1/12

Contents

Title and Copyright Information

Preface

• Where to Find More Information
• Documentation Accessibility

1 Updated Documentation

2 Getting Started

• Log In
• Change Your Password
• Know Your Basics
  • View your Personal Argus Status
  • Use the Quick Launch Toolbar
  • Use Field Validations
  • Use Field-Level Help
  • Acceptable Date Formats
  • Enter Reasons for Missing (Null Flavor) Data
  • Use Other (than English) Language Text
  • Case Form User Preferences
  • Dynamic Workflow Indicator
• View the User Login List
• Clear Cache
• Integrate with Argus Insight

3 Enter Case Data

• Create a New Case
  • Enter a New Case
  • Initial Case Entry—Fields Descriptions
  • Check for Duplicates
    • Receipt Range—Fields Descriptions
  • Initial Case Entry—BookIn Dialog Box
  • Accept Incoming Cases
    • View Pending Case
    • View Rejected Cases
• Enter General Information
  • General Information—Field Descriptions
  • Enter Study Information
    • Study Information—Field Descriptions
  • Enter Reporter Information
    • Add Reporter Information
    • Reporter Information—Field Descriptions
  • Enter Literature Information
• Enter Patient Information
  • Enter Current Medical Status
  • Copy Patient Information from Reporter Information
  • Patient Information—Field Descriptions
  • Enter Patient Notes
  • Enter Patient Details
    • Enter Pregnancy Information
  • Enter Patient Death Details
    • Event Death Details—Field Descriptions
  • Enter Other Relevant History
    • Other Relevant History—Field Descriptions
  • Enter Lab Data—Lab Test and Test Results
    • Lab Data—Field Descriptions
  • Enter Additional Test Information
  • Enter Parent Information
• Enter Product Information
  • Search for Products
  • Enter Time Measurement Information
  • Enter Drug Information
    • Product Information—Field Descriptions
    • Enter Product Indications
    • Enter Quality Control Information
    • Enter Dosage Regimens
    • Enter Product Details
    • Enter Study Drug Information
  • Enter Device Information
    • Enter Product Information
    • Enter Quality Control Information
    • Enter Product Indications
    • Select Product Delivered by Device
    • Enter Device Component Information
    • Device Information—Field Descriptions
  • Enter Vaccine Information
    • Enter Product Details
    • Enter Prior Adverse Events Information
    • Enter Product Information
    • Complete Vaccine Administration Form
    • Enter Vaccine History
• Enter Event Information
  • Enter Event Information
    • Event Information—Field Descriptions
    • Review a Diagnosis-Event Relationship
    • Associate a symptom with the diagnosis
    • Auto-populate Event Information
    • Configure Regulatory Reporting Rules
  • Enter Event Coding Information
  • Enter Seriousness Criteria
    • Enter Death Details
    • Enter Hospitalization Details
    • Select Nature of Event
    • Enter Event Notes
  • Enter Event Assessment Information
    • Event Assessment Tab—User Actions
    • Filter Event Assessment Details
    • Enter Product-Event Details
• Add Attachments to Your Case
  • Enter Additional Information for the Attachments
  • Sort Attachments
  • Search for Documentum Links
  • Attach Files to a Case
  • Enter Keywords
  • Attach References to a Case
  • View and Print Attachments
• Review Local Labeling
• Enable Local Data Entry for Japan
  • Enable Local Data Entry
    • About Local Fields
  • Access Local Case Data Lock Functionality
  • Process an Outlier
  • Activate Local Locking in Argus Safety
    • Enter Local Reports Configuration Seed Data
    • Enter Local Users Seed Data
    • Enter Local Fields Seed Data

