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Oracle® Argus Safety English User's Guide
Release 8.0
E54656-02
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Contents
Title and Copyright Information
Preface
Documentation Accessibility
Related Documents
Checking My Oracle Support
Conventions
1
Getting Started
Product Overview
Logging In and Out
Logging into the Argus Application
User Password Complexity Enhancement
About the Argus Home Page
Additional Tabs
Quick Launch Toolbar
Error Messages
Searching for a Case
Argus Insight Integration
Sharing a Case Series
Basic Features and User Actions
Sorting on Columns
Getting Help
Changing Your Password
Entering Dates
Entering Multiple Language Text
Languages Supported in Argus Safety
2
Argus Affiliate Module
Argus Affiliate Module Information
3
Active Cases
Opening Active Cases
4
Local Lock Functionality
Enabling Local Data Entry
Local Fields
References for Details on Local Case Data Lock Functionality
Changes to Report Scheduling - Auto-Scheduling
Changes to Report Scheduling - Manual Scheduling
Outlier Processing
Upgrade Changes - Enabling Local Locking in Argus Safety
Triggering Local Reports - Changes to the Report Generation Algorithm
5
Case Form
Case Form Functions
Case Form Features
Using Password Acceptance Dialog Boxes
Initial Case Entry
Argus Safety Case Form User Preferences
General Tab
General Usage Information
Dynamic Workflow Indicators
General Tab: General Information Section
General Tab: Study Information Section
General Tab: Reporter Information
General Tab: Literature Information Section
Patient Tab
Patient Tab: Patient Information
Patient Details Section
Event Death Details
Other Relevant History Section
Lab Data Section
Patient Tab: Parent Information
Products Tab
General Usage Information
Products Tab: Drug Tab
Products Tab: Device Tab
Products Tab: Vaccine Tab
Events Tab
General Usage Information
Events Tab: Event Tab
Event Coding Section
Seriousness Criteria Section
Events Tab: Event Assessment Tab
Analysis Tab
Case Analysis Section
Using Auto Narrative Templates
Case Summary Section
Analysis Tab: MedWatch Info Tab
Analysis Tab: BfArM Info Tab
Analysis Tab: AFSSaPS Info Tab
Activities Tab
Activities Tab: Contact Log Section
Activities Tab: Action Items Section
Activities Tab: Routing Comments Section
Activities Tab: Case Lock/Close Section
Additional Information Tab
Additional Info Tab Fields and Field Descriptions
Searching for Documentum Links
Attaching Files to a Case
Entering Keywords
Attaching References to a Case
Regulatory Reports Tab
General Usage Information
Regulatory Report Tab Fields and Field Descriptions
Grouping Regulatory Reports
6
Case Actions
Working with Cases
Finding and Opening Existing Cases
General Usage Information
Case Open Form Fields and Field Descriptions
Search Results Contents
Sharing a Case Series
Processing a Case
Initial Case Entry Fields and Field Descriptions
Booking in Cases and Entering Initial Case Information
Checking for Duplicates
Understanding Receipt Range Limits
Closing a Case
Saving a Case
Copying a Case
Using the Medical Review Function
Common Actions
Using the Medical Review Tab
Using Temporal View Tab
Using the Action Items/Additional Info Tab
Using the Coding Review Function
General Information
Product Information
Event Information
Death Information
Patient Information
Lab Data
Parent Information
Case Analysis
Common Buttons Available in Coding Review
Using the Action Item Tab
Action Item Fields and Field Descriptions
Using the Print Function
Accessing Print Medical Summary Functions
Printing a Case
Printing a Case
Viewing and Printing Letters
Viewing and Printing Attachments
Transmitting a Case
Printing a Medical Summary
Deleting a Case
Viewing Case Revisions
7
Advanced Conditions
Advanced Conditions
About the Advanced Condition Screen
Filtering for Existing Advanced Conditions
Viewing Results from Existing Advanced Conditions
Working with Advanced Conditions
Creating, Viewing or Modifying Advanced Conditions
About the Advanced Condition Set Dialog Box
Additional Information about Properties
Sharing Advanced Conditions
Using Advanced Conditions
Creating an Advanced Condition Query Set
Using the Hit List Tab
8
Worklist
About Worklist
General Usage Information
Worklist Filtering
Worklist Options
New and Open
Workflow Options
Worklist User Options
Worklist Action Items
