{ "schema_version": "1.0", "metadata": { "logic_id": "SYNTHETIC-RESEARCH-GOVERNANCE-001", "title": "Synthetic Research Release Traceability", "version": "0.1-draft", "status": "draft", "owner": "research governance owner", "purpose": "Document evidence, validation, and human-review gates for an offline research artifact.", "decision_role": "research_governance_only", "data_level": "metadata_only", "patient_care_use": false, "executable_logic": false, "change_summary": "Initial synthetic documentation example.", "monitoring_plan": "Review source currency, validation status, subgroup evidence, and unresolved issues at each version.", "retirement_criteria": "Retire when sources, validation evidence, ownership, or intended use are obsolete." }, "intended_use": "Research/governance traceability only; not for patient care or live clinical use.", "prohibited_uses": [ "No diagnosis, treatment recommendation, dosing, triage, urgency, alarm, or autonomous decision.", "No care pathway, EHR rule, or executable clinical logic.", "No claim of authorization or compliance." ], "limitations": [ "The matrix documents plain-language logic and does not execute it.", "Source presence does not establish evidence quality.", "Human review and independent validation remain required." ], "sources": [ { "id": "SRC-GOV-001", "citation": "Synthetic research governance procedure, version 1.", "url": "not_applicable_for_local_synthetic_source", "accessed": "2026-07-23" } ], "nodes": [ { "id": "source_gate", "type": "evidence_rule", "dependency_ids": [], "precondition": "An evidence record is proposed for the research artifact.", "logic_statement": "Check for a stable citation, source version, and retrieval date.", "output_kind": "flag_for_review", "output_value": "missing_source_provenance when any required source field is absent", "source_ids": [ "SRC-GOV-001" ], "rationale": "Reviewers need reproducible source provenance.", "validation_tests": [ "Complete source fields produce no provenance flag.", "Missing retrieval date produces missing_source_provenance." ], "owner": "evidence review owner", "reviewer_role": "independent methodologist", "status": "draft" }, { "id": "validation_gate", "type": "validation_gate", "dependency_ids": [ "source_gate" ], "precondition": "Source provenance is complete.", "logic_statement": "Check whether independent external validation and subgroup uncertainty are documented.", "output_kind": "release_hold", "output_value": "true when required validation documentation is absent", "source_ids": [ "SRC-GOV-001" ], "rationale": "Transportability claims require independent evidence and uncertainty.", "validation_tests": [ "Missing external-validation evidence produces a release hold.", "Complete validation evidence passes to human review." ], "owner": "validation owner", "reviewer_role": "independent statistician", "status": "draft" }, { "id": "human_review_gate", "type": "human_review", "dependency_ids": [ "validation_gate" ], "precondition": "Required documentation gates are complete.", "logic_statement": "Require recorded review by the accountable method, domain, privacy, and governance roles.", "output_kind": "documentation_status", "output_value": "pending until all accountable review roles record a decision", "source_ids": [ "SRC-GOV-001" ], "rationale": "Automated structural checks cannot approve a research artifact.", "validation_tests": [ "Absent reviewer decision produces pending status.", "Recorded reviewer decisions produce complete documentation status." ], "owner": "governance owner", "reviewer_role": "authorized governance approver", "status": "draft" } ], "human_review": { "required": true, "completed": false, "approval_boundary": "Only the accountable organization can approve a research artifact; this matrix never authorizes clinical use." } }