Go to main content
1/17
Contents
Title and Copyright Information
Preface
Where to Find More Information
Documentation Accessibility
1
Updated Documentation
2
Getting Started
2.1
Logging In and Out
2.2
Personal Argus Status
2.3
Quick Launch Toolbar
2.4
Basic Features and User Actions
2.4.1
Field Validations
2.4.2
Field-Level Help
2.4.3
Changing Your Password
2.4.4
Entering Dates
2.4.5
Using Null Flavor Data
2.4.6
Entering Multiple Language Text
2.5
Integrating with Argus Insight
3
Worklist
3.1
Worklist Options
3.1.1
New and Open
3.1.1.1
Filtering Functions—Field Descriptions
3.1.1.2
Total Number of Rows—Field Descriptions
3.1.2
Action Items
3.1.2.1
Query Action Items
3.1.2.2
Filter Function—Field Descriptions
3.1.3
Coding Action Items
3.1.4
Contacts
3.1.4.1
Total Number of Rows—Field Descriptions
3.1.5
Reports
3.1.5.1
Filtering Options—Descriptions
3.1.5.2
Total Number of Rows—Field Descriptions
3.1.6
Bulk Transmit
3.1.6.1
Total Number of Rows—Field Descriptions
3.1.6.2
User Options—Field Descriptions
3.1.6.3
Routing Details
3.1.7
Bulk Print
3.1.7.1
Bulk Print User Options—Field Descriptions
3.1.8
Bulk ICSR Transmit
3.1.8.1
Reports Tab
3.1.8.2
Total Number of Rows Section—Field Descriptions
3.1.8.3
Reports Tab User Options—Field Descriptions
3.1.8.4
Messages Tab
3.1.8.5
Search Criteria Section—Field Descriptions
3.1.8.6
Total Number of Rows Section—Field Descriptions
3.1.8.7
Message Tab User Options—Field Descriptions
3.1.9
Local Labeling
3.1.10
Coding Status
3.1.10.1
Coding Status Icons
3.1.10.2
Search Conditions Section—Field Descriptions
3.1.10.3
Total Number of Rows Section—Field Descriptions
3.1.11
Letters
3.1.11.1
Search Case Section—Field Descriptions
3.1.12
Intake
3.1.12.1
Pending Tab—Field Descriptions
3.1.12.2
Rejected Tab—Field Descriptions
4
Case Actions
4.1
Finding and Opening Existing Cases
4.1.1
Case Open Form—Fields Descriptions
4.1.2
Total Number of Rows—Descriptions
4.2
Creating a New Case
4.2.1
Booking in Cases and Entering Initial Case Information
4.2.2
Initial Case Entry—Fields Descriptions
4.2.3
Checking for Duplicates
4.2.3.1
Receipt Range—Fields Descriptions
4.3
Closing a Case
4.4
Saving a Case
4.5
Copying a Case
4.6
Using the Medical Review Function
4.6.1
Using the Medical Review Tab
4.6.1.1
The Case Narrative Section
4.6.1.2
The Case Assessment Section
4.6.1.3
The Event Assessment Section—Fields Descriptions
4.6.2
Using the Temporal View Tab
4.6.2.1
The Summary Section—Fields Descriptions
4.6.2.1.1
The Display Options Section—Fields Descriptions
4.6.2.1.2
The Event Assessment Section—Fields Descriptions
4.6.2.2
The Relevant Tests Section—Fields Descriptions
4.6.3
Using the Action Items/Additional Info Tab
4.6.3.1
The Contact Log Section
4.6.3.1.1
Generating Letters
4.6.3.1.2
Scheduling Action Items for Letters
4.6.3.2
The Action Items Section—Fields Descriptions
4.6.3.3
The Notes and Attachments Section
4.7
Using the Coding Review Function
4.7.1
The Coding Tab
4.7.1.1
General Information—Fields Descriptions
4.7.1.2
Product Information—Fields Descriptions
4.7.1.3
Event Information—Fields Descriptions
