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Oracle Argus Safety Japanese User's Guide
Release 7.0.3
E40571-01
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Contents
List of Figures
List of Tables
Title and Copyright Information
Preface
Intended Audience
Documentation Accessibility
About This Book
Conventions
1
Case Form
Reporter Information
Products Tab
Analysis Tab
PMDA Information tab
PMDA Information: General Tab
PMDA Information: Comments Tab
Product License Value
PMDA Event Reportability Updates
Case Form - PMDA Analysis tab
PMDA E2B Report Mapping Updates
Additional Information Tab
2
Case Actions
PMDA Event Reportability
3
Worklist
Literature Intake Updates
Import Tab Changes
Processing Tab Changes
Changes to Literature Duplicate Check
Changes to Existing Screen Label
4
Reports
Reports: PMDA Expedited Reports
Manual Scheduling of Expedited Reports: New Expedited Reports Dialog Box
Functionality Changes
Paper Reports
User Interface - Reporting Rules Configuration
Additional Expedited Report Updates
PMDA Device Reports
Reports: PMDA Periodic Reports
DLP at Report Level
Upgrade Considerations
Advance Conditions in J Periodic Reports
Check in/Checkout Enhancements
Other Changes
Periodic Safety Report
Format
PSR /ReSD Details
Clinical Study Periodic Safety Report
Format
CSPSR Details
CSPSR - Cover
Clinical Study Periodic Safety Report - Line Listing
Seiyakukyo Line Listing Report (Individual Report Common Line List)
Configuration Screen
Report Output Format
Report Output Filter Criterion
Report Output Field Mappings
CSV Output Format
Periodic Report Process Flow
5
Utilities
MedDRA Browser