41  Query & Issue Trending

41.1 Why Trending is Critical

Single issues are noise. Patterns are signals.

41.2 Examples of Trends

• Recurrent missing labs
• Frequent consent corrections
• Repeated data entry delays
• Systematic protocol deviations

41.3 CRA Responsibilities

• Maintain issue logs
• Identify recurring patterns
• Escalate systemic risks
• Support CAPA decisions