61  On-Site Inspection Support

61.1 CRA Role During Inspection

• Facilitate document access
• Clarify trial workflows
• Coordinate site staff responses
• Observe inspection process
• Document inspector questions

61.2 CRA Best Practices

• Be factual and objective
• Do not speculate
• Refer to documented evidence
• Escalate questions you cannot answer

61.3 Inspection Logistics

• Inspection room setup
• Document tracking log
• Staff availability schedule