22  Start-Up Templates & Checklists

22.1 SIV Checklist (CRA)

• Regulatory documents complete
• Protocol training conducted
• Safety reporting reviewed
• EDC/IRT training completed
• IP handling reviewed
• Lab/imaging workflows reviewed

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22.2 Site Activation Tracker (Template)

Site	IRB Approved	Training Complete	Systems Access	IP Available	Activation Date	Notes

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22.3 Start-Up Issue Log

Issue	Site	Date Identified	Impact	Action Required	Owner	Due Date