{
  "decision_id": "RGDS-DEC-0002",
  "decision_title": "CANONICAL — No-Go at Data Readiness Gate (traceability + integrity failures)",
  "program_context": {
    "program_id": "PRG-241",
    "asset_or_initiative": "ABC-101",
    "domain": "non_clinical_informatics"
  },
  "status": "decided",
  "created_at": "2025-12-26T10:15:00-05:00",
  "created_by": {
    "name": "Mark Banasihan",
    "role": "Principal AI Business Analyst (Case Study)"
  },
  "gate": {
    "gate_name": "Data Readiness",
    "gate_type": "phase_gate",
    "gate_date": "2026-01-07",
    "decision_deadline": "2026-01-06T17:00:00-05:00",
    "meeting_refs": [
      "CONFL-1012",
      "GCAL-141"
    ]
  },
  "decision_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?",
  "options_considered": [
    {
      "option_id": "A",
      "description": "Proceed to gate with known gaps; plan remediation after approval.",
      "pros": [
        "Maintains near-term timeline",
        "Reduces immediate disruption to downstream teams"
      ],
      "cons": [
        "Material traceability gaps may invalidate downstream artifacts",
        "Elevates regulatory and quality risk by accepting unknown error surface"
      ],
      "estimated_impact": "Short-term schedule benefit with high risk of rework and governance reversal."
    },
    {
      "option_id": "B",
      "description": "No-Go at this gate; require closure of integrity checks, lineage validation, and controlled re-export before re-review.",
      "pros": [
        "Protects decision defensibility and reduces downstream rework",
        "Forces explicit closure of risks before proceeding"
      ],
      "cons": [
        "Likely schedule slip and stakeholder friction",
        "Requires concentrated remediation effort across functions"
      ],
      "estimated_impact": "Short-term delay with reduced cumulative program risk and improved right-first-time posture."
    }
  ],
  "decision_outcome": {
    "outcome": "no_go",
    "selected_option_id": "B",
    "conditions": [],
    "rationale_summary": "The decision is No-Go because the evidence packet cannot support a defensible readiness claim at this time. Multiple traceability and integrity failures were identified: lineage is incomplete for a subset of records, integrity checks did not reconcile across source extracts, and controlled evidence cannot demonstrate stability of the dataset used for analysis. Proceeding would create a high probability of downstream rework and undermine confidence in any outputs derived from the dataset. The program can return to this gate once a controlled re-export is produced, lineage is fully verified, integrity checks reconcile, and closures are documented as controlled evidence."
  },
  "evidence": {
    "evidence_items": [
      {
        "evidence_id": "E-010",
        "type": "dashboard",
        "title": "Data completeness and lineage view (shows unresolved lineage breaks)",
        "source_system": "Power BI",
        "location_ref": "PBI-DSH-452",
        "owner": {
          "name": "Analytics Lead",
          "role": "BI / Reporting"
        },
        "as_of": "2026-01-05T09:10:00-05:00",
        "relevance": "primary",
        "quality_notes": "Dashboard indicates lineage breaks for Study-02 and Study-03 subsets; definitions aligned but lineage evidence incomplete.",
        "confidence": "medium",
        "completeness_state": "complete"
      },
      {
        "evidence_id": "E-011",
        "type": "dataset",
        "title": "Controlled tox dataset export (candidate export_v2)",
        "source_system": "LIMS",
        "location_ref": "SP://controlled-data/ABC-101/tox/export_v2.csv",
        "owner": {
          "name": "Data Steward",
          "role": "Non-clinical Data Operations"
        },
        "as_of": "2026-01-05T08:35:00-05:00",
        "relevance": "primary",
        "quality_notes": "Export contains missing required fields and inconsistent identifiers between source extracts; not stable as a gate-of-record dataset.",
        "confidence": "low",
        "completeness_state": "complete"
      },
      {
        "evidence_id": "E-012",
        "type": "report",
        "title": "Data integrity reconciliation report (source extract vs controlled export)",
        "source_system": "Internal QC",
        "location_ref": "SP://controlled-docs/ABC-101/tox/integrity_recon_report_v1.pdf",
        "owner": {
          "name": "QA Representative",
          "role": "Quality"
        },
        "as_of": "2026-01-05T16:40:00-05:00",
        "relevance": "primary",
        "quality_notes": "Reconciliation failed: record counts and key identifiers do not reconcile across extracts; root cause not yet isolated.",
        "confidence": "high",
        "completeness_state": "complete"
      }
    ]
  },
  "known_gaps_and_assumptions": {
    "gaps": [
      {
        "gap": "Lineage cannot be demonstrated end-to-end for a subset of Study-02 and Study-03 records.",
        "impact": "Traceability failure prevents defensible use of derived analyses and could trigger downstream rework and governance reversal.",
        "mitigation_plan": "Reconstruct lineage with controlled mapping; verify source-to-export transforms; publish lineage validation memo."