4 Review Your Cases

• Find an Existing Case
  • Enter Case Search Criteria
• Open or View New Cases in the Worklist
• Find Cases Assigned to you
• View your Pending Action Items
• View your Case Workload
  • Open Case Summary Reports
  • View Workflow Status
• View your Worklist Action Items
  • Manage your Queries
  • Query your Action Items
• View your Contacts
  • Review your Contact Log
    • Use the Contact Log Section
    • Generate Letters
    • Schedule Action Items for Letters
    • Open a Message Editor
• View and Print Letters Due
  • Enter Case Search Criteria for Letters
  • View and Print Letters
• Perform a Medical Review
  • Use the Medical Review Tab
    • Enter Case Narrative Information
    • Enter Case Assessment Information
    • Enter Event Assessment Information
  • Use the Temporal View Tab
    • View the Summary Section
    • Enter Relevant Tests Information
• Perform a Coding Review
  • Use the Coding Review Function
    • Review General Information
    • Review Product Information
    • Review Event Information
    • Review Death Information
    • Review Patient Information
    • Review Lab Data Information
    • Review Parent Information
    • Review Case Analysis Information
  • Review your Coding Action Items
    • Review Action Items Information
    • Open Action Items Reports
• View Coding Status
  • Coding Status Icons
  • Enter Case Search Criteria
• Review your Case for Regulatory Submission
  • Use the Case Analysis Section
  • Use the Case Summary Section
  • Use the MedWatch Info Tab
    • Check G3 Report Source Checkboxes
  • Use the BfArM Info Tab
  • Use the AFSSaPS Info Tab
• Route a Case to the Next Workflow Step
  • Route Cases
  • Return Cases
• Close, Save or Copy a Case
  • Close a Case
  • Save a Case
  • Copy a Case
• Use the Print Function
  • Print a Case Form
  • Print a Medical Summary
  • View and Print Letters
  • View and Print Attachments
• Unblind a Study
• Lock or Unlock a Case
  • Lock a Case
  • Unlock a Case
• Create a Follow-up Event
• Delete or Undelete a Case
  • Delete a Case
  • Undelete a Case
• View Case Revisions
• View Audit Logs
  • Audit Log Details Screen
  • LAM Audit Log
• View the Error Log

5 Use Advanced Conditions

• Create, View or Modify Advanced Conditions
• Share Advanced Conditions
• Create an Advanced Condition Query Set
  • Rename Query Sets
• Import and Export Cases in the Advanced Conditions
• Re-use an Existing Advanced Condition
• Search for a Case
• Use the Advanced Conditions Library

6 Use the MedDRA Browser

• View the MedDRA Browser
  • MedDRA Browser Dialog Box—Field Descriptions
• Search for a Term
• Search Non-Current Terms within MedDRA Browser
• MedDRA Recoding
  • MedDRA Recoding
  • Recode MedDRA terms at the Enterprise level

7 Manage Your Expedited Report Submissions

• Schedule an Expedited Report
  • Schedule a Report Manually
    • Schedule New Expedited Reports—Field Descriptions
  • Auto-schedule a Report
    • Understand Auto-Schedule a Report
    • Expedited Reporting Rules Algorithm
  • Create Your Follow-up Reports
  • Create Unscheduled Expedited Reports
  • Create Batch Reports
• Review a Draft Expedited Report
• Generate an Expedited Report
• Approve Your Report
• Review Your Scheduled Reports
  • Group Regulatory Reports
    • Group by Report Type, Submit Category, or Reporting Destination
    • Group by Report Type or Reporting Destination
    • Group by Report Type or Reporting Group
  • Review a List of your Scheduled and Generate Reports
    • View Lock State
    • View a Summary of Expedited Regulatory Reports
  • Store Expedited Reports in Documentum
  • View Scheduled and Approved Reports
    • Report Filter Options
    • View Filter Results
• Transmit Your ICSRs
  • Transmit an ICSR
  • Transmit Several ICSRs at Once
    • Filter Reports
    • User Options
    • View Routing Details
• Print Your Reports
  • Bulk Print User Options
• Track ICSR Transmissions
  • View ICSR Transmit Status
    • Search for Reports
    • Search for ESM Messages
    • View Search Results
  • View ICSR Pending Reports
    • Track Incoming ICSR Reports
    • Manage Pending Reports
    • Track Bulk Incoming ICSR Reports
  • Search for Duplicate Reports
    • View Duplicate Search Options
    • Search Duplicates for Incoming Review
    • View Differences Report
  • View Processed ICSR Reports
    • Search for Reports
    • View Search Results
• Track your ICSR Report Submissions
  • Track ICSR Outgoing Status
  • Track ICSR Incoming Status
  • View Message Options
• Check When Your Expedited Reports are Due
  • View Expedited Report Status
  • View Reports Due Soon
• Find Overdue Reports
• Trigger Local Reports—Report Generation Algorithm

