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Oracle® Argus Safety Release Notes
Release 7.0
E16262-01
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Oracle® Argus Safety

Release Notes

Release 7.0

E16262-01

October 2013

Contents:

Revision History

Revision Date Reason for Change
2.0 10-OCT-2013 Added a note to mention about the merger of the Argus Safety 4.2.1.8 patch with Argus Safety 7.0.
1.0 15-APR-2011 Initial Release

Overview

This release installs new environments and upgrades existing databases. This release addresses one or more problems as described in the "Known Issues" section of the Notes.

Release Package

The Oracle Argus Safety 7.0 Media Pack contains the following:

  • V25552-01- Oracle Argus Safety 7.0 Application

  • V25551-01 - Oracle Argus Safety 7.0 Documentation (English)

  • V25725-01 - Oracle Argus Safety 7.0 Documentation (Japanese)

Installing Oracle Argus Safety 7.0

For detailed instructions on how to install Oracle Argus Safety, please see the Oracle Argus Safety Installation Guide (E20622-01).

References

Refer to the following documents, which are available on the Oracle Technology Network (OTN) web site:

  • Oracle Argus Safety User's Guide (E20623-01)

  • Oracle Argus Safety Administrator's Guide (E20621-01)

  • Oracle Argus Safety Service Administrator's Guide (E20620-01)

  • Oracle Argus Affiliate User's Guide (E20618-01)

  • Oracle Argus Unblinding User's Guide (E20625-01)

  • Oracle Argus Dossier User's Guide (E20616-01)

  • Oracle Argus Interchange User's Guide (E20624-01)

  • Oracle Safety DBA Documentation (E20619-01)

Features Implemented

This section provides a brief description of the enhancements made in Oracle Argus Safety 7.0.

Segregate Data by Enterprise

Partitioned Data

The option of segregating data by enterprise profiles allows the user to maintain the data set in one database but protected across different enterprises based on the security permissions defined to the user.

Display Enterprise Identifier

The identifier for the partitioned data set is displayed when a user is viewing or processing enterprise cases.

Change Enterprises Within the Same Session

Users are only able to create or access cases with respect to the partitioned data set being accessed. Users will not be able to have two cases from two different enterprises open at the same time and would be able to access cases across enterprises without the need to log off from the application whilst switching enterprises.

Enter a Case for an Enterprise

The user has to choose the appropriate enterprise while creating a new case.

Intake Cases for an Enterprise

Users have the option to import cases in the correct enterprise via the following based on their permissions as well as the enterprise that they have access.

  1. E2B Import for structured data

  2. Worklist intake for unstructured data

  3. Affiliate intake

Receive E2B Imports for an Enterprise

The messages can be received via email, electronic media, or a gateway. Each E2B message can contain one or many cases. Each message may contain one or more reports. Standard error processing is managed on an enterprise by enterprise basis. It is assumed that the gateway product can be configured to route E2B messages to uniquely identified folders based upon status of the combination of <messagereceiveridentifier> and the <sender ID> or the dedicated web address

Following are a few examples for E2B import:

  • Manually import an E2B message

  • Import an identifiable imported E2B message

  • Import or export additional data elements beyond E2B for an enterprise

  • Export E2B messages for an enterprise

Import or Export Additional Data Elements Beyond E2B for an Enterprise

Extended E2B elements are also supported for Export as well as Import for an enterprise.

Global Work list

Segregate Data Based Upon Enterprise Authorization

CRO users log into the safety application a single time and need to be presented with a Worklist presentation of their cross-enterprise work, and the ability to access each project for which they are authorized. The CRO user needs to review, sort and filter a list of work across their authorized enterprises/projects, create process, review and report cases if authorized, access the query module for each enterprise, and for administrators, manage the configuration for each enterprise.

Process Data for Enterprises a User is Authorized to Access

A given user may have work that extends across several enterprises, not a single enterprise. Users need to see the sum of all work, so they can prioritize effectively and understand the amount of pending work assigned to them.

Global Worklist Types

Global Worklist allows users to view the data across multiple enterprises based on their security permissions.

Following are the sample Worklist available:

  • Case-based (New, Open)

  • Action items

  • Contacts

Multi-tenancy Enterprise Setup and Maintenance

Enable Multi-tenancy Usage

When processing data for an enterprise, a CRO user requires that enterprise's cases and configuration be partitioned. Partitioning of data and the additional interfaces that support accessing separate enterprises are only available in the multi-tenancy deployment and not impact single-tenant implementations.

