{
  "schema_name": "soa-table-resolved",
  "schema_version": "1.2",
  "resolution_metadata": {
    "resolved_at": "2026-10-03T15:50:58.329042+00:00",
    "resolver": "soa2usdm.steps.resolve v1.0",
    "source_extraction": {
      "schema_name": "soa-table-extraction",
      "schema_version": "1.0",
      "extraction_file": "NCT04004988_Table_01_extraction.verified.json",
      "extraction_status": "ready_for_resolution"
    },
    "validation_results": {
      "structure_valid": true,
      "hierarchy_valid": true,
      "annotations_valid": true,
      "validation_warnings": [],
      "validation_errors": [],
      "method_provenance": [
        "indentation_level:assumed_flat: 20",
        "marker_location:synthesized: 14"
      ]
    },
    "resolution_status": "resolved",
    "ready_for_integration": true,
    "resolution_notes": ""
  },
  "extraction_metadata": {
    "extracted_at": "2026-09-27T13:30:00Z",
    "extractor": "Claude, PDF_TO_JSON_PROMPT single-pass",
    "prompt_version": "3.8.1",
    "source_document": {
      "filename": "NCT04004988_soa.pdf",
      "document_type": "protocol"
    },
    "extraction_status": "ready_for_resolution",
    "extraction_notes": "Single SoA table (Study Schedule Protocol I8F-MC-GPGS) printed on document pages 10-11 with the header reprinted on page 11 (de-duplicated). Document page 9 carries only the section heading '2. Schedule of Activities'. Text-layer PDF; marks verified by pdftotext -bbox column binning against the visual read (no disagreements). Right-hand Comments column converted to footnote annotations n1-n12 (synthesised markers). Abbreviation list not emitted (no term printed as a marker).",
    "model": "claude-opus-5-5"
  },
  "table_metadata": {
    "table_id": "table-001",
    "table_number": 1,
    "table_type": "main_soa",
    "table_title": "Study Schedule Protocol I8F-MC-GPGS",
    "table_purpose": "Main schedule: screening, Periods 1 and 2 (crossover periods sharing one day grid, >=35 days washout between Day 1 doses) and early discontinuation",
    "page_start": 10,
    "page_end": 11,
    "track_label": null,
    "column_count": 14,
    "row_count": 22,
    "header_row_count": 2,
    "activity_row_count": 20,
    "notes": "One printed table running over a page break; the page-11 header reprint is not a separate table. Periods 1 and 2 share one printed day grid, so they are not split into tracks. L=1 label column (Procedure); data columns 2-15; the Comments column (16) is not a schedule column."
  },
  "schedule_properties": [
    {
      "property_id": "prop-001",
      "table_id": "table-001",
      "row_position": 1,
      "property_name": "Epoch",
      "property_name_source": {
        "row_position": 1,
        "column_position": 1,
        "cell_value": "",
        "synthesized": true
      },
      "property_type": "epoch",
      "property_comment": "Top header band: 'Screening' over the first data column, 'Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses' merged across columns 3-14, and 'ED' (early discontinuation, footnote c) over column 15. These are study phases, hence epoch. Label cell is empty, so the name is synthesised.",
      "hierarchical_level": 1,
      "parent_property_id": null,
      "child_property_ids": [
        "prop-002"
      ],
      "annotation_markers": "",
      "linked_annotation_ids": []
    },
    {
      "property_id": "prop-002",
      "table_id": "table-001",
      "row_position": 2,
      "property_name": "Study Day",
      "property_name_source": {
        "row_position": 2,
        "column_position": 1,
        "cell_value": "Procedure",
        "synthesized": true
      },
      "property_type": "study_day",
      "property_comment": "Study-day labels per column (D-28 to D-2, D-1, D1 ... D21, D36 (±1)); the ED column has no study-day entry. Values are protocol days, hence study_day. The label cell carries 'Procedure', which is the heading of the activity-name column, not a name for this row, so the property name is synthesised.",
      "hierarchical_level": 2,
      "parent_property_id": "prop-001",
      "child_property_ids": [],
      "annotation_markers": "",
      "linked_annotation_ids": []
    }
  ],
  "schedule_columns": [
    {
      "column_id": "col-002",
      "table_id": "table-001",
      "column_position": 2,
      "is_label_column": false,
      "column_values": [
        {
          "property_id": "prop-001",
          "value": "Screening",
          "is_merged": false,
          "annotation_markers": ""
        },
        {
          "property_id": "prop-002",
          "value": "D-28 to D-2",
          "is_merged": false,
          "annotation_markers": ""
        }
      ],
      "composite_label": "Screening / D-28 to D-2",
      "linked_annotation_ids": []
    },
    {
      "column_id": "col-003",
      "table_id": "table-001",
      "column_position": 3,
      "is_label_column": false,
      "column_values": [
        {
          "property_id": "prop-001",
          "value": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses",
          "is_merged": true,
          "annotation_markers": ""
        },
        {
          "property_id": "prop-002",
          "value": "D-1",
          "is_merged": false,
          "annotation_markers": "b"
        }
      ],
      "composite_label": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses / D-1",
      "linked_annotation_ids": [
        "annot-002"
      ]
    },
