Oracle Empirica Signal


Oracle Empirica Signal – software access is optional.


Oracle Empirica Signal is an online eLearning course that covers basic and advanced concepts of signal detection using the Empirica Signal application. The course starts with an Overview of Empirica Signal and then covers a more detailed look in how it is used to detect, validate, confirm and prioritize signals in pharmacovigilance as well as recommending the necessary actions that need to be taken. It is intended for students and clinical research professional who are willing to make a career in Pharmacovigilance Signal Detection using the Empirica Signal platform.

The course includes hands-on practical training on Oracle Empirica Signal software used as a de-facto standard for signal detection in pharmacovigilance.

The program is made up of 1 module, 8 topics and 9 Quizzes. It provides an Introduction to Signal Detection, Empirica Signal user interface and features, and then goes on to explain the process of Pharmacovigilance signal detection and prioritization in Empirica Signal. The course covers all the Tabs in the Empirica Signal software, the concepts of Queries and Case Series and the task of creating data mining runs which are the basic units of signal detection. The various forms of displaying the signal detection results such as different Graphical representations are also covered. Finally the course covers Drug Profiles, Reporting and Empirica Signal Topics.

On completing your enrolment for the Empirica Signal program you will instantly get access to our online learning portal.

Looking for a course that includes 24×7 access to Oracle Empirica Signal software? Check out this course

Find more information about the Empirica Signal application – What is Oracle Empirica Signal

Key Features

  • Full access to eLearning Portal containing Tutorials, Quizzes and Assessments
  • Full access Recorded sessions
  • Course Instructor support via Discussion Forums


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


At the end of the course, students will be awarded a certificate of completion.



The duration of this program is 2 months.

You will have access to the course for the duration of the program.


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