Eligibility criteria

Criterion types, operators, units, windows, missing-data behaviour, flags and approval.

Types

AGE, CONDITION, LAB (including ULN-relative), MEDICATION, PROCEDURE, MEASUREMENT, TEMPORAL, GROUP (one level of ALL / ANY) and SCREENER-assessed.

Representation

{
  "code": "I3",
  "kind": "inclusion",
  "type": "LAB",
  "analyte": "eGFR",
  "operator": "between",
  "min": 30, "max": 59, "inclusive": true,
  "unit": "mL/min/1.73 m2",
  "value_used": "most_recent",
  "window": { "days_before": 90, "anchor": "run_date" },
  "if_missing": "unknown",
  "source": { "ref": "§5.1(c)", "page": 18 }
}

Illustrative structure for the proposed product, not a published schema.

Missing data

Inclusion criteria with no value in the window are always Unknown. Exclusion criteria based on codes show No record found — distinct from a confirmed negative — for the screener to confirm.

Approval

Requires no unresolved flags, a source reference for each criterion, an attestation, and (by default) an approver who is not the version’s sole editor.