48  Trending & Systemic Risk

48.1 Why Trending Matters

Single deviations may be minor. Patterns indicate systemic risk.

48.2 Examples of Trends

• Repeated consent errors
• Frequent missed visits
• Ongoing safety reporting delays
• Consistent data entry issues

48.3 CRA Role in Trending

• Maintain deviation log
• Identify recurring patterns
• Escalate systemic risks
• Support sponsor QA reviews

48.4 Inspection Reality

Inspectors focus heavily on: - Repeat deviations - Weak CAPA effectiveness - Lack of trend analysis