rgds-dec-0006-ai-assisted-conditional-go.json

{
  "decision_id": "RGDS-DEC-0006",
  "decision_title": "AI-Assisted Conditional Go — IND Readiness (Non-Clinical Package)",
  "program_context": {
    "program_id": "PROGRAM-IND-READINESS-001",
    "asset_or_initiative": "IND Readiness (Non-Clinical Package)",
    "domain": "ind_submission",
    "target_product_profile": {
      "development_stage_relevance": "IND-enabling package readiness review"
    }
  },
  "decision_category": "internal",
  "status": "decided",
  "created_at": "2025-12-30T18:00:00Z",
  "created_by": {
    "name": "RGDS Example Author",
    "role": "Principal AI Business Analyst"
  },
  "gate": {
    "gate_name": "IND Readiness Review",
    "gate_type": "phase_gate",
    "gate_date": "2025-12-30",
    "decision_deadline": "2025-12-30T23:59:59Z",
    "meeting_refs": []
  },
  "decision_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?",
  "options_considered": [
    {
      "option_id": "OPT-1",
      "description": "Proceed with IND submission under conditions (conditional_go).",
      "pros": [
        "Maintains IND timeline while explicitly governing known evidence gaps",
        "Conditions create owned closure path with verifiable evidence"
      ],
      "cons": [
        "Residual risk: limited stability duration at time of filing",
        "Requires disciplined follow-through and post-filing amendment governance"
      ],
      "estimated_impact": "Fastest path to filing while preserving defensibility via explicit conditions and governance controls."
    },
    {
      "option_id": "OPT-2",
      "description": "Defer submission until final GLP tox sign-off and 3-month stability data are available (defer_with_required_evidence).",
      "pros": [
        "Reduces residual risk at time of filing",
        "Improves evidence completeness"
      ],
      "cons": [
        "Delays IND timeline and downstream program activities"
      ],
      "estimated_impact": "Higher evidence completeness but delays program milestones."
    }
  ],
  "decision_outcome": {
    "outcome": "conditional_go",
    "selected_option_id": "OPT-1",
    "conditions": [
      {
        "condition": "Finalize and submit the signed GLP tox report prior to IND filing.",
        "owner": {
          "name": "Head of Non-Clinical Toxicology",
          "role": "Scientific adequacy owner"
        },
        "due_date": "2026-01-05",
        "evidence_to_close": "Final signed GLP tox report (controlled version) referenced in evidence registry."
      },
      {
        "condition": "Submit 3-month stability data amendment within 30 days post-IND filing, with cross-module linkage updated.",
        "owner": {
          "name": "CMC Lead",
          "role": "Manufacturing and stability readiness owner"
        },
        "due_date": "2026-02-01",
        "evidence_to_close": "3-month stability dataset + updated Module 2 summaries and CMC tables reflecting the new data."
      }
    ],
    "rationale_summary": "Proceeding is defensible as a conditional_go because core non-clinical adequacy is supported by audited draft evidence, while two known gaps (final GLP tox sign-off and longer-term stability duration) are explicitly governed through owned, time-bound conditions with verifiable closure evidence. AI assistance was used only to support reviewable gap identification and consistency checks; all interpretation, risk acceptance, and final approval remain human-owned."
  },
  "evidence": {
    "evidence_items": [
      {
        "evidence_id": "EVID-TOX-001",
        "type": "report",
        "title": "GLP Tox Study — Audited Draft v1.1",
        "source_system": "Document Repository",
        "location_ref": "GLP_Tox_Study_Audited_Draft_v1.1",
        "owner": {
          "name": "Head of Non-Clinical Toxicology",
          "role": "Evidence owner"
        },
        "as_of": "2025-12-29T18:00:00Z",
        "relevance": "primary",
        "quality_notes": "Audited draft pending final sign-off; acceptable for conditional_go with explicit closure condition.",
        "confidence": "high",
        "completeness_state": "partial"
      },
      {
        "evidence_id": "EVID-PHARM-001",
        "type": "report",
        "title": "Pharmacology Summary v2.0",
        "source_system": "Document Repository",
        "location_ref": "Pharmacology_Summary_v2.0",
        "owner": {
          "name": "Head of Non-Clinical Toxicology",
          "role": "Evidence owner"
        },
        "as_of": "2025-12-28T18:00:00Z",
        "relevance": "supporting",
        "quality_notes": "Summary aligns with non-clinical package; reviewed for consistency with tox margins.",
        "confidence": "medium",
        "completeness_state": "complete"
      },
      {
        "evidence_id": "EVID-PK-001",
        "type": "report",
        "title": "PK Summary v1.3",
        "source_system": "Document Repository",
        "location_ref": "PK_Summary_v1.3",
