ICSR Management
& Safety
Reporting
Duration: 4 weeks (10 hours)
Can be taken individually: Yes
Learning Objectives
Learners will understand how individual case safety reports are collected, assessed, documented, and submitted.
Weekly Topics
Week 1: Adverse Event Intake
What is an adverse event?
Minimum criteria for valid cases
Solicited vs unsolicited reports
Special situations
Week 2: Seriousness, Expectedness and Causality
Serious vs non-serious cases
Listedness / expectedness
Causality assessment
MedDRA coding principles
Week 3: Case Processing Workflow
Triage
Narrative writing
Follow-up
Quality control
Case closure
Week 4: Regulatory Reporting
Expedited reporting
Periodic reporting
Local and global timelines
Reporting to Health Canada, FDA, EMA
Assessment
Practical case exercise: prepare an ICSR narrative and determine reportability.