 Page Contents

- 8.1.3.3 Page Footer

- 8.2 Working in the Reports Page

- 8.3 Generating Reports

- 8.4 Scheduling and Associating Reports Against a Query or Case Series

9 Creating Custom Reports - BIP

- 9.1 Creating a New Report

- 9.2 Editing Reports

- 9.3 Changing the Report Layout

10 Generating OBIEE Answers and Working on Aggregate Analysis - Sample Dashboard

- 10.1 Argus Insight Catalog

- 10.2 About OBIEE Aggregate Analysis - Sample Dashboard

- 10.3 Working on BI Answers

- 10.3.1 Adding filters in Analysis

11 Working in a Multi-Tenant Environment

- 11.1 Assumptions and Constraints

- 11.2 Data Segregation

- 11.2.1 Module-Wise Impact

- 11.2.2 Enterprise Short Name in Argus Insight

- 11.3 Login and Navigation

- 11.3.1 Single Sign-On Accounts

- 11.3.1.1 Using Separate URLs to Access the Applications

- 11.3.1.2 Opening Argus Insight from Other Applications

- 11.3.2 Enterprise Switching

- 11.3.3 Direct Access

- 11.4 Global Homepage

- 11.4.1 Application Access Portlet

- 11.4.2 Global Enterprise Management Portlet

- 11.4.2.1 Overview of the Global Enterprise Management Page Layout

- 11.4.2.2 Adding a New Enterprise

- 11.4.2.3 Copying an Enterprise

- 11.4.3 Global User Management Portlet

- 11.5 Power Queries and Case Series

- 11.5.1 Importing a Case Series

- 11.5.2 Modifying a Case Series

- 11.5.3 Deleting a Case Series

- 11.5.4 Exporting a Case Series

- 11.6 Common Profile Switches

- 11.7 ETL Scheduler

A Appendix: Argus Insight Case Tables

Glossary

Preface

The describes how to create queries, execute queries to generate a case series, and generate reports on the case series.

Where to Find More Information

Oracle Help Center

The latest user documentation for Oracle Health Sciences products is available at http://docs.oracle.com/en/industries/health-sciences/.

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The latest release notes, patches and white papers are on My Oracle Support (MOS) at https://support.oracle.com. For help with using MOS, see https://docs.oracle.com/cd/E74665_01/MOSHP/toc.htm.

Documentation Accessibility

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Access to Oracle Support

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1 Introduction

Argus Insight, formerly called Power Reports, is a highly optimized reporting module that compliments Argus Safety.

The Argus Insight Extract Transform and Load (ETL) engine extracts data from the Argus Safety database and populates a data warehouse in a format that allows efficient querying. The query, drill-down, and output components of Argus Insight let you analyze your safety, workflow, or product data from all angles and produce reports that provide immediate business impact and maximum efficiency in decision-making.

1.1 Generating Reports in Argus Insight

- Use a query to retrieve a specific set of cases (a case series) from Insight Mart, and then run a predefined report for those cases. Use the following Argus Insight components to retrieve the case series:

- Query By Example (QBE)

- Filters

- Advanced Conditions

- Run the Built-in BIP standard reports on the case series to create and store these in the Reports library.

- Run the Custom reports on the case series/power queries to create and store these in the Reporting Tools.

1.2 Argus Insight Components

- Query by Example (QBE)—Lets you create simple queries by entering specific values in fields on a form that looks substantially like the Argus Safety case form.

- Filters—Lets you create queries by selecting a set of predefined fields and specifying multiple values in a field.

- Advanced Conditions—Lets you create complex queries by selecting any of the fields in the data mart (Insight Mart/Argus Mart), and then applying Boolean and Set operations on them.

- Case Series—Provides a listing of all the cases that match the specified query criteria.

- BIP Standard Reports — Lets you run one or more reports on the case series. The BIP Standard Reports are predefined reports shipped with Argus Insight. These reports are available in the BIP > General folder.

1.3 Argus Insight Process Flow

The flowchart in Figure 1-1 depicts the typical steps to generate a report in Argus Insight. Refer to your company's guidelines for the exact workflow for generating reports and analyzing data in Argus Insight.

Figure 1-1 Overview of Generating a Report in Argus Insight

Table 1-1 Tasks in the Process Flow

Task

Description

Log on to Argus Insight

Log on to the Argus Insight application.

Create a Query

Depending on the complexity of the query, use these Argus Insight components to create a query:

- Query by Example (QBE) — To create simple queries based on the fields in the Argus case form

- Filters — To create queries based on multiple values in a set of predefined fields

- Advanced Conditions — To create complex queries by directly selecting data mart (Insight Mart/Argus Mart) fields and applying Boolean and set operations on them

Execute the Query to Generate a Case Series

Execute the query to have the system search the entire data mart (Insight Mart/Argus Mart) and retrieve a list of cases (case series) that match the criteria you specified while creating the query.

Generate BIP Standard Reports on the Case Series

Select and run a built-in BIP standard report. You can limit this report to only run on the case series.

Generate BIP Custom Reports on the Case Series/Power Queries

Select and run a custom report you created and stored in the BI Tool(s) library. You can limit this report to only run on the Case Series/Power Queries from BI Tool(s).

Query the Data Mart

(Insight Mart/Argus Mart)

Use BI Tool(s) to directly query the mart.

1.4 Product Compatibility and Upgrade Options

1.4.1 Compatibility of Argus Insight with Argus Safety

Argus Insight 8.1.1 is compatible with Argus Safety 8.1.1.

1.4.2 Compatibility of Argus Insight with Reporting Tools

Argus Insight 8.1.1 can be used together with a reporting tool, which can be BI Publisher, BusinessObjects, Cognos, or any combination of these three.

1.4.3 Upgrade Paths to Argus Insight 8.1.1

You can upgrade directly to Argus Insight 8.1.1 from the following versions of Argus Insight:

- Argus Insight 8.1 (single-tenant to single-tenant installation)

- Argus Insight 8.1 (multi-tenant to multi-tenant installation)

The general steps for upgrading to Argus Insight 8.1.1 are as follows:

- Upgrade your current Argus Safety application to the Argus Safety 8.1.1 environment.

- Install the Argus Insight 8.1.1 application.

- Run the Initial ETL.

For information about upgrading your database to Argus Insight 8.1.1, see the Oracle Argus Insight Installation Guide.

1.4.4 Copy Configuration Utility

Use the Copy Configuration utility to import all the configuration data from the following Argus Insight versions and then export the data to Argus Insight 8.1.1:

- Argus Insight 8.1.1 (single-tenant to single-tenant installation).

- Argus Insight 8.1.1 (multi-tenant to multi-tenant installation). In this case, the utility copies all the enterprise data from one multi-tenant enterprise to another multi-tenant enterprise in Argus Insight, including the enterprises that are marked as Inactive.

The Copy Configuration utility:

- Maps the source enterprises to the target enterprises based on the short name of the enterprise.

- Copies the user-specific configuration data only for those users in an enterprise who exist in Argus Safety as well for that enterprise.

- Includes the report packaging data for case series, but does not include the report packaging data for frozen case series.

- Does not include the configuration of those enterprises that do not exist in the target system.

- Does not overwrite the configuration of any additional enterprises that exist in target system.

2 Getting Started

2.1 About Login Accounts and Access

All users can access Argus Insight directly by using the Argus Insight application URL. Argus Insight checks if the Enterprise ID is already present in the incoming request. If the Enterprise ID exists, the system opens Argus Insight for that enterprise.

2.1.1 System Administrator Account

The Argus Insight installation program creates a system administrator account (Admin) that is synced from Argus Safety through Schema Creation and Initial ETL.

The administrator account cannot be deleted. This restriction ensures that the system administrator can always log in to the system. In a given session, only one system administrator can log in to the system.

You can access Argus Insight through Argus Safety. This feature enables you to use a single login user name and password for all Argus modules. The modules that are enabled when you log in to Argus Safety depend on your access rights to Argus modules.

2.1.2 Single Sign-On Accounts

System administrators can create a user account that allows you to log in to Argus Insight, as well as other Argus applications, using the same user name and password. This type of account is a single sign-on account, or SSO account.

For single sign-on accounts, note that:

- A user's login authentication is done by a centralized authentication system. Therefore, users do not need to enter their login credentials for each application they access, every single time. Cognos uses the Power Reports namespace.

- The system administrator defines access to the modules in User Maintenance. If you are assigned to more than one group, the system grants you the highest access level.

- Based on your access rights to modules, the system enables or disables the application buttons access rights in the menus.

- Group access permissions are assigned in web administration.

- If you have access to Argus Safety or Argus Insight, you can start the application modules. The system does not ask you to enter a password again for the Power Reports or Argus Safety modules. This also applies when you start other applications.

- In User Maintenance, the system administrator can link the Argus Safety database and the Argus Insight data mart. When you log in, the system identifies the available application modules for each Argus instance.

- When you click the application module, the system opens a new window where you can work on the other application (Argus Insight or Argus Safety).

- When you start another application through Argus, or vice versa, the application module buttons do not appear in the new windows because you are already logged in to the earlier application.

- The initial login screen is the starting dialog box for all the other modules.

- Logout is available only on the parent application dialog box. Logging out of the parent application dialog box closes all child dialog boxes without saving information in the child applications.

- Argus Insight Session Timeout
You can now configure a value for session expiry time in Argus Safety, based on which the idle session for the configured time is handled. When Single Sign On or Load Balancer is enabled in Argus Safety and Argus Insight, Argus Insight extends the session timeout in Argus Safety, and you may continue the work.

If both Argus Safety and Argus Insight are idle for the configured time, a warning message appears in Argus Safety stating whether you want to continue the work or not. If you do not click on Continue, the session expires, and Argus Insight is closed.

However, when Argus Insight > Medical Review screen is opened through Argus Safety, Argus Safety treats this time as idle and a warning message appears.

If the Medical Review screen is left idle as well, then two separate dialog boxes appears for both Argus Safety and Argus Insight > Medical Review screen.

2.2 Logging In to the Argus Insight Application

1. Open Microsoft Internet Explorer, and enter the Argus Insight Universal Resource Locator (URL) in the address bar.
If you do not know the URL, contact your system administrator configures the URL.

The system uses Secure Socket Layers (SSL) to support third-party digital certificates for secure transmissions at the system level.

2. Press Enter.
Argus Insight Login screen appears.

3. Enter user name and password.

4. Click Login.
The FILTER LIBRARY page appears.

To make another page as your default Home page, refer to "Changing the Default Home Page".

2.3 Setting Your Personal Options

Use the Personal Options tab on the ADMINISTRATION TOOLS page to:

- Specify the default Home page for Argus Insight

- Specify whether the system prompts you for confirmation before overwriting saved case series or queries

- View the groups for which you are a member

Note:
The options available in the Overwrite Confirmation section may vary based on the Argus Insight Data Source (Insight Mart/Argus Mart/Both).

2.3.1 Changing the Default Home Page

The default Argus Insight Home page is the FILTER LIBRARY page.

To change the default Home page:

1. Click Tools on the global toolbar.
The ADMINISTRATION TOOLS page appears with the Personal Options tab in focus.

2. In the Homepage field, select a page from the drop-down list.

3. Click OK.
The default Home page is updated as per the selection, and a confirmation dialog box appears.

4. Click OK to close the dialog box.

Alternative Method to Selecting a Home Page

Alternatively, click Home on the global toolbar to make the current page as your default Home page.

Note that if you cannot make the current page as your Home page, an informational message appears when you hover Home.

2.3.2 Changing Your Preferences for Overwrite Confirmation

When you save your modifications to an existing case series, a QBE, a filter, or an advanced condition, Argus Insight saves your changes directly without prompting you to confirm whether you want to overwrite the existing one. This behavior is the default.

You can choose to have Argus Insight display a confirmation dialog box before overwriting a saved case series or query.

To change whether the system prompts for confirmation:

1. Click Tools on the global toolbar.
The ADMINISTRATION TOOLS page appears with the Personal Options tab in focus.

2. In the Overwrite Confirmation section, select the check boxes to define your preferences, and click OK.
The confirmation dialog box appears.

3. Click OK to close the dialog box.

2.3.3 Viewing Group Memberships

The Group Membership list on the Personal Options tab displays the names of the groups to which you belong.

Group memberships are managed from the Security tab on the ADMINISTRATION TOOLS page. Only a system administrator can manage users and groups.

2.4 Entering Dates in Argus Insight Date Fields

Several fields in Argus Insight are date fields. Some date fields require a full date; other date fields accept a partial date.

Entering a Full Date

For fields that require a full date, you must enter the date in the following format:

dd-mmm-yyyy

where:

dd

=

Day of the month.

mmm

=

3-letter abbreviation for the month. For example, FEB or AUG.
You may also enter a valid month number. In this case, the system converts the number to the 3-letter abbreviation for the corresponding month. For example, the system converts 12 to DEC.

yyyy

=

4-digit year. For example, 1998 or 2012.

Entering Today's Date

To enter today's date in a date field, press the = (equals) key.

Entering a Partial Date

For fields that accept a partial date, Argus Insight displays ??-???-0000 in the field.

For reporting purposes, missing days of the month are approximated to the 15th of the month and missing months are approximated to the month of June.

Valid partial dates must comprise either a year, or a year and a month. If you enter the day, you also need to enter the month.

To enter a date that includes only the month and year (for example, March 2012), you may enter any one of the following sequences:

- /MAR2012

- /32012

- /312

- 00MAR2012

- 0032012

- 00312

- ??MAR2012

- ??32012

- ??312

To enter a date that includes only the year (for example 2012), you may enter any one of the following sequences:

- //2012

- //12

- 00002012

- 000012

- ?? ???2012

- ?? ???12

- ??2012

- ??12

Table 2-1 lists the fields in the tabs on the QUERY BY EXAMPLE page, which is similar to the Argus case form, that accept partial dates.

Table 2-1 QBE Fields that Accept a Partial Date

QBE Tab

Section Name

Field Name

General

General Information

Initial Receipt Date, Central Receipt Date, Follow-up Received, Safety Received, Aware Date

Study Information

Unblinding Date

Patient, Patient

Patient Details

Date of Birth, Date of LMP

Lab Data

Date

Other Relevant History

Start, Stop Date

Patient, Parent

Parent Information

Date of Birth, Date of LMP

Other Relevant History

Start, Stop Date

Products

Dosage Regimens

Start Date/Time, Stop Date/Time, Expiration Date

Product Details

First Dose, Last Dose, Date, Start Date/Time, Stop Date/Time

Events

Event Information

Onset Date/Time, Receipt Date, Stop Date/Time

Activities

Contact Log

Date, Date Start

Action Items

Date Open, Due, Completed

Case Lock/Archive

Lock Date, Closure Date

2.5 Viewing the Database Name and Argus Insight Release

To view the name of the database and the release of Argus Insight that you are using, position the cursor over Help on the global toolbar:

2.6 Viewing the Online Help

To view the online help, click Help on the global toolbar.

Depending on your privileges, the system opens either the user's guide or the administrator's guide in HTML format. Use the Contents, Next, and Previous links, as well as the links on the Contents page and throughout the document, to navigate to topics and pages in the guide.

2.7 Extending Argus Insight Features

For instructions on creating custom reports, as well as customizing code lists and the ETL, refer to the Oracle Argus Insight 8.1.1 Extensibility Guide.

3 Creating Queries by Example

In Argus Insight, you use queries to search the data mart and retrieve a set of cases (known as a case series) with similar attributes. Based on your reporting requirements, your querying criteria may be as simple as a few Argus Safety case form fields with specific values or as complex as a SQL query that uses Boolean and Set operations between data mart fields.

Argus Insight provides several tools that you can use to enter, modify, and save queries. This chapter describes how to use the Query by Example (QBE) tool.

In addition to the QBE tool, Argus Insight provides the following query tools:

- Filters (see Chapter 4, "Using Filters to Create Queries")

- Advanced Conditions (see Chapter 5, "Using Advanced Conditions to Create Queries on Insight Mart")

- Library (see Chapter 6, "Using Advanced Conditions to Create Point-in-Time Queries on Argus Mart")

3.1 Overview of the Query by Example Tool

If you are familiar with the Argus Safety case form, you may want to use Query by Example (QBE) to create simple queries. For a QBE, the querying criteria consists of specific values that you enter in the fields on the QUERY BY EXAMPLE page, which looks substantially like the Argus Safety case form.

Note:
Query By Example is NOT supported, if target data source is set as Argus Mart only.

3.1.1 QUERY BY EXAMPLE Page—Tab Description

The QUERY BY EXAMPLE page has a tab-based interface consisting of eight multiple section tabs.

Each tab on the QUERY BY EXAMPLE page lets you enter query criteria about a specific aspect of a case:

- General tab—Specify general, study, reporter, and literature information about the case.

- Patient tab—Specify information about the patient, lab data, other relevant history, and the patient's parent.

- Products tab—Specify product information and dosage regimens.

- Events tab—Specify event information and its seriousness criteria.

- Analysis tab—Specify information about case analysis and imputability.

- Activities tab—Specify case activity information, such as contact logs, action items, and case lock/archive dates.

- Additional Info tab—Specify additional information about the case such as reference type, ID, and notes.

- Advanced Conditions tab—Integrate a QBE with an advanced condition stored in Argus Insight. The advanced conditions based on Insight Mart only are displayed.
In addition, you can convert a QBE into an advanced condition. For more information, see Chapter 5, "Using Advanced Conditions to Create Queries on Insight Mart."

3.1.2 Example of a QBE

For example, your QBE may consist of values in the following fields:

Tab Name

Field Name

Value

General

Country of Incidence

United States

Products

Product Name

Algoheal Injection

Events

Event Description to be Coded

Injection site rash

Seriousness Criteria

Hospitalized

When you execute this QBE, the system retrieves only those cases in the United States where the patient was given an algoheal injection, and then broke out in a rash due to the injection and was hospitalized.

3.1.3 Using the Type-Ahead Feature in Input Fields

Argus Insight provides type-ahead functionality for some fields in the QUERY BY EXAMPLE page.

When you begin to type a value into a field that supports type-ahead functionality, Argus Insight displays a list of valid values that match your entry. You can then select one of the suggested values from the list.

Alternatively, you can double-click any field that supports type-ahead functionality. In this case, Argus Insight displays a complete list of the valid values for the field. You can then select a value from the list.

Table 3-1 lists the input fields in the QUERY BY EXAMPLE page that support the type-ahead feature.

Table 3-1 Fields that Support the Type-Ahead Feature

Accidental Exposure

Action Taken

Action Type

Age Group

Age Units

Case Outcome

Classification

Code (Activities: Action Items)

Code (Activities: Contact Log)

Condition Type

Dosage Frequency

Dosage Units

Ethnicity

Event Frequency

Event Intensity

Event Outcome (Outcome of Event)

Formulation

Gender

Group (Activities: Action Items)

Group (Activities: Contact Log)

Intermediary

Locked or Closed By

Manufacturer

Occupation

Pack Units

Product Units

References Type

Report Media

Report Type

Reporter Type

Route of Administration (Patient and Parent)

User (Activities: Action Items)

User (Activities: Contact Log)

3.2 Starting a New QBE

This section describes the tasks for creating a new QBE:

- Entering Your Search Criteria and Executing the QBE

- Reviewing the Results of Your QBE

- Reviewing and Modifying the Criteria for an Executed QBE

- Saving the QBE

3.2.1 Entering Your Search Criteria and Executing the QBE

1. Navigate to Queries > Query by Example, and select New.
The QUERY BY EXAMPLE page appears with the General tab in focus.

2. Specify the criteria for your query.
You may enter values into any of the fields on any of the QBE tabs.

Note:
The field labels are displayed as per the field labels configured in Argus Safety.

For a description of each field and for additional information about entering values into certain fields, see the following sections:

- General Tab

- Patient Tab

- Products Tab

- Events Tab

- Analysis Tab

- Activities Tab

- Additional Info Tab

Tip:
When you are entering criteria for your query:

- To clear all the values you entered on the current tab only, click Clear Tab.

- To clear all the values you entered on all the tabs, click Clear All.

3. Click Execute to run your query.
The system searches for cases that match your query, begins to build the case series, and displays a progress message during the process.

4. Wait until the system completes the search.
See "Reviewing the Results of Your QBE", for information about how to continue.

3.2.2 Reviewing the Results of Your QBE

When you click Execute to run a QBE, the system searches for all the cases that match your query criteria and builds a case series.

- If the system finds cases that match your query criteria, the ACTIVE CASE SERIES page displays the results.
Examine the results in the ACTIVE CASE SERIES page:

- If the case series is too large, you may want to modify your query by specifying additional field values in the QBE form to narrow down the case series.
For more information, see "Reviewing and Modifying the Criteria for an Executed QBE".

- If the case series is appropriate, you may want to save your QBE. For more information, see "Saving the QBE".

- If the system does not find any cases that match your query criteria, the ACTIVE CASE SERIES page displays the following message:
No Cases found!

You probably want to modify your query and then execute the QBE again.

For more information, see "Reviewing and Modifying the Criteria for an Executed QBE".

3.2.3 Reviewing and Modifying the Criteria for an Executed QBE

The ACTIVE CASE SERIES page displays the results of your QBE. When you review the results, you may want to modify your query and execute the QBE again.

For example, perhaps the results are too limiting and you want to remove some of the query criteria.

From the ACTIVE CASE SERIES page, you have several options:

- To open a dialog box and review the criteria that you specified for the active case series, click View Query Criteria.

- To return to the QBE form and modify your query, click View Query.
The ACTIVE QUERY BY EXAMPLE page appears.

Note that the page retains all the values you entered for your query.

When you execute a QBE or save modifications to a QBE, the system assigns the active status to the QBE. Therefore, when you click View Query to return to the QBE form, note that the page title changes to ACTIVE QUERY BY EXAMPLE.

See "Working with the Last Modified or Executed QBE" for details on active QBEs.

- To cancel the current QBE and return to the QUERY BY EXAMPLE page, click Cancel.

You can continue to modify the QBE, execute the QBE again, and review the results.

3.2.4 Saving the QBE

1. View your QBE on the ACTIVE QUERY BY EXAMPLE page.

2. Use the Category field to assign a category to the QBE.
The category indicates the reporting aspect to which your QBE pertains.

For example, Case Processing, Compliance, Configuration, General, Management, or Pharmacovigilance. Specifying the category helps you when searching for relevant QBEs from a list of all the QBEs saved in the system.

3. Use the Description field to enter summary information about the QBE.
For example, you can describe the type of cases the QBE retrieves.

4. Click Save As.
The Save QBE As dialog box appears.

5. Enter the name of the QBE.

Note:
Names cannot contain these characters: % " ' $ ^ ~ , ` / ; | #

6. Click OK.
Note that:

- The page title changes to QUERY BY EXAMPLE.

- The Active Query Name field in the upper-right corner of the page now displays the name you specified when saving the QBE.

- The Category and Description fields display the information you entered before you saved the QBE.

Note:
The QUERY BY EXAMPLE LIBRARY page lists all the QBEs saved to the system. See "Working with Saved QBEs" for more information.

Tip:
If you make modifications to the field values after you saved the QBE to the system, click Save to save the changed field values.

3.3 Query By Example Page—Input Fields

When you enter criteria for a QBE, you can enter values into any of the fields in any of the tabs on the QUERY BY EXAMPLE page.

This section summarizes the contents of each tab, describes each field, and provides additional information about entering values into certain fields.

3.3.1 General Tab

In the General tab, you can:

- Specify only one follow-up date.

- Specify only one case classification.

- Specify information only about one reporter.

- Scroll the page to view all the fields available.

Table 3-2 describes the fields in the General tab. The field values you specify are used as the query criteria to retrieve matching cases.

Table 3-2 QUERY BY EXAMPLE Page > General Tab — Field Description

Section

Field or Check Box

Description

General Information

Report Type

Select the case source that the query looks for in cases.

