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Oracle® Argus Insight Release Notes
Release 7.0.1

Part Number E28484-01
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Oracle® Argus Insight

Release Notes

Release 7.0.1

E28484-01

March 2012

Contents

1 Overview

Oracle Argus Insight 7.0.1 introduces report packaging for the case series, includes a new multiple-period frequency report, provides an enhanced copy configuration tool, and supports BusinessObjects XI R3.1 SP4 in a single-tenant environment.

In addition, Argus Insight 7.0.1 no longer supports the cubes features, several profile switches, and some standard reports.

Priority: High
Platforms: BusinessObjects and Cognos
Obsoletes: None
Version: This is the first version.

2 References

This section contains the following topics:

2.1 Oracle Argus Insight Release Notes

You can download the most current version of these release notes in PDF and HTML format from the Oracle Health Sciences documentation page at:

http://www.oracle.com/technetwork/documentation/hsgbu-safety-407502.html

2.2 User Documentation

You can download the most current versions of the user documentation in PDF and HTML format from the Oracle Health Sciences documentation page at:

http://www.oracle.com/technetwork/documentation/hsgbu-safety-407502.html

Note:

Always check the Oracle Health Sciences documentation page to ensure you have the latest updates to the documentation.

The user documentation includes:

  • Oracle Argus Insight Installation Guide (Part E28479)

  • Oracle Argus Insight BusinessObjects Administrator's Guide (Part E28483)

  • Oracle Argus Insight BusinessObjects User's Guide (Part E28482)

  • Oracle Argus Insight Cognos Administrator's Guide (Part E28480)

  • Oracle Argus Insight Cognos User's Guide (Part E28481)

  • Oracle Argus Insight Minimum Security Configuration Guide (Part E28490)

In addition, Oracle Argus Insight customers can request copies of the following Oracle Argus Insight technical reference manuals from Customer Support:

  • Oracle Argus Insight CMN Profile Enterprise Table Guide (Part E28489)

  • Oracle Argus Insight CMN Profile Global Table Guide (Part E28488)

  • Oracle Argus Insight Database Administrator's Guide (Part E28486)

  • Oracle Argus Insight Entity Relationship Diagram Reference (Part E28485)

  • Oracle Argus Insight Report Mapping Reference (Part E28487)

Go to Contents

3 What's New in Oracle Argus Insight 7.0.1

This section describes the features introduced in Oracle Argus Insight 7.0.1:

3.1 Report Packaging for Case Series

Report packaging is the concept of grouping reports together. Multiple reports that are always or often executed at the same time can be defined in a group, offering the end user a large workload reduction when compared to sequential selection and execution of each individual report. Report packaging for scheduled queries was introduced in Oracle Argus Insight 6.0.

Oracle Argus Insight 7.0.1 extends the use of report groups to case series. Report groups can run against an existing case series, so that all of the reports that are part of the group are executed with the cases from the case series. The report output is sent out to the recipients as per the scheduling information. A new option to "run now" executes the report group immediately.

3.2 Multiple-period Frequency Report

Comparing the frequency of adverse events in different time periods can be helpful in understanding the safety profile of a pharmaceutical product.

The Event Comparison of Three Periods report is now included in Cognos as per the specification. (Oracle Argus Insight already includes a frequency comparison report in BusinessObjects.)

3.3 Copy Configuration Tool

The Copy Configuration tool is enhanced to include report packaging on case series. Report packaging on frozen case series is not supported by this tool.

3.4 BusinessObjects Support

Oracle Argus Insight 7.0.1 supports BusinessObjects XI R3.1 SP4 for single-tenant deployment. This restores the BusinessObjects support that was deferred from the scope of Oracle Argus Insight 7.0.

Note:

As with Oracle Argus Insight 7.0, Oracle Argus Insight 7.0.1 continues to support Cognos 8.4.1 Business Intelligence for both single-tenant and multi-tenant deployment.

