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Contents
Title and Copyright Information
Preface
Where to Find More Information
Documentation Accessibility
1
Case Form
1.1
Reporter Information
1.2
Products Tab
1.3
Analysis Tab
1.3.1
PMDA Information tab
1.3.1.1
PMDA Information: General Tab
1.3.1.1.1
Functionality Changes
1.3.1.2
PMDA Information: Comments Tab
1.3.1.2.1
Functionality Changes
1.3.2
Product License Value
1.3.3
PMDA Event Reportability Updates
1.3.4
Case Form - PMDA Analysis tab
1.3.5
PMDA E2B Report Mapping Updates
1.4
Activities Tab
1.5
Additional Information Tab
1.6
Regulatory Reports Tab
1.7
Conformance Rules Tab
2
Case Actions
2.1
PMDA Event Reportability
3
Worklist
3.1
Literature Intake Updates
3.1.1
Import Tab Changes
3.1.2
Processing Tab Changes
3.1.3
Changes to Literature Duplicate Check
3.1.4
Changes to Existing Screen Label
4
Reports
4.1
Reports: PMDA Expedited Reports
4.1.1
Report Scheduling
4.1.2
Paper Reports
4.1.2.1
Additional Expedited Report Updates
4.1.2.2
Printed Paper Reports—Formatting Details
4.1.3
User Interface - Reporting Rules Configuration
4.1.4
Expedited Reports on DLP
4.1.5
PMDA Device Reports
4.2
Reports: PMDA Periodic Reports
4.2.1
DLP at Report Level
4.2.2
Periodic Reports on DLP
4.2.3
Upgrade Considerations
4.2.4
Advanced Conditions in J Periodic Reports
4.2.5
Check in/Checkout Enhancements
4.2.6
Other Changes
4.2.7
Periodic Safety Report
4.2.7.1
Format
4.2.7.2
PSR /ReSD Details
4.2.7.2.1
Subject of Report
4.2.7.2.2
Product Selection
4.2.7.2.3
Periodic Safety Report/ReSD
4.2.7.2.4
Scheduling
4.2.7.2.5
Security
4.2.7.2.6
Printing PSR / ReSD
4.2.7.2.7
Deleting PSR / ReSD
4.2.8
Clinical Study Periodic Safety Report (now J-DSUR)
4.2.8.1
Format
4.2.8.2
J-DSUR Details
4.2.8.2.1
Subject of Report
4.2.8.2.2
Product Selection
4.2.8.2.3
J-DSUR
4.2.8.2.4
Scheduling
4.2.8.2.5
Security
4.2.8.2.6
Printing CSPSR
4.2.8.2.7
Deleting A J-DSUR
4.2.8.3
J-DSUR - Cover
4.2.8.4
J-DSUR - Form 2
4.2.8.4.1
Domestic Serious AE, etc. Case Occurence Status Line Listing
4.2.9
Seiyakukyo Line Listing Report (Individual Report Common Line List)
4.2.9.1
Configuration Screen
4.2.9.2
Report Output Format
4.2.9.3
Report Output Filter Criterion
4.2.9.4
Report Output Field Mappings
4.2.9.5
CSV Output Format
4.2.9.6
Periodic Report Process Flow
4.3
Non-Reportable and Invalid Events
5
Utilities
5.1
MedDRA Browser
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