June 11, 2025

Individual Case Safety Reports (ICSRs) are important for pharmacovigilance. They help detect safety issues and protect patients. But common mistakes can affect data quality and regulatory compliance. Here are the top 10 mistakes and how to avoid them:

1. Missing or Wrong Data

  • Missing key info like patient ID or drug details makes reports invalid.
  • Fix: Use structured digital forms, train staff, and automate checks for complete data.

2. Wrong Event Classification

  • Mislabeling events can hide safety signals.
  • Fix: Use standard coding (MedDRA), train staff regularly, use AI tools, and do audits.

3. Late Reporting

  • Delays can lead to regulatory penalties.
  • Fix: Use E2B-compliant systems, prioritize urgent cases, set alerts, and track timelines.

4. Weak Case Narratives

  • Poorly written reports make clinical review hard.
  • Fix: Use templates, involve medical reviewers, and train staff on clear writing.

5. Follow-Up Gaps

  • Not completing follow-ups leaves data incomplete.
  • Fix: Set SOPs, automate reminders, and record all follow-up attempts.

6. Coding Errors

  • Wrong MedDRA or WHO-DD codes can distort safety analysis.
  • Fix: Use certified coders, standardize practices, and audit regularly.

7. Low-Quality Data from Unstructured Sources

  • Data from patients or social media can be messy.
  • Fix: Use NLP tools to structure data and confirm details through follow-ups.

8. Weak Quality Control

  • Skipping QC checks leads to errors.
  • Fix: Set review checkpoints, do dual reviews, track KPIs, and retrain teams as needed.

9. Old Systems

  • Manual or outdated systems cause mistakes.
  • Fix: Move to cloud-based, AI-enabled platforms and train teams on global standards.

10. Ignoring Local Rules

  • Sending the same report everywhere can cause rejections.
  • Fix: Keep a regulatory repository and adapt reports to each country’s rules.

Final Thoughts

ICSRs are more than paperwork—they protect patients and maintain trust. By using smart systems, standardized practices, and continuous training, organizations can make ICSR reporting accurate, timely, and effective.