        "owner": {
          "name": "Head of Non-Clinical Toxicology",
          "role": "Evidence owner"
        },
        "as_of": "2025-12-28T18:00:00Z",
        "relevance": "supporting",
        "quality_notes": "Reviewed for internal consistency across Module 2 narrative references.",
        "confidence": "medium",
        "completeness_state": "complete"
      },
      {
        "evidence_id": "EVID-CMC-001",
        "type": "dataset",
        "title": "Stability Data — 1 Month (Final)",
        "source_system": "CMC Data Store",
        "location_ref": "Stability_Data_1_Month_vFinal",
        "owner": {
          "name": "CMC Lead",
          "role": "Evidence owner"
        },
        "as_of": "2025-12-27T18:00:00Z",
        "relevance": "primary",
        "quality_notes": "Duration limited at time of filing; longer-term data required via post-filing condition.",
        "confidence": "medium",
        "completeness_state": "complete"
      },
      {
        "evidence_id": "EVID-CMC-002",
        "type": "memo",
        "title": "Manufacturing Control Strategy v1.0",
        "source_system": "Document Repository",
        "location_ref": "Manufacturing_Control_Strategy_v1.0",
        "owner": {
          "name": "CMC Lead",
          "role": "Evidence owner"
        },
        "as_of": "2025-12-27T18:00:00Z",
        "relevance": "supporting",
        "quality_notes": "Adequate for current scope; reviewed for alignment with stability commitments.",
        "confidence": "medium",
        "completeness_state": "complete"
      }
    ]
  },
  "known_gaps_and_assumptions": {
    "gaps": [
      {
        "gap": "Final signed GLP tox report not yet available at time of decision (audited draft only).",
        "impact": "Audit/filing readiness risk if final sign-off is delayed; requires explicit closure prior to filing.",
        "mitigation_plan": "Condition C1 enforces final signed report delivery and evidence linkage prior to filing."
      },
      {
        "gap": "Only 1-month stability data available at time of decision; 3-month data pending.",
        "impact": "Residual CMC risk at filing if longer-term stability is expected for the submission strategy.",
        "mitigation_plan": "Condition C2 enforces 3-month stability amendment within 30 days post-filing with cross-module updates."
      }
    ],
    "assumptions": [
      {
        "assumption": "Audited draft GLP tox report is substantively stable and will not materially change upon final sign-off.",
        "risk_if_wrong": "Material changes could invalidate rationale and require re-review or escalation.",
        "how_to_verify": "Compare final signed report to audited draft; record differences and trigger re-review if materially different."
      }
    ]
  },
  "risk_assessment": {
    "key_risks": [
      {
        "risk": "Limited stability duration at time of filing may be challenged or require post-filing commitments.",
        "severity": "medium",
        "likelihood": "possible",
        "detectability": "moderate",
        "mitigation": "Explicit condition to deliver 3-month stability amendment and update dependent narratives/tables.",
        "owner": {
          "name": "CMC Lead",
          "role": "Risk owner"
        }
      }
    ],
    "residual_risk_statement": "Residual risk is accepted as bounded and governed, contingent on completion of explicit closure evidence for tox sign-off and stability amendment commitments.",
    "risk_acceptance_required": true,
    "residual_risk_items": [
      {
        "risk": "Limited stability duration at time of filing may be challenged or require post-filing commitments.",
        "mitigation": "Explicit condition to deliver 3-month stability amendment and update dependent narratives/tables.",
        "trigger": "If the risk condition materializes or a governed condition is not met by due date.",
        "owner": {
          "name": "CMC Lead",
          "role": "Risk owner"
        }
      }
    ]
  },
  "governance": {
    "decision_owner": {
      "name": "VP Regulatory Affairs",
      "role": "Decision Owner (Final authority)"
    },
    "approvers": [
      {
        "name": "VP Regulatory Affairs",
        "role": "Decision Owner (Final authority)"
      }
    ],
    "reviewers": [
      {
        "name": "Head of Non-Clinical Toxicology",
        "role": "Scientific adequacy reviewer"
      },
      {
        "name": "CMC Lead",
        "role": "CMC readiness reviewer"
      },
      {
        "name": "Quality Representative",
        "role": "Audit readiness reviewer"
      }
    ],
    "approval_method": "meeting_vote",
    "approvals": [
      {
        "person": {
          "name": "VP Regulatory Affairs",
          "role": "Decision Owner (Final authority)"
        },
        "decision": "approve",
        "timestamp": "2025-12-30T18:30:00Z",
        "comments": "Approved as conditional_go with explicit conditions and governed closure evidence."
