{
  "date": "2026-09-13",
  "environment": {
    "python": "3.9.6",
    "jsonschema": "4.25.1",
    "date_time_format_available": true
  },
  "runs": [
    {
      "check": "strict-examples",
      "exit_code": 0
    },
    {
      "check": "regression-tests",
      "exit_code": 0
    },
    {
      "check": "profile-docs",
      "exit_code": 0
    }
  ],
  "examples": [
    {
      "id": "RGDS-DEC-0001",
      "file": "rgds-dec-0001.json",
      "question": "At the Data Readiness gate, is the tox dataset complete, traceable, and integrity-checked enough to proceed, with any remaining gaps handled as explicit, owned conditions?",
      "outcome": "conditional_go",
      "package_state": "complete",
      "evidence_counts": {
        "complete": 3,
        "partial": 0,
        "placeholder": 0
      },
      "conditions": 2,
      "ai_used": true
    },
    {
      "id": "RGDS-DEC-0002",
      "file": "rgds-dec-0002-no-go.json",
      "question": "At the Data Readiness gate, is the tox dataset demonstrably complete, traceable end-to-end, and integrity-reconciled such that downstream analysis and reporting remain defensible?",
      "outcome": "no_go",
      "package_state": "complete",
      "evidence_counts": {
        "complete": 3,
        "partial": 0,
        "placeholder": 0
      },
      "conditions": 0,
      "ai_used": false
    },
    {
      "id": "RGDS-DEC-0003",
      "file": "rgds-dec-0003-defer-required-evidence.json",
      "question": "Do we proceed with IND submission given an unexpected safety signal in the GLP dog tox study synopsis?",
      "outcome": "defer_with_required_evidence",
      "package_state": "complete",
      "evidence_counts": {
        "complete": 1,
        "partial": 1,
        "placeholder": 0
      },
      "conditions": 2,
      "ai_used": false
    },
    {
      "id": "RGDS-DEC-0004",
      "file": "rgds-dec-0004-regulatory-interaction.json",
      "question": "What questions will we submit for the pre-IND meeting and how will we interpret existing FDA feedback to de-risk IND readiness?",
      "outcome": "conditional_go",
      "package_state": "complete",
      "evidence_counts": {
        "complete": 1,
        "partial": 1,
        "placeholder": 0
      },
      "conditions": 2,
      "ai_used": false
    },
    {
      "id": "RGDS-DEC-0005",
      "file": "rgds-dec-0005-ind-conditional-go-author-at-risk.json",
      "question": "Is the evidence sufficient to submit the initial IND on 2026-01-20 while maintaining regulatory defensibility, given (a) pivotal GLP tox report is currently an audited draft and (b) clinical stability dataset is limited to 1\u2011month at time of submission?",
      "outcome": "conditional_go",
      "package_state": "partial",
      "evidence_counts": {
        "complete": 2,
        "partial": 3,
        "placeholder": 0
      },
      "conditions": 3,
      "ai_used": true
    },
    {
      "id": "RGDS-DEC-0006",
      "file": "rgds-dec-0006-ai-assisted-conditional-go.json",
      "question": "Is the current non-clinical evidence package sufficient to proceed with IND submission under explicitly owned conditions, given incomplete long-term stability data and pending final GLP tox report sign-off?",
      "outcome": "conditional_go",
      "package_state": "partial",
      "evidence_counts": {
        "complete": 4,
        "partial": 1,
        "placeholder": 0
      },
      "conditions": 2,
      "ai_used": true
    }
  ],
  "probes": [
    {
      "probe": "Original record",
      "schema_valid": true,
      "semantic_errors": [],
      "warnings": [],
      "strict_valid": true
    },
    {
      "probe": "Delete AI disclosure",
      "schema_valid": false,
      "semantic_errors": [],
      "warnings": [],
      "strict_valid": false
    },
    {
      "probe": "Set AI use to false",
      "schema_valid": true,
      "semantic_errors": [],
      "warnings": [
        "W-AI-003: ai_assistance.used=false but use_cases/artifacts are present; consider setting used=true or clearing fields"
      ],
      "strict_valid": false
    },
    {
      "probe": "Remove human review",
      "schema_valid": true,
      "semantic_errors": [
        "E_AI_006: ai_assistance.used=true requires at least one human_review record"
      ],
      "warnings": [],
      "strict_valid": false
    },
    {
      "probe": "Remove conditions",
      "schema_valid": true,
      "semantic_errors": [
        "E-COND-001: conditional_go requires decision_outcome.conditions (at least 1)"
      ],
      "warnings": [],
      "strict_valid": false
    },
    {
      "probe": "Omit AI confidence",
      "schema_valid": true,
      "semantic_errors": [],
      "warnings": [
        "W_AI_002: ai_assistance.used=true should include ai_risk_assessment.confidence_band"
      ],
      "strict_valid": false
    }
  ],
  "study_arithmetic": {
    "baseline_days": 45,
    "modeled_days": 22,
    "decisions": 15,
    "sum_of_modeled_decision_days_saved": 345
  },
  "boundary": "Local technical reproduction of supplied ZIP snapshots. Profile pinned-git contract check not run: ZIPs lack git history. No substantive AI Dependency Test, field outcome study, or regulator review performed."
}