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decision_logic_traceability_template.json
108 lines · skills/clinical-decision-support/assets/decision_logic_traceability_template.json at 5f2bc03
1{
2 "schema_version": "1.0",
3 "metadata": {
4 "logic_id": "SYNTHETIC-RESEARCH-GOVERNANCE-001",
5 "title": "Synthetic Research Release Traceability",
6 "version": "0.1-draft",
7 "status": "draft",
8 "owner": "research governance owner",
9 "purpose": "Document evidence, validation, and human-review gates for an offline research artifact.",
10 "decision_role": "research_governance_only",
11 "data_level": "metadata_only",
12 "patient_care_use": false,
13 "executable_logic": false,
14 "change_summary": "Initial synthetic documentation example.",
15 "monitoring_plan": "Review source currency, validation status, subgroup evidence, and unresolved issues at each version.",
16 "retirement_criteria": "Retire when sources, validation evidence, ownership, or intended use are obsolete."
17 },
18 "intended_use": "Research/governance traceability only; not for patient care or live clinical use.",
19 "prohibited_uses": [
20 "No diagnosis, treatment recommendation, dosing, triage, urgency, alarm, or autonomous decision.",
21 "No care pathway, EHR rule, or executable clinical logic.",
22 "No claim of authorization or compliance."
23 ],
24 "limitations": [
25 "The matrix documents plain-language logic and does not execute it.",
26 "Source presence does not establish evidence quality.",
27 "Human review and independent validation remain required."
28 ],
29 "sources": [
30 {
31 "id": "SRC-GOV-001",
32 "citation": "Synthetic research governance procedure, version 1.",
33 "url": "not_applicable_for_local_synthetic_source",
34 "accessed": "2026-07-23"
35 }
36 ],
37 "nodes": [
38 {
39 "id": "source_gate",
40 "type": "evidence_rule",
41 "dependency_ids": [],
42 "precondition": "An evidence record is proposed for the research artifact.",
43 "logic_statement": "Check for a stable citation, source version, and retrieval date.",
44 "output_kind": "flag_for_review",
45 "output_value": "missing_source_provenance when any required source field is absent",
46 "source_ids": [
47 "SRC-GOV-001"
48 ],
49 "rationale": "Reviewers need reproducible source provenance.",
50 "validation_tests": [
51 "Complete source fields produce no provenance flag.",
52 "Missing retrieval date produces missing_source_provenance."
53 ],
54 "owner": "evidence review owner",
55 "reviewer_role": "independent methodologist",
56 "status": "draft"
57 },
58 {
59 "id": "validation_gate",
60 "type": "validation_gate",
61 "dependency_ids": [
62 "source_gate"
63 ],
64 "precondition": "Source provenance is complete.",
65 "logic_statement": "Check whether independent external validation and subgroup uncertainty are documented.",
66 "output_kind": "release_hold",
67 "output_value": "true when required validation documentation is absent",
68 "source_ids": [
69 "SRC-GOV-001"
70 ],
71 "rationale": "Transportability claims require independent evidence and uncertainty.",
72 "validation_tests": [
73 "Missing external-validation evidence produces a release hold.",
74 "Complete validation evidence passes to human review."
75 ],
76 "owner": "validation owner",
77 "reviewer_role": "independent statistician",
78 "status": "draft"
79 },
80 {
81 "id": "human_review_gate",
82 "type": "human_review",
83 "dependency_ids": [
84 "validation_gate"
85 ],
86 "precondition": "Required documentation gates are complete.",
87 "logic_statement": "Require recorded review by the accountable method, domain, privacy, and governance roles.",
88 "output_kind": "documentation_status",
89 "output_value": "pending until all accountable review roles record a decision",
90 "source_ids": [
91 "SRC-GOV-001"
92 ],
93 "rationale": "Automated structural checks cannot approve a research artifact.",
94 "validation_tests": [
95 "Absent reviewer decision produces pending status.",
96 "Recorded reviewer decisions produce complete documentation status."
97 ],
98 "owner": "governance owner",
99 "reviewer_role": "authorized governance approver",
100 "status": "draft"
101 }
102 ],
103 "human_review": {
104 "required": true,
105 "completed": false,
106 "approval_boundary": "Only the accountable organization can approve a research artifact; this matrix never authorizes clinical use."
107 }
108}