Country

Select the country of incidence that the query looks for in cases.

Initial Receipt Date

Enter the date when your company first became aware of the case.

Central Receipt Date

Enter the date on which Central Safety received the case.

Case Status

Select the workflow state that the query looks for in cases.

Follow-up Received

Enter the follow-up information receipt date.

Safety Received

Enter the date on which follow-up information was received by Central Safety.

Significant

Select this check box to retrieve cases that had a significant follow-up.

Aware Date

Enter the most recent significant follow-up date or initial receipt date (if there are no follow-ups) that the query looks for in cases.

Classification

Select the classification that the query looks for in cases.

Study Information

Project ID
Study ID
Center ID

Click the Select button associated with these fields to select the Project ID, the Study ID, and the Center ID.

See "Selecting the Study Information" for details.

Other ID

Enter any other ID that can be relevant to the study.

Study Type

Select the study type to include in the query.

Week #

Enter the week number of the study during which the adverse event occurred. The query will only look for such cases.

Visit #

Enter the visit number of the study during which the adverse event occurred. The query will only look for such cases.

Blinding Status

Select the study blinding status that the query looks for in cases.

Unblinding Date

Enter the date on which the study was broken. The query will only look for cases with matching study broken date.

Reporter Information

Sal.

Enter the reporter's salutation that the query looks for in cases.

First Name

Enter the reporter's first name to look for in cases.

Middle Name

Enter the reporter's middle name to look for in cases.

Last Name

Enter the reporter's last name to look for in cases.

Suffix

Enter the reporter's suffix to look for in cases.

Health Care Professional

Select an option from the list to include a query criterion based on whether the reporter is a health care professional.

Occupation

Select the reporter's occupation that the query looks for in cases.

Address

Enter the report address that the query looks for in cases.

Institution

Enter the reporter's institution that the query looks for in cases.

Department

Enter the reporter's department that the query looks for in cases.

City

Enter the reporter's city that the query looks for in cases.

State/Province

Enter the reporter's state that the query looks for in cases.

Postal Code

Enter the reporter's postal code that the query looks for in cases.

Country

Enter the reporter's country ID that the query looks for in cases.

Phone Number

Enter the reporter's phone number that the query looks for in cases.

Alternate Phone

Enter the reporter's alternate phone number that the query looks for in cases.

FAX Number

Enter the reporter's fax number that the query looks for in cases.

Reporter ID

Enter the reporter's ID that the query looks for in cases.

Reporter's Reference #

Enter the reporter's reference number that the query looks for in cases.

Email Address

Enter the reporter's email address that the query looks for in cases.

Reporter Type

Select the reporter type that the query looks for in cases.

Report Media

Select the report media that the query looks for in cases.

Intermediary

Select the intermediary that the query looks for in cases.

Report Sent to Regulatory Authority by Reporter?

Select the Yes, No, Unknown, or Ignore option, as appropriate, to indicate whether the query looks for cases where the reporter has already informed a regulatory authority about the event.

Protect Confidentiality

Select this check box to have the query retrieve only those cases where reporter information is specified as confidential.

Primary Reporter

Select this check box to have the query retrieve only those cases where the reporter is marked as the primary reporter.

Correspondence Contact

Select this check box to have the query retrieve only those cases where the reporter is marked as a correspondence contact.

Literature Information

Author

Enter the literature author name that the query looks for in cases.

Title

Enter the literature title that the query looks for in cases.

Journal

Enter the literature journal name that the query looks for in cases.

Vol

Enter the literature volume that the query looks for in cases.

Year

Enter the literature publication year that the query looks for in cases.

Pgs

Enter the journal page number in which the article appeared. The query will look for this information in cases.

3.3.1.1 Selecting the Study Information

In the Study Information section, Argus Insight populates the Project ID, Study ID, and Center ID fields when you select a study from the Clinical Study Lookup dialog box.

To select a clinical study:

1. Click the Select button associated with the Study ID field.
The Clinical Study Lookup dialog box appears.

2. Enter the first few letters of the project name, study ID, or study center name in their respective text boxes.

Tip:
Alternatively, if you are not sure about the information you are looking for, click Search to list the project name, study, and center for all the clinical studies.

3. Click Search.
The Clinical Study Lookup dialog box appears with the search results in tabular format.

4. Select a clinical study row from the list, and click Select.
You return to the QUERY BY EXAMPLE page, where the selected information is populated into the Project ID, Study ID, and Center ID fields in the Study Information section.

Note:
The Study ID and Center ID are optional fields.

3.3.2 Patient Tab

The Patient tab has two views: Patient and Parent.

3.3.2.1 Patient View

In the Patient view, you can:

- Specify information only about one lab data element

- Specify details of only one relevant history

- Scroll the page to view all the fields available.

Table 3-3 describes the fields in the Patient view of the Patient tab. The field values you specify are used as the query criteria to retrieve matching cases.

Table 3-3 QUERY BY EXAMPLE > Patient Tab > PAtient View — Field Description

Section

Field or Check Box

Description

Patient Information

Sponsor Identifier

Enter the study sponsor's ID. The query will look for this information in cases.

Pat. ID

Enter the patient number that the query looks for in cases.

Randomization #

Enter the patient randomization number that the query looks for in cases.

Initials

Enter the patient's initials that the query looks for in cases.

First Name

Enter the patient's first name that the query looks for in cases.

MI

Enter the patient's middle initials that the query looks for in cases.

Last Name

Enter the patient's last name that the query looks for in cases.

Protect Confidentiality

Select this check box to retrieve those cases where patient information is marked as confidential.

Address

Enter the patient's address that the query looks for in cases.

City

Enter the patient's city that the query looks for in cases.

Country

Enter the patient's country that the query looks for in cases.

State/Province

Enter the patient's state that the query looks for in cases.

Postal Code

Enter the patient's postal code that the query looks for in cases.

Patient Details

Date of Birth

Enter the patient's date of birth that the query looks for in cases.

Age

Enter the patient's age that the query looks for in cases.

Units

Select the age unit for the value you specified in the Patient Age field.

Age Group

Select the patient age group that the query looks for in cases.

Ethnicity

Select the patient's ethnicity that the query looks for in cases.

Occupation

Select the patient occupation that the query looks for in cases.

Gender

Select the patient gender that the query looks for in cases.

Pregnant

Select the Yes, No, Unknown, N/A, or Ignore option, as appropriate, to indicate whether the query looks for cases where the patient's pregnancy status is specified. This field is available only if you specify the patient gender as Female.

Date of LMP

Enter the date of the patient's last menstrual period (LMP) that the query looks for in cases.

Patient Weight

Enter the patient weight that the query looks for in cases. Select the lbs or kg option, as appropriate.

Patient Height

Enter the patient's height that the query looks for in cases. Select the in or cm option, as appropriate.

Number of Patients

Enter the number of patients.

Lab Data

Test Name

Click the associated Select button to select the lab test that the query looks for in cases. See "Selecting a Lab Test" for more information.

Results

Enter the lab data results that the query looks for in cases.

Norm Low

Enter the lab data normal low value that the query looks for in cases.

Date

Enter the lab test date that the query looks for in cases.

Units

Enter the unit for the value you specified in the Results field in the Lab Data section.

Norm High

Enter the lab data normal high value that the query looks for in cases.

Other Relevant History

Start

Enter the relevant history start date that the query looks for in cases.

Condition Type

Select the relevant history condition type that the query looks for in cases.

Notes

Enter the relevant history notes that the query looks for in cases.

Stop Date

Enter the relevant history stop date that the query looks for in cases.

Coded PT

Click the associated Encode button to select the relevant history condition by using the MedDRA Browser. The query will look for the encoded term.

See "Using the MedDRA Browser" for more information.

Ongoing

Select this check box to retrieve cases where the relevant history condition is continuing/ongoing.

Patient Relevant Tests

Enter the relevant patient tests that the query looks for in cases.

3.3.2.2 Parent View

In the Parent view, you can:

- Specify details of only one relevant history.

- Specify details of only one medical history.

Table 3-4 describes the fields in the Parent view of the Patient tab. The field values you specify are used as the query criteria to retrieve matching cases.

Table 3-4 QUERY BY EXAMPLE Page > Patient Tab > Parent View — Field Description

Section

Field or Check Box

Description

Parent Information

Parent Initials

Enter the parent's initials that the query looks for in cases.

Date of Birth

Enter the parent's data of birth that the query looks for in cases.

Age

Enter the parent's age that the query looks for in cases.

Units

Select the age unit for the value you specified in the Age field.

Gender

Select the parent gender that the query looks for in cases.

Date of LMP

Enter the date of the parent's last menstrual period (LMP) that the query looks for in cases. This field is available only if the parent gender is specified as Female.

Parent Weight

Enter the parent's weight that the query looks for in cases. Select the lbs or kg option, as appropriate.

Parent Height

Enter the parent's height that the query looks for in cases. Select the in or cm option, as appropriate.

Parent Breastfeeding

Select this check box to retrieve cases where parent is breast feeding.

Other Relevant History

Start

Enter the relevant history start date that the query looks for in cases.

Condition Type

Select the relevant history condition type that the query looks for in cases.

Notes

Enter the relevant history notes that the query looks for in cases.

Stop Date

Enter the relevant history stop date that the query looks for in cases.

Coded PT

Click the associated Encode button to select the relevant history condition by using the MedDRA Browser. The query will look for the encoded term.

See "Using the MedDRA Browser" for more information.

Ongoing

Select this check box to retrieve cases where the relevant history condition is continuing / ongoing.

3.3.2.3 Selecting a Lab Test

1. Navigate to the QUERY BY EXAMPLE page.

2. Click the Patient tab.
The Patient view appears, by default.

3. In the Lab Data section, click Select associated with the Test Name field.
The Lab Test Name dialog box appears.

4. Search for a lab test:

- To find only those lab tests that match your criteria, enter one or more letters of the test name in the Description field, and click Search.

- To display all lab tests, leave the Description field blank, and click Search.

The search results appears in the Lab Test Types section.

5. Select the required test name, and click Select.
The selected test is populated in the Test Name field.

3.3.2.4 Using the MedDRA Browser

To use the MedDRA Browser to search and select MedDRA terms for an event:

1. Click Encode associated with the QBE tabs to start the MedDRA Browser.
The MedDRA Browser dialog box appears.

Note:
The output returned by the MedDRA Browser for the Patient, Product and Analysis tabs of QBE is the Preferred Term (PT). The Events tab of QBE provides output for multiple options. You can select and search the required term(s), based on the Seriousness Criteria.

2. Enter the first few letters of the SOC, HLGT, HLT, PT, or LLT term in the respective text box.
To search for the specified word in the entire event term, select the Full Search check box.

Note:
The Special Category drop-down list displays all the SMQs that can be selected. The selected SMQ searches across PT and LLT levels of the MedDRA dictionary.
The Special Category drop-down list is hidden in MedDRA 10. The MedDRA SMQs drop-down list is hidden in versions lesser than MedDRA 9.

3. Press Tab.
The MedDRA Browser appears with the search results (for the specified word in the event terms) in a column below the text box in which you entered the text string.

4. Select the required event term from the search results.
The SOC, HLGT, HLT, PT, and LLT fields in the MedDRA Browser display the respective terms for the selected event.

Note that:

- Fields highlighted in yellow indicate the selected hierarchy is the primary SOC path.

- Fields highlighted in gray indicate the selected hierarchy is not the primary SOC path.

5. Select the SOC, HLGT, HLT, PT, and LLT check boxes to populate the corresponding fields in the QBE form.

6. Click Add & Close.
The selected codes for the selected event appears in the respective fields in the QBE form.

3.3.3 Products Tab

In the Products tab, you can:

- Enter information only about one product.

- Specify details of only one dosage regimen.

- Scroll the page to view all the fields available.

Table 3-5 QUERY BY EXAMPLE Page > Products Tab — Field Description

Section

Field or Check Box

Description

Product Information

Product Name

Click the associated Select button to use the Product Browser to specify product information for your query criteria.

Selecting the product name populates the Product Name, Generic Name, Company Drug Code, Formulation, Concentration, and Units fields with the details of the product you selected. See "Using the Product Browser" for details.

Alternatively, click the associated Encode button to use the Drug Coding Browser to specify the WHO drug name as the query criteria. See "Using the WHO Drug Browser" for details.

Drug Type

Select the Suspect, Concomitant, Treatment, or Ignore option, as appropriate, to indicate whether the query looks for cases where drug type is specified.

Generic Name

Click the Select button associated with the Product Name field to select a generic name that the query looks for in cases. See "Using the Product Browser" for details.

Product Indication PT

Click the associated Encode button to use the MedDRA Browser to specify the drug primary indication event term as the query criteria. See "Using the MedDRA Browser" for details.

Company Product

Click the associated Select button to select the company product that the query looks for in cases.

Study Drug

Click the associated Select button to use the Study Drug Lookup dialog box to specify the study drug name as the query criteria. Use this field to retrieve clinical trial cases with the selected study drug. See "Using the Study Drug Lookup" for details.

Company Drug Code

Click the Select button associated with the Product Name field to select the company drug code that the query looks for in cases. See "Using the Product Browser" for details.

Drug Code

Enter the drug code that the query looks for in cases.

Manufacturer

Enter the product manufacturer that the query looks for in cases.

Formulation

Click the Select button associated with the Product Name field to select a drug formulation that the query looks for in cases. See "Using the Product Browser" for details.

WHO DRUG ATC CODE

Enter the Anatomical, Therapeutic, Chemical (ATC) classification code that the query looks for in cases.

WHO DRUG ATC DESCRIPTION

Enter the Anatomical, Therapeutic, Chemical (ATC) classification description that the query looks for in cases.

Concentration

Click the Select button associated with the Product Name field to select a drug concentration that the query looks for in cases. See "Using the Product Browser" for details.

Units

Click the Select button associated with the Product Name field to select the units that the query looks for in cases. See "Using the Product Browser" for details.

Interaction?

Select the Yes, No, Unknown, or Ignore option, as appropriate, to indicate whether the query looks for cases where drug interaction status is specified.

Contraindicated?

Select the Yes, No, or Ignore option, as appropriate, to indicate whether the query looks for cases where drug contraindication status is specified.

Dosage Regimens

Ongoing

Select this check box to retrieve cases where the dosage regimen is ongoing.

Outside Therapeutic Range

Select this check box to retrieve cases where the dosage regimen is outside therapeutic range.

This means that the drug has not been used in accordance with the label or has been used for outside the Therapeutic Range. Consult with your administrator for further company-specific information about the use of this field.

Start Date/Time

Enter the dosage regimen start date that the query looks for in cases.

Stop Date/Time

Enter the dosage regimen start date that the query looks for in cases.

Duration of Regimen

Enter the dosage regimen duration (specified in minutes) as the query criteria.

You can click Calculate to view the Duration Calculator dialog box. You can enter the time in hours, days, weeks, months, or years, and then convert the time to minutes. Alternatively, you can select a duration band and value if available. A system administrator must define the bands.

Dose Number

Enter the drug dose number as the query criteria.

Dose

Enter the drug dose received by the patient as the query criteria.

Units

Specify the units for the value you specified in the Dose field.

Dose Description

Enter the dose description based on the values you specified in Dose, Dose Units, and Frequency fields.

Daily Dosage

Enter the daily dose based on the values you specified in Dose and Frequency fields.

Regimen Daily Dosage Unit

Select the same option you selected in the Dose Units field.

Regimen Dosage

Daily dose, duration, and frequency.

Regimen Dosage Unit

Select the total dose regimen unit based on the values you specified in Dose, Dosage Regimen Duration, and Frequency fields.

Patient Route of Administration

Select the route of dosage administration as the query criteria.

Frequency

Specify the dosage frequency as the query criteria.

Expiration Date

Enter the product expiration date as the query criteria.

Accidental Exposure

Select the area of accidental exposure as the query criteria.

Package ID

Enter the package ID as the query criteria.

Pack Units

Enter the package units.

Batch/Lot #

Enter the batch/lot number as the query criteria.

Alternatively, click the associated Select button to view the Batch/Lot #s dialog box, enter search criteria to find the batch/ lot number you need, and make your selection.

Parent Route of Administration

Select the route of dosage administration of the parent as the query criteria.

Product Details

First Dose

Enter the earliest dosage regimen start date as the query criteria.

Last Dose

Enter the latest regimen stop date as the query criteria.

Duration of Administration

Enter the duration of drug administration as the query criteria.

This duration is the difference between the first and last dose for all dosage regimens.

You can click Calculate to view the Duration Calculator dialog box. You can enter the time in hours, days, weeks, months, or years, and then convert the time to minutes. Alternatively, you can select a duration band and value if available. A system administrator must define the bands.

Date

Enter the date on which the drug dechallenge was carried out. Note that this date is the same as the Drug Dechallenge Date.

Other Information

Select the Abuse, Overdose, and Tampering check boxes.

Time between First Dose / Primary Event

Enter the time between the event onset and the first dose.

Time between Last Dose / Primary Event

Enter the time between the event onset and the last dose.

Total Dose to Primary Event

Enter the total dose for the drug.

Action Taken

Select the action taken to mitigate the adverse event.

Dechallenge Results

Select the Yes, No, Unknown, N/A, or Ignore option, as appropriate, to indicate whether the query looks for cases where drug dechallenge status is specified.

Drug Dechallenge Date

Enter the date on which the drug dechallenge was carried out.

Total Dosage

Enter the total drug usage duration as the query criteria.

Units

Enter the total dosage unit as the query criteria.

This is based on the daily dose, duration and frequency.

Start Date/Time

Enter the rechallenge start date as the query criteria.

Stop Date/Time

Enter the rechallenge stop date as the query criteria.

Taken Previously/Tolerated

Select the Yes, No, Unknown, or Ignore option, as appropriate, to indicate whether the query looks for cases where drug was taken previously.

Rechallenge Results

Select the Yes, No, Unknown, N/A or Ignore option, as appropriate, to indicate whether the query looks for cases where drug rechallenge status is specified.

3.3.3.1 Using the Product Browser

To select a product by using the Product Browser:

1. On the QUERY BY EXAMPLE page, select the Products tab.

2. Click the Select button associated with the Product Name field.
The Product Browser dialog box appears.

3. Enter the first few letters (text string) of the product ingredient, family name, product name, or trade name in the respective field.

- To search for the specified string in the entire product information, select the Full Search check box.

- To remove your search criteria and start over, click Clear.

4. Press Tab (or click another field in the dialog box) to begin the search.
The Product Browser appears with the search results (for the specified text string) in the column below the field in which you entered the search string.

5. Select an item from the search results list.
The details for the selected item are displayed in all the Product Browser fields.

6. Select the required product name or trade name, and click Select.
The Product Name, Generic Name, Company Drug Code, Formulation, Concentration, and Units fields with the details of the selected product are populated on the Products tab.

3.3.3.2 Using the WHO Drug Browser

To select a WHO drug product by using the WHO Drug Browser:

1. On the QUERY BY EXAMPLE page, select the Products tab.

2. Click the Encode button associated with the Product Name field.
The WHO Drug Browser dialog box appears.

Note:
The WHO Drug Browser that appears depends on the configuration settings defined for your account by the administrator.
The browser categories (B or C) are not displayed in the browser window.

The primary difference between the two browsers is the availability of the following fields in WHO Drug Browser:

- Product Type

- MAH (name of the manufacturer)

- Medicinal Prod ID

- Ingredients (product substance name)

3. Use the fields at the top of the WHO Browser dialog box to define your search criteria. You may enter values in one, several, or all fields.

1. In the Product Type field, select the type of product.
You may include all products or a single product. The default value is All.

2. In the ATC Code field, type all or part of the Anatomical Therapeutic Chemical (ATC) classification code.

3. Select either the Drug Code or the Medicinal Prod ID option as one of the search criterion, and then enter the appropriate search string in the text box below the options.
The default option is Drug Code.

4. Select either the Trade Name or Ingredient option as one of the search criterion, and then enter the appropriate search string in the text box below the options.
The default selection is Trade Name.

5. Enter the Formulation and Country details for the drug to be searched.

6. Select the Full Search check box if you want the system to search for the specified string in the entire product information.

4. Click Search.
The WHO Drug Browser appears with the search results (for the specified drug products) in a grid format.

5. Select the required WHO drug.
The WHO Drug Browser highlights the selected drug and populates the fields in the Drug Details section.

6. Click Select.
The Product Name, Generic Name, Drug Code, WHO DRUG ATC CODE, and WHO DRUG ATC DESCRIPTION fields for the selected WHO drug are populated in the Products tab.

Note that the Generic Name field displays all the ingredients for the selected WHO drug.

3.3.3.3 Using the Study Drug Lookup

To select a study drug:

1. On QUERY BY EXAMPLE page, select the Products tab.

2. Click the Select button next to the Study Drug field.
The Study Drugs Lookup dialog box appears.

3. In the Study Drug field, enter the first few letters of the study drug name.

4. Click Search.
The search results based on the specified search string appears.

5. Select the required study drug from the list, and click Add & Close.
You return to the PRoducts tab and the Study Drug field is populated with the selected.

3.3.4 Events Tab

In the Events tab the details of only one event can be specified at a time.

Table 3-6 describes the fields in the Events tab. The field values you specify are used as the query criteria to retrieve matching cases.

Table 3-6 QUERY BY EXAMPLE Page > Events Tab — Field Description

Section

Field or Check Box

Description

Event Information

Diagnosis

Select the Yes, No, or Ignore option, as appropriate, to indicate whether the query looks for cases where event diagnosis flag is set.

Description as Reported

Enter the reported event description that the query looks for in cases.

Description to be Coded

Tab out of this field to use the MedDRA Browser to specify an event term as query criteria.

See "Using the MedDRA Browser" for more information. The MedDRA event terms for the selected term are displayed in the Seriousness Criteria section. The query is restricted to the terms displayed.

Onset Date/Time

Enter the event onset date that the query looks for in cases.

Duration

Enter the event duration that the query looks for in cases.

Onset From Last Dose

Enter the event onset duration from last dose as the query criteria.

Onset Latency

Enter the event onset latency duration that the query looks for in cases.

Time to Onset from First Dose

Enter the duration from first dose to the event onset as the query criteria.

Alternatively, click the associated Calculate button to view the Duration Calculator dialog box and make your selection.

Receipt Date

Enter the event receipt date that the query looks for in cases.

Term Highlighted by Reporter

Select the Yes, No, or Ignore option, as appropriate, to indicate whether the query looks for cases where case seriousness status is specified.

Patient Has Prior History?

Select the Yes, No, Unknown, or Ignore option, as appropriate, to indicate whether the query looks for cases where event past history is specified.

Treatment Received?

Select the Yes, No, Unknown, or Ignore option, as appropriate, to indicate whether the query looks for cases where patient received treatment for the event.

Time to Onset from Last Dose

Enter the duration from last dose to the event onset as the query criteria.

Alternatively, click the associated Calculate button to view the Duration Calculator dialog box and make your selection.

Progression of Disease

Select this check box to retrieve cases where Event Progression of Disease is selected.

Adverse Drug Withdrawal Reaction

Select this check box to retrieve cases where Event Withdrawal Reaction is selected.

Stop Date/Time

Enter the event stop date that the query looks for in cases.

Intensity

Select the event intensity option that the query looks for in cases.

Frequency

Select the event frequency option that the query looks for in cases.

Lack of Efficacy

Select Yes from the drop-down list to retrieve cases where Event Lack of Efficacy is selected, else select No.

Related to Study Conduct? (As Reported)

Select the Yes, No, Unknown, or N/A from the drop-down list, to indicate whether the query looks for cases where the event is related to a study.

Outcome of Event

Enter the event outcome that the query looks for in cases.

Nature of Event

Enter the nature of the event that the query looks for in cases.

