All projects
Project 01
PlannedEnd-to-End ICSR Case Processing Simulation
Simulated intake, validity check, seriousness assessment and medical review of fictional individual case safety reports.
Independent educational simulation · fictional patient data only
01
Project overview
Placeholder - to be added on completion of the project.
Focus areas
- ICSR validity criteria
- Initial case intake and data extraction
- Patient, reporter, suspect drug and adverse event information
- Case completeness and follow-up requirements
- Seriousness assessment
- Medical review and case documentation
- Understanding the ICSR processing lifecycle
02
Objective
Placeholder - to be added on completion of the project.
03
Skills and knowledge applied
- ICSR minimum validity criteria
- Seriousness criteria
- Case lifecycle - intake to medical review
04
Methodology and workflow
Placeholder - to be added on completion of the project.
05
Practical work samples
Planned deliverables: Fictional ICSR case workbook, Case-processing workflow diagram, Sample case assessments, Case completeness checklist.
Case workbook - placeholder
Workflow diagram - placeholder
Completeness checklist - placeholder
06
Results and findings
Placeholder - to be added on completion of the project.
07
Key learnings
Placeholder - to be added on completion of the project.
Limitations: Educational simulation using fictional patient data. Not a formal pharmacovigilance assessment.