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Open in new tab Methods to identify errors; how to classify them and what should be the plan?
Improving ICSR Quality Management in Safety Reporting
Implementing a rigorous ICSR Quality Management system is the only way to ensure that Individual Case Safety Reports meet global regulatory standards. Quality issues in ICSRs can lead to “Request for Information” (RFI) letters from agencies like the EMA or FDA.
Common Quality Issues
In our experience with ICSR Quality Management, the most frequent errors include:
Incorrect MedDRA coding.
Incomplete narrative descriptions.
Missing “Suspect” drug information.
By prioritizing ICSR Quality Management, you ensure that the data being used for signal detection is accurate and reliable.