Event Coding

System Organ Class (SOC)
High Level Group Term
High Level Term
Preferred Term
Lower Level Term

Click the associated Encode button to use the MedDRA Browser to specify event terms as query criteria.

See "Using the MedDRA Browser" for details.

Seriousness Criteria

Seriousness Criteria check boxes

Select one or more check boxes to specify the seriousness criteria that the query looks for in cases. The available values are:

- Death

- Medically Significant

- Hospitalized

- Life-threatening

- Disability

- Intervention Required

- Congenital Anomaly

- Other

3.3.5 Analysis Tab

The Analysis tab has two views: Case Analysis and AFSSaPS.

Analysis information about Regulatory Information (notification log), MedWatch Information, BfArM Information, and EU devices is not available. For more sophisticated queries, use filters or advanced conditions.

Table 3-7 describes all the fields in the Case Analysis view. The field values you specify are used as the query criteria to retrieve matching cases.

Table 3-7 QUERY BY EXAMPLE Page > Analysis Tab > Case Analysis View — Field Description

Section

Field or Check Box

Description

Narrative

Narrative

Enter the case narrative that the query looks for in cases.

Case Comment

Enter the case comment that the query looks for in cases.

Local Evaluator Comment

Enter the local evaluator' comment that the query looks for in cases.

Company Comment

Enter the company's comment that the query looks for in cases.

Abbreviated Narrative

Enter the abbreviated case narrative that the query looks for in cases.

Evaluation in light of similar events in the past

Enter the evaluation comment that takes in to consideration similar events that have occurred in the past. The query will look for the specified text in cases.

Other Information

Case Serious

Select the Yes, No, or Ignore option, as appropriate, to indicate whether the query looks for cases where case seriousness status is specified.

Notes

Enter the case seriousness notes that the query looks for in cases.

Company Agent Causal

Select the Yes, No, Unknown, or Ignore option, as appropriate, to indicate whether the query looks for cases where the company agent causality status is specified.

Notes

Enter the company agent causality notes that the query looks for in cases.

Listedness Determination

Select the case listedness status that the query looks for in cases.

Notes

Enter the case assessment listedness notes that the query looks for in cases.

Case Outcome

Select the case outcome that the query looks for in cases.

Company Diagnosis/Syndrome

Click the associated Encode button to use the MedDRA Browser to specify the company diagnosis as query criteria. See "Using the MedDRA Browser" for more information.

Notes

Enter the company diagnosis/syndrome notes that the query looks for in cases.

Table 3-8 describes all the fields in the AFSSaPS view. The field values you specify are used as the query criteria to retrieve matching cases.

Table 3-8 QUERY BY EXAMPLE Page > Analysis Tab > AFSSaPS View — Field Description

Section

Field

Description

Case Event Imputability Details

Preferred Term

Click the associated Select button to use the MedDRA Browser to specify the Event Preferred Term as query criteria.

See "Using the MedDRA Browser" for more information.

Agent

Click the associated Select button to choose the suspect product that the query looks for in cases.

Chronology

Select the imputability chronology code that the query looks for in cases.

Semiology

Select the imputability semiology code that the query looks for in cases.

Bibliography

Select the imputability bibliography code that the query looks for in cases.

Imputability

Select the imputability score that the query looks for in cases.

3.3.6 Activities Tab

In the Activities tab, you can:

- Specify information only about one contact log.

- Specify information only about one action item.

Note that routing search is not applicable in Argus Insight.

Table 3-9 describes all the fields in the Activities tab. The field values you specify are used as the query criteria to retrieve matching cases.

Table 3-9 QUERY BY EXAMPLE Page > Activities Tab — Field Description

Section

Field

Description

Contact Log

Date

Enter the contact log date that the query looks for in cases.

Code

Select the contact log code that the query looks for in cases.

Group

Select the contact log group that the query looks for in cases.

Date Sent

Enter the sent date for the contact.

Description

Enter the contact log description that the query looks for in cases.

User

Select the user responsible for the contact log. The query will look for the user name you select.

Action Items

Date Open

Enter the action item opening date that the query looks for in cases.

Code

Select the action type that the query looks for in cases.

Group

Select the responsible group that the query looks for in cases.

Due

Enter the action item due date that the query looks for in cases.

Description

Enter the action item description that the query looks for in cases.

User

Select the user responsible for the action item. The query looks for the specified user name.

Completed

Enter the action item completion date that the query looks for in cases.

Case Lock/Archive

Lock Date

Enter the case lock date that the query looks for in cases.

Locked or Closed By

Enter the user who locked or closed the case.

Closure Date

Enter the date when the case was closed.

3.3.7 Additional Info Tab

In the Additional Info tab:

- You can specify information only about one note.

- Attachments are not permitted.

- You can specify information only about one reference.

Table 3-10 describes all the fields in the Additional Info tab. The field values you specify are used as the query criteria to retrieve matching cases.

Table 3-10 QUERY BY EXAMPLE Page > Additional Information Tab — Field Description

Section

Field

Description

References

Type

Enter the reference type that the query looks for in cases.

ID

Enter the referenced case ID that the query looks for in cases.

Notes

Enter the reference notes that the query looks for in cases.

3.4 Assigning Group-Level Permissions to a Saved QBE

1. Click Permissions.
The Permissions dialog box appears with the names of all the groups (except the Administrator group) that the system administrator has created.

2. Use the drop-down list next to a group name to assign permissions to the group members on the QBE you have created. The available options are:

Permission

Description

R/W/D/P

Group members will be able to view, modify, delete, and assign permission on the QBE.

R/W/D

Group members will be able to view, modify, and delete the QBE.

R/W

Group members will be able to view and modify the QBE.

R

Group members will be able to only view the QBE.

No Access (Default)

No group members will be able to access the QBE.

3. Click OK.
The permission settings are saved.

3.5 Working with the Last Modified or Executed QBE

This section describes how to view the QBE that you last modified or executed.

The system assigns the active status to a QBE when you save modifications to it or execute it. Unless you save the modifications to another QBE or execute another QBE, the last QBE you modified or executed remains active. This is helpful in situations when you want to access a frequently used QBE.

To view an active QBE:

1. Navigate to Queries > Query by Example > Active.
The ACTIVE QUERY BY EXAMPLE page appears with the QBE form for the last QBE you executed.

- If the active QBE was saved to the system before executing, both the Active Query Name field and the Name field appears with the name of the QBE.

- If the active QBE was not saved before executing, the Active Query Name field displays the following text:
<Not Saved>

You may enter the name of the QBE in the Name field, and click Save.

2. To rename an already saved QBE, enter the new name in the Name field, and click Save.

Modifying the Description and Values for the Active QBE

To change the description of the active QBE, add or modify the text in the Description field.

In addition, you may modify the value of any field on any of the QBE tabs (that is, the QBE form).

When you modify the values of a QBE:

- To clear all the values for the current tab, click Clear Tab.

- To clear all the values specified in all the tabs for this active QBE, click Clear All.

Saving the Active QBE

You have two options for saving the active QBE:

- To save any changes or updates you make to the active QBE, click Save.
The Save button is enabled for a saved active QBE only.

- To save the active QBE with a different name, click Save As.

The QUERY BY EXAMPLE LIBRARY page lists all the QBEs saved to the system.

See "Working with Saved QBEs" for more information.

Converting the Active QBE to an Advanced Condition

To convert the QBE to an Advanced Condition, click Convert to Advanced Condition.

See "Using QBEs with Advanced Conditions" for more information.

Assigning Permissions

To set the group-level access permissions on the QBE, click Permissions.

The Permissions button is only available for saved active QBEs.

See "Assigning Group-Level Permissions to a Saved QBE" for more information.

Executing the Active QBE

To generate a case series by using the active QBE, click Execute.

Modifying the field values in the QBE form for an active QBE or saving the active QBE with a different name changes the active QBE to reflect the most recent changes. The active QBE also changes if you modify the field values in the QBE form and execute the QBE without saving the QBE form modifications.

3.6 Working with Saved QBEs

The QUERY BY EXAMPLE LIBRARY page lists all the QBEs saved to the system.

To view the list of saved QBEs, navigate to Queries > Query by Example > Library.

The QUERY BY EXAMPLE LIBRARY page appears with the following information about the saved QBE:

- Name of the QBE that was entered when the query was saved.

- Description of the QBE that was entered in the Description field on the QBE form.

- Date when the QBE was last modified.

- Full name of the user who created the QBE.

- Category that was selected on the QBE form and assigned to the query.

3.6.1 Searching for a Saved QBE

1. Perform one of the following to specify the search criteria:

- To search for a QBE by its name, type the QBE name in the Name field.

- To search for a QBE by its description, type the first few words of the description in the Description field.
The system searches for the specified search string in all QBE descriptions.

- To search for a QBE by its date of modification, enter the modification date in the first Last Modified date field.
You may also specify a date range by typing the start and end dates in the first and second date fields, respectively.

- To search for a QBE by its author, select the author name from the User Full Name drop-down list.

- To search for a QBE by its category, select the category from the Category drop-down list.

Note:
If you search for a text comprising an underscore, it is treated as a wildcard and is replaced by a letter in the displayed results. For example, If you have queries with names - CURE, CORE, and CARE and you search for C_RE, all three queries are displayed in the result.

2. Click Search.
The search results appear in a list based on the search criteria.

- To sort search results, click the sort icon next to the column headers in the list.

- To clear the search results and display all the saved QBEs in the list, click Clear.

3.6.2 Creating a New QBE

To create a new QBE, navigate to Queries > Query By Example > New.

Alternatively, click New in the QUERY BY EXAMPLE LIBRARY page to open a new QBE form directly.

3.6.3 Modifying a Saved QBE

1. On the QUERY BY EXAMPLE LIBRARY page, select a QBE from the list of QBEs.

2. Click Modify.
The QBE form for the selected QBE appears.

3. Modify the field values in the QBE form, and save the changes.

- To save the current query, click Save.

- To save the current query by another name, click Save As.

3.6.4 Deleting a Saved QBE

1. On the QUERY BY EXAMPLE LIBRARY page, select a QBE from the list of QBEs.

2. Click Delete.
A confirmation dialog box appears.

3. Click OK.

3.6.5 Executing a Saved QBE

1. Navigate to Queries > Query by Example > Library.
The QUERY BY EXAMPLE LIBRARY page appears.

2. Select a QBE from the list.

3. Click Execute.
When execution is complete, the ACTIVE CASE SERIES page appears.

After generating the case series, you may add cases to or delete cases from the series, freeze the case series, or export the case series results into a Microsoft Excel file.

For more information, see Chapter 7, "Working with Case Series."

3.6.6 Executing a Saved QBE on the Active Case Series

Just as the system assigns the active status to a QBE when you save modifications to it or execute it, the last saved or generated case series becomes the active case series.

You may want to run an existing QBE on an active case series instead of creating and running a new QBE on the entire data mart and generating a new case series.

To narrow down the list of cases in the active case series:

1. Generate the case series on which you want to run another QBE as follows:

- If the case series on which you want to run another QBE is not yet generated or active, you can either create a new QBE and execute it, or execute a saved QBE as explained in "Executing a Saved QBE".
This case series becomes the active case series and remains so until you execute another query to generate a different case series.

- Alternatively, if the case series on which you want to run another QBE is already saved in the system, navigate to Case Series > Open Case Series > Library.
When the CASE SERIES LIBRARY page opens, select the case series, and click Make Active.

2. Navigate to Queries > Query by Example > Library.
The QUERY BY EXAMPLE LIBRARY page appears.

3. Select a query to run on the active case series that was generated in Step 1.

4. Select the Limit Query to Active Case Series check box.

5. Click Execute.
The selected QBE is executed on the active case series and the ACTIVE CASE SERIES appears.

Note that the case series you just generated becomes the active case series.

3.7 Using QBEs with Advanced Conditions

Advanced conditions let you create complex queries that involve Boolean and set operations among fields.

To create advanced conditions, use the Advanced Conditions Editor, which uses a spreadsheet-like approach for adding query conditions (fields and their values) and conditional operators (Boolean or set).

In Argus Insight, QBEs are integrated with advanced conditions to let you perform the following tasks:

- Converting a QBE to an Advanced Condition

- Integrating a QBE with an Advanced Condition

3.7.1 Converting a QBE to an Advanced Condition

You can use an existing QBE to start to build an advanced condition that uses Boolean or set operations between QBE form fields that have specific values. When you convert a QBE to an advanced condition, all the QBE form fields in which you entered values are listed on the ACTIVE ADVANCED CONDITIONS EDITOR page as advanced condition attributes.

To convert a QBE to an advanced condition:

1. Open a QBE form by either starting a new QBE, opening the active QBE, or opening a saved QBE.

2. Verify the field values you specified in the tab pages in the QBE form.

3. Click Convert to Advanced Condition.
The ACTIVE ADVANCED CONDITIONS EDITOR page appears.

All the fields in which you specified values in the QBE form are listed as advanced condition attributes.

4. Build your query further by:

- Adding additional attributes (fields) and specifying their values.

- Adding another advanced condition as an attribute.

- Placing runtime parameters in attributes.

- Placing parentheses to determine the query execution order.

- Specifying conditions for attributes values.

- Specifying Boolean and set operators to join the attributes.

See Chapter 5, "Using Advanced Conditions to Create Queries on Insight Mart" for detailed information about using the Advanced Conditions Editor.

3.7.2 Integrating a QBE with an Advanced Condition

You can integrate a new, active, or saved QBE with an existing advanced condition through these set operators:

- INTERSECT

- MINUS

- UNION

If required, you can integrate your QBE with multiple advanced conditions that can have Boolean or set operations between them.

To integrate a QBE with existing advanced conditions:

1. Open a QBE form by either starting a new QBE, opening the active QBE, or opening a saved QBE.

2. Verify the field values you specified in the tab pages in the QBE form.

3. Click the Advanced Conditions tab.

4. In the Operator field, select a set operator to integrate the QBE and the advanced condition.
You may select INTERSECT, MINUS, or UNION.

5. Select the advanced condition to integrate with the QBE as follows:

1. Click the Add Advanced Condition Above icon on the left bar to open the Advanced Conditions menu.
This menu lists all the advanced conditions (based on Insight Mart only) that are stored in the system and accessible to you. The conditions are organized by categories.

2. Browse to the appropriate category, and select the required advanced condition.
The selected row is added in the Advanced Conditions Editor.

3. Click the Add Advanced Condition Above icon, or the Add Advanced Condition Below icon to insert another advanced condition above or below the existing advanced condition.

Tip:
To change the structure of the query by changing the order of the rows, select a row and then click the arrow icons to move the row up or down.

6. Enter parentheses in the ( and ) columns to determine the order of execution for the selected advanced conditions.

7. In the Operator column, specify the set operation to perform between the selected advanced conditions.

8. Click Save As to save your integrated query.

- To run the integrated QBE and generate the case series, click Execute.
The ACTIVE CASE SERIES page appears with the case series.

See Chapter 7, "Working with Case Series" for more information.

- To convert the integrated QBE and advanced condition into a single advanced condition, click Convert to Advanced Condition.
See "Converting a QBE to an Advanced Condition" for more information.

For detailed information about using the Advanced Conditions Editor, see Chapter 5, "Using Advanced Conditions to Create Queries on Insight Mart."

4 Using Filters to Create Queries

Filters let you create queries by specifying multiple values or a range of values (in numeric or date fields) for each field in a set of fields displayed on a single page. Therefore, you may choose filters in situations when the querying criteria is based on multiple values or a range of values in fields.

Note:
Filters are NOT supported, if target data source is set as Argus Mart only.

In addition to filters, Argus Insight provides the following query tools:

- QBEs (see Chapter 3, "Creating Queries by Example")

- Advanced Conditions (see Chapter 5, "Using Advanced Conditions to Create Queries on Insight Mart")

4.1 About Filters

Argus Insight provides predefined filters. Each predefined filter comprises of a set of specific data mart fields called filter elements. Table 4-1 lists the five predefined filters and the elements associated with them.

Note:
The field labels for each filter are displayed as per the field labels configured in Argus Safety.

Table 4-1 Argus Insight Predefined Filters and Elements

Predefined Filter

Associated Filter Elements (Fields)

Compliance

Advanced Conditions
Case Initial Receipt Date
Country of Incidence
Family Name
Product
Related to Study Conduct? (As Reported)
Report Form
Reporting Group

Case Followup Receipt Date
Case Report Type
Event Listedness/Lic Country
Owned by Site
Project/Study/Center
Report Agency
Report Submission Date

Configuration

Advanced Conditions
Product

Country of Incidence
Project/Study/Center

Management

Advanced Conditions
Case Followup Receipt Date
Case Report Type
Case Status
Has Followup
Product
Workflow Group

Case Delayed/Open
Case Initial Receipt Date
Case Seriousness
Country of Incidence
Owned by Site
Reports Pending

Pharmacovigilance

Advanced Conditions
BMI
Case Comment
Case Initial Receipt Date
Case Outcome
Company Comment
Dosage Regimen Route of Administration
Drug Duration of Administration
Event Diagnosis Flag
Event Term
Onset Latency (minutes)
Patient Age (In Years)
Patient Ethnicity
Patient Relevant Tests
Product Type
Rechallenge/Dechallenge
Reporter Type/HCP
Time to Onset from First Dose

ATC Code
Case Abbreviated Narrative
Case Followup Receipt Date
Case Narrative
Case Seriousness
Country of Incidence
Dose
Evaluation in Light of Similar Events
Event Seriousness
Local Evaluator Comment
Outcome of Event
Patient Age Group
Patient Gender/Pregnancy
Product
Project/Study/Center
Relevant History Condition
Study Blinding Status
Time to Onset from Last Dose

Workflow

Advanced Conditions
Case Followup Receipt Date
Case Report Type
Case Status
Event Term
Has Followup
Product
Workflow Group

Case Delayed/Open
Case Initial Receipt Date
Case Seriousness
Event Listedness/Lic Country
Family Name
Owned by Site
Project/Study

Argus Insight also lets you define custom filters by letting you select a set of elements (data mart fields) and saving the selection as your own filter.

To create a filter using queries:

1. Select a predefined or custom filter.

2. Specify values (multiple or range) in the desired filter elements associated with the filter.

3. To generate a case series, execute this query (value set).

The set of values you specify in the elements associated with a filter is called a value set. For example, a particular filter may have this value set:

Filter Element

Values Specified

Country of Incidence

United States and Germany

Product Name

CureAll Injection and CureAll Capsule

Coded Event Description

Injection site rash and aggravated nausea

Seriousness Criteria

Hospitalized and intervention required

Patient Age

25 to 65 years
Note that ranges can only be specified for fields that have numeric values.

Argus Insight lets you save value sets. Therefore, each filter can have multiple value sets. The advantage of saving value sets is that this enables you to execute a value set later without having to select a filter and then entering values in the associated elements.

4.2 Using Predefined Filters

4.2.1 Selecting a Predefined Filter

1. Navigate to Queries > Filters > New Value Set.
The Select Filter for New Value Set dialog box appears.

Note:
The Select Filter for New Value Set dialog box displays a list of all the predefined as well as custom filters and their associated elements. Use the scroll bar to view all the filters in the list.

2. Select a predefined filters (Compliance, Configuration, Management, Pharmacovigilance, or Workflow).
If custom filters are saved to the system, you may select a custom filter instead.

3. Click OK.
The FILTER VALUE SET page appears.

Note:
In the FILTER VALUE SET page, all the elements associated with the filter are organized in sections. You need to scroll the page to view all the sections. All the predefined value sets contain the Advanced Condition section. You can use the options in this section to select an existing advanced condition and integrate your value set with it. See "Integrating a Value Set with an Advanced Condition" for details. To convert the entire value set to an advanced condition, see "Converting a Value Set to an Advanced Condition" for details.

4.2.2 Creating a Value Set for the Predefined Filter

1. Specify values for the filter elements in the sections.
Depending on the filter you selected, the FILTER VALUE SET page may contain these sections:

Sections in the New FILTER VALUE SET Page

Associated Elements (Fields)

Case Information

Case Followup Receipt Date
Case Report Type
Family Name
Product

Case Initial Receipt Date
Event Listedness/Lic Country
Owned by Site
Project/Study

Patient Information

BMI
Patient Age (In Years)
Patient Ethnicity

Patient Age Group
Patient Gender/Pregnancy

Product Information

ATC Code
Product
Regimen Daily Dose
Total Regimen Dosage

Drug Primary Indication Code
Rechallenge/Dechallenge
Total Drug Dosage

Event Information

Event Seriousness
Event Listedness/Lic Country
Outcome of Event

Event Term
Onset Latency (minutes)
Related to Study Conduct? (As Reported)

Workflow Information

Case Delayed/Open
Has Followup

Case Status
Workflow Group

Miscellaneous Information

Lab Results

Lab Test/Assessment

Report Information

Report Agency
Report Submission Date
Reporting Group

Report Form
Reports Pending

Note:
To access the MedDRA Browser from the Pharmacovigilance or Workflow filters, navigate to Queries > Filters > New Value Set. The MedDRA Browser for the Pharmacovigilance and Workflow filters support the following options specific to filters:

- All hierarchy option — Use this option to enable a query search based on all/selected hierarchical terms in MedDRA. The search output captured depends on the check boxes selected in the MedDRA Browser window.

- Term only option — Use this option to select multiple terms within a specific AE term. Click on the term(s) you want to include in your search criteria. These terms are highlighted in yellow. The output based on the term(s) selected in the MedDRA Browser is populated in the relevant section of the filter.

2. Examine the value set results.

3. Click Execute.
While the system searches for matching cases, the following dialog box appears:

Tip:
To cancel the query execution at this point and return to the FILTER VALUE SET page, click Cancel Query.

If the system finds cases that match the query criteria, the list of cases appear on the ACTIVE CASE SERIES page.

4. Examine the case series. If the case series is too large, you may want to modify the value set to narrow down the case series.
Alternatively, if you find the case series to be appropriate, you can save the value set to the system.

5. Click View Query in the ACTIVE CASE SERIES page to return to the FILTER VALUE SET page.

Note:
When you save the modifications to a value set or execute a value set, the system assigns the active status to the value set. Therefore, when you return to the VALUE SET page, the Active Query Name label displays the name of the filter.

6. If required, modify the value set and examine the results again or proceed to save the value set.

7. Save the value set to the system.

8. In the Description field, enter a description of the value set.
For example, you may describe the type of cases the value set retrieves.

9. Click Save Values.
The Save Value Set dialog box appears.

10. In the Name field, enter the name of the value set.

11. Click OK to close the dialog box and refresh the FILTER VALUE SET page.
Note that:

- The Name label displays the name of the value set you specified.

- The Save Values As button and the Permissions button are now enabled.

Note:
The FILTER LIBRARY page displays all the value sets saved to the system. See "Working with Saved Filters and Value Sets" for more information.

Tip:
If you make modifications to the field values after you saved the value set to the system, click Save Values to save the changed field values. To save the value set by another name, click Save Values As. To clear all the field values in the FILTER VALUE SET page, click Clear.

12. To assign group-level permissions on the saved value set, click Permissions.
The Permissions dialog box appears with the names of all the groups (except the Administrator group) that the system administrator has created.

13. To assign permissions to the group members on the value set you have created, use the drop-down list next to a group name.
The available options are:

Permission

Description

R/W/D/P

Group members will be able to view, modify, delete, and assign permission on the value set.

R/W/D

Group members will be able to view, modify, and delete the Value Set.

R/W

Group members will be able to view and modify the value set.

R

Group members will be able to only view the value set.

No Access (Default)

No group members will be able to access the value set.

14. Click OK to save the permission settings.

Note:
The author of the value set always has the highest level of permission (R/W/D/P) on it. For example, suppose you belong to the Data Entry group and you assign the No Access permission level to the Data Entry group on a value set that you create. In this case, you will continue to have the highest level of permission on your value set; other members in your group cannot access your value set.

