This Argus Standard Edition 7.x/8.x Processing Safety Cases training teaches you how to perform safety case processing using the Argus Standard Edition software, while helping you navigate the user interface. It's ideal for safety case processing professionals who are new to Argus Standard Edition.
Required Prerequisites:
The Argus Standard Edition Environment
Argus Standard Edition modules
Argus Enterprise Edition modules
Other products that interface with Argus Safety
A Tour of Argus Standard Edition
Demo: Taking a tour of Argus Standard Edition
Creating a Case in Argus Safety
Overview of creating a case in Argus Safety
Typical serious case processing workflow
Typical non-serious case processing workflow
Typical case creation scenario
Demo: Creating and booking in a new case
Exercise: Enter general and patient data
Entering General Case and Patient Data
Overview of entering case data
Typical case data entry scenario
Demo: Entering general and patient data
Exercise: Enter general and patient data
Entering Product Data
Overview of entering product data
Demo: Entering product data
Exercise: Enter product data
Entering Event Data
Overview of entering events data
Demo: Entering events data
Exercise: Enter events data
Performing Data Analysis and Reviewing Activities
Overview of data analysis and reviewing activities
Demo: Generating a narrative and reviewing case data entry pages
Exercise: Generate a narrative and review case data entry pages
Processing Parent / Child Safety Cases
Overview of parent / child safety cases.
Demo: Adding information and cross-references in Parent / Child cases
Exercise: Add information and cross-references in Parent / Child cases
Processing Literature Safety Cases
Overview of literature safety cases
Demo: Creating literature cases:
Exercise: Create two literature cases
The Fundamentals of Reviewing Case Safety Data
Overview of work lists
Demo: Reviewing a Case and Routing to the Next Workflow Step
Exercise: Review a Case and Route to the Next Workflow Step
Performing Code Reviews
Overview of code reviews
Demo: Performing safety management and code reviews
Exercise: Perform safety management and code reviews
Performing Medical Reviews
Overview of medical reviews
Demo: Performing a medical review
Exercise: Perform a medical review
Performing a Quality Review
Overview of quality reviews
Demo: Performing a quality review
Exercise: Perform a medical review
Entering Follow-up Information
Overview of follow-up information
Scenarios for entering follow-up information
Demo: Adding significant information to an ICSR
Exercise: Add significant information to an ICSR
Creating Search Criteria and Advanced Conditions
Overview of system searches
Typical search creation scenario
Demo: Creating search criteria and an advanced condition
Exercise: Create search criteria and an advanced conditio
Creating Hit Lists
Overview of hit lists
Demo: Creating a hit list
Exercise: Create a hit list
Working with the Advanced Conditions Library
Overview of the Advanced Conditions Library
Demo: Accessing the Advanced Conditions Library
Exercise: Access the Advanced Conditions Library
Final Assessment
Required Prerequisites:
- Experience with Medical industry concepts and terminology
- Experience with Safety case processing and reporting
- Completion of the Oracle Health Sciences Argus Standard Edition Jumpstart Training online course or have equivalent experience
Course Content:
The Argus Standard Edition Environment
Argus Standard Edition modules
Argus Enterprise Edition modules
Other products that interface with Argus Safety
A Tour of Argus Standard Edition
Demo: Taking a tour of Argus Standard Edition
Creating a Case in Argus Safety
Overview of creating a case in Argus Safety
Typical serious case processing workflow
Typical non-serious case processing workflow
Typical case creation scenario
Demo: Creating and booking in a new case
Exercise: Enter general and patient data
Entering General Case and Patient Data
Overview of entering case data
Typical case data entry scenario
Demo: Entering general and patient data
Exercise: Enter general and patient data
Entering Product Data
Overview of entering product data
Demo: Entering product data
Exercise: Enter product data
Entering Event Data
Overview of entering events data
Demo: Entering events data
Exercise: Enter events data
Performing Data Analysis and Reviewing Activities
Overview of data analysis and reviewing activities
Demo: Generating a narrative and reviewing case data entry pages
Exercise: Generate a narrative and review case data entry pages
Processing Parent / Child Safety Cases
Overview of parent / child safety cases.
Demo: Adding information and cross-references in Parent / Child cases
Exercise: Add information and cross-references in Parent / Child cases
Processing Literature Safety Cases
Overview of literature safety cases
Demo: Creating literature cases:
Exercise: Create two literature cases
The Fundamentals of Reviewing Case Safety Data
Overview of work lists
Demo: Reviewing a Case and Routing to the Next Workflow Step
Exercise: Review a Case and Route to the Next Workflow Step
Performing Code Reviews
Overview of code reviews
Demo: Performing safety management and code reviews
Exercise: Perform safety management and code reviews
Performing Medical Reviews
Overview of medical reviews
Demo: Performing a medical review
Exercise: Perform a medical review
Performing a Quality Review
Overview of quality reviews
Demo: Performing a quality review
Exercise: Perform a medical review
Entering Follow-up Information
Overview of follow-up information
Scenarios for entering follow-up information
Demo: Adding significant information to an ICSR
Exercise: Add significant information to an ICSR
Creating Search Criteria and Advanced Conditions
Overview of system searches
Typical search creation scenario
Demo: Creating search criteria and an advanced condition
Exercise: Create search criteria and an advanced conditio
Creating Hit Lists
Overview of hit lists
Demo: Creating a hit list
Exercise: Create a hit list
Working with the Advanced Conditions Library
Overview of the Advanced Conditions Library
Demo: Accessing the Advanced Conditions Library
Exercise: Access the Advanced Conditions Library
Final Assessment