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Oracle® Argus Safety Japanese User's Guide
Release 8.0
E54657-01
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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
Activities Tab
Additional Information Tab
Regulatory Reports 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
Paper Reports
User Interface - Reporting Rules Configuration
Expedited Reports on DLP
Additional Expedited Report Updates
PMDA Device Reports
Reports: PMDA Periodic Reports
DLP at Report Level
Periodic Reports on DLP
Upgrade Considerations
Advanced Conditions in J Periodic Reports
Check in/Checkout Enhancements
Other Changes
Periodic Safety Report
Format
PSR /ReSD Details
Clinical Study Periodic Safety Report (now J-DSUR)
Format
J-DSUR Details
J-DSUR - Cover
J-DSUR - Form 2
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
Non-Reportable and Invalid Events
5
Utilities
MedDRA Browser