      }
    ],
    "final_signoff": {
      "person": {
        "name": "VP Regulatory Affairs",
        "role": "Decision Owner (Final authority)"
      },
      "timestamp": "2025-12-30T18:35:00Z",
      "notes": "Human accountability confirmed; AI assistance treated as non-authoritative drafting/review support only."
    },
    "authority_scope": "decide",
    "escalation_path": [
      {
        "name": "QA Representative",
        "role": "Quality (Deadlock resolver)"
      },
      {
        "name": "Executive Sponsor",
        "role": "SVP, Development (Escalation authority)"
      }
    ]
  },
  "ai_assistance": {
    "used": true,
    "use_cases": [
      "compare",
      "extract",
      "draft"
    ],
    "artifacts": [
      {
        "artifact_id": "AI-ART-0006-01",
        "description": "Cross-document consistency scan for tox margin phrasing and stability linkage across Module 2 narratives.",
        "input_refs": [
          "GLP_Tox_Study_Audited_Draft_v1.1",
          "Pharmacology_Summary_v2.0",
          "PK_Summary_v1.3",
          "Stability_Data_1_Month_vFinal"
        ],
        "output_ref": "AI_Output_Consistency_Findings_0006-01",
        "human_reviewer": {
          "name": "Quality Representative",
          "role": "Human reviewer"
        },
        "disposition": "edited"
      }
    ],
    "controls": {
      "prompt_or_instruction_ref": "rgds-ai-assistance-policy-v1.4.0 + non-agentic-ai-contract-v1.0",
      "schema_or_format_constraints": "All outputs constrained to RGDS decision-log schema sections; no autonomous actions; no evidence generation.",
      "versioning": "Tooling: ChatGPT-style assistant (version not pinned); outputs treated as drafts with mandatory human review.",
      "safety_notes": "AI cannot approve decisions, accept risk, or create evidence of record. Outputs must be reviewable, reversible, and source-linked."
    },
    "confidence_band": "high",
    "human_override": true,
    "tool_name": "ChatGPT-style assistant",
    "tool_purpose": "Bounded decision-support drafting and structured consistency checks; no autonomy; human review required.",
    "disclosure_notes": "AI outputs treated as drafts; reviewers confirm source fidelity, remove unsupported claims, and record overrides.",
    "tool_characteristics": {
      "model_type": "LLM",
      "training_data_notes": "Not pinned; treat as opaque tool; do not assume domain grounding.",
      "benchmarks_or_validation": "Not used as evidence; tool outputs validated via human review and source cross-check.",
      "limitations": "May hallucinate, omit constraints, or misinterpret regulatory context; cannot approve decisions or accept risk."
    },
    "human_review": [
      {
        "tier": "tier2",
        "reviewer": {
          "name": "Quality Representative",
          "role": "Human reviewer"
        },
        "finding_summary": "Reviewed AI output for fidelity and removed unsupported claims.",
        "actions_taken": "edited"
      }
    ],
    "human_override_log": [],
    "ai_risk_assessment": {
      "confidence_band": "high",
      "cautions": "Use for synthesis only; verify all factual claims against controlled sources."
    }
  },
  "actions": [
    {
      "action_id": "ACT-0006-01",
      "description": "Deliver final signed GLP tox report and update evidence registry reference for EVID-TOX-001.",
      "owner": {
        "name": "Head of Non-Clinical Toxicology",
        "role": "Action owner"
      },
      "due_date": "2026-01-05",
      "success_criteria": "Final signed report is stored as a controlled record and linked in the decision evidence registry.",
      "status": "open"
    },
    {
      "action_id": "ACT-0006-02",
      "description": "Deliver 3-month stability data amendment and update dependent Module 2 narratives/CMC tables.",
      "owner": {
        "name": "CMC Lead",
        "role": "Action owner"
      },
      "due_date": "2026-02-01",
      "success_criteria": "3-month stability dataset is stored and all dependent narratives/tables are updated with traceable references.",
      "status": "open"
    }
  ],
  "dependencies": [],
  "change_control": {
    "change_requests": [],
    "release_or_validation_refs": [
      "CI: validate_all_examples.py"
    ]
  },
  "audit": {
    "record_version": 1,
    "change_log": [],
    "supersedes": null,
    "superseded_by": null,
    "retention_class": "controlled_record"
  },
  "risk_posture": "risk_neutral",
  "evidence_completeness": {
    "state": "partial",
    "expected_resolution_date": "2026-02-01",
    "author_at_risk": false,
    "notes": "Partial evidence accepted only under explicit closure conditions for tox sign-off and stability amendment."
  },
  "propagation_required": [
    "M2.6",
    "CMC",
    "Other"
  ]
}