Contents

Title and Copyright Information

Preface

• Documentation Accessibility
• About This Book
• Conventions

1 Product Overview

• Application Map

2 Getting Started

• Logging In and Out
  • Logging into the Argus Application
• About the Argus Home Page
• Additional Tabs
  • Quick Launch Toolbar
  • Error Messages
  • Searching for a Case
  • Sharing a Case Series
  • Basic Features and User Actions
    • Sorting on Columns
    • Getting Help
    • Changing Your Password
    • Entering Dates
    • Entering Multiple Language Text
    • Languages Supported in Argus Safety

3 Active Cases

• Opening Active Cases

4 Case Form

• Case Form Functions
  • Case Form Features
    • Using Password Acceptance Dialog Boxes
    • Initial Case Entry
    • Argus Safety Case Form User Preferences
    • Argus Safety Japan Split Screen Feature
    • Multi-Lingual Text Box
  • General Tab
    • General Usage Information
    • Dynamic Workflow Indicators
    • General Tab: General Information Section
    • General Tab: Study Information Section
    • General Tab: Reporter Information
    • J Reporter Lookup Dialog Box
    • General Tab: Literature Information Section
  • Patient Tab
    • Patient Tab: Patient Information
    • Patient Details Section
    • Event Death Details
    • Other Relevant History Section
    • Lab Data Section
    • Patient Tab: Parent Information
  • Products Tab
    • General Usage Information
    • Products Tab: Drug Tab
    • Products Tab: Device Tab
  • Products Tab: Vaccine Tab
    • Product Information Section
    • Product Indication Section
    • Product Details Section
    • Vaccine Information Section
    • Vaccine History Section
  • Events Tab
    • General Usage Information
    • Events Tab: Event Tab
    • Event Coding Section
    • Seriousness Criteria Section
    • Events Tab: Event Assessment Tab
    • Events Tab: Product -- Event Details Tab
  • Analysis Tab
    • Case Analysis Section
    • Using Auto Narrative Templates
    • Case Summary Section
    • Analysis Tab: MedWatch Info Tab
    • Analysis Tab: BfArM Info Tab
    • Analysis Tab: AFSSaPS Info Tab
  • Analysis Tab: PMDA Tab
    • General Tab: Keyword Search Product Assessment
    • Information Tab: Reason for the Research Report
    • PMDA Tab: Field Label Rules, User Defined Fields, and Help
  • Activities Tab
    • Activities Tab: Contact Log Section
    • Activities Tab: Action Items Section
    • Activities Tab: Routing Comments Section
    • Activities Tab: Case Lock/Close Section
  • Additional Information Tab
    • Additional Info Tab Fields and Field Descriptions
    • Searching for Documentum Links
    • Attaching Files to a Case
    • Entering Keywords
    • Attaching References to a Case
  • Regulatory Reports Tab
    • General Usage Information
    • Regulatory Report Tab Fields and Field Descriptions
    • Grouping Regulatory Reports

5 Case Actions

• Working with Cases
  • Finding and Opening Existing Cases
    • General Usage Information
    • Case Open Form Fields and Field Descriptions
    • Search Results Contents
    • Sharing a Case Series
  • Processing a Case
    • Initial Case Entry Fields and Field Descriptions
    • Booking in Cases and Entering Initial Case Information
    • Checking for Duplicates
    • Understanding Receipt Range Limits
  • Closing a Case
  • Saving a Case
  • Copying a Case
  • Using the Medical Review Function
    • Common Actions
    • Using the Medical Review Tab
    • Using Temporal View Tab
  • Using the Action Items/Addl Info Tab
    • About the Contact Log Section
    • About the Action Items Section
    • About the Notes and Attachments Section
  • Using the Coding Review Function
    • General Information
    • Product Information
    • Event Information
    • Death Information
    • Patient Information
    • Lab Data
    • Parent Information
    • Case Analysis
  • Using the Action Item Tab
    • Action Item Fields and Field Descriptions
  • Using the Print Function
    • Accessing Print Medical Summary Functions
  • Printing a Case
    • Printing a Case
    • Viewing and Printing Letters
    • Viewing and Printing Attachments
    • Transmitting a Case
  • Printing a Medical Summary
  • Deleting a Case
  • Viewing Case Revisions

6 Advanced Conditions

• Advanced Conditions
  • About the Advanced Condition Screen
    • Filtering for Existing Advanced Conditions
    • Viewing Results from Existing Advanced Conditions
  • Working with Advanced Conditions
    • Creating, Viewing or Modifying Advanced Conditions
    • About the Advanced Condition Set Dialog Box
    • Additional Information about Properties
    • Sharing Advanced Conditions
    • Using Advanced Conditions
    • Creating an Advanced Condition Query Set
    • Using the Hit List Tab

7 Worklist

• About Worklist
  • General Usage Information
  • Worklist Filtering
  • Worklist Options
    • New and Open
  • Workflow Options
    • Worklist User Options
  • Worklist Action Items
    • General Usage Information
    • Query Management
    • Query Action Item Example
    • Search Case
    • Filter Function
  • Coding Action Items
    • Search Case
    • Filter Functions
    • Total Number of Rows
  • Contacts
    • Search Case
  • Reports
    • Search Case
    • Filter Function
    • Total Number of Rows
  • Bulk Transmit
    • To view the Bulk Transmit page
    • General Usage Information
  • Bulk Print
    • General Usage Information
  • Bulk E2B Transmit
    • General Usage Information
  • Local Labeling
  • Coding Status
    • Search Conditions Section
    • Total Number of Rows Section
    • Coding Status Icons
  • Letters
    • Search Case Section
    • Total Number of Rows Section
  • J Literature Book-in
    • Import Tab
    • Processing Tab
    • Processed Tab

