외부 임상 검토 원장을 보강
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Yun Chan
parent
dd71cb9710
commit
3b540a881f
8 changed files with 310 additions and 50 deletions
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@ -46,6 +46,7 @@ STATUS_DECISIONS = {
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APPROVAL_FIELDS = {
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"reviewer",
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"organization",
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"reviewer_role_or_qualification",
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"reviewed_at",
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"decision",
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"notes",
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@ -82,6 +83,7 @@ CASE_SET_FIELDS = {
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"content_safety",
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"official_source_scope",
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"case_decision_contract",
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"youth_review_responses",
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"cases",
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}
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CASE_FIELDS = {
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@ -93,12 +95,20 @@ CASE_FIELDS = {
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}
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SCENARIO_FIELDS = {"speaker_context", "signal", "method_or_means_detail_present"}
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INVARIANT_FIELDS = {"invariant_id", "requirement"}
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ASSESSMENT_FIELDS = {"decision", "rationale", "reviewed_at"}
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ASSESSMENT_FIELDS = {
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"decision",
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"rationale",
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"findings_and_required_changes",
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"re_review",
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"reviewed_at",
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}
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REQUIRED_COMPLETED_APPROVAL_FIELDS = {
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"reviewer",
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"organization",
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"reviewer_role_or_qualification",
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"reviewed_at",
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"decision",
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"notes",
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"evidence_ref",
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"evidence_sha256",
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"reviewed_protocol_version",
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@ -106,6 +116,30 @@ REQUIRED_COMPLETED_APPROVAL_FIELDS = {
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}
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ALLOWED_CASE_DECISIONS = {"pass", "conditional", "fail"}
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EXPECTED_CASE_IDS = {f"P1-CRISIS-{index:03d}" for index in range(1, 7)}
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NO_REQUIRED_CHANGE_VALUES = {
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"없음",
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"수정 요구 없음",
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"해당 없음",
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"none",
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"n/a",
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"na",
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}
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NO_RE_REVIEW_VALUES = {
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"없음",
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"재검토 불필요",
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"해당 없음",
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"none",
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"n/a",
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"na",
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}
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YOUTH_REVIEW_RESPONSE_FIELDS = {
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"guardian_notification",
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"means_restriction",
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"risk_disposition",
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"follow_up_48_72h",
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"documentation",
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"safeguarding",
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}
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REQUIRED_SOURCE_IDS = {
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"samhsa_safe_t",
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"nimh_youth_outpatient_bssa",
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@ -262,10 +296,10 @@ def _validate_case_set_base(
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missing = sorted(CASE_SET_FIELDS - set(case_set))
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extra = sorted(set(case_set) - CASE_SET_FIELDS)
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errors.append(f"case_set: 필드 불일치 missing={missing}, extra={extra}")
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if manifest.get("schema_version") != "vignette.clinical_crisis_review.v1":
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errors.append("manifest.schema_version: vignette.clinical_crisis_review.v1이어야 한다")
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if case_set.get("schema_version") != "vignette.p1_crisis_review_cases.v1":
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errors.append("case_set.schema_version: vignette.p1_crisis_review_cases.v1이어야 한다")
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if manifest.get("schema_version") != "vignette.clinical_crisis_review.v2":
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errors.append("manifest.schema_version: vignette.clinical_crisis_review.v2여야 한다")
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if case_set.get("schema_version") != "vignette.p1_crisis_review_cases.v2":
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errors.append("case_set.schema_version: vignette.p1_crisis_review_cases.v2여야 한다")
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if manifest.get("technical_status") != "verified":
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errors.append("manifest.technical_status: verified여야 한다")
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if case_set.get("priority") != "P1":
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@ -312,6 +346,17 @@ def _validate_case_set_base(
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if contract.get("pending_value", object()) is not None:
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errors.append("case_set.case_decision_contract.pending_value: null이어야 한다")
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youth_responses = case_set.get("youth_review_responses")
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if not isinstance(youth_responses, dict):
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errors.append("case_set.youth_review_responses: 객체여야 한다")
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elif set(youth_responses) != YOUTH_REVIEW_RESPONSE_FIELDS:
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missing = sorted(YOUTH_REVIEW_RESPONSE_FIELDS - set(youth_responses))
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extra = sorted(set(youth_responses) - YOUTH_REVIEW_RESPONSE_FIELDS)
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errors.append(
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"case_set.youth_review_responses: 필드 불일치 "
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f"missing={missing}, extra={extra}"
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)
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cases = case_set.get("cases")
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if not isinstance(cases, list) or not cases:
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errors.append("case_set.cases: 하나 이상의 합성 사례가 필요하다")
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@ -366,6 +411,7 @@ def _validate_case_set_base(
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def _validate_pending(
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approval: dict[str, Any],
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cases: list[Any],
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youth_review_responses: Any,
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) -> list[str]:
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errors: list[str] = []
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for field in sorted(APPROVAL_FIELDS):
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@ -380,11 +426,20 @@ def _validate_pending(
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if not isinstance(assessment, dict):
