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Oracle® Argus Safety Japanese User's Guide
Release 6.0.1
E23602-01
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Contents
Title and Copyright Information
Preface
Documentation Accessibility
About This Book
Conventions
1
Product Overview
Application Map
2
Getting Started
Logging In and Out
Logging into the Argus Application
About the Argus Home Page
Additional Tabs
Quick Launch Toolbar
Error Messages
Searching for a Case
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
3
Active Cases
Opening Active Cases
4
Case Form
Case Form Functions
Case Form Features
Using Password Acceptance Dialog Boxes
Initial Case Entry
Argus Safety Case Form User Preferences
Argus Safety Japan Split Screen Feature
Multi-Lingual Text Box
General Tab
General Usage Information
Dynamic Workflow Indicators
General Tab: General Information Section
General Tab: Study Information Section
General Tab: Reporter Information
J Reporter Lookup Dialog Box
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
Product Information Section
Product Indication Section
Product Details Section
Vaccine Information Section
Vaccine History Section
Events Tab
General Usage Information
Events Tab: Event Tab
Event Coding Section
Seriousness Criteria Section
Events Tab: Event Assessment Tab
Events Tab: Product -- Event Details 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
Analysis Tab: PMDA Tab
General Tab: Keyword Search Product Assessment
Information Tab: Reason for the Research Report
PMDA Tab: Field Label Rules, User Defined Fields, and Help
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
5
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/Addl Info Tab
About the Contact Log Section
About the Action Items Section
About the Notes and Attachments Section
Using the Coding Review Function
General Information
Product Information
Event Information
Death Information
Patient Information
Lab Data
Parent Information
Case Analysis
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
6
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
7
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 Item Example
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
J Literature Book-in
Import Tab
Processing Tab
Processed Tab
8
MedDRA Browser
MedDRA Browser Functionality
Using the MedDRA Browser
MedDRA Browser Dialog Fields and Field Descriptions
MedDRA Searches and Search Results
MedDRA Recoding
MedDRA Recoding Logic
9
Argus Affiliate Module
Argus Affiliate Module Information
10
Argus Reports
Reports
Compliance Reports
About Expedited Reports
About Periodic Reports
Submitted Reports
Submitting Reports
Submitted Reports Search Results
Unsubmitting Reports
Lock State Header Options
Aggregate Reports
General Usage Information
Using the System Reports Library
About Case Data Analysis Reports
Creating a Case Data Analysis Report
Memorizing the Criteria Specified for a Particular Report.
Saving, Deleting, or Cancelling a Report
About CIOMS II Line Listing Reports
Creating a CIOMS II Line Listing Report
About Case Listing Reports
About System (Memorized) Reports
General Usage Information
Periodic Report Types
Storing Periodic Reports in Documentum
Viewing a Summary of Periodic Regulatory Reports
Using the Library Page
About Clinical Trial Periodic Reports
General Usage Information
Common Tab Fields
ICH PSUR Reports
General Usage Information
CIOMS Reports
Cumulative Summary
FDA PSUR Support
Single Case Submission Support
UD Summaries Tab
Scheduling Tab
Security Tab
US IND Periodic Reports
Common Fields
US 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
Incoming E2B Reports
Incoming E2B Reports Fields
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
PMDA Reports
Expedited Reports
General Usage Information
Scheduling Expedited Reports
Scheduled Expedited Reports
Periodic Reports
PSR/ReSD Reports
Scheduling Periodic Reports
Creating Unscheduled Periodic Reports
Clinical Study Periodic Safety Reports (CSPSR)
11
Dashboards
Dashboards Options
Open Case Summary Reports
Open Action Items Reports
Quick Signal Report
Quick Signal Report Fields
Memorized Reports
Increased Frequency Reports
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
12
Utilities
Utilities
Change Password
MedDRA Browser
MedDRA J 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
Argus Reconciliation
Source Database Definition
Interactive Reconciliation
Editing Interactive Reconciliation Reports
Reconciliation Scheduling
Reconciliation Scheduler Dialog Box Fields and Field Descriptions
Editing Reconciliation Scheduling
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
Blank Report Forms
End of Study
End of Study Unblinding Dialog Box Fields and Field Descriptions
Clear Cache
Advanced Condition Library
13
About dsNavigator
dsNavigator
dsNavigator Coding Process
Case Processing - Event Coding Process Flow
List Maintenance Coding Process Flow
Central Coding Process Management
Configuring through dsNavigator
Configuring Central Coding Options
Configuring Encode
Configuring Coding Review and Coding Status Role