Definition

A detailed clinical review of multiple individual cases sharing common characteristics to identify patterns and support signal evaluation.

Example

Fifteen cases of pancreatitis are identified. Case series analysis examines: patient demographics, time to onset, concomitant drugs, dechallenge/rechallenge, and outcomes to characterize the signal.

Regulatory source

EU GVP Module IX, Signal Evaluation

Common mistakes

Treating case series as epidemiological studies. Case series can generate hypotheses but cannot establish incidence or comparative risk.

Inspector question

Show me a case series analysis you conducted. What clinical patterns did you identify?

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