19  Site Initiation Visit (SIV)

19.1 Purpose

Ensure site staff are fully trained and operationally ready to conduct the trial.

19.2 SIV Preparation (CRA)

• Review protocol and amendments
• Confirm required regulatory documents collected
• Prepare SIV agenda and training materials
• Coordinate site staff attendance

19.3 SIV Execution Topics

• Protocol overview
• Informed consent process
• Safety reporting procedures
• Data entry and EDC training
• IP handling and accountability
• Lab and imaging workflows

19.4 CRA Deliverables

• Attendance/training log
• SIV report or documentation
• Follow-up action items