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C-001 임상 검토 게이트 보강

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Yun Chan 2026-08-28 19:04:17 +09:00
parent 391fb9f4d0
commit 6988280b30
18 changed files with 1896 additions and 67 deletions
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214
data/clinical/crisis-protocol-validation.schema.json Normal file
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{
"$schema": "https://json-schema.org/draft/2020-12/schema",
"$id": "vignette.clinical_crisis_review.v1",
"title": "Vignette P1 crisis protocol external clinical review contract",
"type": "object",
"additionalProperties": false,
"required": [
"schema_version",
"protocol_id",
"version",
"scope",
"technical_status",
"clinical_status",
"external_review_boundary",
"review_case_set",
"review_case_set_id",
"review_case_set_version",
"sources",
"review_sequence",
"technical_gates",
"approval"
],
"properties": {
"schema_version": { "const": "vignette.clinical_crisis_review.v1" },
"protocol_id": { "const": "p1-suicide-ideation-response" },
"version": { "type": "string", "pattern": "^[0-9]{4}-[0-9]{2}-[0-9]{2}\\.[0-9]+$" },
"scope": { "type": "string", "minLength": 1 },
"technical_status": { "const": "verified" },
"clinical_status": {
"enum": ["pending_external_review", "approved", "conditional", "rejected"]
},
"external_review_boundary": {
"const": "공식 근거와 자동 검사는 기술 안전 범위만 확인하며 외부 임상 검토와 승인을 대신하지 않는다."
},
"review_case_set": { "const": "data/clinical/p1-crisis-review-cases.json" },
"review_case_set_id": { "const": "p1-crisis-review-cases" },
"review_case_set_version": { "type": "string", "minLength": 1 },
"sources": {
"type": "array",
"minItems": 4,
"uniqueItems": true,
"items": { "$ref": "#/$defs/source" }
},
"review_sequence": {
"type": "array",
"minItems": 6,
"items": { "type": "string", "minLength": 1 }
},
"technical_gates": {
"type": "array",
"minItems": 6,
"items": { "type": "string", "minLength": 1 }
},
"approval": { "$ref": "#/$defs/approval" }
},
"$defs": {
"nullableString": {
"anyOf": [
{ "type": "null" },
{ "type": "string", "minLength": 1 }
]
},
"nullableSha256": {
"anyOf": [
{ "type": "null" },
{ "type": "string", "pattern": "^[0-9a-f]{64}$" }
]
},
"source": {
"type": "object",
"additionalProperties": false,
"required": ["source_id", "authority", "title", "url", "applied_to"],
"properties": {
"source_id": { "type": "string", "minLength": 1 },
"authority": { "type": "string", "minLength": 1 },
"title": { "type": "string", "minLength": 1 },
"url": { "type": "string", "pattern": "^https://" },
"applied_to": {
"type": "array",
"minItems": 1,
"items": { "type": "string", "minLength": 1 }
}
}
},
"approval": {
"type": "object",
"additionalProperties": false,
"required": [
"reviewer",
"organization",
"reviewed_at",
"decision",
"notes",
"evidence_ref",
"evidence_sha256",
"reviewed_protocol_version",
"reviewed_case_set_sha256"
],
"properties": {
"reviewer": { "$ref": "#/$defs/nullableString" },
"organization": { "$ref": "#/$defs/nullableString" },
"reviewed_at": {
"anyOf": [
{ "type": "null" },
{ "type": "string", "format": "date" }
]
},
"decision": {
"anyOf": [
{ "type": "null" },
{ "enum": ["approved", "conditional", "rejected"] }
]
},
"notes": { "$ref": "#/$defs/nullableString" },
"evidence_ref": { "$ref": "#/$defs/nullableString" },
"evidence_sha256": { "$ref": "#/$defs/nullableSha256" },
"reviewed_protocol_version": { "$ref": "#/$defs/nullableString" },
"reviewed_case_set_sha256": { "$ref": "#/$defs/nullableSha256" }
}
}
},
"allOf": [
{
"if": {
"properties": { "clinical_status": { "const": "pending_external_review" } },
"required": ["clinical_status"]
},
"then": {
"properties": {
"approval": {
"properties": {
"reviewer": { "type": "null" },
"organization": { "type": "null" },
"reviewed_at": { "type": "null" },
"decision": { "type": "null" },
"notes": { "type": "null" },
"evidence_ref": { "type": "null" },
"evidence_sha256": { "type": "null" },
"reviewed_protocol_version": { "type": "null" },
"reviewed_case_set_sha256": { "type": "null" }
}
}
}
}
},
{
"if": {
"properties": {
"clinical_status": { "enum": ["approved", "conditional", "rejected"] }
},
"required": ["clinical_status"]
},
"then": {
"properties": {
"approval": {
"properties": {
"reviewer": { "type": "string", "minLength": 1 },
"organization": { "type": "string", "minLength": 1 },
"reviewed_at": { "type": "string", "format": "date" },
"decision": { "enum": ["approved", "conditional", "rejected"] },
"evidence_ref": { "type": "string", "minLength": 1 },
"evidence_sha256": { "type": "string", "pattern": "^[0-9a-f]{64}$" },
"reviewed_protocol_version": { "type": "string", "minLength": 1 },
"reviewed_case_set_sha256": { "type": "string", "pattern": "^[0-9a-f]{64}$" }
}
}
}
}
},
{
"if": {
"properties": { "clinical_status": { "const": "approved" } },
"required": ["clinical_status"]
},
"then": {
"properties": {
"approval": { "properties": { "decision": { "const": "approved" } } }
}
}
},
{
"if": {
"properties": { "clinical_status": { "const": "conditional" } },
"required": ["clinical_status"]
},
"then": {
"properties": {
"approval": {
"properties": {
"decision": { "const": "conditional" },
"notes": { "type": "string", "minLength": 1 }
}
}
}
}
},
{
"if": {
"properties": { "clinical_status": { "const": "rejected" } },
"required": ["clinical_status"]
},
"then": {
"properties": {
"approval": {
"properties": {
"decision": { "const": "rejected" },
"notes": { "type": "string", "minLength": 1 }
}
}
}
}
}
]
}