{
  "decision_id": "RGDS-DEC-0003",
  "decision_title": "Defer IND submission until tox signal is resolved",
  "program_context": {
    "program_id": "IND-PROG-001",
    "asset_or_initiative": "Asset-XYZ",
    "domain": "non_clinical_informatics",
    "target_product_profile": {
      "intended_indication": "(example) Indication under evaluation",
      "patient_population": "(example) Adult patients; specifics TBD",
      "route_of_administration": "(example) Oral",
      "dosing_regimen": "(example) Once daily; dose escalation planned",
      "key_safety_considerations": [
        "(example) QT prolongation signal monitoring",
        "(example) Hepatic liability"
      ],
      "development_stage_relevance": "IND-enabling package decision; context for deferral and re-entry criteria."
    }
  },
  "status": "decided",
  "created_at": "2025-12-27T12:00:00-05:00",
  "created_by": {
    "name": "Program PM",
    "role": "Program Management"
  },
  "gate": {
    "gate_name": "IND Readiness",
    "gate_type": "phase_gate",
    "gate_date": "2025-12-27",
    "decision_deadline": "2025-12-27T17:00:00-05:00",
    "meeting_refs": [
      "WEBINAR-IND-CHAT-001"
    ]
  },
  "decision_question": "Do we proceed with IND submission given an unexpected safety signal in the GLP dog tox study synopsis?",
  "options_considered": [
    {
      "option_id": "A",
      "description": "Proceed as planned; submit IND with current dataset and address questions post-submission.",
      "pros": [
        "Maintains target submission date",
        "Avoids immediate resourcing changes"
      ],
      "cons": [
        "Higher chance of FDA questions/clinical hold",
        "Downstream rework likely under time pressure"
      ],
      "estimated_impact": "Schedule benefit now; regulatory risk increased (potential hold / major information request)."
    },
    {
      "option_id": "B",
      "description": "Defer submission; adjudicate signal and seek focused FDA feedback (pre-IND) before finalizing.",
      "pros": [
        "Improves safety narrative and audit posture",
        "Reduces downstream rework and hold risk"
      ],
      "cons": [
        "Submission date slips",
        "Requires rapid cross-functional coordination"
      ],
      "estimated_impact": "Short-term delay; improves probability of clean acceptance and reduces late-cycle churn."
    }
  ],
  "decision_outcome": {
    "outcome": "defer_with_required_evidence",
    "selected_option_id": "B",
    "conditions": [
      {
        "condition": "Complete tox adjudication memo (mechanism, human relevance, mitigation) and store in controlled location.",
        "owner": {
          "name": "Nonclinical Safety Lead",
          "role": "Toxicology"
        },
        "due_date": "2026-01-06",
        "evidence_to_close": "Signed tox adjudication memo (controlled)"
      },
      {
        "condition": "Submit focused pre-IND briefing package on tox signal; capture feedback and update IND nonclinical + protocol sections.",
        "owner": {
          "name": "Regulatory Lead",
          "role": "Regulatory Strategy"
        },
        "due_date": "2026-01-20",
        "evidence_to_close": "Pre-IND minutes + updated risk mitigation plan (controlled)"
      }
    ],
    "rationale_summary": "Evidence is not yet decision-ready: the safety signal is not reconciled and could trigger avoidable agency action. Deferral preserves patient safety posture and improves first-pass acceptance."
  },
  "evidence": {
    "evidence_items": [
      {
        "evidence_id": "EV-001",
        "type": "validation_artifact",
        "title": "GLP Dog Tox Study (audited draft synopsis)",
        "source_system": "Vendor Portal",
        "location_ref": "controlled://nonclinical/tox/dog_glp_audited_draft_v0.9.pdf",
        "owner": {
          "name": "Study Lead",
          "role": "Non-clinical Study Lead"
        },
        "as_of": "2025-12-26T00:00:00Z",
        "relevance": "primary",
        "quality_notes": "Audited draft available; final signed report pending. Synopsis vs appendix reconciliation pending.",
        "confidence": "medium",
        "completeness_state": "partial"
      },
      {
        "evidence_id": "EV-002",
        "type": "memo",
        "title": "Safety signal triage notes",
        "source_system": "Teams/SharePoint",
        "location_ref": "controlled://program/triage/safety_signal_notes_2025-12-26.docx",
        "owner": {
          "name": "Nonclinical Safety Lead",
          "role": "Toxicology"
        },
        "as_of": "2025-12-26T00:00:00Z",
        "relevance": "supporting",
        "quality_notes": "Working notes; must be reconciled into adjudication memo.",
        "confidence": "low",
        "completeness_state": "complete"
      }
    ]
  },
  "known_gaps_and_assumptions": {
    "gaps": [
      {
        "gap": "Final signed GLP tox report not available; human relevance not yet justified.",
        "impact": "Blocks confident safety narrative; may trigger agency questions/hold.",
        "mitigation_plan": "Complete tox adjudication memo; reconcile synopsis vs appendix; update nonclinical summaries + protocol safeguards."
