43  Protocol Deviations & CAPA

43.1 Purpose

This module defines how protocol deviations are identified, documented, classified, and corrected through CAPA (Corrective and Preventive Actions).

43.2 CRA Accountability (Practical)

• Identify deviations during monitoring
• Ensure deviations are documented and reported appropriately
• Assess risk and impact with the study team
• Track CAPAs to resolution
• Detect trends and systemic issues

43.3 Why This Matters

Deviations and CAPAs are one of the highest inspection risk areas in clinical trials.