4.7.1.4
Death Information—Fields Descriptions
4.7.1.5
Patient Information—Fields Descriptions
4.7.1.6
Lab Data—Fields Descriptions
4.7.1.7
Parent Information—Fields Descriptions
4.7.1.8
Case Analysis—Fields Descriptions
4.8
Using the Action Item Tab
4.8.1
Action Item—Fields Descriptions
4.9
Using the Print Function
4.9.1
Printing a Case Form
4.9.1.1
Viewing and Printing Letters
4.9.1.2
Viewing and Printing Attachments
4.9.1.3
Transmitting a Case
4.9.2
Printing a Medical Summary
4.10
Deleting a Case
4.11
Viewing Case Revisions
5
Case Form
5.1
Case Form Features
5.1.1
Initial Case Entry—BookIn Dialog Box
5.1.2
Argus Safety Case Form User Preferences
5.2
General Tab
5.2.1
Dynamic Workflow Indicators
5.2.2
General Information
5.2.2.1
General Information—Field Descriptions
5.2.3
Study Information
5.2.3.1
Study Information—Field Descriptions
5.2.4
Reporter Information
5.2.4.1
Adding Reporter Information
5.2.4.2
Reporter Information—Field Descriptions
5.2.5
Literature Information Section
5.3
Patient Tab
5.3.1
Patient Information
5.3.1.1
Entering Current Medical Status
5.3.1.2
Copying Patient Information from Reporter Information
5.3.1.3
Patient Information—Field Descriptions
5.3.2
Patient Details
5.3.2.1
Entering Pregnancy Information
5.3.3
Event Death Details
5.3.3.1
Event Death Details—Field Descriptions
5.3.4
Other Relevant History
5.3.4.1
Other Relevant History—Field Descriptions
5.3.5
Lab Data
5.3.5.1
Lab Data—Field Descriptions
5.3.6
Relevant Tests
5.3.7
Parent Information
5.4
Products Tab
5.4.1
Searching for Products
5.4.2
Time Measurement Fields
5.4.3
Drug Tab
5.4.3.1
Product Information—Field Descriptions
5.4.3.2
The Product Indication
5.4.3.3
Entering Quality Control Information
5.4.3.4
Dosage Regimens—Field Descriptions
5.4.3.5
Product Details—Field Descriptions
5.4.3.6
Study Drug Information
5.4.4
The Device Tab
5.4.4.1
Product Information—Field Descriptions
5.4.4.2
Entering Quality Control Information
5.4.4.3
Product Indication
5.4.4.4
Product Delivered by Device—Field Descriptions
5.4.4.5
Device Component Information—Field Descriptions
5.4.4.6
Device Information—Field Descriptions
5.4.5
Vaccine Tab
5.4.5.1
Product Details
5.4.5.2
Prior Adverse Events Information
5.4.5.3
Product Information Section—Field Descriptions
5.4.5.4
Vaccine Administration Form—Field Descriptions
5.4.5.5
Vaccine History Section—Field Descriptions
5.5
Events Tab
5.5.1
Event Tab
5.5.1.1
Event Information Section
5.5.1.1.1
Understanding the Diagnosis-Event Relationship
5.5.1.1.2
Associating a symptom with a diagnosis
5.5.1.1.3
Using the MedDRA Browser
5.5.1.1.4
Configuring Regulatory Reporting Rules
5.5.2
Event Coding Section
5.5.3
Seriousness Criteria Section
5.5.3.1
Entering Death Details
5.5.3.2
Entering Hospitalization Details
5.5.3.3
Nature of Event Section
5.5.3.4
Details Section
5.5.4
Event Assessment Tab
5.5.4.1
Event Assessment Tab—User Actions
5.5.4.2
Event Assessment Tab—Filtering
5.5.4.3
Product-Event Details Tab
5.6
Analysis Tab
5.6.1
Analysis Tab
5.6.1.1
Case Analysis Section
5.6.1.2
Case Summary Section
