CEU Credits: 0.1
Course Code: ELM-935
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 04/18/2024
Curriculum for this course
Course Introduction
What is a Signal?
Sources of Data
Active Surveillance Systems
Data Management and Reporting of Adverse Reactions
Signal Validation and Further Assessment
Signal Validation Flow
Prioritizing Signals
Quality Requirements for Signal Management
Activity
Statistical Methods
Reporting Frequency
Specific Groups of Adverse Events
Methods for Specific Patient Populations
Specific Circumstances of Medicine Use
Case Study
Conclusion
Summary
Test Your Knowledge
v1.1 Minor update on 02/24/2025. Assessment question updated for clarity. Additionally, the course template was enhanced to provide more specific quiz completion data and a Version History document.
v1.0 Course released on 05/22/2024