    {
      "column_id": "col-004",
      "table_id": "table-001",
      "column_position": 4,
      "is_label_column": false,
      "column_values": [
        {
          "property_id": "prop-001",
          "value": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses",
          "is_merged": true,
          "annotation_markers": ""
        },
        {
          "property_id": "prop-002",
          "value": "D1",
          "is_merged": false,
          "annotation_markers": "b"
        }
      ],
      "composite_label": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses / D1",
      "linked_annotation_ids": [
        "annot-002"
      ]
    },
    {
      "column_id": "col-005",
      "table_id": "table-001",
      "column_position": 5,
      "is_label_column": false,
      "column_values": [
        {
          "property_id": "prop-001",
          "value": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses",
          "is_merged": true,
          "annotation_markers": ""
        },
        {
          "property_id": "prop-002",
          "value": "D2",
          "is_merged": false,
          "annotation_markers": ""
        }
      ],
      "composite_label": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses / D2",
      "linked_annotation_ids": []
    },
    {
      "column_id": "col-006",
      "table_id": "table-001",
      "column_position": 6,
      "is_label_column": false,
      "column_values": [
        {
          "property_id": "prop-001",
          "value": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses",
          "is_merged": true,
          "annotation_markers": ""
        },
        {
          "property_id": "prop-002",
          "value": "D3",
          "is_merged": false,
          "annotation_markers": ""
        }
      ],
      "composite_label": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses / D3",
      "linked_annotation_ids": []
    },
    {
      "column_id": "col-007",
      "table_id": "table-001",
      "column_position": 7,
      "is_label_column": false,
      "column_values": [
        {
          "property_id": "prop-001",
          "value": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses",
          "is_merged": true,
          "annotation_markers": ""
        },
        {
          "property_id": "prop-002",
          "value": "D4",
          "is_merged": false,
          "annotation_markers": ""
        }
      ],
      "composite_label": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses / D4",
      "linked_annotation_ids": []
    },
    {
      "column_id": "col-008",
      "table_id": "table-001",
      "column_position": 8,
      "is_label_column": false,
      "column_values": [
        {
          "property_id": "prop-001",
          "value": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses",
          "is_merged": true,
          "annotation_markers": ""
        },
        {
          "property_id": "prop-002",
          "value": "D5",
          "is_merged": false,
          "annotation_markers": ""
        }
      ],
      "composite_label": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses / D5",
      "linked_annotation_ids": []
    },
    {
      "column_id": "col-009",
      "table_id": "table-001",
      "column_position": 9,
      "is_label_column": false,
      "column_values": [
        {
          "property_id": "prop-001",
          "value": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses",
          "is_merged": true,
          "annotation_markers": ""
        },
        {
          "property_id": "prop-002",
          "value": "D6",
          "is_merged": false,
          "annotation_markers": ""
        }
      ],
      "composite_label": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses / D6",
      "linked_annotation_ids": []
    },
    {
      "column_id": "col-010",
      "table_id": "table-001",
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      "is_label_column": false,
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        {
          "property_id": "prop-001",
          "value": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses",
          "is_merged": true,
          "annotation_markers": ""
        },
        {
          "property_id": "prop-002",
          "value": "D7",
          "is_merged": false,
          "annotation_markers": ""
        }
      ],
      "composite_label": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses / D7",
      "linked_annotation_ids": []
    },
    {
      "column_id": "col-011",
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        {
          "property_id": "prop-001",
          "value": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses",
          "is_merged": true,
          "annotation_markers": ""
        },
        {
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          "is_merged": false,
          "annotation_markers": ""
        }
      ],
      "composite_label": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses / D8",
      "linked_annotation_ids": []
    },
    {
      "column_id": "col-012",
      "table_id": "table-001",
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        {
          "property_id": "prop-001",
          "value": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses",
          "is_merged": true,
          "annotation_markers": ""
        },
        {