8 Manage Your Periodic Report Submissions

• Prepare Content for Periodic Reports
  • Prepare your Aggregate Reports
    • Understand Aggregate Reports
    • View Saved Aggregate Reports
    • Create a Case Data Analysis Report
    • Create a CIOMS II Line Listing Report
    • Create a Case Listing Report
    • Check Aggregate Report Execution Status
  • Periodic Report Types
    • Store Periodic Reports in Documentum
    • View a Summary of Periodic Regulatory Reports
    • Use the Library Page
  • Prepare Content for a Clinical Trial Periodic Report
    • Create a Clinical Trial Periodic Report
    • Enter Common Fields Information
    • Configure Subject in the Report Header
    • Select Products to include in CTPR
    • Configure License or Study in the Report Header
    • Select Inclusion Criteria
    • Use the Data Lock Point (DLP) Version
    • Use DLP Queries for Dates
    • Use As of Reporting Function
    • Find DLP and As of query functionality
    • Include Line Listing
    • Add Data Elements
    • View Selected Data Elements
    • Group Cases
    • Specify Summary Tabulations for Line Listing
    • Generate Single Case Submission Report
    • Select Summary Listing
    • Schedule the Report
    • Setup Frequency of the Scheduled Reports
    • Configure Security Level of the Report
  • Prepare Content for an ICH PSUR
    • Create Periodic Safety Update Reports (PSURs)
    • Enter Common Fields Information
    • Configure Subject in the Report Header
    • Select Products to include in ICH PSUR
    • Select Inclusion Criteria
    • Include Line Listing
    • Add Data Elements
    • View Selected Data Elements
    • Group Cases
    • Specify Summary Tabulations for Line Listing
    • Include CIOMS Reports
    • Add Cumulative Summary
    • Add FDA PSUR Support Information
    • Generate Single Case Submission Report
    • Select Summary Listing
    • Schedule the Report
    • Setup Frequency of the Scheduled Reports
    • Configure Security Level of the Report
  • Prepare Content for a US IND Periodic Report
    • Create New IND Report
    • Enter Common Fields Information
    • Configure Subject in the Report Header
    • Select Products to Generate the Report
    • Select Inclusion Criteria
    • Include Line Listing
    • Specify Summary Tabulations for Line Listing
    • Schedule the Report
    • Configure Security Level of the Report
  • Prepare Content for an NDA Periodic Report
    • Create NDA Summary Report
    • Enter Common Fields Information
    • Configure Subject in the Report Header
    • Select Products to Generate the Report
    • Select Inclusion Criteria
    • Include Line Listing
    • Specify Summary Tabulations for Line Listing
    • Schedule the Report
    • Configure Security Level of the Report
• View Scheduled Periodic Report Information
  • Available User Options
  • View Report Details
  • View Report Schedule Details
  • View Report Routing History
• Submit a Periodic Report
  • Specify Submission Details
  • Add Comments
  • Transmit a Report
  • View Report Generation Status
  • Create Unscheduled Periodic Reports
  • Approve and Submit a Report
  • View Submitted Reports
  • Use Bulk Report
    • Filter Bulk Reports
    • View Bulk Report Filter Results
    • Print Reports in Bulk
    • Sort Cases
    • Lock State Icon Options
• Track your Periodic Report Submission
  • Use Submitted Reports Search Results
  • Reopen Submitted Reports
  • About Initial and Follow-up Cases in Periodic Reports
  • View Batch Reports Scheduled for Generation

9 Multi-Tenancy

• Know more about Multi-tenancy
  • Use Multi-tenancy in Argus Safety
  • Perform Data Segregation
    • Data Segregation by Module
    • Data Segregation impact on system-level configuration items
    • Dictionaries
• Filter Worklists
  • Use Options in Global Worklists Tab
    • Link to Argus Safety
  • Perform Case Actions
  • Search for a Case
    • View Options
  • Manage Global Enterprises
  • Add a New Enterprise
  • Manage Global Users
    • Associate Users to an Enterprise
    • Apply Synchronizable User Attributes
    • Modify User Attributes
  • Provide Access to the Application
    • Enterprise
    • Application