      },
      {
        "gap": "Integrity checks do not reconcile across source extracts and the controlled export (record counts and identifiers mismatch).",
        "impact": "High risk of incorrect analyses and decisions based on unstable or inconsistent data.",
        "mitigation_plan": "Isolate root cause; re-run integrity checks on controlled re-export; document closure in reconciliation report v2."
      }
    ],
    "assumptions": [
      {
        "assumption": "Root cause is within transformation/mapping steps rather than upstream source corruption.",
        "risk_if_wrong": "May require upstream remediation, broader timeline impact, and updated governance plan.",
        "how_to_verify": "Perform controlled re-export directly from validated source extracts; compare identifiers and counts at each step."
      }
    ]
  },
  "risk_assessment": {
    "key_risks": [
      {
        "risk": "Proceeding with unresolved integrity reconciliation could invalidate downstream reports and require rework under governance scrutiny.",
        "severity": "high",
        "likelihood": "likely",
        "detectability": "moderate",
        "mitigation": "No-Go until reconciliation passes and lineage is demonstrably complete; require controlled evidence of closure before re-review.",
        "owner": {
          "name": "QA Representative",
          "role": "Quality"
        }
      },
      {
        "risk": "Incomplete lineage could undermine audit defensibility of any derived submissions or internal decisions.",
        "severity": "high",
        "likelihood": "possible",
        "detectability": "hard",
        "mitigation": "Produce lineage validation memo linking source → transforms → export; require sign-off prior to gate re-attempt.",
        "owner": {
          "name": "Data Steward",
          "role": "Non-clinical Data Operations"
        }
      }
    ],
    "residual_risk_statement": "Residual risk is not acceptable at this gate because the dataset cannot be defended as stable, traceable, and integrity-checked. Risk is reduced by pausing and requiring controlled closure evidence before re-review.",
    "risk_acceptance_required": true,
    "residual_risk_items": [
      {
        "risk": "Proceeding with unresolved integrity reconciliation could invalidate downstream reports and require rework under governance scrutiny.",
        "mitigation": "No-Go until reconciliation passes and lineage is demonstrably complete; require controlled evidence of closure before re-review.",
        "trigger": "If the risk condition materializes or a governed condition is not met by due date.",
        "owner": {
          "name": "QA Representative",
          "role": "Quality"
        }
      },
      {
        "risk": "Incomplete lineage could undermine audit defensibility of any derived submissions or internal decisions.",
        "mitigation": "Produce lineage validation memo linking source → transforms → export; require sign-off prior to gate re-attempt.",
        "trigger": "If the risk condition materializes or a governed condition is not met by due date.",
        "owner": {
          "name": "Data Steward",
          "role": "Non-clinical Data Operations"
        }
      }
    ]
  },
  "governance": {
    "decision_owner": {
      "name": "Program Lead",
      "role": "Non-clinical Program Lead"
    },
    "approvers": [
      {
        "name": "QA Representative",
        "role": "Quality"
      },
      {
        "name": "Executive Sponsor",
        "role": "VP, Development"
      }
    ],
    "reviewers": [
      {
        "name": "Data Steward",
        "role": "Non-clinical Data Operations"
      },
      {
        "name": "Analytics Lead",
        "role": "BI / Reporting"
      }
    ],
    "approval_method": "meeting_vote",
    "approvals": [
      {
        "person": {
          "name": "QA Representative",
          "role": "Quality"
        },
        "decision": "approve",
        "timestamp": "2026-01-06T15:50:00-05:00",
        "comments": "No-Go required. Integrity reconciliation failure and incomplete lineage prevent defensible readiness claim."
