Description
Oracle Empirica Signal – eLearning is a self-paced online training program designed to build knowledge of pharmacovigilance signal detection, signal management and safety-data analysis using Oracle Empirica Signal.
The program begins with foundational concepts in pharmacovigilance and signal management before progressing to signal detection and prioritization, data mining, disproportionality analysis, application navigation, queries and case series, data mining runs, graphical analysis, drug profiles, reporting and signal Topics.
Through structured multimedia tutorials, recorded sessions and software demonstrations, learners develop an understanding of how safety data can be analyzed to identify, evaluate and prioritize potential safety signals.
This eLearning option includes Oracle Empirica Signal training and software demonstrations but does not include login access to the software.
Program at a Glance
Signal Detection | Data Mining | Safety Analytics
2 Months | Self-Paced eLearning | Certificate on Completion
What You’ll Learn
- Understand pharmacovigilance signal-management concepts
- Explore signal detection, validation and prioritization principles
- Understand data mining and disproportionality analysis
- Become familiar with the Oracle Empirica Signal interface and key features
- Understand data configurations and application preferences
- Learn how queries and case series are used in signal analysis
- Understand the creation and use of data mining runs
- Explore graphical approaches to analyzing data mining results
- Understand drug profiles and reporting functionality
- Explore the use of Topics in signal management
Who Is This Program For?
- Pharmacovigilance and drug safety professionals
- Safety reviewers interested in signal detection and management
- Pharmacovigilance professionals seeking knowledge of safety-data analysis
- Clinical research professionals interested in drug safety analytics
- Pharmacy, life sciences, medical and healthcare graduates
- Learners seeking structured training in pharmacovigilance signal-detection software
Looking for Hands-On Empirica Signal Training?
If you want to apply the signal-detection and data-analysis concepts covered in this program directly within the software, choose Oracle Empirica Signal with Software Access.
The software-inclusive option combines the same core eLearning curriculum with 24×7 access to Oracle Empirica Signal, allowing learners to practise queries, case series, data mining runs, graphical analysis, drug profiles and other applicable workflows.
Explore eLearning + Software
New to Oracle Empirica Signal? Learn more about the application and its role in pharmacovigilance signal detection through our free ClinSkill learning resources.
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
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
Course Completion
- Final Assessment
- Course Certification
The curriculum includes Oracle Empirica Signal training and software demonstrations. Hands-on Oracle Empirica Signal login access is not included with this eLearning program.
Certification
Upon successful completion of the program and final assessment, learners receive a ClinSkill Certificate of Completion.
Duration
The program duration is 2 months, with flexible, self-paced access to the online learning portal.
This eLearning option does not include Oracle Empirica Signal software login access.
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