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          "value": "D15",
          "is_merged": false,
          "annotation_markers": ""
        }
      ],
      "composite_label": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses / D15",
      "linked_annotation_ids": []
    },
    {
      "column_id": "col-013",
      "table_id": "table-001",
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        {
          "property_id": "prop-001",
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          "is_merged": true,
          "annotation_markers": ""
        },
        {
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          "is_merged": false,
          "annotation_markers": ""
        }
      ],
      "composite_label": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses / D21",
      "linked_annotation_ids": []
    },
    {
      "column_id": "col-014",
      "table_id": "table-001",
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      "is_label_column": false,
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        {
          "property_id": "prop-001",
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          "is_merged": true,
          "annotation_markers": ""
        },
        {
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          "is_merged": false,
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        }
      ],
      "composite_label": "Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses / D36 (±1)",
      "linked_annotation_ids": [
        "annot-002"
      ]
    },
    {
      "column_id": "col-015",
      "table_id": "table-001",
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        {
          "property_id": "prop-001",
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          "is_merged": false,
          "annotation_markers": "c"
        },
        {
          "property_id": "prop-002",
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          "is_merged": false,
          "annotation_markers": ""
        }
      ],
      "composite_label": "ED",
      "linked_annotation_ids": [
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      ]
    }
  ],
  "activities": [
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      "table_id": "table-001",
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      "activity_name": "Informed Consent",
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        "indentation_method": "assumed_flat"
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      "hierarchy_level": 0,
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    },
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        "indentation_method": "assumed_flat"
      },
      "hierarchy_level": 0,
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    },
    {
      "activity_id": "act-003",
      "table_id": "table-001",
      "row_position": 5,
      "activity_name": "Tirzepatide Dosing",
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      "linked_annotation_ids": [
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    },
    {
      "activity_id": "act-004",
      "table_id": "table-001",
      "row_position": 6,
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        "indentation_method": "assumed_flat"
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    },
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    },
    {
      "activity_id": "act-012",
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      "activity_id": "act-016",
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      "activity_name": "AEs/Concomitant Medications",
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      "activity_id": "act-017",
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      "activity_name": "Pharmacogenetic Sample",
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      "activity_id": "act-018",
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          "row_position": 14,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_id": "annot-009",
      "table_id": "table-001",
      "annotation_marker": "n6",
      "annotation_type": "footnote",
      "annotation_text": "See Appendix 2 for details. Day 1 predose sample is for baseline only.",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
          "act-013"
        ],
        "cell_references": []
      },
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 15,
          "method": "synthesized"
        }
      ],
      "document_references": [
        {
          "kind": "appendix",
          "target": "2"
        }
      ]
    },
    {
      "annotation_id": "annot-010",
      "table_id": "table-001",
      "annotation_marker": "n7",
      "annotation_type": "footnote",
      "annotation_text": "Female subjects only. Serum pregnancy test will be performed at screening and urine pregnancy tests at subsequent visits.",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
          "act-014"
        ],
        "cell_references": []
      },
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 16,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_id": "annot-011",
      "table_id": "table-001",
      "annotation_marker": "n8",
      "annotation_type": "footnote",
      "annotation_text": "Female subjects considered to be postmenopausal only. Women with confirmed nonchildbearing potential status can be exempted from further pregnancy tests during the study after screening.",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