      },
      {
        "person": {
          "name": "Executive Sponsor",
          "role": "VP, Development"
        },
        "decision": "approve",
        "timestamp": "2026-01-06T16:05:00-05:00",
        "comments": "Agree No-Go. Re-review once controlled evidence demonstrates closure; reset timeline with governance visibility."
      }
    ],
    "final_signoff": {
      "person": {
        "name": "Executive Sponsor",
        "role": "VP, Development"
      },
      "timestamp": "2026-01-06T16:10:00-05:00",
      "notes": "No-Go recorded. Remediation required before returning to gate."
    },
    "authority_scope": "decide",
    "escalation_path": [
      {
        "name": "QA Representative",
        "role": "Quality (Deadlock resolver)"
      },
      {
        "name": "Executive Sponsor",
        "role": "VP, Development (Final escalation)"
      }
    ]
  },
  "ai_assistance": {
    "used": false,
    "use_cases": [],
    "artifacts": [],
    "controls": {
      "prompt_or_instruction_ref": "",
      "schema_or_format_constraints": "",
      "versioning": "",
      "safety_notes": ""
    },
    "confidence_band": null,
    "human_override": null
  },
  "actions": [
    {
      "action_id": "ACT-0010",
      "description": "Isolate root cause of integrity reconciliation failure and publish reconciliation report v2 with passing checks.",
      "owner": {
        "name": "QA Representative",
        "role": "Quality"
      },
      "due_date": "2026-01-14",
      "success_criteria": "Reconciliation passes: record counts and identifiers match across extracts and controlled export; report v2 stored and linked.",
      "status": "open"
    },
    {
      "action_id": "ACT-0011",
      "description": "Produce controlled re-export (export_v3) with verified mapping and publish lineage validation memo.",
      "owner": {
        "name": "Data Steward",
        "role": "Non-clinical Data Operations"
      },
      "due_date": "2026-01-14",
      "success_criteria": "End-to-end lineage demonstrable for all required records; memo stored and linked; export_v3 becomes dataset of record.",
      "status": "open"
    },
    {
      "action_id": "ACT-0012",
      "description": "Schedule re-review of Data Readiness gate once closure evidence is complete and linked.",
      "owner": {
        "name": "Program Lead",
        "role": "Non-clinical Program Lead"
      },
      "due_date": "2026-01-15",
      "success_criteria": "Gate re-review scheduled with evidence packet references; approvers notified.",
      "status": "open"
    }
  ],
  "dependencies": [
    "DATA-PIPELINE-CR-41",
    "IND-TIMELINE-REF-12"
  ],
  "change_control": {
    "change_requests": [
      "CR-41"
    ],
    "release_or_validation_refs": [
      "VAL-TOX-PIPELINE-08"
    ]
  },
  "audit": {
    "record_version": 1,
    "change_log": [
      {
        "version": 1,
        "changed_by": {
          "name": "Mark Banasihan",
          "role": "Principal AI Business Analyst (Case Study)"
        },
        "changed_at": "2026-01-06T16:20:00-05:00",
        "summary": "No-Go decision finalized with approvals; evidence packet documents integrity and lineage failures."
      }
    ],
    "supersedes": null,
    "superseded_by": null,
    "retention_class": "controlled_record"
  },
  "decision_category": "internal",
  "evidence_completeness": {
    "state": "complete",
    "expected_resolution_date": null,
    "author_at_risk": false,
    "notes": null
  },
  "propagation_required": [],
  "risk_posture": "risk_accepting"
}