4.2.3 Executing a Value Set

To execute a value set, on the FILTER VALUE SET page, click Execute.

The ACTIVE CASE SERIES page appears with the cases that match the value set criteria.

After generating the case series, you may manually modify or save the series.

See Chapter 7, "Working with Case Series" for more information.

4.3 Creating Custom Filters

1. Navigate to Queries > Filters > Library.
The FILTER LIBRARY page appears.

This page lists the predefined as well as custom filters and their value sets in a control tree format.

2. Click New Filter.
The FILTER ELEMENTS page appears.

3. From the Available Elements list, select an element to associate with the custom filter.

4. Click the right arrow ( >) button to associate the selected element with the custom filter.
The selected element appears in the Selected Elements list.

Tip:
To add all the elements in Available Elements list to the Selected Elements list, click the >> button.
To remove an element from the Selected Elements list, click the > button.

To remove all the elements from the Selected Elements list, click >> the button.

5. Save the filter.

6. To assign a category to the custom filter, use the Category drop-down list.
A category indicates the reporting aspect to which your filter pertains: Compliance, Configuration, General, Management, or Pharmacovigilance. Specifying the category also helps you in searching the relevant filters from a list of all the filters saved in the system.

7. In the Description field, enter a description of the custom filter.

8. Click Save.
The Save Filter dialog box appears.

9. Enter a name for the custom filter.

10. Click OK to save the custom filter and refresh the FILTER ELEMENTS page.
Note that:

- The Name label displays the name of the saved filter.

- The Active Query Name label in the upper-right corner of the page now displays the name of the filter you specified.

- The Save As button and the Permissions button are now enabled.

Note:
If you make modifications to the filter elements after you saved the filter to the system, click Save to save the changes. To save the filter by another name, click Save As.

11. To assign group-level permissions on the filter, click Permissions.
The Permissions dialog box appears with the names of all the groups (except the Administrator group) that the system administrator has created.

12. To assign permissions to the group members on the filter you have created, use the drop-down list next to a group name. The available options are:

Permission

Description

R/W/D/P

Group members will be able to view, modify, delete, and assign permission on the filter.

R/W/D

Group members will be able to view, modify, and delete the filter.

R/W

Group members will be able to view and modify the filter.

R

Group members will be able to only view the filter.

No Access (Default)

No group members will be able to access the filter.

Note:
The author of the filter always has the highest level of permission (R/W/D/P) on the filter. For example, suppose you belong to the Data Entry group and you assign the No Access permission level to the Data Entry group on a filter that you create. In this case, you will continue to have the highest level of permission on your filter; other members in your group cannot access the filter.

13. Click OK to save the permission settings.

4.3.1 Creating a Value Set for a Custom Filter

1. On the FILTER ELEMENTS page, click Continue.
The FILTER VALUE SET page appears.

Note:
In the FILTER VALUE SET page, all the elements associated with the filter are organized in sections. You need to scroll the page to view all the sections. If you included the advanced condition element while creating your filter in Step 2, the FILTER VALUE SET page displays an additional Advanced Conditions section. You can use the options in this section to create an advanced condition and integrate your value set with it. See "Integrating a Value Set with an Advanced Condition" for details. To convert the entire value set to an advanced condition, see "Converting a Value Set to an Advanced Condition" for details.

2. Specify values for the filter elements.
See "Using Predefined Filters" for details.

3. Examine the value set results.

4. Click Execute.
While the system searches for matching cases, the following dialog box appears:

Note:
To cancel the query execution at this point and return to the FILTER VALUE SET page, click Cancel Query.

5. If the system does not find any cases that match the querying criteria, warning message appears.
Click OK in this dialog box to return to the Value Set form, modify the criteria, and execute the value set again

6. If the system finds cases that match the query criteria, a list of such cases appears in the ACTIVE CASE SERIES page.

7. Examine the case series. If the case series is too large, you may want to add additional elements to the filter or modify the value set.
Alternatively, if you find the case series to be appropriate, you can save the value set to the system.

8. Click View Query to return to the FILTER VALUE SET page.

9. Modify the value set, if required, and examine the results again or proceed to save the value set.

10. Save the value set to the system.

11. In the Description field, enter a description of the value set.
For example, you may describe the type of cases the value set retrieves.

12. Click Save Values.
The Save Value Set dialog box appears.

13. Enter a name for the value set.

Note:
The name cannot contain following characters: % " ' ^ ~,;|#`

14. Click OK.
The FILTER VALUE SET page refreshes.

Note that the Save Values As button and the Permissions button are now enabled.

Note:
The FILTER LIBRARY page displays the custom as well as predefined filters and their value sets in a control tree format. From this page, you can select a value set and directly execute it. See "Working with Saved Filters and Value Sets" for more information. The saved filters also appear in the Select Filter for New Value Set dialog box from where you can select the desired filter, enter values in the NEW VALUE SET page and execute. See "Using Predefined Filters" for more information.

Tip:
If you make modifications to the field values after you saved the value set to the system, click Save Values to save the changed field values. To save the value set by another name, click Save Values As. To clear all the field values in the FILTER VALUE SET page, click Clear.

15. To assign group-level permissions on the saved value set, click Permissions.
The Permissions dialog box appears with the names of all the groups (except the Administrator group) that the system administrator has created.

16. To assign permissions to the group members on the value set you have created, use the drop-down list next to a group name. The available options are:

Permission

Description

R/W/D/P

Group members will be able to view, modify, delete, and assign permission on the value set.

R/W/D

Group members will be able to view, modify, and delete the Value Set.

R/W

Group members will be able to view and modify the value set.

R

Group members will be able to only view the value set.

No Access (Default)

No group members will be able to access the value set.

Note:
The author of the value set always has the highest level of permission (R/W/D/P) on it. For example, suppose you belong to the Data Entry group and you assign the No Access permission level to the Data Entry group on a value set that you create. In this case, you will continue to have the highest level of permission on your value set; other members in your group cannot access your value set.

17. Click OK to save the permission settings.

18. Click Execute.
The ACTIVE CASE SERIES page appears with the cases that match the value set criteria.

After generating the case series, you may manually modify or save the series. See Chapter 7, "Working with Case Series" for more information.

4.4 Working with the Last Modified or Executed Value Set

The system assigns the active status to a value set when you save modifications to it or execute it. Unless you save the modifications to another value set or execute it, the last value set you modified or executed remains active. This is helpful in situations when you want to access a frequently used value set.

To view an active value set:

1. Navigate to Queries > Filters > Active.
The FILTER VALUE SET page appears with the value set you executed or modified last.

2. If the value set was saved to the system before executing, the name of the value set appears in the Name field.
In addition, the name of the filter appears next to the Active Query Name label.

To rename an already saved value set, enter the new name in the Name field, and click Save Values.

3. If the value set was not saved to the system before executing, the text <Not Saved> is displayed in the Name field.
You may enter the name of the value set in the Name field, and click Save.

4. From the ACTIVE FILTER VALUE SET page, you can perform the following tasks:

Task

Description

Modify the Active Value Set

If required, you can modify the value set by changing the field values.
While entering field values, if you want to remove all the values you entered, click Clear.

Click Save Values to save the changed field values. This button is only available for a saved value set.

Save the Active Value Set by another name

Click Save Values As to save the active value set by a different name.
The FILTER LIBRARY page displays all the value sets you saved to the system. See "Working with Saved Filters and Value Sets" for more information.

Convert Active Value Set to Advanced Condition

Click Convert to Advanced Condition to convert the active value set to an advanced condition. See "Converting a Value Set to an Advanced Condition" for more information.

Assign Permissions on the Active Value Set

Click Permissions to set the group-level access permissions.
The Permissions button is only available for saved value sets.

Change the Description of the Active Value Set

You can change the description of the active value set by modifying the text displayed in the Description field.
Click Save Values to store the changed description.

Execute the Active Value Set

Click Execute to generate a case series by using the active value set.

Note:
When the field values for an active value set are modified or the active value set is saved by a different name, the changes in the active value set reflect the most recent changes. The active value set also changes in case you modify the field values and execute the value set without saving the modifications.

4.5 Working with Saved Filters and Value Sets

The FILTER LIBRARY page lists all the predefined as well as saved custom filters and their value sets in a control tree format.

To access this page, navigate to Queries > Filters > Library.

To view the value sets associated with a filter, expand the control tree for a filter. The saved value sets are displayed below each filter.

The descriptions of the columns in the FILTER LIBRARY page follow.

Column

Description

Name

Displays the name of the filters and value sets.

Description

Displays the description of the filters and value sets.

Last Modified

Displays the date when the filters/value set was last modified.

User Full Name

Displays the name of the user who created the filter/value set.

Category

Displays the filter category.

Value Set

Displays the number of value sets created for a filter.

4.5.1 Searching Saved Filters and Value Sets

1. Specify the search criteria.

- To search for a filter/value set by its name, type the filter/value set name in the Name text box.

- To search for a filter/value set by its description, type the first few words of the description in the Description text box. The system searches for the specified search string in all filter/value set descriptions.

- To search for a filter/value set by its date of modification, enter the modification date in the first Last Modified date field. You can specify a date range by typing the start and end dates in the first and second date fields, respectively.

- To search a filter/value set by its author, select the author name from the User Full Name drop-down list.

- To search for a filter by its category, select the category from the Category drop-down list.

Note:
If you search for a text comprising an underscore, it is treated as a wildcard and is replaced by a letter in the displayed results. For example, If you have queries with names - CURE, CORE, and CARE and you search for C_RE, all three queries are displayed in the result.

2. Click Search.
The search results appear in a list based on the search criteria.

3. To sort the search results list, click the sort icon next to the column headers in the list.

4.5.2 Creating a New Filter

On the FILTER LIBRARY page, click New Filter.

4.5.3 Creating a New Value Set

To create a new value set, navigate to Queries > Filters > New Value Set.

Alternatively, on the FILTER LIBRARY page, click New Value Set.

You may create value sets for predefined as well as custom filters by using this method.

See "Using Predefined Filters" for details.

4.5.4 Modifying a Filter or Value Set

1. On the FILTER LIBRARY page, select the value set or the filter from the list.

2. Click Modify.

- If you selected a filter, the FILTER ELEMENTS page appears.

- If you selected a value set, the FILTER VALUE SET page appears.

3. Make your modifications to the filter or value set.

4. Click Save to save the modifications you made in the FILTER ELEMENTS page.
If you modified a value set, click Save Values in the FILTER VALUE SET page to save the changes.

4.5.5 Deleting a Filter or Value Set

You may delete the value sets for predefined as well as custom filters. You may also delete custom filters. However, you cannot delete the predefined filters. When you delete a filter, all its associated value sets are also deleted.

To delete a value set or a custom filter:

1. Navigate to the FILTER LIBRARY page.

2. Select the value set or custom filter that you want to delete.

3. Click Delete.
A confirmation dialog box appears.

4. Click OK.
The system deletes the selected filter/value set, and returns to the FILTER LIBRARY page.

4.5.6 Executing a Value Set

1. Navigate to the FILTER LIBRARY page.

2. Select a value set from the list.

3. Click Execute.
The system executes the value set, and the ACTIVE CASE SERIES page appears.

4. If a report is associated with the saved QBE, click Execute.
The ACTIVE CASE SERIES page and PRE FILTER page of the associated report is displayed.

5. Enter the prompts value in the PRE FILTER page.

6. Click Execute to generate the report.
After generating the case series, you can manually modify it or save it. See Chapter 7, "Working with Case Series" for more information.

4.5.7 Executing a Saved Value Set on the Active Case Series

Just as the system assigns the active status to a value set when you save modifications to it or execute it, the last saved or generated case series becomes the active case series.

You may want to run a value set on an active case series.

To narrow down the list of cases in the active case series:

1. Generate the case series to run another value set:

- You may generate the case series by using predefined filters or creating custom filters and executing a value set. This case series becomes the active case series and remains so until you execute another query to generate a different case series.

- Alternatively, if the case series on which you want to run another value set is already saved in the system, navigate to Case Series > Open Case Series > Library.
When the CASE SERIES LIBRARY page appears, select the case series, and click Make Active.

2. Navigate to Queries > Filters > Library.
The FILTER LIBRARY page appears.

3. Select the value set to run on the active case series you generated in Step 1.

4. Select the Limit Query to Active Case Series check box.

5. Click Execute.
The system runs the selected value set on the active case series and displays the ACTIVE CASE SERIES page.

Note that the case series you just generated becomes the active case series.

4.6 Using Filters with Advanced Conditions

Advanced conditions let you create complex queries that involve Boolean and set operations among fields. To create advanced conditions, you use the Advanced Conditions Editor, which uses a spreadsheet-like approach for adding query conditions (fields and their values) and conditional operators (Boolean or set).

In Argus Insight, filters are integrated with advanced conditions to let you perform the following tasks:

- Converting a Value Set to an Advanced Condition

- Integrating a Value Set with an Advanced Condition

4.6.1 Converting a Value Set to an Advanced Condition

You can use an existing filter value set to start to build an advanced condition that uses Boolean or set operations between elements that have multiple values. When you convert a value set to an advanced condition, all the fields in which you entered values are listed on the ACTIVE ADVANCED CONDITIONS EDITOR page as advanced condition attributes.

To convert a value set to an advanced condition:

1. Create a new value set by either using predefined filters or creating custom filters.
Alternatively, from the FILTER LIBRARY page, open a saved value set (see "Working with Saved Filters and Value Sets").

2. Verify the field values specified in the fields in the value set.

3. Click Convert to Advanced Condition.
The ACTIVE ADVANCED CONDITIONS EDITOR page appears.

All the fields in which the values were specified are listed as advanced condition attributes. The fields with multiple values are repeated.

4. Build your query further by:

- Adding additional attributes (fields) and specifying their values

- Adding another advanced condition as an attribute

- Placing runtime parameters in attributes

- Placing parentheses to determine the query execution order

- Specifying conditions for attributes values

- Specifying Boolean and set operators to join the attributes

See Chapter 5, "Using Advanced Conditions to Create Queries on Insight Mart" for detailed information about using the Advanced Conditions Editor.

4.6.2 Integrating a Value Set with an Advanced Condition

You can integrate a value set with an existing advanced condition through these set operators:

- INTERSECT

- MINUS

- UNION

If required, you can integrate the value set with multiple advanced conditions that can have Boolean or set operations between them.

Note:
Only those value sets that have the Advanced Condition element can be integrated with advanced conditions. All value sets that you create for predefined filters contain the Advanced Condition element. If you want to convert a custom filter value set to an advanced condition, make sure you select the Advanced Condition element when creating the custom filter.

To integrate a value set with an existing advanced conditions:

1. Create a new value set by either using predefined filters or creating custom filters.
Alternatively, from the FILTER LIBRARY page, open a saved value set (see "Working with Saved Filters and Value Sets").

If you create a custom value set, make sure you include the Advanced Condition element.

2. Verify the field values specified for the value set.

3. On the FILTER VALUE SET page, scroll to the Advanced Condition section.

4. To enter the operator to use to integrate the value set and the advanced condition, use the Operator field.
You may select INTERSECT, MINUS, or UNION.

5. Select the advanced condition to integrate with the value set as follows:

1. Click the Add Advanced Condition Above icon on the left bar.
The Advanced Conditions menu lists the advanced conditions that are stored in the system and available to you. The conditions are organized by categories.

2. Browse to a category and select the required advanced condition.
The selection is added as a row in the Advanced Conditions Editor

3. Click the Add Advanced Condition Above icon or the Add Advanced Condition Below icon to insert another advanced condition above or below the existing advanced condition.

Tip:
To change the structure of the query by reordering of the rows, select a row and click the arrow icons to move the row up or down.

6. Type parentheses in the ( and ) columns to determine the order of execution for the selected advanced conditions.

7. To specify the set operation to perform between the selected advanced conditions, use the field in the Operator column.

8. Click Save As to save your integrated value set.

- To run the integrated value set and generate the case series, click Execute.
The ACTIVE CASE SERIES page appears with the case series.

See Chapter 7, "Working with Case Series" for more information.

- To convert the integrated value set and advanced condition into a single advanced condition, click Convert to Advanced Condition.
See "Converting a Value Set to an Advanced Condition" for more information.

For detailed information about using the Advanced Conditions Editor, see Chapter 5, "Using Advanced Conditions to Create Queries on Insight Mart."

5 Using Advanced Conditions to Create Queries on Insight Mart

The advanced conditions querying tool is designed to allow the greatest flexibility in designing the most advanced queries. You can use advanced conditions to create complex queries that involve Boolean and Set operations and use Structured Query Language (SQL).

You create advanced conditions in the Advanced Conditions Editor, which employs a spreadsheet-like approach for adding query conditions (fields and their values) and conditional operators (Boolean or Set).

Besides, Argus Insight also supports queries for analysis of the historical case data based on specific date/time through Argus Mart. To enable access to this data in Argus Mart, you need to set specific attributes.

See Chapter 6, "Using Advanced Conditions to Create Point-in-Time Queries on Argus Mart."

Note:
The labels for the advanced conditions field are displayed as per the field labels configured in Argus Safety.

5.1 Creating a New Advanced Condition

To start a new Insight Mart advanced condition:

1. Navigate to Queries > Advanced Conditions > New (Insight Mart).
The ADVANCED CONDITIONS EDITOR page appears with the data source.

Note:
You may also start an advanced condition by converting a QBE or a filter value set to an advanced condition. See "Converting a QBE to an Advanced Condition" and "Converting a Value Set to an Advanced Condition" for details.

2. Enter the attributes (fields and values) for the advanced condition.

3. Click the context menu icon (Add Advanced Condition Element Above/Below icon).
In the context menu, the categories (Activities, Additional Info, Analysis, Events, General, Patients, and Products) represent the Argus case form tabs. In these categories, the data mart fields that pertain to case information are organized in this hierarchy:

- Argus case form tab

- Sections within the tab

- Fields within the section

You may browse through the appropriate hierarchy and select the required field as an advanced condition attribute.

The AC Library category lists all the advanced conditions stored in the system. You may browse through the AC Library category and select a stored advanced condition as an attribute for the new advanced condition.

4. Browse through a category hierarchy, and select the required attribute.
The selected attribute appears as a row in the editor.

Note:
The user defined fields in Argus Safety which have been converted as a look up are also available as attributes for the advanced condition search.

5. In the Value field, enter the value for the selected attribute.
Depending on the type of the selected attribute, the Value field populates a:

- Drop-down list to select from a set of predefined values

- Text box to enter text strings or numerals

- Date field to enter dates

- Browser to select MedDRA dictionary terms, company products, WHO drugs, clinical study IDs, Drugs in Study (incl. Comparators) and Investigational Drugs.
To use a browser to populate the Value field, click the ellipsis button next to the Value field. From the context menu, select the option corresponding to the browser you want to start. For example, you can start the MedDRA Browser and enter criteria to search for a preferred term based on a specific code or description. You can add a selected term to the Value field.

6. Click the Conditions field, and select a condition for the attribute value.
See Table 5-1 for a description of each condition. The availability of the conditions depends on the selected attribute.

Table 5-1 Conditions for Defining an Advanced Condition

Condition

Select this option if you want to…

equal to

Retrieve cases where the selected attribute's value is equal to what the Value field specifies

not equal to

Retrieve cases where the selected attribute's value is not equal to what the Value field specifies

greater than

Retrieve cases where the selected attribute's value is greater than what the Value field specifies

greater than or equal to

Retrieve cases where the selected attribute's value is greater than or equal to what the Value field specifies

less than

Retrieve cases where the selected attribute's value is less than what the Value field specifies

less than or equal to

Retrieve cases where the selected attribute's value is less than or equal to the Value that the field specifies

missing

Retrieve cases where the selected attribute's value has not been specified

exists

Retrieve cases where the selected attribute has any value

begins with

Retrieve cases where the selected attribute's value begins with what the Value field specifies

contains

Retrieve cases where the selected attribute's value contains what the Value field specifies

does not contain

Retrieve cases where the selected attribute's value does not contain what the Value field specifies

in

Retrieve cases where the selected attribute's value exists in what the Value field specifies

not in

Retrieve cases where the selected attribute's value does not exist in what the Value field specifies

Tip:
To change the structure of the query by changing the order of the attribute rows, select a row and then click the arrow icons to move the row up or down. To delete a row from the editor, select the row and click the Delete icon.

7. Specify the operator.
Use the Operator drop-down list to specify the Boolean or Set operator to join the attribute with another attribute.

8. To add more attributes to your advanced condition, click the icons on the left bar to insert another attribute above or below the existing attribute.

9. Specify runtime parameters.

Note:
Argus Insight lets you create advanced conditions which when executed, ask for user-specified values for certain attributes to generate the case series. For example, you may create an advanced condition in which the Case Number or the Product name may be specified only at the time of execution. In this case, the advanced condition would only retrieve those cases where the Case Number/Product Name is as specified at the time of execution.
Creating an advanced condition using same field name multiple times requires to change the Parameter name so that while executing the advanced condition different parameters values can be entered.

10. Identify the attribute row to specify runtime parameters.

11. Click the ellipsis button next to the Value field, and then select Parameters from the menu.

12. Click Parameter.
The Parameter dialog box appears.

13. To pass multiple runtime values for a single attribute, select the Multi Select check box.
For example, you might want to pass more than one case number or product name as runtime parameters.

14. Click OK.
If the field is configured to accept single runtime parameter, the field you configured as a runtime parameter is displayed in the Value text box enclosed within % symbol. For example, %Product Type%.

If the field is configured to accept multiple runtime parameters, the field name appears in the Value text box enclosed within %% symbol. For example, %%Product Type%%.

15. To determine the order of execution for the selected advanced conditions, enter parentheses in the ( and ) columns.

16. Examine the advanced condition results.

17. Click Execute.

Tip:
To cancel the query execution at this point and return to the Advanced Conditions Editor, click Cancel Query.

- If any runtime parameter is configured, the Parameters dialog box appears with all the fields available based on the categorization of different fields from the tree view.

- Specify the parameter values by using the options in the dialog box, and click Execute.
Select at least one parameter for query execution.

The ACTIVE CASE SERIES page appears with the matching cases from the data mart.

Tip:
If you select one runtime parameter and execute the search, you must enter a field.
If you select multiple runtime parameters and execute the search, you have the option to ignore the runtime parameters.

- To ignore the field criteria for query execution, select All.

- To save the selected values on the Advanced Condition Parameters screen, click Save.

Note:

- When the Save button is clicked, the values of the current Advance Condition only are saved, and not for the Nested Advance Conditions.

- The Save button is enabled only when Advance Condition is saved, and not when the Advanced Condition is executed from Query By Example, Filter, or Advance Condition Library page.

You may enter value for one or more parameters.

If no value is selected for any parameter that is if you try to save a parameterized advanced condition without providing any value, then an error message appears as 'You must select values in order to save.'

All the fields where value is been provided are stored for the future use.

- Upon execution of these advanced conditions again, the previously selected values will appear by default on the Advanced Condition Parameters page.

Note:
On the Advanced Condition Editor page, the parameterized advanced conditions appears in their original structure, and the saved parameter values are not available. These values appear only while executing the advanced condition.

- Query criteria for the case series generated using such advanced conditions will only display fields for which values for the parameter were provided.

- The selective use of parameters can also be used while converting existing filters into advanced conditions.

- If no cases are found that match the querying criteria, a warning message appears.
Click View Query to return to the Advanced Conditions Editor, modify the criteria and execute again.

- If the cases that match the query criteria are found, the ACTIVE CASE SERIES page appears with the list of such cases.

18. Examine the case series. If the case series is too large, you may want to modify the advanced condition by specifying additional attributes or changing values.
Alternatively, if you find the case series to be appropriate, you can save the advanced condition to the system.

The system retrieves the matching cases from the data mart and displays them in the ACTIVE CASE SERIES page.