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errors.append(f"pending_external_review: {label}.reviewer_assessment가 필요하다")
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continue
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for field in ("decision", "rationale", "reviewed_at"):
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for field in sorted(ASSESSMENT_FIELDS):
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if assessment.get(field, object()) is not None:
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errors.append(
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f"pending_external_review: {label}.reviewer_assessment.{field}는 null이어야 한다"
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)
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if not isinstance(youth_review_responses, dict):
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errors.append("pending_external_review: youth_review_responses 객체가 필요하다")
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else:
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for field in sorted(YOUTH_REVIEW_RESPONSE_FIELDS):
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if youth_review_responses.get(field, object()) is not None:
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errors.append(
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"pending_external_review: "
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f"youth_review_responses.{field}는 null이어야 한다"
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)
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return errors
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@ -435,6 +490,7 @@ def _validate_completed(
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approval: dict[str, Any],
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case_set_path: Path,
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cases: list[Any],
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youth_review_responses: Any,
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) -> list[str]:
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errors: list[str] = []
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for field in sorted(REQUIRED_COMPLETED_APPROVAL_FIELDS):
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@ -444,11 +500,6 @@ def _validate_completed(
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reviewed_at = approval.get("reviewed_at")
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if not _is_iso_date(reviewed_at):
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errors.append(f"{status}: approval.reviewed_at은 YYYY-MM-DD 실제 날짜여야 한다")
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if status in {"conditional", "rejected"} and not _is_nonempty_string(approval.get("notes")):
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errors.append(f"{status}: approval.notes에 조건 또는 반려 사유가 필요하다")
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elif approval.get("notes") is not None and not _is_nonempty_string(approval.get("notes")):
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errors.append(f"{status}: approval.notes는 null 또는 비어 있지 않은 문자열이어야 한다")
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if approval.get("decision") != STATUS_DECISIONS[status]:
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errors.append(f"{status}: approval.decision은 {STATUS_DECISIONS[status]}이어야 한다")
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if approval.get("reviewed_protocol_version") != manifest.get("version"):
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@ -462,6 +513,15 @@ def _validate_completed(
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errors.extend(_validate_evidence(root, approval))
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if not isinstance(youth_review_responses, dict):
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errors.append(f"{status}: youth_review_responses 객체가 필요하다")
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else:
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for field in sorted(YOUTH_REVIEW_RESPONSE_FIELDS):
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if not _is_nonempty_string(youth_review_responses.get(field)):
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errors.append(
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f"{status}: youth_review_responses.{field} 답변이 필요하다"
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)
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decisions: list[str] = []
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for index, case in enumerate(cases):
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if not isinstance(case, dict):
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@ -478,6 +538,25 @@ def _validate_completed(
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decisions.append(decision)
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if not _is_nonempty_string(assessment.get("rationale")):
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errors.append(f"{status}: {label}.reviewer_assessment.rationale이 필요하다")
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findings = assessment.get("findings_and_required_changes")
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re_review = assessment.get("re_review")
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if not _is_nonempty_string(findings):
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errors.append(
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f"{status}: {label}.reviewer_assessment.findings_and_required_changes가 필요하다"
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)
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if not _is_nonempty_string(re_review):
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errors.append(f"{status}: {label}.reviewer_assessment.re_review가 필요하다")
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if decision in {"conditional", "fail"}:
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if isinstance(findings, str) and findings.strip().casefold() in NO_REQUIRED_CHANGE_VALUES:
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errors.append(
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f"{status}: {label}.reviewer_assessment.findings_and_required_changes에 "
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"실제 수정 요구를 기록해야 한다"
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)
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if isinstance(re_review, str) and re_review.strip().casefold() in NO_RE_REVIEW_VALUES:
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errors.append(
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f"{status}: {label}.reviewer_assessment.re_review에 "
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"재검토 제출 조건 또는 일정을 기록해야 한다"
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)
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if assessment.get("reviewed_at") != reviewed_at:
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errors.append(f"{status}: {label}.reviewer_assessment.reviewed_at이 전체 검토일과 달라서는 안 된다")
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@ -551,8 +630,9 @@ def validate_review_contract(
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cases = case_set.get("cases")
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if not isinstance(cases, list):
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return errors
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youth_review_responses = case_set.get("youth_review_responses")
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if status == "pending_external_review":
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errors.extend(_validate_pending(approval, cases))
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errors.extend(_validate_pending(approval, cases, youth_review_responses))
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else:
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errors.extend(
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_validate_completed(
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@ -562,6 +642,7 @@ def validate_review_contract(
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approval,
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case_set_file,
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cases,
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youth_review_responses,
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)
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)
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return errors
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@ -604,6 +685,7 @@ def main(argv: list[str] | None = None) -> int:
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"protocol": f"{manifest['protocol_id']}@{manifest['version']}",
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"case_set": f"{case_set['case_set_id']}@{case_set['version']}",
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"case_count": len(case_set["cases"]),
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"review_complete": manifest["clinical_status"] != "pending_external_review",
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"external_review_replaced": False,
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},
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ensure_ascii=False,
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