Establish Enterprises

An 'enterprise' is the highest level for which data is isolated. An enterprise can include one or more studies/programs, one or more products, one configuration, and one set of user permissions such as unblinding access. Each enterprise may have one or more dictionaries (i.e., dictionary by study).

Enterprise Configuration Setup Wizard

To correctly setup a new enterprise, several sequential steps must be completed. The system administrator must be able to quickly establish a new enterprise in the database, based upon selecting from standard libraries or by copying from an existing setup. Enterprise-specific adjustments can be made during the initial setup, or alternatively at some later time when enterprise-specific configurations are clearly identified.

  1. Enable the administrator to copy a setup from an existing setup. Note some enterprise-specific data is not included in a copy, including products, actual study information and license information.

  2. The wizard includes some or all the following:

    • Enterprise ID

    • Drug Dictionary (Create, Load and configure for the enterprise)

    • Reportability rules

    • Workflow steps

    • Code list values

    • E2B settings

    • Grant user access to enterprise

    • Screen/field modifications

Modify an Enterprise

The setup of an enterprise may need to be change. New studies or post marketing services may be added or completed to an existing enterprise; configuration such as workflow steps, code list items, screen and field setup, and spare field use may be changed.

Control User Access to Enterprise(s) Data

Access to each enterprise 's study/project is controlled on a user-by-user basis.

Migrate to Multi-tenancy

Existing CRO enterprises must migrate from a single-tenant implementation to a multi-tenant implementation.

Case Form Enhancements

  1. A checkbox "Sent in Letter" is added in Case Form Activities tab to track the items sent to investigators/reporters.

  2. A new checkbox "Overdue Action Items" is added to Action Items Worklist and Personal Argus Status screen to enable filter on overdue action items.

Argus Console

  1. New common profile switches are provided in Console to specify Lot Number Web Service Configuration XML file and XSLT file.

  2. Documentum Configuration in Console common profile switches have been modified to support specification of "Document Type" for E2B, Expedited and Periodic Reports. The concept of Logged in User's Username/Password is also removed. Only Common Login Username/Password is supported to integrate Argus Safety with Documentum Server.

  3. Different dictionary configuration supported under Case Form Configuration in Console for the following items have been merged into single configuration for all these.

    • Case Form Events

    • Case Form Indications

    • LM Events and LM Indications

    • The same is merged into one dictionary configuration under Study Encoding as well.

  4. A new common profile switch is now available to "Enable Data Lock Point" under Case Form Configuration in Console to control the display of DLP related features in Argus Safety UI.

  5. The Console User Configuration screen fields are re-organized in a more logical manner for efficient configuration. New fields are introduced for "Service User" and "User Roles".

  6. Site Printer Configuration is moved from AG Service configuration tool to Console Site Configuration.

Product and Study Security

Product and Study security is now supported in Worklist Intake and E2B Pending/Processed screens.

E2B Mapping Rules

EMA Guidelines Revision 1 as released in Nov 2009 is supported in Argus Safety.

ESM Mapping Utility

  1. In ESM Mapping Utility, Incoming and Outgoing folders for different methods - EDI, XML, Binary and Physical are now merged a single configuration applicable for all methods.

  2. Documentum related configuration is moved from ESM Mapping Utility to Console.

  3. MAPI and Lotus Notes are no longer support as email options. SMTP is the only email method supported in Argus Safety.

AG Service

FaX Senior is no longer supported as faxing solution. Right Fax is the only faxing solution supported in Argus Safety.

MedDRA Recoding Tool

"New Schema Owner" field is now removed. All cases will be re-coded to the MedDRA version configured in Console.

PDF Properties for Expedited Report

"Enterprise Short Name" is added as another attribute.

Argus Perceptive

References, Configuration and Support for Argus Perceptive is removed from Argus Safety as Argus Perceptive product is no longer supported in Argus Suite of products.

DS Navigator and Reconciliation

DS Navigator and Reconciliation are not supported in current release. They will be supported soon in a future release.

Argus Safety Installer

It support the installation of Global Homepage & Portlets for multi-tenancy support.

Database

  1. New Schema Creation and Database Upgrade tools will now prompt the users to specify the name of the default enterprise to which all the safety data and configurations shall be associated.

  2. Argus Safety Upgrade tool supports the database upgrade from 6.0.1 and 6.0.1.1 versions to 7.0 version.

  3. Argus Safety product installer provides scripts to merge multiple 7.0 single tenant databases into single multi-tenant database.

