{
  "schema_version": "2.0",
  "artifact_kind": "clinical_study_report_draft",
  "draft_status": "BLOCKED_INCOMPLETE_DRAFT_NOT_FOR_FILING_OR_SUBMISSION",
  "safety_notice": "Populate only from verified aggregate trial outputs and authorized source-fact manifests. Do not invent analyses, efficacy, safety, conclusions, or appendices. Qualified medical, statistical, safety, privacy, quality, and regulatory review is required.",
  "data_classification": null,
  "authorized_purpose": null,
  "authorization_verified": false,
  "guidance": {
    "base": "ICH E3",
    "base_version": "Step 4 1995-11-30",
    "qa_version": "R1 2012-07-06",
    "gcp_version_considered": "ICH E6(R3) consolidated 2026-06-16",
    "regional_adoption_verified": false
  },
  "study_metadata": {
    "protocol_reference": null,
    "sap_reference": null,
    "data_cut_reference": null,
    "analysis_output_reference": null,
    "coding_dictionary_versions": []
  },
  "sections": {
    "title_page": {"status": "missing", "source_fact_ids": [], "rationale": null},
    "synopsis": {"status": "missing", "source_fact_ids": [], "rationale": null},
    "table_of_contents": {"status": "missing", "source_fact_ids": [], "rationale": null},
    "abbreviations_and_definitions": {"status": "missing", "source_fact_ids": [], "rationale": null},
    "ethics": {"status": "missing", "source_fact_ids": [], "rationale": null},
    "investigators_and_administration": {"status": "missing", "source_fact_ids": [], "rationale": null},
    "introduction": {"status": "missing", "source_fact_ids": [], "rationale": null},
    "study_objectives": {"status": "missing", "source_fact_ids": [], "rationale": null},
    "investigational_plan": {"status": "missing", "source_fact_ids": [], "rationale": null},
    "study_patients": {"status": "missing", "source_fact_ids": [], "rationale": null},
    "efficacy_evaluation": {"status": "missing", "source_fact_ids": [], "rationale": null},
    "safety_evaluation": {"status": "missing", "source_fact_ids": [], "rationale": null},
    "discussion_and_conclusions": {"status": "missing", "source_fact_ids": [], "rationale": null},
    "tables_figures_graphs_not_in_text": {"status": "missing", "source_fact_ids": [], "rationale": null},
    "reference_list": {"status": "missing", "source_fact_ids": [], "rationale": null},
    "appendices": {"status": "missing", "source_fact_ids": [], "rationale": null}
  },
  "provenance_manifest": null,
  "review": {
    "medical_review": "pending",
    "statistical_review": "pending",
    "safety_review": "pending",
    "privacy_legal_review": "pending",
    "quality_review": "pending",
    "regulatory_review": "pending",
    "submission_authorized": false
  }
}