Go to Contents

4 Hardware and Software Requirements

Oracle Argus Insight 7.0.1 includes updates to the technology stack. See Chapter 1 of the Oracle Argus Insight Installation Guide (Part E28479) for more detailed information.

Note:

Cognos Content Store is not supported by Cognos on Oracle Database 11.2.0.3 when it is installed on an Oracle Enterprise Linux (OEL) operating system. If you are using one of the following OEL operating systems for Argus Insight and Cognos, you must use Oracle Database 11.2.0.1:
  • Oracle Enterprise Linux x86 (Version 5.5.0.0.0, English)

  • Oracle Enterprise Linux x86-64 (Version 5.5.0.0.0, English)

4.1 Argus Safety Compatibility

Oracle Argus Insight 7.0.1 is compatible with Oracle Argus Safety 7.0.1.

4.2 Windows Compatibility

The Oracle Argus Insight 7.0.1 client is compatible with Windows Vista SP1, Windows XP Professional SP3, and Windows 7.

Go to Contents

5 Downloading Oracle Argus Insight 7.0.1

To download Oracle Argus Insight 7.0.1 from My Oracle Support:

  1. Sign in to My Oracle Support at https://support.oracle.com.

  2. Click the Patches & Updates link.

  3. Enter 13843227 in the Patch ID field.

  4. Click Search.

  5. Click the Download button and save the compressed file to a temporary location on your local system.

Go to Contents

6 Installing Oracle Argus Insight 7.0.1

For detailed instructions about installing Oracle Argus Insight 7.0.1, see the Oracle Argus Insight Installation Guide (Part E28479).

Go to Contents

7 Features No Longer Supported

The following features are not supported in Oracle Argus Insight 7.0.1:

Note:

Many Oracle tables and Cognos/BusinessObjects metadata are no longer supported in Oracle Argus Insight 7.0.1. Therefore, if you are upgrading from a prior release, review the Oracle Argus Insight Database Administrator's Guide (Part E28486) and the Oracle Argus Insight Report Mapping Reference (Part E28487) for the current usage.

7.1 Cubes

The Cubes feature is no longer supported in Oracle Argus Insight 7.0.1.

7.2 Obsolete Profile Switches

The following profile switches have been removed from the application. These switches are no longer available when you select Profile Switches from the List Maintenance tab on the ADMINISTRATION TOOLS page in Oracle Argus Insight 7.0.1:

  • CUBE-ON-THE-FLY-LIFESPAN

  • DATE DIFFERENCE BAND

  • DOSE CATEGORY UNITS

  • COGNOS CUBE PASSWORD

  • COGNOS CUBE SERVER

  • COGNOS CUBE USER

  • COGNOS CUBE VERSION

  • POPULATE CUBES FACT DATA

7.3 Obsolete Standard Reports

Table 1 lists the standard reports that are obsolete as of Oracle Argus Insight 7.0.1.

Table 1 Obsolete Standard Reports

Report Category Report Name

Compliance

External Clinical QC Report

Compliance

KPI List Report Country Group 2

Compliance

KPI Overview Report Group 1

Compliance

KPI Overview Report Group 2

Compliance

Labeling Detail Listing by Case Number

Compliance

Labeling Detail Listing by Preferred Term

Compliance

Labeling Summary

Compliance

Outstanding Expedited Reports by Responsible Group

Compliance

Outstanding Report Submission by Responsible Group Listing (Detail)

Compliance

Outstanding Report Submission by Responsible Group Listing (Summary)

Compliance

Outstanding Report Submissions by Destination Listing - Detail

Compliance

Outstanding Report Submissions by Destination Listing - Summary

Compliance

Reporting Compliance by Destination (Count)

Compliance

Reporting Compliance by Destination (Percentage)

