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2/15
List of Figures
2-1 Enabled Modules Screen
2-2 BIP Reporting Screen
2-3 ICH PSUR Configuration Screen
2-4 BIP Logo
2-5 Line Listing Tab
2-6 Summary Tabulations Tab
2-7 Data Line Listing Criteria for Ad hoc Line Listings
2-8 Ad hoc Line Listings Screen
2-9 Query Criteria from Memorized Configuration
2-10 Message Displayed
2-11 Advanced Condition Library Screen
2-12 Advanced Condition Set Screen
2-13 Justification Dialog Box
2-14 Report Batch Printing
2-15 Reports Tree Entry Screen
2-16 Selecting the Report Format
2-17 Reports Tree Entry Screen
2-18 ICH PSUR Line Listing Reports
2-19 Background Case Series Execution Status
2-20 Report Generation Complete Screen
6-1 ICH PSUR Summary Tabulations Tab
6-2 Section 6.2 Layout
6-3 Section 6.3 Layout
6-4 PBRER Cover Page
6-5 List of Case Numbers
6-6 Labels Configured for Drugs
6-7 Cases Missing Assessments
6-8 Trailer Section
6-9 The Reports Tree Entry Screen
6-10 PBRER Format Selection
7-1 BIP Logo
7-2 Line Listing Tab
7-3 Summary Tabulation Tab
7-4 Ad Hoc Line Listing Query Criteria
7-5 Aggregate Line Listings
7-6 DSUR Main Line Listing
7-7 Table Format
7-8 Drug Roles
7-9 Summary Count Table
8-1 Report Format
8-2 Format for HCP Summary Tabulations
8-3 Consumer Summary Tabulation Screen
8-4 Summary Tabulation for Clinical Trials Screen
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