Note:
If the Argus Insight case series are created by using the Argus Mart advanced condition, then these case series records only case IDs, case revision effective start dates, and query criteria (as a text string).

5.1.1 Returning to the Advanced Conditions Editor

1. On the ACTIVE CASE SERIES page, click View Query.
The ACTIVE ADVANCED CONDITIONS EDITOR page appears.

Note:
When you save the modifications to an advanced condition or execute it, the system assigns the active status to the advanced condition. Therefore, when you return to the editor after executing the advanced condition, the page title changes to ACTIVE ADVANCED CONDITIONS EDITOR. The field values you specified in the editor before executing are retained. See "Working with the Last Modified or Saved Advanced Condition" for details.

2. If required, modify the advanced condition and examine the results again or proceed to save the advanced condition.

3. Save the advanced condition.

5.1.2 Assigning a Category to an Advanced Condition

A category indicates the reporting aspect to which your advanced condition pertains:

- Case Processing

- Compliance

- Configuration

- General

- Management

- Pharmacovigilance

Specifying the category also helps in searching the relevant advanced conditions from a list of all the advanced conditions saved in the system.

To assign a category to an advanced condition:

1. On the ACTIVE ADVANCED CONDITIONS EDITOR page, from the Category drop-down list, select a category.

2. In the Description field, enter a description of the advanced condition.
For example, you may describe the type of cases the advanced condition retrieves.

3. Click Save.
The Advanced Condition - Save dialog box appears.

4. In the Name field, enter the name of the advanced condition.

5. Click OK to save the advanced condition and refresh the ACTIVE ADVANCED CONDITIONS EDITOR page.
Note that:

- The Active Query Name field in the upper-right corner of the page now displays the name of the advanced condition you specified while saving the advanced condition.

- The Save As, View SQL, and Permissions buttons are now enabled.

Note:
The ADVANCED CONDITION LIBRARY page lists all the advanced conditions saved to the system. See "Working with Saved Advanced Conditions" for more information.

Tip:
If the field values are modified after saving the advanced condition to the system, click Save to save the changed field values.

6. Click View SQL to view the underlying SQL query for the advanced condition.

1. Modify the SQL, if necessary.

2. Click Save SQL after editing the query.

Note:
When using the Save SQL functionality, the advanced condition can be executed only from the ADVANCED CONDITIONS LIBRARY page.

Tip:
Revert to Original lets you to revert back to the original advanced condition. This button is enabled only when you edit the SQL.

3. Click Close.

7. To assign group-level permissions on the saved advanced condition, click Permissions.
The Permissions dialog box appears with the names of all the groups (except the Administrator group) that the system administrator has created.

8. To assign permissions to the group members on the advanced condition you have created, use the drop-down list next to a group name. The available options are:

Permission

Description

R/W/D/P

Group members will be able to view, modify, delete, and assign permission on the advanced condition.

R/W/D

Group members will be able to view, modify, and delete the advanced condition.

R/W

Group members will be able to view and modify the advanced condition.

R

Group members will be able to only view the advanced condition.

No Access (Default)

No group members will be able to access the advanced condition.

Note:
The author of the advanced condition always has the highest level of permission (R/W/D/P) on it. For example, suppose you belong to the Data Entry group and you assign the No Access permission level to the Data Entry group on an advanced condition that you create. In this case, you will continue to have the highest level of permission on your advanced condition; other members in your group cannot access your advanced condition.

9. Click OK to save the permission settings.

10. Click Execute to generate the case series.

- The ACTIVE CASE SERIES page appears with the matching cases from the data mart.

- If any runtime parameters are configured, the Parameters dialog box appears.
Specify the parameter values by using the options in the dialog box, and click Execute.

The ACTIVE CASE SERIES page appears with the matching cases from the data mart.

See Chapter 7, "Working with Case Series" for more information.

5.1.3 Using and Ordering Advanced Condition Operators

Use the following order of precedence for the operators you can select when creating an advanced condition.

Order

Operator

Use

1

AND

Use with all fields available in an advanced condition.

2

OR

Use with all fields available in an advanced condition.

3

INTERSECT

Use between queries (AC Library Attributes)

4

MINUS

Use between queries (AC Library Attributes)

5

UNION

Use between queries (AC Library Attributes)

Using an INTERSECT, MINUS, or UNION operator results in the creation of two separate select clauses. Therefore, use these operators between different queries.

Be sure to use correct PL/SQL syntax:

SELECT
table1.common_column
FROM
Table1, table2, table3
WHERE
Table1.column2 = table2.column2
AND
Table2.column3 = table3.column3
INTERSECT
SELECT
Table4.common_column
FROM
Table4, table5, table6
WHERE
Table4.column2 = table5.column2
AND
Table5.column3 = table6.column3

5.1.3.1 Advanced Condition Example

Suppose you want to create an advanced condition as follows:

WHERE Country = "Australia" AND Co-Drug Code w Study = "LAS + TAB" OR Co-Drug Code w Study = "LAS+" AND Overdose = "Yes" AND Interaction? = "Yes"

AND

You want to INTERSECT the results of this advanced condition with the existing advanced condition:

WHERE Country = "United States" OR Country = "Australia"

Table 5-2 lists the values that you enter to create the advanced condition specified in the previous example.

Table 5-2 Values Entered for the Advanced Condition Example

(

Attributes

Condition

Value

)

Operator

(

Country

equal to

AUSTRALIA

AND

(

Co-Drug Code w Study

equal to

LAS + TAB

OR

Co-Drug Code w Study

equal to

LAS+

)

AND

Overdose

equal to

Yes

AND

Interaction?

equal to

Yes

)

INTERSECT

COI USA OR AUSTRALIA

(Advanced Condition)

You do not need to include the parentheses if the PL/SQL syntax, the order and precedence of operators are correct.

5.1.3.2 Sample SQL Generated

The following SQL is generated for the previous example:

SELECT DISTINCT v_rpt_case.case_id
FROM v_rpt_case, rpt_product
WHERE v_rpt_case.case_id = rpt_product.case_id
AND ( (v_rpt_case.country_id = 13)
AND ( UPPER (rpt_product.co_drug_code) = 'LAS+TAB'
OR (pat_exposure IN (
SELECT product_id
FROM lm_product
WHERE UPPER (lm_product.drug_code) ='LAS+TAB')))
OR (UPPER (rpt_product.co_drug_code) = 'LAS+'
OR (pat_exposure IN (SELECT product_id FROM lm_product
WHERE UPPER (lm_product.drug_code) ='LAS+')))
AND (rpt_product.is_overdose = 1)
AND (rpt_product.interaction = 1))
INTERSECT
SELECT DISTINCT v_rpt_case.case_id
FROM v_rpt_case
WHERE v_rpt_case.case_id IN (
SELECT DISTINCT v_rpt_case.case_id
FROM v_rpt_case
WHERE (v_rpt_case.country_id = 13)
OR (v_rpt_case.country_id = 223))

Note:
While creating a new Advanced Condition using the saved Advanced Condition, always enclose the saved Advanced Condition within the parenthesis as using Union, Minus, or Intersect will create different select statements and if you use parenthesis with the saved Advanced Condition with new fields, wrong SQL will be generated.

This is the desired and correct SQL.

The following SQL gets generated in this case.

(SELECT DISTINCT v_rpt_case.case_id                FROM v_rpt_case                WHERE v_rpt_case.case_id IN (                                              SELECT DISTINCT v_rpt_case.case_id                                         FROM v_rpt_case                                         WHERE (v_rpt_case.case_num IS NOT NULL)))
UNION
(SELECT DISTINCT v_rpt_case.case_id                FROM v_rpt_case, rpt_event, rpt_product                WHERE v_rpt_case.case_id = rpt_event.case_id                AND v_rpt_case.case_id = rpt_product.case_id                AND ((rpt_event.agent_seq_num = 1)))

Below Query will execute fine but parenthesis will not be at right place. Following is the SQL generated.

SELECT DISTINCT v_rpt_case.case_id
FROM v_rpt_case, rpt_product
WHERE v_rpt_case.case_id = rpt_product.case_id
AND ( (UPPER (rpt_product.co_drug_code) = 'RELVAC1'
OR (pat_exposure IN (
SELECT product_id
FROM lm_product
WHERE UPPER (lm_product.drug_code) = 'RELVAC1')
))
OR ( UPPER (rpt_product.co_drug_code) = 'C_TEST DRUG 1'
OR (pat_exposure IN (
SELECT product_id
FROM lm_product
WHERE UPPER (lm_product.drug_code) = 'C_TEST DRUG 1')
)
)
)
INTERSECT
(SELECT DISTINCT v_rpt_case.case_id
FROM v_rpt_case
WHERE (v_rpt_case.country_id = 81)
UNION
SELECT DISTINCT v_rpt_case.case_id
FROM v_rpt_case, rpt_followup
WHERE v_rpt_case.case_id = rpt_followup.case_id
AND (( (TRUNC (rpt_followup.receipt_date) =
TO_DATE ('17-MAR-2009', 'DD-MON-YYYY')
)
AND rpt_followup.seq_num > 0
)
)
UNION
SELECT DISTINCT v_rpt_case.case_id
FROM v_rpt_case, rpt_reporters
WHERE v_rpt_case.case_id = rpt_reporters.case_id
AND ((v_rpt_case.state_id = 3))
OR (rpt_reporters.primary_contact = 1))

Note: Parenthesis shown in red are not at correct place as compared to AC created. Last parenthesis will come only after complete query creation.

5.2 Working with the Last Modified or Saved Advanced Condition

The system assigns an active status to a advanced condition when you modify and save it or when you execute it. Unless you save the modifications to another advanced condition or execute another advanced condition, the last advanced condition you modified or executed remains active. This is helpful in situations when you want to access a frequently used advanced condition.

To work with last modified or saved advanced condition:

- For Argus Insight database, select Active (Insight Mart)

- For Argus Mart database, select Active (Argus Mart)

To view an active advanced condition:

1. Navigate to Queries > Advanced Condition > Active (Insight Mart).
The ACTIVE ADVANCED CONDITIONS EDITOR page appears with data source and the advanced condition you executed or modified last.

2. If the active advanced condition was saved to the system before executing, the name of the advanced condition appears next to the Active Query Name and in the Name field.
However, if the active advanced condition was not saved to the system before executing, the text <Not Saved> is displayed next to the Active Query Name label.

You can enter the name of the advanced condition in the Name field and click Save.

To rename an already saved advanced condition, in the Name field, enter the new name, and click Save.

From the ACTIVE ADVANCED CONDITION page, you can perform the following tasks:

Task

Description

Modify the attributes in the Advanced Conditions Editor

If required, you can modify the attributes (fields and values) in the Advanced Conditions Editor. See "Creating a New Advanced Condition" for more information.
Click Save to save the changed field values. This button is only available for a saved active advanced condition.

Save Active Advanced Condition with another name

Click Save As to save the active advanced condition by a different name.
The ADVANCED CONDITIONS LIBRARY page lists all the advanced conditions saved to the system. See "Working with Saved Advanced Conditions" for more information.

View the Advanced Condition in SQL

Click View SQL to view the underlying SQL query for the advanced condition.
In this SQL, manually replace the V_RPT_CASE with RPT_CASE. This is required to execute the query in the Oracle database.

Assign Permissions

Click Permissions to set the group-level access permissions on the advanced condition. See "Creating a New Advanced Condition" for more information.
The Permissions button is only available for saved active advanced conditions.

Change the Description of the Active Advanced Condition

You can change the description of the active advanced condition by modifying the text displayed in the Description field.
Click Save to store the changed description.

Execute the Active Advanced Condition

Click Execute to generate a case series by using the active advanced condition.

Note that modifying the field values in the Advanced Conditions Editor for an active advanced condition or saving the active advanced condition by a different name changes the active advanced condition to reflect the most recent changes. The active advanced condition also changes in case you modify the field values in the Advanced Conditions Editor and execute the advanced condition without saving the modifications.

5.3 Working with Saved Advanced Conditions

The ADVANCED CONDITIONS LIBRARY page lists all the advanced conditions saved to the system.

To access this page, navigate to Queries > Advanced Conditions > Library.

The ADVANCED CONDITIONS LIBRARY page appears with the following information about each saved advanced condition:

- Name of the advanced condition.

- Description of the advanced condition.

- Date when the advanced condition was last modified.

- Full name of the user who created the advanced condition.

- Category assigned to the advanced condition.

- Data source (Insight Mart/Argus Mart) of the advanced condition.

- Query type and Date (Current/Historical) for Argus Mart data source only.

5.3.1 Searching Saved Advanced Conditions

1. Specify the search criteria:

- To search for an advanced condition by its name, type the advanced condition name in the Name text box.

- To search for an advanced condition by its description, type the first few words of the description in the Description text box. The system searches for the specified search string in all advanced condition descriptions.

- To search for an advanced condition by its date of modification, enter the modification date in the first Last Modified date field. You can specify a date range by typing the start and end dates in the first and second date fields, respectively.

- To search for an advanced condition by its author, select the author name from the User Full Name drop-down list.

- To search for an advanced condition by its category, select the category from the Category drop-down list.

Note:
If you search for a text comprising an underscore, it is treated as a wildcard and is replaced by a letter in the displayed results. For example, If you have queries with names - CURE, CORE, and CARE and you search for C_RE, all three queries are displayed in the result.

2. Click Search.
The search results appear based the search criteria.

- To sort the search results, click the sort icon next to the column headers in the list.

- To clear the search results and display all the advanced conditions in the list, click Clear.

5.3.2 Creating a New Advanced Condition

See "Creating a New Advanced Condition" for details.

5.3.3 Modifying an Advanced Condition

1. Navigate to the ADVANCED CONDITIONS LIBRARY page.

2. Select the advanced condition you want to modify.

3. Click Modify.

4. Make your modifications to the advanced condition.

5. Click Save to save your changes.
Alternatively, click Save As to save the modified advanced condition by another name.

5.3.4 Modifying the SQL of an Advanced Condition

1. Navigate to the ADVANCED CONDITIONS LIBRARY page.

2. Select the advanced condition.

3. Click Modify.
The ACTIVE ADVANCED CONDITIONS EDITOR page appears.

4. Click View SQL.
The Advanced Conditions SQL dialog appears.

5. Modify the SQL as per your requirement.

6. Click Save SQL to save your changes.

7. Click Close to return to the ADVANCED CONDITIONS LIBRARY page.

8. Select the modified advanced condition.

9. Click Execute.
The search results appear based on your modified SQL.

Note:
You cannot modify an advanced condition once you have added user defined SQL in that, you can modify SQL but cannot add new items in advanced condition.
If you want to add new items, you have to revert the SQL to original by clicking Revert to Original.

5.3.5 Deleting an Advanced Condition

1. Navigate to the ADVANCED CONDITIONS LIBRARY page.

2. Select the advanced condition you want to delete.

3. Click Delete.
A confirmation dialog box appears.

4. Click OK.

5.3.6 Executing an Advanced Condition

1. Navigate to the ADVANCED CONDITIONS LIBRARY page.

2. Select an advanced condition.

3. Click Execute.
The ACTIVE CASE SERIES page appears with the results of the executed advanced condition.

After generating the case series, you can manually modify it or save it. See Chapter 7, "Working with Case Series" for more information.

5.3.7 Executing a Saved Advanced Condition on the Active Case Series

Just as the system assigns the active status to an advanced condition when you save modifications to it or execute it, the last saved or generated case series becomes the active case series.

You may want to run an advanced condition on an active case series.

To narrow down the list of cases in the active case series:

1. Generate the case series to run another Value Set:

- You may generate the case series by either using QBE, filters, or advanced conditions. This case series becomes the active case series and remains so until you execute another query to generate a different case series.

- Alternatively, if the case series on which you want to run another Value Set is already saved in the system, navigate to Case Series > Open Case Series > Library.
The CASE SERIES LIBRARY page appears.

Select the case series, and click Make Active.

2. Navigate to Queries > Advanced Conditions > Library.
The ADVANCED CONDITIONS LIBRARY page appears.

3. Select the advanced condition to run on the active case series you generated in Step 1.

4. Select the Limit Query to Active Case Series check box.

Note:
The Limit Query to Active Case Series check box is enabled only when the selected active case series and advance condition are of same type (Insight Mart/Argus Mart).

5. Click Execute.
The ACTIVE CASE SERIES page appears with the execution results of the selected advanced condition on the active case series.

Note that the case series you just generated becomes the active case series.

6 Using Advanced Conditions to Create Point-in-Time Queries on Argus Mart

Argus Insight also supports point-in-time queries for analysis of the historical case data based on specific date/time through Argus Mart.

To enable access to this data in Argus Mart, you need to set specific attributes.

For more information on these attributes, contact your administrator.

Benefits of running queries on Argus Mart:

- Enables you to create the advanced condition queries using the list of fields configured in the common fields table for Argus Mart data source. These advanced condition can be executed to generate case series.

- Displays the Effective Start Date of the case revision in the resultant case series for all the case series generated on Argus Mart data.

- Supports different type of queries for fetching the historical data while executing queries on Argus Mart data source.

- Current Data Queries—Provides a consistent view of the most recent revisions available in Argus Safety regardless of whether the cases are locked or unlocked. These queries and query results are same as the existing queries created on Argus Insight data source that is, case data for cases present in the case series will be refreshed if a case changes in Argus Safety. Any reporting done on such case series/queries will always return the latest data related to cases in the case series.

- As of Date (Historical Data)—Refers to the data that was current at some point in the past. This query type allows the use of an As of Date that is earlier than the most recent ETL high water mark and later than ETL low water mark. These queries uses the Effective Start Date and End Date of the locked and unlocked revisions.

Note:

- ETL High Watermark — Date when ETL was executed for the last time.

- ETL Low Watermark — Date when ETL was executed for the first time.

- At Lock—Provides the case data at one or more user lock actions. A typical use case for an At Lock query displays the data that was provided to local affiliates for review and possible submission. The query returns the revisions at the time of the user lock action. That is, the post-lock revisions are not included. The list of lock dates (and times) is provided by Argus Safety tables that record the user lock action. These queries use the valid Start Date and End Date of the locked revisions.

- Last Locked Revision as of a Point in Time—Provides a consistent view of the most recent locked revisions that were committed to the database on or before the as-of date. The as-of date can be arbitrary (a date that may not correspond to any actual transaction). When there are post-lock revisions, the query returns any post-lock revision data valid at the given point-in-time. These queries return only a single revision of each case. The as-of date is the same for all cases (a single value for the query). These queries use the valid Start Date and End Date of the locked revisions.

- Last Locked Revision for a Version in a Period—Provides a consistent view of the most recent locked revision for case versions in a time period. You can choose between Case Creation Date, Case Receipt Date, and Case Lock Date for determining the versions in a period. Regardless of the kind of date used for determining in period, the key point of this type of query is that the revision may have been committed to the database outside the period. However, revisions that belong to later versions of a case not included in the period are not returned. These queries return only a single revision of each case. The as-of date may vary by case (no single as-of date will be sufficient to return the needed revisions across all cases). These queries use the valid Start Date and End Date of the locked revisions.

- Aggregate Queries—Provides a consistent view of the most recent locked revision for case versions for a specific time period based on the Case Receipt Date. You may also view the most recent unlocked revision with this type of query.

- Enables saving the advanced conditions along with query type and As of Date for future use.

- Supports all the existing features of advanced conditions with Argus Mart data source and point in time queries. For example, View SQL, Parameterized queries, and etc.

6.1 Creating a New Advanced Condition

1. Navigate to Queries > Advanced Conditions > New (Argus Mart).
The ADVANCED CONDITIONS EDITOR page appears with the data source.

2. Enter the attributes (fields and values) for the advanced condition.

3. Click the context menu icon (Add Advanced Condition Element Above/Below icon).
In the context menu, the categories (Activities, Additional Info, Analysis, Events, General, Patients, and Products) represent the Argus case form tabs. In these categories, the data mart fields that pertain to case information are organized in this hierarchy:

- Argus case form tab

- Sections within the tab

- Fields within the section

You may browse through the appropriate hierarchy and select the required field as an advanced condition attribute.

The AC Library category lists all the advanced conditions stored in the system. You may browse through the AC Library category and select a stored advanced condition as an attribute for the new advanced condition.

4. Browse through a category hierarchy, and select the required attribute.
The selected attribute appears as a row in the editor.

Note:
The user defined fields in Argus Safety which have been converted as a look up are also available as attributes for the advanced condition search.

5. In the Value field, enter the value for the selected attribute.
Depending on the type of the selected attribute, the Value field populates a:

- Drop-down list to select from a set of predefined values

- Text box to enter text strings or numerals

- Date field to enter dates

- Browser to select MedDRA dictionary terms, company products, WHO drugs, clinical study IDs, Drugs in Study (incl. Comparators) and Investigational Drugs.
To use a browser to populate the Value field, click the ellipsis button next to the Value field. From the context menu, select the option corresponding to the browser you want to start. For example, you can start the MedDRA Browser and enter criteria to search for a preferred term based on a specific code or description. You can add a selected term to the Value field.

6. Click the Conditions field, and select a condition for the attribute value.
See Table 6-1 for a description of each condition. The availability of the conditions depends on the selected attribute.

Table 6-1 Conditions for Defining an Advanced Condition

Condition

Select this option if you want to…

equal to

Retrieve cases where the selected attribute's value is equal to what the Value field specifies

not equal to

Retrieve cases where the selected attribute's value is not equal to what the Value field specifies

greater than

Retrieve cases where the selected attribute's value is greater than what the Value field specifies

greater than or equal to

Retrieve cases where the selected attribute's value is greater than or equal to what the Value field specifies

less than

Retrieve cases where the selected attribute's value is less than what the Value field specifies

less than or equal to

Retrieve cases where the selected attribute's value is less than or equal to the Value that the field specifies

missing

Retrieve cases where the selected attribute's value has not been specified

exists

Retrieve cases where the selected attribute has any value

begins with

Retrieve cases where the selected attribute's value begins with what the Value field specifies

contains

Retrieve cases where the selected attribute's value contains what the Value field specifies

does not contain

Retrieve cases where the selected attribute's value does not contain what the Value field specifies

in

Retrieve cases where the selected attribute's value exists in what the Value field specifies

not in

Retrieve cases where the selected attribute's value does not exist in what the Value field specifies

Tip:
To change the structure of the query by changing the order of the attribute rows, select a row and then click the arrow icons to move the row up or down. To delete a row from the editor, select the row and click the Delete icon.

7. Specify the operator.
Use the Operator drop-down list to specify the Boolean or Set operator to join the attribute with another attribute.

8. To add more attributes to your advanced condition, click the icons on the left bar to insert another attribute above or below the existing attribute.

9. Specify runtime parameters.

Note:
Argus Insight lets you create advanced conditions which when executed, ask for user-specified values for certain attributes to generate the case series. For example, you may create an advanced condition in which the Case Number or the Product name may be specified only at the time of execution. In this case, the advanced condition would only retrieve those cases where the Case Number/Product Name is as specified at the time of execution.
Creating an advanced condition using same field name multiple times requires to change the Parameter name so that while executing the advanced condition different parameters values can be entered.

10. Identify the attribute row to specify runtime parameters.

11. Click the ellipsis button next to the Value field, and then select Parameters from the menu.

12. Click Parameter.
The Parameter dialog box appears.

13. To pass multiple runtime values for a single attribute, select the Multi Select check box.
For example, you might want to pass more than one case number or product name as runtime parameters.

14. Click OK.
If the field is configured to accept single runtime parameter, the field you configured as a runtime parameter is displayed in the Value text box enclosed within % symbol. For example, %Product Type%.

If the field is configured to accept multiple runtime parameters, the field name appears in the Value text box enclosed within %% symbol. For example, %%Product Type%%.