  4. Table Partitioning option is no longer supported in Schema Creation Tool.

  5. Argus Safety product installer comes with the previous database upgrades for 6.0, 6.0.1 and 6.0.1.1 version.

Technology Stack Support

Refer to Oracle Argus Safety 7.0 Installation Guide for latest technology stack supported by Argus Safety.

Note: The issues fixed in a previous Argus Safety patch (Argus Safety 4.2.1.8) have been merged with this (Argus Safety 7.0) release.

Known Issues

The following table describes the Known Issues in the Oracle Argus Safety 7.0 application at the time of the release.

Bug # Description Sev Component
12325558 EOSU BATCH CASE CLOSE NOT ARCHIVING CASES PROPERLY IF CUSTOM WF STATE IS USED 3 UNBLNGPROC
11868819 PERFORMANCE CAN BE IMPROVED ON GLOBAL WORKLIST OPEN UNDER HIGH VOLUME AND USER LOAD 3 WKLT
11858112 CPU UTILIZATION NEEDS TO BE OPTIMIZED FOR THE WORKLIST UNDER HIGH VOLUME AND USER LOAD 3 WKLT
11797554 EASYPDF INSTALLER HANGS ON WINDOWS 2008 3 DOC
11844183 PURE INSIGHT USERS CANNOT ACCESS INSIGHT USING ARGUS SAFETY URL 4 LOGIN
11905010 2ND USER IS ABLE TO UPDATE THE AC ALREADY OPENED BY 1ST USER 4 ADVDCONDS
11885291 DOCUMENT AUTO UPLOAD ACTIVEX CONTROL DOESN'T WORK WITH HTTPS 4 LETS
11731402 E2B REPORT NOT AUTOSUBMITTED ON TRANSMISSION WHEN AUTOSUBMIT OPTIONS ARE ENABLED 4 RPT
10377287 AC DIALOG DOES NOT RESTRICT COPY PASTING TEXT DATA IN NUMERIC FIELD 4 ADVDCONDS
12323118 WORKLIST LETTERS DIALOG DOES NOT KEEP THE ADVC NAME AFTER USER CLICKS SEARCH 4 WKLT
12321235 HIT LIST EXPORT IS NOT HANDLING NULL VALUES CORRECTLY 4 RPTSYS
11884992 MERGE IMPORT FAILS IF THE SOURCE AND TARGET SAFETY SCHEMA OWNER IS DIFFERENT 4 DOC

Resolution for Known Issue: Bug 11884992

If the Safety Schema owner is different between the Source and Target Database, then follow the manual steps required before the Merge Import process.

Modify the following 3 files using the instructions below:

-- safety_import_safety.par -- safety_import_safety_DUP_LAM_SEARCH_DATA.par -- safety_import_safety_DUP_SEARCH_DATA.par

Open each file and add Safety schema owner name before the table name in the tables section of the par file.

Example: If Safety schema owner in Source database is SAFETY_SOURCE then add as follows: CASE_ACTIONS, should be changed to SAFETY_SOURCE.CASE_ACTIONS,

If the Interchange Schema owner is different between Source and Target Database then following manual steps required before the Merge Import process. Modify following file using the instructions below: -- safety_import_interchange.par Open the file and add Interchange schema owner name before the table name in the tables section of the par file.Example: If Interchange schema owner in Source database is INTERCHANGE_SOURCE then add as follows: CFG_SENDER, should be changed to INTERCHANGE_SOURCE.CFG_SENDER,

Resolution for Known Issue: Bug 11797554

During the installation of Argus, the installer may hang at the time when the following message is displayed on the screen:

"Setup is installing easyPDF 6.0..."

If this message is stuck for more than 10 minutes, please check to see if the following process is running in the Windows Task manager: bclloader.exe If you see this process running, please terminate the process so the installer can continue. The Installation will not fail and the process runs correctly after rebooting.

Argus Safety 6.0 Database Installation and Upgrade Code Updates

This document summarizes the enhancements and bug fix implemented on existing AS 6.0 release database code. A new zip file (Database_released_code_60.zip) that implements these enhancements and bug fix is now part of AS 7.0.

  • Enhancement: AS 5.1.1 to AS 6.0 Upgrade: The updated zip file now allows AS 5.1.1 to AS 6.0 upgrade in addition to existing AS 5.1 to AS 6.0 upgrade.