      },
      {
        "gap": "FDA feedback on mitigation approach not yet obtained.",
        "impact": "Submission risk; could require additional studies or protocol changes.",
        "mitigation_plan": "Seek focused pre-IND interaction; document outcomes; update IND narrative and monitoring plan accordingly."
      }
    ],
    "assumptions": [
      {
        "assumption": "Signal is monitorable/mitigable once mechanism clarified.",
        "risk_if_wrong": "Could still warrant clinical hold or require additional nonclinical work.",
        "how_to_verify": "Mechanism review + FDA feedback; incorporate into monitoring/mitigation section of protocol and IB."
      }
    ]
  },
  "risk_assessment": {
    "key_risks": [
      {
        "risk": "Clinical hold or major information request due to incomplete safety narrative",
        "severity": "high",
        "likelihood": "possible",
        "detectability": "moderate",
        "mitigation": "Defer; adjudicate tox signal; align with FDA before submission.",
        "owner": {
          "name": "Regulatory Lead",
          "role": "Regulatory Strategy"
        }
      }
    ],
    "residual_risk_statement": "Residual risk remains until adjudication and FDA feedback are incorporated; proceeding now is not justified.",
    "risk_acceptance_required": true,
    "residual_risk_items": [
      {
        "risk": "Clinical hold or major information request due to incomplete safety narrative",
        "mitigation": "Defer; adjudicate tox signal; align with FDA before submission.",
        "trigger": "If the risk condition materializes or a governed condition is not met by due date.",
        "owner": {
          "name": "Regulatory Lead",
          "role": "Regulatory Strategy"
        }
      }
    ]
  },
  "governance": {
    "decision_owner": {
      "name": "Program Director",
      "role": "Program Leadership"
    },
    "approvers": [
      {
        "name": "QA Representative",
        "role": "Quality"
      },
      {
        "name": "Executive Sponsor",
        "role": "VP, Development"
      }
    ],
    "reviewers": [
      {
        "name": "Regulatory Lead",
        "role": "Regulatory Strategy"
      },
      {
        "name": "Nonclinical Safety Lead",
        "role": "Toxicology"
      },
      {
        "name": "CMC Lead",
        "role": "CMC"
      },
      {
        "name": "Medical Writing PM",
        "role": "Medical Writing PM"
      }
    ],
    "approval_method": "meeting_vote",
    "approvals": [
      {
        "person": {
          "name": "QA Representative",
          "role": "Quality"
        },
        "decision": "approve",
        "timestamp": "2025-12-27T12:25:00-05:00",
        "comments": "Deferral is appropriate given unresolved safety signal; ensure controlled documentation of adjudication + FDA feedback."
      },
      {
        "person": {
          "name": "Executive Sponsor",
          "role": "VP, Development"
        },
        "decision": "approve",
        "timestamp": "2025-12-27T12:30:00-05:00",
        "comments": "Approve deferral; re-baseline timeline after pre-IND feedback and final tox report."
      }
    ],
    "final_signoff": {
      "person": {
        "name": "Executive Sponsor",
        "role": "VP, Development"
      },
      "timestamp": "2025-12-27T12:31:00-05:00",
      "notes": "Defer_with_required_evidence recorded; conditions and actions must close before resubmitting for gate approval."
    },
    "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": "N/A",
      "schema_or_format_constraints": "N/A",
      "versioning": "N/A",
      "safety_notes": "No AI assistance used in this decision."
    },
    "confidence_band": null,
    "human_override": null
  },
  "actions": [
    {
      "action_id": "ACT-001",
      "description": "Draft tox adjudication memo and circulate for QC",
      "owner": {
        "name": "Nonclinical Safety Lead",
        "role": "Toxicology"
      },
      "due_date": "2026-01-06",
      "success_criteria": "Memo signed and stored; discrepancies resolved.",
      "status": "open"
    },
    {
      "action_id": "ACT-002",
      "description": "Draft pre-IND questions + briefing outline; schedule internal dry run",
      "owner": {
        "name": "Regulatory Lead",
        "role": "Regulatory Strategy"
      },
      "due_date": "2026-01-13",
      "success_criteria": "Briefing package ready; questions approved by core team.",
      "status": "open"
    }
  ],
  "dependencies": [
    "Final signed GLP tox report delivery from vendor (needed by 2026-01-10; currently at risk)"
  ],
  "change_control": {
    "change_requests": [
      "CR-IND-001"
    ],
    "release_or_validation_refs": [
      "VAL-NONCLIN-TOX-001"
    ]
  },
  "audit": {
    "record_version": 1,
    "change_log": [
      {
        "version": 1,
        "changed_by": {
          "name": "Program PM",
          "role": "Program Management"
        },
        "changed_at": "2025-12-27T12:10:00-05:00",
        "summary": "Created defer_with_required_evidence decision due to unexpected tox signal; linked to CR-IND-001."
      }
    ],
    "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"
}