15. To determine the order of execution for the selected advanced conditions, enter parentheses in the ( and ) columns.

16. Examine the advanced condition results.

17. Click Execute.

Tip:
To cancel the query execution at this point and return to the Advanced Conditions Editor, click Cancel Query.

- If any runtime parameter is configured, the Parameters dialog box appears with all the fields available based on the categorization of different fields from the tree view.

- Specify the parameter values by using the options in the dialog box, and click Execute.
Select at least one parameter for query execution.

The ACTIVE CASE SERIES page appears with the matching cases from the data mart.

Tip:
If you select one runtime parameter and execute the search, you must enter a field.
If you select multiple runtime parameters and execute the search, you have the option to ignore the runtime parameters.

- To ignore the field criteria for query execution, select All.

- To save the selected values on the Advanced Condition Parameters screen, click Save.

Note:

- When the Save button is clicked, the values of the current Advance Condition only are saved, and not for the Nested Advance Conditions.

- The Save button is enabled only when Advance Condition is saved, and not when the Advanced Condition is executed from Query By Example, Filter, or Advance Condition Library page.

You may enter value for one or more parameters.

If no value is selected for any parameter that is if you try to save a parameterized advanced condition without providing any value, then an error message appears as 'You must select values in order to save.'

All the fields where value is been provided are stored for the future use.

- Upon execution of these advanced conditions again, the previously selected values will appear by default on the Advanced Condition Parameters page.

Note:
On the Advanced Condition Editor page, the parameterized advanced conditions appears in their original structure, and the saved parameter values are not available. These values appear only while executing the advanced condition.

- Query criteria for the case series generated using such advanced conditions will only display fields for which values for the parameter were provided.

- The selective use of parameters can also be used while converting existing filters into advanced conditions.

- If no cases are found that match the querying criteria, a warning message appears.
Click View Query to return to the Advanced Conditions Editor, modify the criteria and execute again.

- If the cases that match the query criteria are found, the ACTIVE CASE SERIES page appears with the list of such cases.

18. Examine the case series. If the case series is too large, you may want to modify the advanced condition by specifying additional attributes or changing values.
Alternatively, if you find the case series to be appropriate, you can save the advanced condition to the system.

The system retrieves the matching cases from the data mart and displays them in the ACTIVE CASE SERIES page.

Note:
If the Argus Insight case series are created by using the Argus Mart advanced condition, then these case series records only case IDs, case revision effective start dates, and query criteria (as a text string).

6.1.1 Saving and Providing Point-in-Time Query Date

1. On the ACTIVE ADVANCED CONDITIONS EDITOR page, from the Category drop-down list, select a category.

2. In the Description field, enter a description of the advanced condition.
For example, you may describe the type of cases the advanced condition retrieves.

3. In the Query Type field:

1. To execute the query based on current data, select Current Data.
The As of Date field is disabled.

2. To execute the query based on historical data, select As of Date.

3. To execute the query based on one or more user lock actions, select At Lock.

4. To view the most recent locked revisions that were committed to the database on or before As of Date, select Last Locked Revision as of a Point in Time.
For steps 3b to 3d, the As of Date field is enabled.

In the As of Date field, enter the date based on which advanced condition will be executed.

Note:
As of Date field contains date-time, populated with ETL high water mark as the default value for all query types.
As of Date cannot be greater than ETL high watermark or less than ETL low watermark.

5. To view the most recent locked revision for case versions in a time period, select Last Locked Revision for a Version in a Period.
The Last Locked Revision for a Version In a Period dialog box appears.

i. To execute the query based on the receipt date, select Case Receipt Date (default), and enter dates in the From and To fields. Click Save.

ii. To execute the query based on the lock date, select Case Lock Date, and enter dates in the From and To fields. Click Save.

iii. To execute the query based on the creation date, select Case Creation Date, and enter dates in the From and To fields. Click Save.

6. To view the most recent locked revision for case versions for a specific time period, select Aggregate Queries.
The Aggregate Queries dialog box appears.

i. Enter the date range for the Case Receipt Date in From and To fields, and click Save.

Based on the selected date range, only the last locked revision of a case for the version falling in that period based on initial/follow-up receipt date are displayed. Post lock revisions are also displayed

ii. To view the latest unlocked revision of the cases, select Include Unlocked Cases.

4. Click Save.
The Advanced Condition - Save dialog box appears.

5. In the Name field, enter the name of the advanced condition.

6. Click OK to save the advanced condition and refresh the ACTIVE ADVANCED CONDITIONS EDITOR page.
Note that:

- The Active Query Name field in the upper-right corner of the page now displays the name of the advanced condition you specified while saving the advanced condition.

- The Save As, View SQL, and Permissions buttons are now enabled.

Note:
The ADVANCED CONDITION LIBRARY page lists all the advanced conditions saved to the system. See "Working with Saved Advanced Conditions" for more information.

Tip:
If the field values are modified after saving the advanced condition to the system, click Save to save the changed field values.

7. Click View SQL to view the underlying SQL query for the advanced condition.
Note that the creation of advanced conditions custom SQL on Argus Mart requires the use of CASE_MASTER table instead of V_RTP_CASE, and additional EFFECTIVE_START_DATE in the query.

1. Modify the SQL, if necessary.

2. Click Save SQL after editing the query.

Note:
When using the Save SQL functionality, the advanced condition can be executed only from the ADVANCED CONDITIONS LIBRARY page.

Tip:
Revert to Original lets you to revert back to the original advanced condition. This button is enabled only when you edit the SQL.

3. Click Close.

8. To assign group-level permissions on the saved advanced condition, click Permissions.
The Permissions dialog box appears with the names of all the groups (except the Administrator group) that the system administrator has created.

9. To assign permissions to the group members on the advanced condition you have created, use the drop-down list next to a group name. The available options are:

Permission

Description

R/W/D/P

Group members will be able to view, modify, delete, and assign permission on the advanced condition.

R/W/D

Group members will be able to view, modify, and delete the advanced condition.

R/W

Group members will be able to view and modify the advanced condition.

R

Group members will be able to only view the advanced condition.

No Access (Default)

No group members will be able to access the advanced condition.

Note:
The author of the advanced condition always has the highest level of permission (R/W/D/P) on it. For example, suppose you belong to the Data Entry group and you assign the No Access permission level to the Data Entry group on an advanced condition that you create. In this case, you will continue to have the highest level of permission on your advanced condition; other members in your group cannot access your advanced condition.

10. Click OK to save the permission settings.

11. Click Execute to generate the case series.

- The ACTIVE CASE SERIES page appears with the matching cases from the data mart.

- If any runtime parameters are configured, the Parameters dialog box appears.
Specify the parameter values by using the options in the dialog box, and click Execute.

The ACTIVE CASE SERIES page appears with the matching cases from the data mart.

Note:
The case series generated using Argus Mart data source also displays EFFECTIVE_START_DATE/LOCKED_DATE in the Case Series Editor page.

See Chapter 7, "Working with Case Series" for more information.

6.1.2 Returning to the Advanced Conditions Editor

Refer to Chapter 5 > "Returning to the Advanced Conditions Editor".

6.1.3 Assigning a Category to an Advanced Condition

Similar to assigning categories to Insight advanced conditions, you may assign categories to advanced conditions created on Argus Mart.

For more details, refer to Chapter 5 > "Assigning a Category to an Advanced Condition".

6.1.4 Using and Ordering Advanced Condition Operators

Each SQL generated on Argus Mart contains EFFECIVE_START_DATE for supporting point-in-time querying.

The following is the syntax of PL/SQL generated on Argus Mart:

SELECT
table1.common_column
FROM
Table1, table2, table3
WHERE
Table1.column2 = table2.column2
AND
Table2.column3 = table3.column3
INTERSECT
SELECT
Table4.common_column
FROM
Table4, table5, table6
WHERE
Table4.column2 = table5.column2
AND
Table5.column3 = table6.column3

For more details, refer to Chapter 5 > "Using and Ordering Advanced Condition Operators".

6.2 Working with the Last Modified or Saved Advanced Condition

The system assigns an active status to a advanced condition when you modify and save it or when you execute it. Unless you save the modifications to another advanced condition or execute another advanced condition, the last advanced condition you modified or executed remains active. This is helpful in situations when you want to access a frequently used advanced condition.

To work with last modified or saved advanced condition:

- For Argus Insight database, select Active (Insight Mart)

- For Argus Mart database, select Active (Argus Mart)

To view an active advanced condition:

1. Navigate to Queries > Advanced Condition > Active (Argus Mart).
The ACTIVE ADVANCED CONDITIONS EDITOR page appears with data source and the advanced condition you executed or modified last.

2. If the active advanced condition was saved to the system before executing, the name of the advanced condition appears next to the Active Query Name and in the Name field.
However, if the active advanced condition was not saved to the system before executing, the text <Not Saved> is displayed next to the Active Query Name label.

You can enter the name of the advanced condition in the Name field and click Save.

To rename an already saved advanced condition, in the Name field, enter the new name, and click Save.

From the ACTIVE ADVANCED CONDITION page, you can perform the following tasks:

Task

Description

Modify the attributes in the Advanced Conditions Editor

If required, you can modify the attributes (fields and values) in the Advanced Conditions Editor. See "Creating a New Advanced Condition" for more information.
Click Save to save the changed field values. This button is only available for a saved active advanced condition.

Save Active Advanced Condition with another name

Click Save As to save the active advanced condition by a different name.
The ADVANCED CONDITIONS LIBRARY page lists all the advanced conditions saved to the system. See "Working with Saved Advanced Conditions" for more information.

View the Advanced Condition in SQL

Click View SQL to view the underlying SQL query for the advanced condition.

Assign Permissions

Click Permissions to set the group-level access permissions on the advanced condition. See "Creating a New Advanced Condition" for more information.
The Permissions button is only available for saved active advanced conditions.

Change the Description of the Active Advanced Condition

You can change the description of the active advanced condition by modifying the text displayed in the Description field.
Click Save to store the changed description.

Execute the Active Advanced Condition

Click Execute to generate a case series by using the active advanced condition.

Note that modifying the field values in the Advanced Conditions Editor for an active advanced condition or saving the active advanced condition by a different name changes the active advanced condition to reflect the most recent changes. The active advanced condition also changes in case you modify the field values in the Advanced Conditions Editor and execute the advanced condition without saving the modifications.

6.3 Working with Saved Advanced Conditions

Refer to Chapter 5, "Working with Saved Advanced Conditions".

6.3.1 Searching Saved Advanced Conditions

Refer to Chapter 5 > "Searching Saved Advanced Conditions".

6.3.2 Creating a New Advanced Condition

See "Creating a New Advanced Condition" for details.

6.3.3 Modifying an Advanced Condition

1. Navigate to the ADVANCED CONDITIONS LIBRARY page.

2. Select the advanced condition you want to modify.

3. Click Modify.

4. Make your modifications to the advanced condition.

5. Click Save to save your changes.
Alternatively, click Save As to save the modified advanced condition by another name.

6.3.4 Modifying the SQL of an Advanced Condition

1. Navigate to the ADVANCED CONDITIONS LIBRARY page.

2. Select the advanced condition.

3. Click Modify.
The ACTIVE ADVANCED CONDITIONS EDITOR page appears.

4. Click View SQL.
The Advanced Conditions SQL dialog appears.

5. Modify the SQL.

6. Click Save SQL to save your changes.

7. Click Close to return to the ADVANCED CONDITIONS LIBRARY page.

8. Select the modified advanced condition.

9. From the Query Type drop-down list, select:

- Current Data—Executes the custom SQL based on the current data and returns the latest revisions of the cases.

- As of Date—Executes the modified SQL based on the historical date.

- At Lock—Executes the modified SQL based on one or more user lock actions.

- Last Locked Revision as of a Point-in-Time—Executes the modified SQL to display the most recent locked revisions that were committed to the database on or before As of Date.

- Last Locked Revision for a Version in a Period—Executes the modified SQL to display the most recent locked revision for case versions in a time period based on Case Receipt Date, Case Lock Date, or Case Creation Date.

- Aggregate Queries—Executes the most recent locked revision for case versions for a specific time period.

You cannot edit the date for an Advanced Condition with Custom SQL from the library.

Once executed the query criteria displays the custom SQL as-is, and does not mentions the Query Type.

Note:
The custom SQL should begin with:

SELECT DISTINCT CASE_MASTER.CASE_ID,CASE_MASTER.EFFECTIVE_START_DATE FROM CASE_MASTER

10. Click Execute.
The search results appear based on your modified SQL.

Note:
You cannot modify an advanced condition once you have added user defined SQL in that, you can modify SQL but cannot add new items in advanced condition.
If you want to add new items, you have to revert the SQL to original by clicking Revert to Original.

6.3.5 Deleting an Advanced Condition

Refer to Chapter 5 > "Deleting an Advanced Condition".

6.3.6 Executing an Advanced Condition

Refer to Chapter 5 > "Executing an Advanced Condition".

6.3.7 Executing a Saved Advanced Condition on the Active Case Series

Just as the system assigns the active status to an advanced condition when you save modifications to it or execute it, the last saved or generated case series becomes the active case series.

You may want to run an advanced condition on an active case series.

To narrow down the list of cases in the active case series:

1. Generate the case series to run another Value Set:

- You may generate the case series by either using QBE, filters, or advanced conditions. This case series becomes the active case series and remains so until you execute another query to generate a different case series.

- Alternatively, if the case series on which you want to run another Value Set is already saved in the system, navigate to Case Series > Open Case Series > Library.
The CASE SERIES LIBRARY page appears.

Select the case series, and click Make Active.

2. Navigate to Queries > Advanced Conditions > Library.
The ADVANCED CONDITIONS LIBRARY page appears.

3. Select the advanced condition to run on the active case series you generated in Step 1.

4. Select the Limit Query to Active Case Series check box.

Note:
The Limit Query to Active Case Series check box is enabled:

- When the selected active case series and advance condition are of same type (Insight Mart/Argus Mart).

- When Argus Aggregate case series is active.

5. Click Execute.
The ACTIVE CASE SERIES page appears with the execution results of the selected advanced condition on the active case series.

Note that the case series you just generated becomes the active case series.

7 Working with Case Series

When you execute a QBE, a filter, or an advanced condition, Argus Insight generates a list of cases that match the querying criteria. This list of cases is called a case series. Argus Insight displays the case series in a listing format on the ACTIVE CASE SERIES page.

The case series is the communication foundation between all modules of Argus Insight.

If the Argus Insight case series are created by using the Argus Mart advanced condition, then these case series records only case IDs, case revision effective start dates, and query criteria (as a text string).

Note:
The case series might become obsolete each time the data mart is refreshed by running an ETL because new cases with similar attributes might get added to the data mart.

7.1 Working with the Active Case Series

7.1.1 Viewing the Active Case Series

The system assigns the active status to the case series that was last generated by executing a query. Only one case series can be active at a time. The last case series generated remains active until you:

- Generate another case series.

- Save modifications to an existing case series.

- Manually assign the active status to a case series that has been saved to the case series library.
See "Making a Case Series Active" for details.

To view the active case series, navigate to Case Series > Open Case Series > Active.

The ACTIVE CASE SERIES page appears with the last case series that is executed, modified, or manually made active.

The ACTIVE CASE SERIES page displays different fields based on the type of the point-in-time query used to generate the case series.

- The Effective Start Date field appears for Current Data, and As of Date queries with the most recent revisions available in Argus Safety regardless of whether the cases are locked or unlocked, and historical data respectively.

- The Locked Date field appears for At Lock, Last Locked Revision as of a Point in Time, and Last Locked Revision for a Version in Period queries with locked date for all the case revisions which are returned in the case series.
The tool tip for this field also displays <Locked Date> (<Effective Start Date>) values for each row.

7.1.1.1 Active Case Series and Active Query Names

On the ACTIVE CASE SERIES page, note that:

- The Active Query Name label displays the name of the saved query (QBE, filter, or advanced condition) that generated the case series. If the query was not saved, the label displays the text <Not Saved>.
Now, Argus Insight supports two Active Queries: Active Query for Argus Mart and Active Query for Insight Mart.

- The Active Case Series label displays the text <Not Saved> until you save the case series by a name. Similarly, the Name field displays the text <Not Saved> until you save the case series by a name.
You can enter the name of the case series in the Name field, and click Save.

To rename an already saved case series, enter the new name in the Name field, and click Save.

7.1.1.2 Sorting, Searching, and Navigating

On the ACTIVE CASE SERIES page, use the tools in the table header to sort, search, and navigate through the list of cases.

- To sort the list by a specific column, click the arrow icon next to a column heading.

- To filter the list, enter search criteria into one or more of the fields below the column headings, and then click Search.

Note:
If you search for a text comprising an underscore, it is treated as a wildcard and is replaced by a letter in the displayed results. For example, If you have queries with names - CURE, CORE, and CARE and you search for C_RE, all three queries are displayed in the result.

- To move forward and backward through the pages of case series, click the Page Navigation icons. A page displays 50 cases.

When you export the data to a Microsoft Excel file, the system retains any changes you made to the sorting and filtering order.

See "Exporting a Case Series to Microsoft Excel" for more information.

Note:
The ACTIVE CASE SERIES page displays different fields (Effective Start Date/Locked Date) based on the type of the point-in-time query used to generate the case series.

7.1.2 Saving the Active Case Series

Before you can save a case series, you must enter a description for the case series in the Description field.

If you have not saved the active case series to the system yet, click either Save or Save As to assign a name to the case series and save it to the Case Series library.

If you are modifying a case series that is already saved, click Save to save your modifications or click Save As to save the case series by another name.

Note:
All the Argus Aggregate Case Series will be saved under Compliance category by default after copying these from Argus Safety database through ETL process.
Besides, the Save As option for Aggregate Case Series will save the case series as Argus Mart case series.

7.1.3 Viewing the Criteria that Generated the Active Case Series

Use one of the following options to view the query criteria that generated the active case series:

- To return to the appropriate Queries page (QUERY BY EXAMPLE page, FILTER VALUE SET page, or ADVANCED CONDITIONS EDITOR page) and view the query criteria that generated the case series, click View Query.
The View Query button is enabled only if the active case series is not yet saved to the system.

- To view the query criteria in a statement format, click View Query Criteria. The Query Criteria dialog box opens and displays the query.

7.1.4 Assigning Group-Level Access Permissions

You can assign group-level access permissions for the case series. These permissions determine which user groups will be able to view, modify, or delete a case series.

Note:
You can set permissions only on case series you saved to the system.

To set case series permissions:

1. Navigate to Case Series > Open Case Series > Active.
The ACTIVE CASE SERIES page appears.

2. To assign group-level permissions on the saved case series, click Permissions.
The Permissions dialog box appears with the names of all the groups (except the Administrator group) that the system administrator has created.

Note:
For Argus Aggregate case series, the Permission button will be enabled if you have permission to share case series in Case Editor page.
For example, if Argus Aggregate case series is shared to any Argus Insight group (Group_1) using the Permission settings, then the shared aggregate case series will be available to all the users belonging to that group (Group_1). This permission will not be effected by Argus Mart ETL.

3. To assign permissions to the group members on the case series you have created, use the drop-down list next to a group name. The available options are:

Permission

Description

R/W/D/P

Group members will be able to view, modify, delete, and assign permission on the case series.

R/W/D

Group members will be able to view, modify, and delete the case series.

R/W

Group members will be able to view and modify the case series.

R

Group members will be able to only view the case series.

No Access (Default)

No group members will be able to access the case series.

Note:
The author of the case series always has the highest level of permission (R/W/D/P) on the case series. For example, suppose you belong to the Data Entry group and you assign the No Access permission level to the Data Entry group on a case series that you generate. In this case, you will continue to have the highest level of permission on your case series; other members in your group cannot access your case series.

4. Click OK to save the permission settings.

7.1.5 Adding an Annotation to a Case

A case annotation is the addition of notes to a case. For example, you may want to add explanatory notes, critical comments about the case, or updates for the reporter. Adding relevant and important information about a case makes for better understanding of that case.

7.1.5.1 About Case Annotations

A case annotation:

- Supports a maximum of 200 characters.

- Is saved with the case series. Once entered, an annotation is saved for the case series. You do not need to explicitly save a case series to save the annotations.

- Is applicable for the case in only the same case series where it was saved. It is not applicable even for the same case if the case is in a different case series.

- Is frozen along with a frozen case series. Therefore, you cannot edit, add, or delete an annotation in a frozen case series.

- Is copied to a new case series if the case series where it was created is also copied.

- Is exported to Microsoft Excel when you use the Export to Excel feature.

- Is kept with a case if the case series is subsetted.

- Is retained when the case series merges with another case series. As shown in the following graphic, the Case Series #1 section title on the CASE SERIES MERGE page includes a statement that the notes from this series will be preserved in the merged case series:

If you can access a case series, you can access its corresponding case annotations.

7.1.5.2 Annotations in the Active Case Series

For any case in the active case series, you may include an annotation with the case.

To add an annotation to a specific case:

1. Navigate to the ACTIVE CASE SERIES page.

2. Select the case that you want to annotate.

3. In the Notes column, click the Annotate icon.

4. From the drop-down menu, select Annotate.
The Case Annotation dialog box appears.

5. Enter notes, comments, or remarks about the case.

6. Click Save & Close.

The selected case is updated with the annotation. In addition, the Notes column displays the beginning text of the annotation.

To view the complete annotation, position the cursor over the Annotate icon.

To modify or delete an existing annotation, open the Case Annotation dialog box, edit the text, and save your changes.

7.1.5.3 Annotations in Advanced Conditions

To use annotations when you create an advanced condition, navigate to Case Series, Cases, and select Case Annotations. This field is a freehand text field and supports single select only.

This note is not available in Argus Safety and does not impact the case series in Argus Safety.

7.1.6 Adding a Case to a Case Series

If required, you can modify the case series by adding cases manually.

To add a case to the case series:

1. Navigate to the ACTIVE CASE SERIES page.

2. Click the Add Case icon on the left bar.
The Add Case to Case Series dialog box appears.

3. Enter the case number to add to the case series manually.

4. To select the reason to modify the case series, click the Justification field.
Alternatively, you may type your own justification text to explain why you are modifying the case series.

In addition, you may define the choices that Argus Insight lists for the Justification field by using the Case Series Modification Justification option in the List Maintenance tab on the ADMINISTRATION TOOLS page.

5. Click OK.

- If the case number you specified exists in the data mart, the system adds the case to the case series and saves the changes. A message dialog box reports that the case number was successfully inserted.

- If the case number you specified does not exist in the data mart, the system displays an error message. For example:

6. Click OK to close the message dialog box.

7.1.7 Deleting a Case from a Case Series

1. Navigate to the ACTIVE CASE SERIES page.

2. Select the case you want to delete.

3. Click the Delete Case icon on the left bar.
The Delete Case Number dialog box appears.

4. To select the reason to delete the case, click the Justification field.
Alternatively, you may type your own justification text to explain why you are deleting the case.

In addition, you may define the justification choices that Argus Insight lists for the Justification field by using the Case Series Modification Justification option in the List Maintenance tab on the ADMINISTRATION TOOLS page.

5. Click OK to delete the case from the case series and saves the changes.

7.2 Working with Case Series Saved in the Library

When you execute a QBE, a filter, or an advanced condition, Argus Insight generates a list of cases that match your query criteria. This list of cases is called a case series.

You can choose to save a case series for future reference. You provide a brief description and a unique name for the case series; the system stores all saved case series in the Case Series library.

7.2.1 Opening the CASE SERIES LIBRARY Page

The CASE SERIES LIBRARY page, lists all the case series saved to the system.

To open the CASE SERIES LIBRARY page, navigate to Case Series > Open Case Series > Library.

The CASE SERIES LIBRARY page displays the following information for each case series:

- Name of the case series.

- Brief description of the case series.

- Date when the case series was last modified.

- Name of the user who generated the case series.