          "act-015"
        ],
        "cell_references": []
      },
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 17,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_id": "annot-012",
      "table_id": "table-001",
      "annotation_marker": "n9",
      "annotation_type": "footnote",
      "annotation_text": "Single sample in Period 1 only.",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
          "act-017"
        ],
        "cell_references": []
      },
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 19,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_id": "annot-013",
      "table_id": "table-001",
      "annotation_marker": "n10",
      "annotation_type": "footnote",
      "annotation_text": "Where applicable, collection times should match with PK sampling time points. In the event of immediate or non-immediate drug hypersensitivity reactions, unscheduled samples will be collected as detailed in Section 9.4.6. Subjects with TE ADA at follow-up/ED will undergo additional follow-up as detailed in Section 9.7.",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
          "act-018"
        ],
        "cell_references": []
      },
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 20,
          "method": "synthesized"
        }
      ],
      "document_references": [
        {
          "kind": "section",
          "target": "9.4.6"
        },
        {
          "kind": "section",
          "target": "9.7"
        }
      ]
    },
    {
      "annotation_id": "annot-014",
      "table_id": "table-001",
      "annotation_marker": "n11",
      "annotation_type": "footnote",
      "annotation_text": "Performed using a bedside glucose monitor. Additional unscheduled measurements may be taken at the discretion of the investigator where clinically indicated.",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
          "act-019"
        ],
        "cell_references": []
      },
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 21,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_id": "annot-015",
      "table_id": "table-001",
      "annotation_marker": "n12",
      "annotation_type": "footnote",
      "annotation_text": "Up to a 10% deviation from the nominal collection time is permissible as long as actual sampling time is recorded.",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
          "act-020"
        ],
        "cell_references": []
      },
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 22,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_id": "annot-016",
      "table_id": "table-001",
      "annotation_marker": "g1",
      "annotation_type": "footnote",
      "annotation_text": "Note: All sampling times are given relative to dosing (Time 0 hour) with tirzepatide (predose or hours postdose). Unless otherwise indicated, predose procedure may be performed any time prior to dosing.",
      "annotation_scope": "table",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [],
        "cell_references": []
      },
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "schedule_property",
          "row_position": 1,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_id": "annot-017",
      "table_id": "table-001",
      "annotation_marker": "g2",
      "annotation_type": "footnote",
      "annotation_text": "If multiple procedures take place at the same time point, the following order of the procedures should be used: ECGs, vital signs, PK sample (record of actual PK sampling time is the priority), clinical laboratory sample, immunogenicity, blood glucose and pharmacogenetic sample.",
      "annotation_scope": "table",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [],
        "cell_references": []
      },
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "schedule_property",
          "row_position": 1,
          "method": "synthesized"
        }
      ]
    }
  ],
  "review_items": [
    {
      "id": "D1",
      "severity": "high",
      "location": {
        "page": 11,
        "annotation_marker": "g2"
      },
      "call_made": "The unmarked general note on the order of procedures at a shared time point is kept as one table-wide note, anchored to the top header row for traceability only.",
      "alternative": "Bind the note to the seven activities it names (Safety 12-lead ECG, Supine Vital Signs, PK Sampling, Clinical Laboratory Tests, Immunogenicity, Blood glucose monitoring, Pharmacogenetic Sample).",
      "report_section": "4"
    },
    {
      "id": "D2",
      "severity": "medium",
      "location": {
        "page": 10,
        "row_position": 2
      },
      "call_made": "The second header row is named 'Study Day' (synthesised); the printed 'Procedure' in its label cell is treated as the heading of the activity-name column.",
      "alternative": "Keep the printed text 'Procedure' as the property name of the study-day row.",
      "report_section": "3"
    },
    {
      "id": "D3",
      "severity": "medium",
      "location": {
        "page": 10,
        "row_position": 1,
        "column_position": 15
      },
      "call_made": "'ED' (early discontinuation) is recorded as a value of the Epoch header row over column 15, with an empty study-day cell below it.",
      "alternative": "Treat ED as a visit (unscheduled early-discontinuation visit) rather than an epoch value.",
      "report_section": "3"
    }
  ]
}