8 MedDRA Browser

• MedDRA Browser Functionality
  • Using the MedDRA Browser
    • MedDRA Browser Dialog Fields and Field Descriptions
    • MedDRA Searches and Search Results
  • MedDRA Recoding
    • MedDRA Recoding Logic

9 Argus Affiliate Module

• Argus Affiliate Module Information

10 Argus Reports

• Reports
  • Compliance Reports
    • About Expedited Reports
    • About Periodic Reports
  • Submitted Reports
    • Submitting Reports
    • Submitted Reports Search Results
    • Unsubmitting Reports
    • Lock State Header Options
  • Aggregate Reports
    • General Usage Information
    • Using the System Reports Library
  • About Case Data Analysis Reports
    • Creating a Case Data Analysis Report
    • Memorizing the Criteria Specified for a Particular Report.
    • Saving, Deleting, or Cancelling a Report
  • About CIOMS II Line Listing Reports
    • Creating a CIOMS II Line Listing Report
  • About Case Listing Reports
  • About System (Memorized) Reports
    • General Usage Information
  • Periodic Report Types
    • Storing Periodic Reports in Documentum
    • Viewing a Summary of Periodic Regulatory Reports
    • Using the Library Page
  • About Clinical Trial Periodic Reports
    • General Usage Information
    • Common Tab Fields
  • ICH PSUR Reports
    • General Usage Information
  • CIOMS Reports
    • Cumulative Summary
    • FDA PSUR Support
    • Single Case Submission Support
    • UD Summaries Tab
    • Scheduling Tab
    • Security Tab
  • US IND Periodic Reports
    • Common Fields
  • US NDA Periodic Reports
    • General Usage Information
    • Common Fields
    • Subject of Report Tab
    • Product Selection Tab
    • Inclusion Criteria Tab
    • Line Listing Tab
    • Summary Tabulations Tab
    • Scheduling Tab
    • Security Tab
  • Bulk Reporting
    • Bulk Reporting Filter Section
    • Total Number of Rows Section
    • Printing Options
    • User Options
  • Incoming E2B Reports
    • Incoming E2B Reports Fields
    • Pending Reports
  • Bulk Incoming E2B Reports
  • Duplicate Search
    • Duplicate Search Dialog Box Fields and Field Descriptions
    • Duplicate Search for Incoming Review
  • View Differences Report
    • Displaying Differences
  • Processed E2B Reports
    • Search Criteria Section
    • Total Number of Rows Section
• PMDA Reports
  • Expedited Reports
    • General Usage Information
    • Scheduling Expedited Reports
    • Scheduled Expedited Reports
  • Periodic Reports
    • PSR/ReSD Reports
    • Scheduling Periodic Reports
    • Creating Unscheduled Periodic Reports
    • Clinical Study Periodic Safety Reports (CSPSR)

11 Dashboards

• Dashboards Options
  • Open Case Summary Reports
  • Open Action Items Reports
  • Quick Signal Report
    • Quick Signal Report Fields
  • Memorized Reports
  • Increased Frequency Reports
    • Increased Frequency Wizard
  • Expedited Report Status
    • Expedited Report Status Fields and Field Descriptions
  • Workflow Status
    • General Usage Information
    • Workflow Status Fields and Field Descriptions
  • Reports Due Soon
  • Personal Argus Status
    • Cases Assigned Section
    • Contact Log Entries Section
    • Action Items Entries
  • Case Workload

12 Utilities

• Utilities
  • Change Password
  • MedDRA Browser
  • MedDRA J Browser
  • User Login List
    • General Usage Information
  • Logs
  • View Audit Log
    • Search Conditions Section
    • Total Number of Rows Section
    • Audit Log Details Screen
  • LAM Audit Log
    • General Usage Information
  • Error Log
    • Search Conditions Section
    • Total Number of Rows Section
  • E2B Screens
    • E2B Transmit Status Screen
    • E2B Receive Status
  • Argus Reconciliation
    • Source Database Definition
    • Interactive Reconciliation
    • Editing Interactive Reconciliation Reports
  • Reconciliation Scheduling
    • Reconciliation Scheduler Dialog Box Fields and Field Descriptions
    • Editing Reconciliation Scheduling
  • Case Undelete
    • Case Search Criteria Fields and Field Descriptions
    • Total Number of Rows Fields and Field Descriptions
    • General Usage Information
    • Action Justification Dialog Box Fields and Field Descriptions
  • Batch Reports
  • Blank Report Forms
  • End of Study
    • End of Study Unblinding Dialog Box Fields and Field Descriptions
  • Clear Cache
  • Advanced Condition Library

13 About dsNavigator

• dsNavigator
  • dsNavigator Coding Process
    • Case Processing - Event Coding Process Flow
    • List Maintenance Coding Process Flow
    • Central Coding Process Management
  • Configuring through dsNavigator
    • Configuring Central Coding Options
    • Configuring Encode
    • Configuring Coding Review and Coding Status Role