- Category assigned to the case series.
For example, Compliance, General, Management, or Pharmacovigilance.

- Source of the case series.

- Argus Insight indicates the case series was generated using Argus Insight querying tools.

- Argus Mart indicates the case series was generated using Argus Mart querying tools.

Note:
To import Argus Insight or Argus Mart based case series, see "Importing a Case Series from an External Source".

- Argus Aggregate indicates the case series was imported into Argus Insight (for Argus Mart data source only) from Argus Safety via ETL process. These case series belongs to Argus periodic/aggregate reporting.
Access permission for all the Aggregate Case Series are brought over from Argus Safety database to Argus Insight. You may access Aggregate Case Series, only when you have access to Argus Safety or Argus Insight, assigned from Argus Insight Group Permissions.

For more information in Group Permissions, see Assigning Group-Level Access Permissions.

All Aggregate Case Series fetched from Argus Safety will have query criteria as Argus Aggregate Case Series.

To view all these case series, select Include Aggregate Case Series check box. This check box is disabled if there are either no Aggregate Case Series in Argus Insight database or you do not have access to any of the Aggregate Case Series. This check box is not available when application is running on Insight Mart data source only.

- Number of cases in the case series.
In addition, the Cases column displays the following icons:

- For Argus Insight Case Series—A snowflake icon if the case series is frozen. Positioning the cursor over the icon displays the date and time the case series was frozen.

- For Argus Mart Case Series—A snowflake icon along with the case counts for all case series other that Current Data. Positioning the cursor over the icon displays the type of the case series.

7.2.2 Searching for a Saved Case Series in the Library

You can search a saved case series by its name, description, modified date, author, category, and source. You can enter a value for one, several, or all search fields to find a saved case series.

To search for a saved case series:

1. Navigate to the CASE SERIES LIBRARY page.

2. Enter search criteria into one or more of the fields below the column headings.
To search for a case series:

- By its name, type the name of the case series in the Name field.

- By its description, type part of the description in the Description field. The system searches for the specified text string in all case series descriptions.

- By its date of modification, enter the modification date in the first Last Modified date field. To specify a date range, type the start and end dates in the first and second date fields, respectively.

- By its author, select the author name from the User Full Name field.

- By its category, select the category from the Category field.

- By its source, select the source from the Source field.

Note:
If you search for a text comprising an underscore, it is treated as a wildcard and is replaced by a letter in the displayed results. For example, If you have queries with names - CURE, CORE, and CARE and you search for C_RE, all three queries are displayed in the result.

3. Click Search.
The search results appear based on the specified criteria.

- To sort the search results, click the sort icon next to a column header.

- To clear the search results and list all the saved case series, click Clear.

7.2.3 Making a Case Series Active

1. Navigate to the CASE SERIES LIBRARY page.

2. To view Argus Aggregate Case Series, select Include Aggregate Case Series check box.

3. Select a case series to make active.

4. Click Make Active.
The Active Case Series label in the upper-right corner of the CASE SERIES LIBRARY page displays the name of the case series you made active.

7.2.4 Modifying a Case Series

You may want to modify an existing case series by adding cases to it or deleting existing cases. You can also change the group-level access permissions on the case series.

To modify a case series:

1. Navigate to the CASE SERIES LIBRARY page.

2. Select the case series you want to modify.

3. Click Modify.
See "Working with the Active Case Series" for detailed information about making modifications to the case series and setting permissions.

7.2.5 Merging Case Series

Argus Insight lets you create a new case series by merging two case series through a set operator. The set operator you select works on the case numbers. The case numbers included in the merged case series depend on the type of set operator you use:

- Union — Creates a new case series that contains all the cases in both case series; common case numbers are included, and are listed only once.

- Intersect — Creates a new case series that contains only those case numbers that exist in both case series.

- Minus — Creates a new case series that contains only those case numbers that are present in the first case series, but are not present in the second case series.

To generate a merged case series:

1. Navigate to the CASE SERIES LIBRARY page.

2. Click Merge.
The CASE SERIES MERGE page appears.

3. From the Data Source drop-down list, select a data source (Insight Mart/Argus Mart).
Based on the selected data source, the list of case series in both the columns Case Series #1 and Case Series #2 are updated.

Note:
Argus Aggregate case series are available for merging only when Data Source from the drop-down list is selected as Argus Mart. Beside, merged aggregate case series will be reflected as Argus Mart.

4. Select the two case series to merge:

1. From the Case Series # 1 list, select the first case series.

2. From the Case Series # 2 list, select the second case series.

Note that the system populates the Description and Author fields for each selected case. You may modify the information if necessary.

5. Select the Action (set operator) to merge the two selected case series.
As described previously, you can select one of the following actions:

- Union — Creates a new case series that contains all the cases in both case series; common case numbers are included, and are listed only once.

- Intersect — Creates a new case series that contains only those case numbers that exist in both case series.

- Minus — Creates a new case series that contains only those case numbers present in the first case series, but not present in the second case series.

6. For Data Source as Argus Mart, from Merge Type drop-down list, select:

- Current Data—To save single revision per case after UNION/INTERSECT/MINUS. Every time you open the saved case series, the latest data in case series is displayed.

- Latest Revision—To save single revision per case after UNION/INTERSECT/MINUS. Saved Revision will be the highest revision of the case at the time of operation. Every time you open the saved case series, data as per saved revision is displayed.

- All Revisions from Source—To save all the revisions after UNION/INTERSECT/MINUS. Every time you open saved case series, the data as per saved revision is displayed.

To view Locked Date in the Case Series Editor page for the merged case series, select Show Locked Date.

7. Click Merge.
The ACTIVE CASE SERIES page appears with the resultant case series.

7.2.6 Importing a Case Series from an External Source

You can import a case series from an external source into Argus Insight. The requirements are as follows:

- The external source file can be a text (TXT) file or a comma-separated values (CSV) file.

- Each case number in the file must be on a new line.

- Each case number must be separated by a line return (Enter) or a semicolon (;).

To import a case series from an external source into Argus Insight:

1. Navigate to the CASE SERIES LIBRARY page.

2. Click Import.
The Select File For Import dialog box appears.

3. From the Target Data Source drop-down list, select a data source (Insight Mart/Argus Mart).

4. To locate and select the external case series source file, click Browse.
Alternatively, in the File field, enter the file name with its complete system path.

5. Verify if the first row in your TXT or CSV file has the column headings. If so, be sure to select the First row contains column header(s) check box.

6. Click OK.
The Import Case Series dialog box appears with the status of the import operation.

Note:
To view the import operation log, click View Log.

7. Click OK to display the imported case series on the ACTIVE CASE SERIES page.

7.2.7 Deleting a Case Series from the Library

1. Navigate to the CASE SERIES LIBRARY page.

2. Select Include Aggregate Case Series check box.

3. Select the case series to delete.

4. Click Delete.
A confirmation dialog box appears.

5. Click OK.
You return to the CASE SERIES LIBRARY page.

Note:
When Argus Aggregate Case Series is deleted from Argus Insight, it will be re-populated if that case series is still available in Argus Safety. Beside, when any Aggregate Case Series is deleted from Argus Safety then it will also be deleted from Argus Insight.

7.2.8 Viewing the Query Criteria that Generated the Case Series

1. Navigate to the CASE SERIES LIBRARY page.

2. Select a case series.

3. Click Query Criteria to open the Query Criteria dialog box and display the query in an SQL-statement format.

Note:
For a saved case series, you can view the query details only in a SQL-statement format in the Query Criteria dialog box.
However, for an active case series that is not yet saved to the system, you can view the query details within the query tool interface as well as in the SQL-statement format. See "Viewing the Criteria that Generated the Active Case Series" for more information.

7.3 Sharing Case Series with Argus Safety Web

You can share cases between Argus Safety Web and Argus Insight.

To enable case sharing between these two applications, you need a common user name (ID) and password for Argus Safety Web and Argus Insight. If you do not have a valid user ID in Argus Safety Web, the system displays the following error message:

Your user ID is not present in Argus.

Note:
Import from Argus Safety option is available only when the target data source is selected as Insight Mart or Both (Insight Mart and Argus Mart).

To share cases between Argus Insight and Argus Safety Web:

1. Log in to Argus Insight.

2. Navigate to Case Series > Open Case Series > Import from Argus Safety.
The list of active case series appears from Argus Safety Web.

The active case series present in Argus Safety are now the active case series in Argus Insight.

Note:
An error message appears if there are no cases present in the active series of Argus Safety.

3. Click Save or Save As to save the case series.

7.4 Exporting a Case Series to Microsoft Excel

1. Create a new query using a QBE, a filter, or an advanced condition, or open a saved query from the Query library.

2. Click Execute to open the ACTIVE CASE SERIES page with the list of cases.

3. Make adjustments to the listing, if necessary. You can sort the list or enter search criteria to filter the list. The system retains the sorting and filtering order when you export the data to a Microsoft Excel file.

4. Click Export to Excel. The File Download dialog box opens and prompts you to open or save the Microsoft Excel file.

- To open the Excel file and view the case series results, click Open.

- To save the Excel file to your system, click Save.
The system prompts for the location to save the file. Once the file is saved, you can open the file and view the case series results.

The Excel spreadsheet has two tabs:

- The Case Series tab provides information about each case in the case series, including the case number, report type, primary company product, primary event, seriousness criteria, and outcome.

- The Case Series Details tab provides information about the entire case series, including the name specified when the case series was saved, the total number of cases in the series, the description specified when the case series was saved, and the query criteria (in SQL-statement format) used to generate the case series.

7.5 Freezing and Unfreezing Case Series Data

Note:
The Freeze and Unfreeze functionality is available for Insight Mart only. Argus Mart case series cannot be frozen. The Freeze and Unfreeze buttons are not available for Argus Mart.

Before you freeze the data in a case series, review the information in this section to understand the restrictions and usage for frozen case series.

- Access Rights
System administrators define the freeze and unfreeze access rights when creating user groups.

You can freeze and unfreeze case series only if you have the access rights (privileges).

- Working with Frozen Case Series
When you work with frozen case series, note that:

- You cannot insert cases into a frozen case series.

- You cannot share a frozen case series with Argus Safety.

- You can delete cases from a frozen case series.

- When you run a query or an advanced condition against a frozen case series, Argus Insight uses the frozen data.

- The link to the Medical Review dialog box accesses the latest data for the case.

- The following Argus Insight features do not require all case data to be frozen:

- Copy Configuration utility

- Derivation rules

- List Maintenance Items and Derivation Rules in a Frozen Case Series

- List Maintenance items are not frozen. Therefore, some reports will have a mismatch of List Maintenance items and the frozen case series data.

- The derivation rules operate against current case data if the List Maintenance rules are modified. The frozen case series are shown if there is a change in the case data resulting from the derivation rules.

- If suppress condition is checked in the derivation rule, then List Maintenance records related to the derivation rule will not be deleted in cases used in the frozen case data table.

7.5.1 Freezing a Case Series

You can freeze a custom case series when editing the case series from the CASE SERIES LIBRARY page.

To freeze the existing cases in a case series:

1. Navigate to the CASE SERIES LIBRARY page.

2. Select a case series.

3. Click Freeze Case Series.
The Freeze Case Series dialog box appears.

4. Enter a name for this frozen case series.

5. Click OK.
The system freezes and saves the case series with the specified name.

7.5.1.1 Recognizing a Frozen Case Series

To indicate that a case series is frozen, the Cases column on the CASE SERIES LIBRARY page displays a snowflake icon. Positioning the cursor over the snowflake icon displays the date and time the selected case series was frozen.

7.5.1.2 Freezing and Saving Case Series

You can freeze any system-generated case series (active or inactive) (for example, using Argus Insight queries, filters, and advanced conditions) by clicking Freeze and Save.

The system freezes the case series and then displays the standard Case Series Save dialog box. You must enter a name for the saved case series.

If you have not yet saved the case series from the ACTIVE CASE SERIES page, and you click Freeze and Save, the system saves only one copy of the frozen case in the library. The frozen case series is now the active case series.

On the CASE SERIES LIBRARY page, you can position the cursor over the snowflake icon in the Cases column to view the date and time the selected case series was frozen.

7.5.2 Unfreezing Case Series Data

On the CASE SERIES LIBRARY page, you have the option to unfreeze a currently frozen case series. Unfreezing a case series forces Argus Insight to retrieve the latest information for all the cases in the series.

When you unfreeze a case series, you must provide a justification, or reason, for this action. You can either type a new justification or select a preconfigured justification.

If you have access rights to the List Maintenance tab on the ADMINISTRATION TOOLS page, use the Case Series Un-Freezing Justification option to configure one or more justifications that can be selected when you unfreeze a case series. You can add new justifications, modify existing justifications, or delete an existing justification.

To unfreeze a case series that is currently frozen:

1. Navigate to the CASE SERIES LIBRARY page.

2. Select the frozen case series to unfreeze.
If a case series is frozen, the Cases column displays a snowflake icon for that series.

The Un-freeze Case Series button is enabled only if you select a case series that is frozen.

3. Click Un-freeze Case Series.
The Un-freeze Case Series dialog box appears.

4. From the Justification drop-down list, select the reason to unfreeze the case series.
Alternatively, you may enter your own justification text to explain why you are unfreezing the case series.

In addition, you may define the choices that Argus Insight lists for the Justification field if you have access rights to the Case Series Un-freezing Justification option in the List Maintenance tab on the ADMINISTRATION TOOLS page.

5. Click OK.
The system retrieves the latest information for all the cases in the series, refreshes the CASE SERIES LIBRARY page, and displays the updated case series in the list.

In addition, system removes the snowflake icon from the Cases column because the case series is no longer frozen.

7.6 Using the Link to Argus Safety Medical Review

On the ACTIVE CASE SERIES page, you can click a link in the Case Number column to access Argus Safety and open the Medical Review dialog box in read-only mode.

All reports that can be executed from the Medical Review dialog box are available to you.

You may not be able to link successfully to the Medical Review dialog box for the following reasons:

- If you do not have access to the case from an Argus Safety perspective, the system displays the following message:
user_name does not have access to the case in Argus Safety.

- If you try to access a case that has been deleted since the last ETL, the system displays the following message:
This case has been deleted in Argus Safety since the last ETL.

- If Oracle Access Manager (OAM) is not enabled in Argus Safety and Argus Insight, and you log in to Argus Insight without logging through Argus Safety, the system displays the following message:
user_name is not logged into Argus Safety.

8 Generating and Scheduling Standard Reports - BIP

Argus Insight provides built-in Reports that you can run on active case series to analyze your company's safety, workflow, and product data.

In addition to the preformatted and predefined BIP standard reports, you can create custom reports using the BI Publisher tool. For more information, see Chapter 9, "Creating Custom Reports - BIP."

8.1 About BIP Standard Reports

Although BIP standard reports are predefined reports, you can define pre-filters before generating a BIP standard report to have the report output display information only about specific types of cases. Pre-filters let you narrow down the case series further so that the system runs the report only on those cases that conform to the pre-filter criteria.

For example, suppose your case series consists of cases that were reported in all countries for a particular product. However, you only want information about cases reported in the United States. In this case, you can specify a pre-filter such that the report output includes only those cases that were reported in the United States.

8.1.1 Case Series, ETL, and Association

Because a case series might become obsolete each time the data mart is refreshed by running an ETL, you may need to generate the case series again before generating a BIP standard report.

Alternatively, you can directly associate a query (QBE, filter, or advanced condition) to a BIP standard report to avoid manual generation of the case series.

8.1.2 Browser Configuration

Before using Argus Insight to generate reports, configure the browser as defined in the Oracle Argus Insight Installation Guide.

8.1.3 Report Cover Page

The report cover page has three main sections:

- Page header

- Page contents

- Page footer

You can customize some of the information on the report cover page. The sections that follow provide more information about each component of the cover page.

8.1.3.1 Page Header

The page header of the report cover page includes the following information:

- Company logo. The upper-left box is a placeholder for a logo. You can configure your company logo to print in this space.

- Name of the category to which the selected report belongs. For example, Compliance, Management, or Pharmacovigilance.

- Date and time (Greenwich Mean Time [GMT]) that the report was run.

8.1.3.2 Page Contents

The page contents of the report cover page includes the following information:

- Title of the selected report.

- Report subtitle. You configure the subtitle when you run the report. Subtitles are useful in further defining the contents of the report. For example, 01-JAN-2000 to 31-DEC-2012.

- Filters defined for the selected report.

- Start date and time (GMT) of the last successful ETL run.

- Count of the total number of unique cases in the case series.

- Name of the saved case series on which the report has been executed.

- Reports that are run on frozen case series data include the following text next to the case series name on the report:
The data in this report was frozen as of date_and_time.

Time is the database system time with the GMT offset.

- Reports that are run on normal case series data include the following text next to the case series name on the report:
The case series was last modified on date_and_time.

- Query criteria to get case series on which the report has been executed.

8.1.3.3 Page Footer

The page footer of the report cover page includes the following information:

- Name of the user who executed the report.

- Confidential text. You can configure the text that prints in the center of the page footer.

- Page number (Page x of y).

In addition, some reports include a placeholder in the footer for another logo. You can configure the image for the logo.

8.2 Working in the Reports Page

The Reports page, lists all the BI Publisher reports built in to Argus Insight.

To display the Reports page:

1. Select Reporting > BI Publisher.
The BIP login page appears in new window.

2. Log on to the BI Publisher tool.
The BIP Home page appears.

3. Click Catalog.

4. In the Folders section, navigate to Shared Folders > Argus Insight > General > Reports.
The Generic Line Listing Report in LE and RTF formats appears in the right pane.

8.3 Generating Reports

1. Click the Report link or Open on the Reports page.
The Generic Line Listing Report-LE page appears.

2. Enter the values for all the fields and select the Output Type.

3. Click Apply.
The values entered are displayed in the generated report.

For more information on Viewing Reports using the BI Publisher tool, refer to the Viewing a Report section of the Oracle Fusion Middleware User's Guide for Oracle Business Intelligence Publisher.

8.4 Scheduling and Associating Reports Against a Query or Case Series

You may refer to the Creating Report Jobs and Viewing and Managing Report Jobs sections of the Oracle Fusion Middleware User's Guide for Oracle Business Intelligence Publisher for information on Scheduling and Associating Reports against a query or a case series.

9 Creating Custom Reports - BIP

In addition to the preformatted BIP standard reports, the BI Publisher tool also enables you to create custom reports.

9.1 Creating a New Report

Creating a new report using the BI Publisher tool comprises two parts:.

- Creating Reports

- Creating Data Models

For information on creating reports using the BI Publisher tool, refer to the Creating Reports and Layouts section of the Oracle Fusion Middleware Report Designer's Guide for Oracle Business Intelligence Publisher.

For information on creating Data Models, refer to the Oracle Fusion Middleware Data Modeling Guide for Oracle Business Intelligence Publisher.

9.2 Editing Reports

For information on editing reports, refer to the Creating and Editing Reports section of the Oracle Fusion Middleware Report Designer's Guide for Oracle Business Intelligence Publisher.

9.3 Changing the Report Layout

For information on changing the Report Layout, refer to the following sections of Oracle Fusion Middleware Report Designer's Guide for Oracle Business Intelligence Publisher:

- Creating BI Publisher Layout Templates

- Creating RTF Templates

- Creating RTF Templates Using the Template Builder for Word

In addition, you may also refer to the following sections of the Oracle Argus Insight Extensibility Guide:

- Extend Current Data Model — This section explains the steps to extend the existing report.

- Add New Data Set — This section explains the steps to add new data set in BIP data model.

- BIP Report Templates — This section explains the steps to add or modify existing layout or report templates.

10 Generating OBIEE Answers and Working on Aggregate Analysis - Sample Dashboard

Argus Insight provides an out-of-the-box RPD for analyzing the data of aggregated reports generated through Argus Safety or BI Publisher.

Note:
Analysis can be done on the RPD once the Argus Mart ETL has brought all the necessary data from BIP Enabled Argus Safety.

To bring BIP FAR reports data, you must configure the system to persist executed reports data in Argus Safety:

1. Login to Argus Safety and navigate to
Argus Console > System Configuration > Common Profile Switches > Reporting > BIP Aggregate Reporting.

2. In the BIP Aggregate Temp tables, set the following:
- Persist data—Yes

- Number of days to persist—For example, 50

The BIP Aggregate Reporting data is purged based on the number of the days mentioned here, but when that data is transferred to Argus Mart tables via ETL that data will be persisted. However, re-running the Initial ETL of Argus Mart will purge all the data from Argus Mart tables, and then only data available in Argus Safety BIP Aggregate Temp tables will be populated in Argus Mart tables.

3. Run the BIP Aggregate Reports (PMAR, DSUR, PBRER) to persist data.
The BIP Aggregate Reports data in OBIEE dashboard can only be seen by the user who has access to that particular report in Argus Safety

4. Run Argus Mart ETL to transfer the BIP Aggregate Reports in to Mart DB.

5. Login to Analytics with the user who has access to the above executed report in Argus Safety, and check the Dashboard and Answers.

10.1 Argus Insight Catalog

The following components are available as part of the Argus Insight Catalog:

- Aggregate Analysis - Sample Dashboard — Provides Dashboard and Page Level prompts, and displays data on Sample Report based on these prompts.

- Dashboard Prompt — Enables selection of the Enterprise ID.

- Page Prompts — Comprises three-level page prompts: Aggregate Configuration Name, Report Form Name and Report Type.

- Sample Line Listing — Generates as Sample Line Listing Report comprising the following dimensions:

- Case Number

- Product Name

- Event Reported

- Event Seriousness

- Event Listedness

- As Reported Causality

- Sample Report — Generates as Sample Report comprising the following dimensions:

- Initial Receipt Year

- Product Name

- Event Reported

- Event Seriousness

- Case Count

10.2 About OBIEE Aggregate Analysis - Sample Dashboard

To view OBIEE Aggregate Analysis - Sample Dashboard:

1. From Argus Insight, navigate to Reporting > BI Answers.
The OBIEE URL is opened in a new window as configured in the Argus Insight > List Maintenance > Profile Switch.

2. Go to Dashboard > Aggregate Analysis - Sample Dashboard.
A sample dashboard as available in Argus Insight catalog, will generate a report based on the selected prompt values.

The Sample Report displays the data based on the prompts available on the dashboard, such as:

- Enterprise ID

- Aggregate Configuration Name

- Report Form Name

- Report Type

You may drill-down based on the Case Count Dimension.

Note:
By default, the drill-down option is available only for Sample Dashboard. For Custom Dashboards, add the drill-down option manually.

3. To view the Sample Line Listing Report, click the case count.

10.3 Working on BI Answers

To create new Analysis or Answers, navigate to New > Analysis, and select the dimensions from the Subject Area.

The Subject Area displays all the dimensions created in the RPD.

For more information on these dimensions, refer to Oracle Argus Insight Extensibility Guide > Appendix: Dimensions and their Mapping.

10.3.1 Adding filters in Analysis

To add filters in the Answers, select a dimension, and click Create a Filter.

To add filter on the non-selected columns, click More Columns.

A list of all the available dimensions appears.

Go to the Results tab, to view the result of the analysis based on the dimensions and filters.

Note:
For more information on each dimension, refer to Oracle Argus Insight Extensibility Guide > Appendix: Dimensions and Mappings.
For more information on each field description, refer to Oracle Argus Safety BIP Aggregate Reporting Extensibility Guide > Appendix A: Data Model.

11 Working in a Multi-Tenant Environment

This chapter describes the unique features and key differences for running Argus Insight in a multi-tenant environment versus a single-tenant environment.

11.1 Assumptions and Constraints

- Single Sign-On Account (SSO)—To have the capability to switch client context and to open Argus Insight from the Application Access Portlet, you must have a SSO account enabled.
When Argus Insight is configured for SSO, Cognos still uses the PowerReports namespace.

