Stage 9 · Toolkit 9.1
ICSR Case Management
Manage adverse event case intake, processing, QC, medical review, reporting, follow-up, and closure.
What it helps control
Operational support
Helps teams establish the procedures, working records, trackers, and evidence needed for ICSR Case Management.
How it helps your team
Connect day-to-day safety operations with visible ownership, evidence, and inspection readiness.
Designed for
QPPVs, Heads of Pharmacovigilance, Drug Safety, PV Operations, Medical Safety, Quality, and affiliate teams.
Included files
Know exactly what the toolkit contains
The file names below show what is included. File contents become available only after purchase.
Word documents
- ICSR Case Management SOP
- ICSR Intake Form
- Case Processing QC Checklist
- Medical Review Worksheet
- Follow-up Tracking Log Guidance
- ICSR Decision Memo
Excel workbooks
- ICSR Follow-up Tracking Log
- Case Processing Tracker
- Safety Query Tracker
- ICSR Evidence Tracker
Related toolkits
Continue within stage 9
Literature Surveillance & Review
Manage literature search, screening, medical review, reportability, and evidence of surveillance.
9.3Signal Management
Detect, validate, prioritise, assess, escalate, document, and close safety signals.
9.4Risk Management / RMP
Manage safety concerns, RMP commitments, risk minimisation, effectiveness, and updates.