General Usage Information
Query Management
Query Action Items
Search Case
Filter Function
Coding Action Items
Search Case
Filter Functions
Total Number of Rows
Contacts
Search Case
Reports
Search Case
Filter Function
Total Number of Rows
Bulk Transmit
To view the Bulk Transmit page
General Usage Information
Bulk Print
General Usage Information
Bulk E2B Transmit
General Usage Information
Local Labeling
Coding Status
Search Conditions Section
Total Number of Rows Section
Coding Status Icons
Letters
Search Case Section
Total Number of Rows Section
Intake
Pending Tab
Rejected Tab
9
MedDRA Browser
MedDRA Browser Functionality
Using the MedDRA Browser
MedDRA Browser Dialog Fields and Field Descriptions
MedDRA Searches and Search Results
Non-Current Terms Search within MedDRA Browser
MedDRA Recoding
MedDRA Recoding Logic
Recode MedDRA terms at the Enterprise level
10
Reports: Compliance and Aggregate Reports
Reports
Compliance Reports
About Expedited Reports
About Periodic Reports
Creating Unscheduled Periodic Reports
About Submitted Reports
Aggregate Reports
General Usage Information
Using the System Reports Library
About Case Data Analysis Reports
About CIOMS II Line Listing Reports
About Case Listing Reports
About System Reports Library
11
Reports: Periodic Reports
Periodic Report Types
Initial and Follow-up Cases in Periodic Reports
Storing Periodic Reports in Documentum
Viewing a Summary of Periodic Regulatory Reports
Using the Library Page
About CTPR: Clinical Trial Periodic Reports
General Usage Information
Common Tab Fields
About ICH PSUR Reports
General Usage Information
Common Tab Fields
CIOMS Reports
About US IND Periodic Reports
Common Fields
About NDA Periodic Reports
General Usage Information
Common Fields
Subject of Report Tab
Product Selection Tab
Inclusion Criteria Tab
Line Listing Tab
Summary Tabulations Tab
Scheduling Tab
Security Tab
Bulk Reporting
Bulk Reporting Filter Section
Total Number of Rows Section
Printing Options
User Options
Initial and Follow-up Cases in Periodic Reports
12
Reports: Bulk Reporting, E2B Pending, and Processed E2B Reports
Bulk Reporting
Bulk Reporting Filter Section
Total Number of Rows Section
Printing Options
Suppress Default Printer option in Select Site Printer dialog
User Options
Lock State Header Options
Lock State Icon Options
E2B Pending Reports
Incoming E2B Reports Fields
Button and Right-click Options
Pending Reports
Bulk Incoming E2B Reports
Duplicate Search
Duplicate Search Dialog Box Fields and Field Descriptions
Duplicate Search for Incoming Review
View Differences Report
Displaying Differences
Processed E2B Reports
Search Criteria Section
Total Number of Rows Section
13
Dashboards
Dashboards Options
Open Case Summary Reports
Open Action Items Reports
Quick Signal Report
Quick Signal Report Fields
Memorized Reports
Increased Frequency Wizard
Increased Frequency Wizard
Expedited Report Status
Expedited Report Status Fields and Field Descriptions
Workflow Status
General Usage Information
Workflow Status Fields and Field Descriptions
Reports Due Soon
Personal Argus Status
Cases Assigned Section
Contact Log Entries Section
Action Items Entries
Case Workload
14
Utilities
Utilities
Change Password
MedDRA Browser
User Login List
General Usage Information
Logs
View Audit Log
Search Conditions Section
Total Number of Rows Section
Audit Log Details Screen
LAM Audit Log
General Usage Information
Error Log
Search Conditions Section
Total Number of Rows Section
E2B Screens
E2B Transmit Status Screen
E2B Receive Status
Case Undelete
Case Search Criteria Fields and Field Descriptions
Total Number of Rows Fields and Field Descriptions
General Usage Information
Action Justification Dialog Box Fields and Field Descriptions
Batch Reports
End of Study Unblinding
End-of-Study-Unblinding Dialog Box Fields and Field Descriptions
Clear Cache
Advanced Condition Library
15
Multi-Tenancy
Introduction to Multi-tenancy
Multi-tenancy in Argus Safety
Data Segregation
Data Segregation by Module
Data Segregation impact on system level configuration items
Dictionaries
Global Worklists
Global Worklist Tabs
Link to Argus Safety
Case Actions
Search Case
View Options
Global Enterprise Management
Add New Enterprise
Global User Management
Associate Enterprise
Synchronizable User Attributes
Configure Synchronizable Attributes
Modifying User Attributes
Application Access
Enterprise
Application