5.6.2
The MedWatch Info Tab
5.6.2.1
Selecting G3 Report Source Checkboxes—Guidelines
5.6.3
The BfArM Info Tab
5.6.4
The AFSSaPS Info Tab
5.7
Activities Tab
5.7.1
Contact Log Section
5.7.1.1
Generating Letters
5.7.1.2
Scheduling Action Items for Letters
5.7.1.3
Opening a Message Editor
5.7.2
Action Items Section
5.7.3
Routing Comments Section
5.7.3.1
Routing Cases
5.7.3.2
Returning Cases
5.7.4
Case Lock/Close Section
5.7.4.1
Locking a Case
5.7.4.2
Unlocking a Case
5.7.4.3
Setting the Focus for a Follow-up Event
5.8
Additional Information Tab
5.8.1
Searching for Documentum Links
5.8.2
Attaching Files to a Case
5.8.2.1
To attach files to a case
5.8.3
Entering Keywords
5.8.4
Attaching References to a Case
5.9
Regulatory Reports Tab
5.9.1
Grouping Regulatory Reports
5.9.1.1
Grouping by Report Type/Submit Category/Reporting Destination
5.9.1.2
Grouping by Report Type/Reporting Destination
5.9.1.3
Grouping by Report Type/Reporting Group
6
Reports: Compliance and Aggregate Reports
6.1
Reports
6.1.1
Compliance Reports
6.1.1.1
About Expedited Reports
6.1.1.1.1
Storing Expedited Reports in Documentum
6.1.1.1.2
Understanding Follow-up Reports
6.1.1.1.3
Viewing a Summary of Expedited Regulatory Reports
6.1.1.1.4
User Options
6.1.1.1.5
Scheduling Reports
6.1.1.1.6
Generating Reports
6.1.1.1.7
Approving Reports
6.1.1.1.8
Creating Unscheduled Expedited Reports
6.1.1.1.9
Creating Batch Reports
6.1.1.1.10
Expedited Reporting Rules Algorithm
6.1.1.2
About Periodic Reports
6.1.1.2.1
Periodic Report—Fields and Field Descriptions
6.1.1.2.2
User Options
6.1.1.2.3
About the Report Details dialog box
6.1.1.2.4
Scheduling Tab
6.1.1.2.5
Routing Tab
6.1.1.2.6
Submission Tab
6.1.1.2.7
Comment Tab
6.1.1.2.8
Report Generation Status
6.1.1.3
Creating Unscheduled Periodic Reports
6.1.1.4
About Submitted Reports
6.1.1.4.1
Submitting Reports
6.1.1.4.2
Submitted Reports Search Results—Fields and Field Descriptions
6.1.1.4.3
Unsubmitting Reports
6.1.1.4.4
Lock State Header Options
6.1.2
Aggregate Reports
6.1.2.1
Using the System Reports Library
6.1.2.2
About Case Data Analysis Reports
6.1.2.2.1
Creating a Case Data Analysis Report
6.1.2.3
About CIOMS II Line Listing Reports
6.1.2.3.1
Creating a CIOMS II Line Listing Report
6.1.2.4
About Case Listing Reports
6.1.2.5
Checking the Aggregate Report Status
7
Reports: Periodic Reports
7.1
Periodic Report Types
7.1.1
Categorize Cases in Periodic Reports
7.1.2
Store Periodic Reports in Documentum
7.1.3
View a Summary of Periodic Regulatory Reports
7.1.4
Use the Library Page
7.1.5
Create Clinical Trial Periodic Reports
7.1.5.1
Common Tab Fields—Field Descriptions
7.1.5.1.1
Subject of Report Tab—Fields Descriptions
7.1.5.1.2
Product Selection Tab—Fields Descriptions
7.1.5.1.3
License/Study Tab—Fields Descriptions
7.1.5.1.4
Inclusion Criteria Tab—Fields Descriptions
7.1.5.1.5
Using the DLP Version
7.1.5.1.6
Dates for Using DLP/
As of reporting
Function
7.1.5.1.7
As of Reporting Function
7.1.5.1.8
Availability of DLP/As of query functionality
7.1.5.1.9
Line Listing Tab—Fields Descriptions
7.1.5.1.10