Compliance

Reporting Compliance by Responsible Group

Compliance

Reports Out of Compliance with Delayed Workflow Detail

Configuration

Workflow Configuration by State

Configuration

Workflow Configuration by Transition

General

Case Count by Reporter Type

General

Case Narrative Listing - Multilingual

General

Case Origin Listing

General

Clinical Medical Review List

General

Detailed Line Listing by SOC

General

Downgraded Reports Listing

General

Literature Listing

General

Relevant Medical History Listing

General

SAE Clinical Trial Co-Medication

General

SAE Clinical Trial Laboratory Test

General

SAE Clinical Trial Medical Conditions

General

SAE Clinical Trial Project Overview

General

Simple Line Listing by SOC

General

Simple Line Listing by Case Number

Management

Case Load History by Day

Management

Case Load History by Month

Management

Case Load History by Quarter

Management

Case Load History by Week

Management

Case Load History by Year

Management

Case Processing Times Listing

Management

Case Seriousness Distribution

Management

Case Seriousness Distribution Graphical Summary

Management

Case Volume by Reporter Type

Management

Case Volume History split by Initial and Follow-up

Management

Case Volume History - Initial and Significant Follow-ups

Management

Case Volume History (Reporter Type)

Management

Case Volume History (Seriousness)

Management

Cases by Reporter Type Listing

Management

Cases by Reporter Type Tabulation

Management

Delayed Workflow Listing by Case

Management

Delayed Workflow Listing by Workflow State

Management

First and Last Reporter Contact

Management

Listing of Cases Due for Lock

Management

Listing of Cases Late for Lock

Management

Product Tabulation by Site and Case Source

Management

Report Volume History

Management

Reports by Causality

Management

Reports by Month

Management

Reports by Product Family

Management

Reports by Seriousness

Management

Reports by Year

Pharmacovigilance

Age Group Vs Gender

Pharmacovigilance

Aggregate Diagnosis Listing

Pharmacovigilance

Annual Product Review

Pharmacovigilance

Case Listing

Pharmacovigilance

Case Listing with all Regimens and Events

Pharmacovigilance

Clinical Case Listing

Pharmacovigilance

Clinical Trial Causality

Pharmacovigilance

Data Quality Indicator (Alphabetically by Quality Indicator)

Pharmacovigilance

Data Quality Indicator (Ascending Order of Count)

Pharmacovigilance

Data Quality Indicator Listing

Pharmacovigilance

Dechallenge and Rechallenge Listing

Pharmacovigilance

Dosage Frequency Tabulation

Pharmacovigilance

Dose Formulation Product Relationship

Pharmacovigilance

Duration of Treatment until Event (time to onset) per Event

Pharmacovigilance

Event (PT) Vs Daily Dose

Pharmacovigilance

Event (PT) Vs Duration of Treatment until Event

Pharmacovigilance

Event Vs Duration of Treatment until Event

Pharmacovigilance

Event Vs Report Type

Pharmacovigilance

Fatal Case Listing

Pharmacovigilance

Fatal/Life-Threatening Cases Listing

Pharmacovigilance

Frequency Listing of Events

Pharmacovigilance

Gender Group by Age Group

Pharmacovigilance

MedDRA SOC-PT Group by Age Group

Pharmacovigilance

MedDRA SOC-PT Stratified by Daily Dose

Pharmacovigilance

MedDRA SOC-PT Stratified by Gender

Pharmacovigilance

MedDRA SOC-PT Stratified Report Type, Event Seriousness, Causality

Pharmacovigilance

Product and Disease Listing

Pharmacovigilance

Seriousness Case Listing

Pharmacovigilance

Temporal Relationships

Pharmacovigilance

Top 10 Substances


Go to Contents

8 Documentation Accessibility

For information about Oracle's commitment to accessibility, visit the Oracle Accessibility Program website at http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc.

Access to Oracle Support

Oracle customers have access to electronic support through My Oracle Support. For information, visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=info or visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs if you are hearing impaired.


Oracle Argus Insight Release Notes, Release 7.0.1

E28484-01

Copyright © 2012, Oracle and/or its affiliates. All rights reserved.

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