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Contents
List of Figures
List of Tables
Title and Copyright Information
Preface
Where to Find More Information
Documentation Accessibility
1
Introduction
2
BI Publisher and the Argus Safety Application
2.1
Enabling BI Publisher Aggregate Reporting
2.2
Configuring the Argus BIP Integration
2.3
Report Execution Flow from BI Publisher and Argus Safety
2.3.1
Report Execution Flow from Argus Safety
2.3.2
Report Execution Flow from BI Publisher
2.4
Periodic Configuration Identification of BIP Parameters
2.4.1
Subject of Report Tab
2.4.2
Product Selection Tab
2.4.3
Inclusion Criteria and Special Interest AE Tabs
2.4.4
Line Listing Tab
2.4.5
Summary Tabulations Tab
2.4.6
UD Summaries Tab
2.4.7
Security Tab
2.5
Generating and Modifying a Case Series
2.5.1
Generating a Case Series
2.5.2
Modifying a Case Series
2.5.3
Advanced Condition Library
2.5.4
Deleting a Case Series
2.6
Running BIP Reports through Argus Safety
2.7
Running Reports through BIP Console
2.8
Running Reports through the BIP Scheduler
2.9
Data Security
2.10
Report Output Management
2.11
Viewing Aggregate Reports from Argus Safety
2.12
Background Periodic Report Status
3
Aggregate Reporting Data Model
3.1
Aggregate Reporting Data Model
4
Reporting Algorithms
4.1
Labeling Algorithm
4.1.1
Listedness Determination based on Event Assess Table
4.1.2
Listedness Determination Based on Event Assess Table and Datasheets
4.1.3
Listedness Determination based on Datasheets
4.1.4
Additional Considerations for Determining Listedness
4.2
Choosing a Categorization Algorithm for Compiling PBRER and DSUR
4.3
Initial or Follow-up Algorithm
4.3.1
Using Submission Tracking
4.3.2
Using Initial Receipt Date
5
Argus Insight Compatibility
5.1
Configuring Changes for Argus Insight RPD Integration
5.1.1
Common Profile Entries
5.1.2
Data Purging
6
Periodic Benefit Risk Assessment Report
6.1
Report Objective
6.2
Configuring Argus Safety for PBRER
6.2.1
Product Types in Study Configuration for Supporting PBRER and DSUR
6.3
PBRER Section 6.2 - Cumulative Summary Tabulations of Serious Adverse Events from Clinical Trials
6.3.1
Generating the Case Series for Section 6.2
6.3.1.1
Company or Configured Study Cases
6.3.1.2
Non-Company or Non-Configured Study Cases
6.3.2
Grand Totals
6.3.3
Section 6.2 Layout
6.4
PBRER Section 6.3 - Cumulative and Interval Summary Tabulations from Post-Marketing Data Sources
6.4.1
Case Selection
6.4.2
Section 6.3 Layout
6.5
Sample Report
6.5.1
Cover Page
6.5.1.1
Information on Drugs and Studies
6.5.2
Labels Configured for Drugs in the Drug List Format
6.5.3
Cases with Missing Assessments
6.5.4
Trailer Section
6.6
Executing the PBRER from BIP
7
Development Safety Update Report
7.1
Report Objective
7.2
Argus Configuration for DSUR
7.2.1
Subject of Report Tab
7.2.2
Line Listing Tab
7.2.3
Summary Tabulation Tab
7.2.4
UD Summaries Tab
7.2.5
Security Tab
7.2.6
Scheduling and Template Tabs
7.3
DSUR Main Line Listings
7.3.1
Grouping
7.3.2
Main Line Listing
7.3.3
Report Parameters for Printing Reactions or Serious Events
7.3.4
Summary Columns
7.3.5
DSUR Main Line Listing Format
7.3.6
DSUR Fatal Line Listing
7.4
Summary Tabulations of Serious Adverse Events
7.4.1
Groupings
7.4.2
Count Breakdown in Tabulations based on IMP, Comparator, Placebo, and Blinded
7.4.3
DSUR Tabulation Format
7.4.4
Totals
7.4.5
Summary Counts
7.5
Executing a DSUR from BIP
8
Post Marketed Aggregate Report
8.1
Report Objective and Sections
8.2
PMAR Sections
8.3
Argus Configuration (PSUR) for PMAR
8.4
Main Line Listing
8.4.1
Grouping
8.5
Line Listing Columns
8.6
Summary Columns for Count
8.7
Report Format
8.7.1
Ad Hoc Line Listing Sections
8.7.2
Summary Tabulations
8.7.3
PMAR Summary Tabulation
8.7.4
Grouping
8.8
HCP Summary Tabulation Columns
8.8.1
Format for HCP Summary Tabulations
8.9
Summary Tabulation for Consumer Cases
8.10
Format for Clinical Trial Summary Tabulations
8.10.1
Cumulative Summary Tabulation for Serious Unlisted Events
8.11
Executing a PMAR from BIP
A
Report Parameters and their Definitions
Glossary
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