Available Data Elements
7.1.5.1.11
Selected Data Elements
7.1.5.1.12
Grouping Tab—Fields Descriptions
7.1.5.1.13
Summary Tabulations Tab—Fields Descriptions
7.1.5.1.14
Single Case Submission Support—Fields Descriptions
7.1.5.1.15
UD Summaries Tab—Fields Descriptions
7.1.5.1.16
Scheduling Tab—Fields Descriptions
7.1.5.1.17
Scheduling Frequency—Fields Descriptions
7.1.5.1.18
Security Tab—Fields Descriptions
7.1.6
About ICH PSUR Reports
7.1.6.1
Common Tab Fields—Fields Descriptions
7.1.6.1.1
Subject of Report Tab—Fields Descriptions
7.1.6.1.2
Product Selection Tab—Fields Descriptions
7.1.6.1.3
Inclusion Criteria Tab—Fields Descriptions
7.1.6.1.4
Inclusion Criteria—Fields Descriptions
7.1.6.1.5
Line Listing Tab—Fields Descriptions
7.1.6.1.6
Available Data Elements
7.1.6.1.7
Selected Data Elements—Fields Descriptions
7.1.6.1.8
Grouping Tab—Fields Descriptions
7.1.6.1.9
Summary Tabulations Tab
7.1.6.2
CIOMS Reports—Fields Descriptions
7.1.6.2.1
PBRER Section 6.2 - Cumulative Summary Tabulations of SAEs from clinical trials
7.1.6.2.2
PBRER Section 6.3 - Cumulative and Interval Summary Tabulations from Post-Marketing Data Sources
7.1.6.2.3
Cumulative Summary—Fields Descriptions
7.1.6.2.4
FDA PSUR Support—Fields Descriptions
7.1.6.2.5
Single Case Submission Support—Fields Descriptions
7.1.6.2.6
UD Summaries Tab—Fields Descriptions
7.1.6.2.7
Scheduling Tab—Fields Descriptions
7.1.6.2.8
Scheduling Frequency—Fields Descriptions
7.1.6.2.9
Security Tab
7.1.6.2.10
Templates Tab
7.1.7
About US IND Periodic Reports
7.1.7.1
Common Fields—Fields Descriptions
7.1.7.1.1
Subject of Report Tab—Fields Descriptions
7.1.7.1.2
Product Selection Tab—Fields Descriptions
7.1.7.1.3
Inclusion Criteria Tab—Fields Descriptions
7.1.7.1.4
Line Listing Tab—Fields Descriptions
7.1.7.1.5
Summary Tabulations Tab—Fields Descriptions
7.1.7.1.6
Scheduling Tab—Fields Descriptions
7.1.7.1.7
Security Tab—Fields Descriptions
7.1.8
About NDA Periodic Reports
7.1.8.1
Common Fields—Fields Descriptions
7.1.8.2
Subject of Report Tab—Fields Descriptions
7.1.8.3
Product Selection Tab—Fields Descriptions
7.1.8.4
Inclusion Criteria Tab—Fields Descriptions
7.1.8.5
Line Listing Tab—Fields Descriptions
7.1.8.6
Summary Tabulations Tab—Fields Descriptions
7.1.8.7
Scheduling Tab—Fields Descriptions
7.1.8.7.1
Scheduling Frequency
7.1.8.8
Security Tab—Fields Descriptions
7.1.9
Bulk Reporting
7.1.9.1
Bulk Reporting Filter Section—Fields Descriptions
7.1.9.2
Total Number of Rows Section—Fields Descriptions
7.1.9.3
Printing Options—Fields Descriptions
7.1.9.4
User Options
7.1.9.4.1
Lock State Header Options
7.1.9.4.2
Lock State Icon Options—Fields Descriptions
7.1.10
Initial and Follow-up Cases in Periodic Reports
8
Reports: Bulk Reporting, ICSR Pending, and Processed ICSR Reports
8.1
Bulk Reporting
8.1.1
Bulk Report—Filter Options
8.1.2
Viewing Bulk Reporting Search Results
8.1.3
Printing Options
8.1.4
Lock State User Options
8.2
ICSR Pending Reports
8.2.1
Incoming ICSR Reports—Fields Description
8.2.1.1
Button and Right-click Options
8.2.2
Pending Reports
8.2.3
