PMCF STATISTICAL SAMPLING
Estimate a follow-up sample size
Separate from AQL.
Estimated n—
MICT · EVIDENCE OPERATIONS
Independent PMCF Sampling
MICT-controlled participant selection.
—
INDEPENDENT SELECTION
Locked primary sample + reserve pool
The company cannot hand-pick replacements.
PRIMARY SAMPLE
Selected participants and contact workflow
Contact and replacement workflow.
| # | Subject | Age | Sex | Stratum | Status | Attempts | Reason / replacement | Action |
|---|
LOCKED RESERVE POOL
Reserve participants
Locked reserve participants.
| # | Subject | Age | Sex | Stratum | Status |
|---|
ISO 2859-1 CONCEPT SEPARATION
Acceptance sampling — entered Ac/Re plan
AQL is not observed reject rate.
Observed reject rate—