20  Site Activation & Readiness

20.1 Activation Criteria (Typical)

• IRB/IEC approval in place
• Regulatory documents complete
• Training completed and documented
• EDC/IRT access granted
• IP available on-site (if applicable)

20.2 CRA Activation Verification

• All approvals current
• DOA completed
• Training logs complete
• Systems access verified
• Pharmacy/lab ready

NoteOncology-Specific Considerations

• Central imaging and lab activation may be gating items
• Pharmacy readiness for cytotoxic handling

NoteVaccine Trial Consideration

Vaccine trials often require rapid site activation and high enrollment capacity. Site selection may prioritize throughput and population access over therapeutic specialization.