Bulk Incoming ICSR Reports
8.2.4
Duplicate Search
8.2.4.1
Duplicate Search Dialog Box—Field Description
8.2.4.2
Duplicate Search for Incoming Review
8.2.5
View Differences Report
8.2.5.1
Accept Initial E2B Cases As Follow-Up
8.3
Processed ICSR Reports
8.3.1
Search Criteria Section—Field Description
8.3.2
Viewing Search Results
9
Local Lock Functionality
9.1
Enabling Local Data Entry
9.1.1
Local Fields
9.2
References for Details on Local Case Data Lock Functionality
9.3
Report Scheduling - Auto-Scheduling
9.4
Report Scheduling - Manual Scheduling
9.5
Outlier Processing
9.6
Upgrade Changes - Enabling Local Locking in Argus Safety
9.7
Triggering Local Reports - Report Generation Algorithm
10
Utilities
10.1
Change Password
10.2
MedDRA Browser
10.3
User Login List
10.4
Logs
10.4.1
View Audit Log
10.4.1.1
Audit Log Details Screen
10.4.2
LAM Audit Log
10.4.3
Error Log
10.5
Tracking ICSR
10.5.1
ICSR Transmit
10.5.1.1
Type Icon
10.5.2
ICSR Receive Status
10.6
Case Undelete
10.7
Batch Reports
10.8
Argus Unblinding
10.9
Clear Cache
10.10
Advanced Condition Library
11
MedDRA Browser
11.1
Using the MedDRA Browser
11.1.1
MedDRA Browser Dialog Box—Field Descriptions
11.1.2
MedDRA Searches and Search Results
11.1.2.1
Using the MedDRA Browser for Advanced Conditions
11.1.3
Non-Current Terms Search within MedDRA Browser
11.2
MedDRA Recoding
11.2.1
MedDRA Recoding Logic
11.2.2
Recode MedDRA terms at the Enterprise level
12
Advanced Conditions
12.1
Importing and Exporting Cases in the Advanced Conditions
12.2
Filtering an existing Advanced Condition
12.3
Viewing Results of an existing Advanced Conditions
12.4
Creating, Viewing or Modifying Advanced Conditions
12.5
Using the Advanced Condition Set Dialog Box
12.6
Additional Information about Properties
12.7
Sharing Advanced Conditions
12.8
Using Advanced Conditions from Case Selection Dialog Box
12.9
Creating an Advanced Condition Query Set
12.9.1
Renaming Query Sets
12.10
Searching a Case
13
Dashboards
13.1
Open Case Summary Reports
13.2
Open Action Items Reports
13.3
Quick Signal Report
13.3.1
Searching Products in the Quick Signal Report
13.4
Increased Frequency Wizard
13.5
Expedited Report Status
13.6
Workflow Status
13.7
Reports Due Soon
13.8
Personal Argus Status
13.9
Case Workload
14
Multi-Tenancy
14.1
Introduction to Multi-tenancy
14.1.1
Multi-tenancy in Argus Safety
14.1.2
Data Segregation
14.1.2.1
Data Segregation by Module
14.1.2.2
Data Segregation impact on system-level configuration items
14.1.2.3
Dictionaries
14.1.2.3.1
Coding Web Service
14.2
Global Worklists
14.2.1
Global Worklist Tabs
14.2.1.1
Link to Argus Safety
14.2.2
Case Actions
14.2.3
Search Case
14.2.3.1
View Options
14.2.3.1.1
List Actions
14.2.4
Global Enterprise Management
14.2.5
Add New Enterprise
14.2.6
Global User Management
14.2.6.1
Associate Enterprise
14.2.6.1.1
Print
14.2.6.2
Synchronizable User Attributes
14.2.6.3
Modifying User Attributes
14.2.7
Application Access
14.2.7.1
Enterprise
14.2.7.2
Application
Scripting on this page enhances content navigation, but does not change the content in any way.