Oracle Empirica Signal – Live Online

Curriculum

Chapter 1 – Introduction to Signal Detection

• Define Pharmacovigilance and Learn about the Evolution of Pharmacovigilance
• Understand the Pharmacovigilance process
• Determine the Rationale for Pharmacovigilance
• Define Pharmacoepidemiology, Signals and Risk Management  in Pharmacovigilance
• Understand process of Signal Management in Pharmacovigilance
• Determine the Benefit Risk Profile in Pharmacovigilance

Chapter 2 – Introduction to Empirica Signal

• Empirica Signal – Definition
• Source Data
• Data Configurations
• Data Mining Runs
• Data Mining Results
• Queries and Reports
• Drug Profiles
• Topics

Chapter 3 – Empirica Signal – Signal Detection and Prioritization

• Signal Detection
• Data Mining
• Data Mining Statistics
• Signal Prioritizing
• Disproportionality Analysis
• Benefits of Signal Detection and Prioritization
• False Alarms
• Signal Detection Comparison Methods
• Signaling Sensitivity and Specificity

Chapter 4a – User Interface – Settings and Features

• Empirica Signal Web Configuration
• Software Features
• Settings
• User Permissions
• System Configurations

Chapter 4b – User Interface – Preferences

• Data Configurations
• Drug Profile Configurations
• Workflow States
• Topic Workflow Configurations
• User Preferences

Chapter 5 – Navigating with Tabs

• Home
• Drugs
• Data Mining Runs
• Data Mining Results
• Queries
• Case Series
• Reports
• Topics

Chapter 6 – Queries and Case Series

• Queries
• Case Series

Chapter 7 – Creating Data Mining runs

• Data Mining
• Data Mining Uses
• Data Mining Runs – Database Restriction
• Data Mining Runs – Create MGPS Run
• Data Mining Runs – Parameters
• Data Mining Runs – Custom Terms
• Data Mining Runs – Subsets
• Data Mining Runs – Create LR Run
• Data Mining Runs – Variables & Variable selection

Chapter 8a – Data Mining Results

• Understand Data Mining Results

Chapter 8b – Data Mining Results – Graphical Display

• Data Mining Results – Graphs
• Graph Cut point and Palette Choices
• Bar Graph
• Confidence Interval Bar Graph
• Discrete Map Graphs
• Cumulative Map Graphs
• Sector Maps
• Nested Confidence Interval Graph
• Hierarchy Graph
• Overlap Graph

Chapter 9 – Drug Profiles and Reports

• Drug Profile
• Drug Profile Configuration
• Drug Profile Layout
• Drug Profile Manage Layout
• Reporting Feature
• Report Structure
• Report Definition
• Report Batch Runs

Chapter 10 – Empirica Signal Topics

• Topics

Course Completion

• Final Assessment
• Course Certification