- Accessing Argus Insight directly by using URL—It is expected that customers will pass the internal enterprise ID as a URL parameter for the Argus Insight application to open with the appropriate enterprise context. If the enterprise ID is not passed, the system validates the user against the default enterprise.

- Global User Management—To apply updates to the Synchronizable fields for all the enterprises in the system, you must maintain some administrative users in Argus Insight. Use the User and Group Administration options in the Security tab on the ADMINISTRATION TOOLS page to modify user accounts and enable access for all enterprises in the system.

- User-Enterprise Association—To copy a user account from one enterprise to another, you must have already set up the appropriate user groups in the target enterprise. Otherwise, the user association will fail with an appropriate error message.

- New User Creation/Association—Argus Insight lets you use the same user ID to create different users across multiple enterprises. However, use this feature only if you do not expect to share the users across enterprises.
If you expect to share users across multiple enterprises, do not use the same user ID to create different users across different enterprises. Instead, create the user in one enterprise, and then use Global User Management to associate the user to other enterprises.

- New Enterprise Setup—It is expected that you will create and choose appropriate enterprises with generic configuration data that can be used as a source for copying the configuration data to create new enterprises.
Power Queries used within any configuration item is recommended to ensure that the values being copied from the source enterprise are appropriate for the newly created enterprise.

MedDRA, WHO dictionaries, and Default enterprise are common for all enterprises.

- Post-Database Upgrade Considerations—There are no post-database upgrade considerations for existing users.

11.2 Data Segregation

Having a system that can partition client data within a single, access-driven database significantly reduces operational and ownership costs for the client. Argus Insight achieves this objective through database segregation.

The entire Argus Insight application, including all its components and data, have been partitioned by an enterprise ID. This ID is a unique, customer-specified identifier.

11.2.1 Module-Wise Impact

Table 11-1 describes the modules in Argus Insight as per their data segregation status in Clinical Research Organization mode (CRO mode) and hosting installations.

Table 11-1 Data Segregation Status for Argus Insight Modules

Module

Data Segregation

Notes

Power Query

Yes

Displays QBEs, filters, and advanced conditions only for one enterprise at a time, to the logged-in user. The type of display is based on the selected enterprise.

Case Series

Yes

Retrieves cases only from the logged-in enterprise.The Case Series library displays the case series belonging to the logged-in enterprise only.

MedDRA Dictionary and SMQs

No

Each enterprise can configure a specific version of the MedDRA dictionary.A single copy of each version is to be shared by the enterprises.

WHO Dictionary

No

Each enterprise can configure a specific version of WHO Drug dictionaries (B2 as well as C formats).A single copy of each version is to be shared by the enterprises.

ETL

No

The ETL schedule is universal across all enterprises.Any user with administrator privileges who has access to this portlet can view and modify the ETL schedule.When an enterprise is added to an existing CRO setup, the Initial ETL can also run for individual new enterprises.The Initial/Reinitial/Incremental ETL cannot be run in parallel at any point of time in the application.

BI Tool

No

A single BI Tool supports all the enterprises.When you log in to BI Tool directly, you can see all the common objects as well as the enterprise-specific objects that are accessible to you.When you run a report, you can access the cases for a specific enterprise only.For reports that you can access, you can run the report against any enterprise data for which you have access.

11.2.2 Enterprise Short Name in Argus Insight

The Enterprise Short Name is an abbreviated, unique name of a client. You can configure Argus Insight to display the Enterprise Short Name in the title bar for the Argus Insight application.

The Display Enterprise Short Name in Application Header check box in Global Enterprise Management controls the display of the Enterprise Short Name.

If this check box is selected, the Enterprise Short Name is displayed in the Argus Safety header along with database name (DB_Name – Enterprise_Short_Name), where Enterprise_Short_Name is the unique short name of the enterprise.

In addition, the Argus Insight application displays the Enterprise Short Name in the title bar.

If the Display Enterprise Short Name in Application Header check box is not selected, Argus Insight does not display the Enterprise Short Name in the title bar.

11.3 Login and Navigation

Clinical Research Organization (CRO) users can operate on only specific enterprises. Users have access to only certain Argus Insight modules.

Note:
The default enterprise in Argus Insight is the same as the default enterprise configured in Argus Safety.

11.3.1 Single Sign-On Accounts

Having a single sign-on account (SSO account) for the modules that you have access to and providing navigation to these modules simplifies your login and authentication process.

With a SSO account, your login authentication is done using a centralized authentication system. Therefore, you do not need to enter your login credentials for each application you access, every single time.

In multi-tenant installations, Global Homepage and Argus Insight are two different applications that are available to you, other users, and CRO/Hosting administrators.

11.3.1.1 Using Separate URLs to Access the Applications

The Global Homepage and Argus Insight web applications have separate URLs, which can be accessed independent of each other.

When you enter the URL of either the Global Homepage or Argus Insight application, the SSO module authenticates your credentials and allows access to these applications without asking for any user credentials.

- For Global Homepage, if the SSO authentication fails for your account, the system displays an appropriate error message.

- For Argus Insight, if the SSO authentication fails for your account, the system displays an appropriate error message in the Argus Insight login screen.

In this scenario, Argus Insight does not display Argus Safety buttons on the top navigation bar because the system expected you to access these applications from the Application Access Portlet on the Global Homepage. These applications are available to be opened in separate windows.

11.3.1.2 Opening Argus Insight from Other Applications

To access Argus Insight from other applications, you can either:

- Open Global Homepage and select the Application Access Portlet

- Open Argus Safety and click the Argus Insight link

In this scenario, Argus Insight opens in a separate browser window for either the enterprise you selected in the Application Access Portlet or the enterprise you selected in the Argus Safety.

- When you log out of Argus Insight, the system closes Argus Insight and its child windows after prompting you to save any unsaved changes. The Global Homepage window is not affected when you log out of Argus Insight.

- When you click Close in the Global Homepage application, only the Global Homepage closes. The Argus Insight window is not affected when you close Global Homepage.

If Argus Insight is defined as the default application in Argus Console for your account and you try to log in to Argus Safety by using the direct Safety link, the Argus Insight application opens. Argus Insight displays the Argus Safety button in the top navigation bar, based on whether you logged in using a SSO account and have access to Argus Safety.

11.3.2 Enterprise Switching

The capability to switch enterprises within the same session gives you significant usability benefits.

You must have a SSO account enabled if you want to switch enterprise context and open Argus Insight from within the Argus Safety application or the Application Access Portlet on the Global Homepage.

The system lets you open Argus Insight in a separate window with the context set to a specific active enterprise from Argus Safety and Application Access Portlet on the Global Homepage.

You can switch the context to a different enterprise from Global Homepage without logging out.

If Argus Insight is already opened for an enterprise and you switch to a different enterprise from the Application Access Portlet, the system displays a message before switching.

11.3.3 Direct Access

You can access Argus Insight directly by using the Argus Insight application URL. The system checks if the enterprise ID is already present in the URL request. If the enterprise ID exists, the system opens Argus Insight for that enterprise.

11.4 Global Homepage

Argus Insight provides a Global Homepage that can host multiple portlets. With this feature, CRO users can now access different views of their work items for Argus Safety.

A CRO can access the following modules from the Global Homepage:

- Application Access Portlet (which allows access to Argus Insight for different enterprises)

- Global Enterprise Management Portlet

- Global User Management Portlet

11.4.1 Application Access Portlet

You can use the Applications Access portlet within the Global Homepage to start Argus applications for any enterprise to which you have access privileges.

If you have access to both Argus Safety and Argus Insight, this portlet lets you select between Argus Safety and Argus Insight.

Use the Enterprise and Application fields to make your selections, and then click Open to access the selected application.

11.4.2 Global Enterprise Management Portlet

The Global Enterprise Management portlet lets you define and manage enterprises easily, as per the configuration of the already existing enterprises. You can access this portlet from the Global Homepage provided you have the proper privileges.

From the Global Enterprise Management portlet, you can:

- Copy the enterprise created in Argus Safety to Argus Insight

- Copy the configuration data from an existing enterprise in Argus Insight

Note:
The Argus Insight module is available in the Global Enterprise Management portlet only if the Safety to Insight database link is set up in the database.
If this link is not created, the Copy Enterprise to Insight button does not appear on the Global Enterprise Management screen.

Oracle recommends that when you click Copy Enterprise to Insight, you select the same enterprise as the source enterprise with which the Argus Safety enterprise has been created.

11.4.2.1 Overview of the Global Enterprise Management Page Layout

The Global Enterprise Management portlet, has two panes:

- The left pane lists all the enterprises of the portal user, in a tree-view structure.

- The right pane, by default, loads as blank, in disabled mode.

When you select an enterprise from the left pane, the right pane refreshes and displays the details for the selected enterprise.

11.4.2.2 Adding a New Enterprise

To create a new enterprise in Argus Insight, click Add New Enterprise.

Note:
You can create a new enterprise in Argus Insight only after the enterprise and its details are entered and saved in Argus Safety.

11.4.2.3 Copying an Enterprise

1. Open the Global Enterprise Management portlet.

2. Click Copy Enterprise to Insight.

Note:
The Copy Enterprise to Insight button is disabled for the default enterprise.

The system updates the right pane and displays information about the enterprise to copy. The details in the Enterprise Name and Enterprise Short Name fields are read-only.

3. From the Copy Enterprise Configuration From field, select an enterprise.

4. Click Setup.
(The Setup button is enabled only after you specify all mandatory enterprise information.)

The system copies all the configuration data from the enterprise that you selected and reports status information throughout the process.

When enterprise creation is completed for an enterprise, the Copy Enterprise to Insight button is disabled for that enterprise because enterprise creation in Argus Insight is a one-time operation.

Note:
The Copy Enterprise to Insight button can be created in Argus Insight only after the enterprise and its details have been entered and saved in Argus Safety.

Once all the configuration data has been successfully copied, the user who is setting up the new enterprise is associated as a new user in Enterprise Manager, to the newly created enterprise partition.The user attributes of the user get copied from the source enterprise.

See the Oracle Argus Safety Administrator's Guide for additional details about the Global Enterprise Management portlet.

11.4.3 Global User Management Portlet

The Global User Management portlet within the Global Homepage lets you associate yourself to multiple enterprises, and keep your user attributes consistent across all the enterprises.

All the Argus Insight users are created from Argus Safety Console only. See the Oracle Argus Safety Administrator's Guide for additional details.

11.5 Power Queries and Case Series

Power queries include QBEs, filter value sets, and advanced conditions.

In a multi-tenant environment, power queries and case series work as follows:

- A new power query/case series created and saved stores the value of the enterprise along with the other details.

- The value for the enterprise is derived from the logged-in enterprise.

- The Query and Case Series libraries display only the power query/case series specific to the logged-in enterprise.

- The Active function retrieves the active power query/case series for the user within the enterprise.

- You can grant permissions on a power query/case series to the groups that belong to the currently logged-in enterprise. The Permissions dialog box displays the User Groups that are associated with the logged-in enterprise.

- The power query/case series created by users that are currently disabled or has been disassociated from the enterprise through which the power query/case series was created, are displayed in the respective library for users who have access to the respective power query/case series.
The power query/case series created by the users are deleted when the user account is deleted.

- When you execute a power query, the results display the cases from the currently logged-in enterprise only.

- All Query and Case Series libraries display the data pertaining to the logged-in enterprise only.

- SSO must be enabled to have the capability to switch client context and to open Argus Insight from the Application Access Portlet.

- There are no post-database upgrade considerations for existing users.

11.5.1 Importing a Case Series

When you import a case series, the system validates whether each case being imported belongs to the logged-in enterprise.

- If the case belongs to the current enterprise, the system imports the case successfully.

- If the case does not belong to the current enterprise, the system rejects the import. The log file displays the following message against the specific case number:
Case Rejected

11.5.2 Modifying a Case Series

When you add a new case number to an existing case series, the system validates whether the case being added belongs to the logged-in enterprise.

- If the case belongs to the current enterprise, the system adds the specified case into the case series.

- If the case does not belong to the current enterprise, the system does not add the case and displays the following error message:
Case Number does not exist.

11.5.3 Deleting a Case Series

Deleting a case from a case series functions the same way in multi-tenant and single-tenant installations.

11.5.4 Exporting a Case Series

When you export a case series to a Microsoft Excel document, the system can include the enterprise as part of the export details.

If you select the Display Enterprise Short Name in Application Header check box in Global Enterprise Management, the Case Series Details tab in the Excel document displays the Enterprise Short Name. The system derives the value from the currently logged-in enterprise.

The Enterprise Short Name is displayed in CRO, hosting, and single-tenant mode of an installation.

11.6 Common Profile Switches

All the global-level switches are displayed, updated, and audit logged in the default enterprise.

To view or edit Profile Switches:

1. Click Tools on the Argus Insight global toolbar.
The ADMINISTRATION TOOLS page appears.

2. Click the List Maintenance tab.

3. From the List Maintenance Items section, select Profile Switches.
The Attributes section is updated with the profile switches that you can configure.

11.7 ETL Scheduler

Beginning with Argus Insight 7.0, administrators must assign the ETL Scheduler role to any user who needs to configure the schedule and run an ETL process. The ETL Scheduler role is available across all enterprises at a global level.

Argus Insight administrators can configure the ETL Scheduler role by modifying the user account listed in the Security tab on the ADMINISTRATION TOOLS page.

The ETL Scheduler screen can be displayed, updated, and audit logged from the default enterprise in a multi-tenant installation. However, only those users who have been assigned the ETL Scheduler role can view the ETL Scheduler screen.

A Appendix: Argus Insight Case Tables

AIR_AUDITLOG_CASES

REA_CAUSALITY_DATA

TMP_ASSOCIATED_SYMPTOM

AIR_AUDITLOG_CASES_LOG

REP_CASE_DETAIL_TMP

TMP_CASE_AGENCY

AIR_CASES_TO_PROCESS

REP_CASE_DETAIL_TP_TMP

TMP_CASE_REFERENCE

AIR_CASES_TO_PROCESS_CHUNK

REP_CASE_LOG

TMP_DQI

AIR_FREEZE_CASES_TO_PROCESS

REP_CASE_TMP

TMP_DTL_CASE

AIR_MANUAL_LOG_CASES

REP_EVENT_LOG

TMP_DURATION_BAND

AIR_MANUAL_LOG_CASES_LOG

REP_EVENT_TMP

TMP_DURATION_DELAY

AIR_PRE_REQ_LOG

REP_EVT_ASSESS_LOG

TMP_EVENT_CASES

AIR_REPORTS_TO_DELETE

REP_EVT_ASSESS_TMP

TMP_EVENT_DETAILS

AIR_REPORTS_TO_DELETE_LOG

REP_PROD_DOSE_LOG

TMP_EVENT_DETAILS_ORPHAN

AIR_REPORTS_TO_PROCESS

REP_PROD_DOSE_TMP

TMP_EVENT_UD_RC

AIR_REPORTS_TO_PROCESS_LOG

RPT_CASE

TMP_LATE_REPORTS

AIR_UNFREEZE_CASES_TO_DELETE

RPT_CASE_DELTA_MESSAGE

TMP_PRIMARY_PRODUCT

AIR_UPDATED_STUDY_CASES

RPT_CASE_EVENT_PROD

TMP_PRODUCT_CASES

CASE_AGENCY

RPT_CASE_EVENT_PRODUCT

TMP_PRODUCT_DATASHEET

CASE_DETAIL

RPT_CASE_EVENT_PRODUCT_ASSESS

TMP_PRODUCT_DETAILS

CASE_STUDY_REFERENCE

RPT_CASE_SUMMARY

TMP_PRODUCT_REGIMENS

CMN_AUDIT_LOG

RPT_CASE_SUMMARY_PRODUCT

TMP_PROD_IND_CODE

DTL_CASE

RPT_CASE_SUMMARY_REPORTS

TMP_RPT_CASE

DTL_CA_EVALUATION

RPT_CLD_NOTES

TMP_RPT_DEATH_DETAILS

DTL_CMD_NARRATIVE_TEXT

RPT_CLINICAL_TRIAL_CAUSALITY

TMP_RPT_EVENT

ETL_CASE_UPDATE_LOG

RPT_CNL_ENGLISH

TMP_RPT_PRODUCT

ETL_PROCEDURES_LOG

RPT_EVENT_ASSESS_CAUSALITY

TMP_RPT_PROD_INDICATIONS

FACT_PROD_LICENSE

RPT_REPORT_SUBMISSION

TMP_RRR_SD2

FROZEN_CASE_DETAIL

RPT_WORKFLOW

USER_ACCESS

-----

-----

USER_CASE

Glossary

adverse experience

Any adverse event associated with the use of a drug or biological product in humans, whether or not considered product-related, including:

- An adverse event occurring in the course of the use of a drug product in professional practice

- An adverse event occurring from drug overdose whether accidental or intentional

- An adverse event occurring from drug abuse

- An adverse event occurring from drug withdrawal

- Any failure of expected pharmacological action

Reporting an adverse experience does not necessarily reflect a conclusion by the applicant or the FDA that the product caused or contributed to the adverse experience.

Adverse experience is synonymous with adverse drug experience, adverse biological experience, adverse product experience, and adverse event.

affiliate

Any individual or entity related by employment or organizational structure to the applicant, including all subsidiaries, whether domestic or foreign.

applicant

An individual or entity who holds the new drug application (NDA), the abbreviated new drug application (ANDA), or the biologics license application (BLA). For purposes of this glossary, this term includes any person whose name appears on the label of a marketed drug or licensed biological product as its manufacturer, packer, distributor, shared manufacturer, joint manufacturer, or any participant involved in divided manufacturing.

causality assessment

Determination of whether there is a reasonable possibility that the product is etiologically related to the adverse experience. For example, causality assessment includes assessment of temporal relationships, dechallenge/rechallenge information, association with (or lack of association with) underlying disease, presence (or absence) of a more likely cause, and physiologic plausibility.

challenge

Administration of a suspect product by any route.

chart

A picture defined in graphics primitives and graphics attributes.

column

A character position within a print line or on display. The positions are numbered consecutively from 1, starting at the leftmost character position and extending to the rightmost position. In relational database, a field defined for a given record.

comma-separated values (.CSV) file

See .CSV file.

command

A statement used to initiate an action or start a service. Administrators use commands to start database administration functions that access and maintain the database. Commands consists of the command name abbreviation, and its parameters and flags if applicable.

.CSV file

Comma-separated values file. In computers, a CSV file contains the values in a table as a series of ASCII text lines organized so that each column value is separated by a comma from the next column's value and each row starts a new line.

data mart

A subset of a data warehouse that contains data that is tailored and optimized for the specific reporting needs of a department or team. A data mart can be a subset of a warehouse for an entire organization, such as data that is contained in online analytical processing (OLAP) tools.

data mining

The process of collecting critical business information from a data warehouse, correlating the information, and uncovering associations, patterns, and trends.

data warehouse

A central repository for all or significant parts of the data that an organization's business systems collect. A subject-oriented nonvolatile collection of data used to support strategic decision making. The warehouse is the central point of data integration for business intelligence. It is the source of data for data marts within an enterprise and delivers a common view of enterprise data.

dechallenge

Withdrawal of a suspect product from the patients therapeutic regimen.

disability

A substantial disruption in one's ability to conduct normal life functions.

electronic document

A document that is stored on the computer, instead of printed on paper.

encode

To convert data by the use of a code in such a manner that reconversion to the original form is possible.

ETL

Extract, transform, and load (ETL) process. The ETL process extracts a subset of data from the central data warehouse, transforms it, and loads it into one or more star schemas. These schemas can be included in data marts to answer specific business questions.

event log

A log that contains information about events for a particular system or group, for a particular metric, or for all the events that are associated with a specific monitor.

expected adverse experience

Adverse experience listed in the current FDA-approved labeling for the drug or licensed biological product. This would include any section of the labeling that refers to adverse experience information.

extract, transform, and load (ETL)

See ETL.

field

In a record, a specified area used for a particular category of data. For example, a record about an employee might be subdivided into fields containing the employee's name, address, and salary.

field description

Information that describes the characteristics of data in a field.

field format

A format in which the output consists of structured field introducers and variable data rather than output in line format.

filter

A device or program that separates data, signals, or material in accordance with specified criteria.

form

In query management, an object that describes how to format the data for printing or displaying a report. A display screen, printed document, or file with defined spaces for information to be inserted.

home page

The top-level web page of a portal. Sometimes used as a synonym for default portal page.

initial reporter

The original source of information concerning an adverse experience (for example, consumer or healthcare professional).

life-threatening adverse experience

An adverse experience that in the view of the initial reporter places the patient at immediate risk of death from the adverse experience as it occurred. It does not include an adverse experience that, had it occurred in a more severe form, might have caused death.

negative dechallenge

Continued presence of an adverse experience after withdrawal of the suspect product.

negative rechallenge

Failure of the product, when reintroduced, to produce signs or symptoms similar to those observed when the suspect product was previously introduced.

positive dechallenge

Partial or complete disappearance of an adverse experience after withdrawal of the suspect product.

positive rechallenge

Reoccurrence of similar signs and symptoms upon reintroduction of the suspect product.

query

A request for information from the database based on specific conditions.

rechallenge

Reintroduction of a suspect product suspected of having caused an adverse experience following a positive dechallenge.

report

In query management, the formatted data that results from running a query and applying a form to it. Data that has been selected and extracted according to the reporting tool, type of report desired, and formatting criteria.

report type

A data source and how it is mapped.

role

A job function that identifies the tasks a user can perform, defines the access level the user has, and specifies the resources the user can access and modify at those levels. Users are limited in how they can access information if they do not have the proper role. A user can be assigned one or more roles.

serious adverse experience

An adverse experience occurring from any dose that results in any of the following outcomes: death, life-threatening adverse experience, initial inpatient hospitalization, prolongation of hospitalization, significant or persistent disability/incapacity, or congenital anomaly/birth defect (including that occurring in a fetus). Important medical events, based upon appropriate medical judgment, that may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed above.

spontaneous report

A communication from an individual (for example, consumer or healthcare professional) to a company or regulatory authority that describes a suspected adverse experience. It does not include cases identified from information solicited by the applicant such as individual cases or findings derived from a study.

study

Any organized data collection system (for example, adverse experience information derived from a clinical trial or patient registry including pregnancy registries). Reports from company sponsored patient support programs and disease management programs should be handled as if they were study reports and not spontaneous reports.

suspect product

Drug or biological product associated with an adverse experience as determined by the initial reporter, regardless of the opinion of the applicant.

type-ahead feature

Functionality where you begin to type a value in a field and the system displays the like values in a drop-down list. You can then select a value from the list.

unexpected adverse experience

Adverse experience not included in any section of the current FDA-approved labeling for the drug or licensed biological product. Includes an adverse experience that may differ from a labeled adverse experience because of greater severity or specificity (for example, abnormal liver function versus hepatic necrosis).

In addition, adverse experiences listed as occurring with a class of drugs or biological products but not specifically mentioned with a particular drug or biological product are considered unexpected (for example, a rash with antibiotic X would be considered unexpected if the labeling states rash may be associated with antibiotics because the labeling does not specifically state rash is associated with antibiotic X). Reports of death from an adverse experience are considered unexpected unless the possibility of a fatal outcome from that adverse experience is stated in the labeling.

web-based application

An application that is downloaded from the web each time it is run. The advantage is the application can be run from any computer, and the software is routinely upgraded and maintained by the hosting organization rather than by each individual user.

web browser

A client program that initiates requests to a web server and displays the information that the server returns.

web page

Any document that can be accessed by a URL on the World Wide Web.

web server

A software program that is capable of servicing Hypertext Transfer Protocol (HTTP) requests.

website

A related collection of files available on the web that is managed by a single entity (an organization or an individual) and contains information for its users. A website often includes links to other websites.

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