  • Enhancement: Removed Dependency on WMSYS schema during Argus Safety DB Installation: Some customers choose to remove WMSYS schema from their database installations. Updates to ArgusDBInstall.exe now remove dependencies on that schema.

  • Bug Fix: MedDRA Recoding "Table already exists" message during upgrade: The MedDRA recode process creates MEDDRA_RECODE_SUCCESS, MEDDRA_RECODE_FAILURE, and MEDDRA_RECODE_OPTIONS in Safety Schema. From AS 6.0 onwards, these tables are part of Argus Safety Schema. Due to this "Table already exists" message display during upgrade process.

As these tables may or may not exist in Argus Safety installations of v5.1 depending on whether the customers performed MEDDRA recoding procedure, the scripts have been updated to avoid these oracle errors (Table already exists) related to existence of MEDDRA recoding tables during AS 5.1.1 to AS 6.0 upgrade.

Pre-Database Upgrade Considerations for Existing Customers

  1. Multi-tenant customers must ensure that all the AG Service users (login user id) in all the databases that are to be merged into a single database are in sync with the DEFAULT ENTERPRISE. If there are AG Service users in other enterprises who do not exist in the DEFAULT ENTERPRISE, then customers must either rename their login user IDs to map them to existing AG Service users in the DEFAULT ENTERPRISE, or delete them. If extra users are found in other enterprises during multi-tenant database migration, then they are marked disabled and the customer cannot enable them later.

  2. Multi-tenant customers must ensure that all the event, indication, and who-drug encoding dictionaries used in Argus Console -> System Configuration -> Common Profile Switches -> Case Form Configuration -> Auto Encoding, Dictionary and Central Encoding section and Argus Console -> Business Configuration -> Studies -> Enable Study Specific Encoding -> Auto Encoding dialog, in all databases that are to be merged into a single database are already loaded in the target database with the same name. This is required to enable the automatic linking of dictionaries configured in the separate databases to the already existing dictionaries present in the target database during the database merge script/process.

Post-Database Upgrade Considerations for Existing Customers

  1. E2B Outgoing and Incoming folders must be configured again in the ESM Mapping Utility because various folders for different transmission methods are now merged as one pair of folders for all transmission methods. These are now saved into the database rather than the ESM Service INI file.

  2. The Document Type field value from ESM Service configuration and AG Service configuration tool must now be configured again into Argus Console -> Common Profile Switches -> Documentum configuration as these fields are now moved to Argus Console.

  3. A multi-tenant customer must ensure that all the event, indication, and who-drug encoding dictionaries used in Argus Console -> System Configuration -> Common Profile Switches -> Case Form Configuration -> Auto Encoding, Dictionary and Central Encoding section and Argus Console -> Business Configuration -> Studies -> Enable Study Specific Encoding -> Auto Encoding dialog, in the newly migrated enterprises are linked properly to the global dictionaries already present in the target database. This is required to correct any dictionary configuration linking that could not be done automatically by the database merge script due to mismatch in dictionary names in the source and target databases.

  4. All customers using Lot Number Web Service shall configure the values of new common profile switches for web service configuration XML and XSLT.

  5. The list of fields that can be used in Advanced Conditons configured for Field Validation (In Argus Console/System Configuration) is limited in 7.0. Only the fields returned by the following query are available for Field Validation: Select * from cmn_fields where source_type = 1 In previous releases, there were many more fields available (particularly from views). If any of these fields (which are not visible from 7.0 onwards) are used in field validation advanced conditions configured prior to upgrade, then they will not be removed automatically by the upgrade code. You must update the Advanced Condition manually through the Console->System Configuration->Field Validation screen.

Migration for Documentum Customers

  1. Existing single-tenant (as well as multi-tenant) customers who are upgrading to Argus Safety 7.0, and are migrating/keeping all the documents in the Documentum server, must also add additional attributes: "enterprise_id" and "enterprise_short_name", and populate these appropriately for all their documents that are to be accessed by Argus Safety in the Documentum server.

  2. Existing single-tenant (as well as multi-tenant) customers who are upgrading to Argus Safety 7.0 release, and have configured "Use Logged in User's Username/Password" for Argus Console -> System Configuration -> Common Profile Switches -> Document Management for Case Attachments must switch to Common Username/Password for Documentum login if not already configured for E2B, Expedited, and Periodic Reports.

Documentation Accessibility

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Accessibility of Code Examples in Documentation

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TTY Access to Oracle Support Services

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Oracle Argus Safety Release Notes, Release 7.0

E16262-01

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