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Phase
Process
Pre-consent
Screening
Screening
Patient
Consent
Post-consent
Screening
Enrollment
& Accrual
Is Eligible?
Randomization
(Optional)
Active Monitoring
Registration
Intervention
Cycle
(Optional)
Active
Monitoring &
Observation
Initial
Follow-Up
Follow-Up
Long-Term
Follow-Up
Fig. 6.2 Phase I-III clinical trial processes. Such processes can generally be divided into the
screening, active monitoring, and follow-up phases
 
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