{
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    "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"
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    "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"
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  "table_metadata": {
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    "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,
    "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": [
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      "property_name": "Epoch",
      "property_name_source": {
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        "column_position": 1,
        "cell_value": "",
        "synthesized": true
      },
      "property_type": "epoch",
      "hierarchical_level": 1,
      "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."
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      "row_position": 2,
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      "property_name_source": {
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        "column_position": 1,
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      },
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      "hierarchical_level": 2,
      "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."
    }
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      "column_position": 10,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 19,
      "column_position": 11,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 19,
      "column_position": 12,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 19,
      "column_position": 13,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 19,
      "column_position": 14,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 19,
      "column_position": 15,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 20,
      "column_position": 2,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 20,
      "column_position": 3,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 20,
      "column_position": 4,
      "cell_value": "Predose"
    },
    {
      "table_number": 1,
      "row_position": 20,
      "column_position": 5,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 20,
      "column_position": 6,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 20,
      "column_position": 7,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 20,
      "column_position": 8,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 20,
      "column_position": 9,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 20,
      "column_position": 10,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 20,
      "column_position": 11,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 20,
      "column_position": 12,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 20,
      "column_position": 13,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 20,
      "column_position": 14,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 20,
      "column_position": 15,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 21,
      "column_position": 2,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 21,
      "column_position": 3,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 21,
      "column_position": 4,
      "cell_value": "Predose, 12"
    },
    {
      "table_number": 1,
      "row_position": 21,
      "column_position": 5,
      "cell_value": "24, 36"
    },
    {
      "table_number": 1,
      "row_position": 21,
      "column_position": 6,
      "cell_value": "48"
    },
    {
      "table_number": 1,
      "row_position": 21,
      "column_position": 7,
      "cell_value": "72"
    },
    {
      "table_number": 1,
      "row_position": 21,
      "column_position": 8,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 21,
      "column_position": 9,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 21,
      "column_position": 10,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 21,
      "column_position": 11,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 21,
      "column_position": 12,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 21,
      "column_position": 13,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 21,
      "column_position": 14,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 21,
      "column_position": 15,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 22,
      "column_position": 2,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 22,
      "column_position": 3,
      "cell_value": ""
    },
    {
      "table_number": 1,
      "row_position": 22,
      "column_position": 4,
      "cell_value": "Predose, 8, 12"
    },
    {
      "table_number": 1,
      "row_position": 22,
      "column_position": 5,
      "cell_value": "24, 36"
    },
    {
      "table_number": 1,
      "row_position": 22,
      "column_position": 6,
      "cell_value": "48"
    },
    {
      "table_number": 1,
      "row_position": 22,
      "column_position": 7,
      "cell_value": "72"
    },
    {
      "table_number": 1,
      "row_position": 22,
      "column_position": 8,
      "cell_value": "96"
    },
    {
      "table_number": 1,
      "row_position": 22,
      "column_position": 9,
      "cell_value": "120"
    },
    {
      "table_number": 1,
      "row_position": 22,
      "column_position": 10,
      "cell_value": "144"
    },
    {
      "table_number": 1,
      "row_position": 22,
      "column_position": 11,
      "cell_value": "168"
    },
    {
      "table_number": 1,
      "row_position": 22,
      "column_position": 12,
      "cell_value": "336"
    },
    {
      "table_number": 1,
      "row_position": 22,
      "column_position": 13,
      "cell_value": "480"
    },
    {
      "table_number": 1,
      "row_position": 22,
      "column_position": 14,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 22,
      "column_position": 15,
      "cell_value": "X"
    }
  ],
  "annotations": [
    {
      "annotation_marker": "a",
      "annotation_type": "footnote",
      "annotation_text": "Specified times are approximate, and actual times will be recorded. Actual sampling time should not exceed 1 hour prior to dosing for the predose sample.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 13
        },
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 19
        },
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 20
        },
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 21
        },
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 22
        }
      ]
    },
    {
      "annotation_marker": "b",
      "annotation_type": "footnote",
      "annotation_text": "Period 2, Day -1 procedures (pregnancy tests) and some Period 2, Predose procedures (physical examinations, medical assessments, and clinical laboratory assessments) may be omitted if Period 1, D36 (±1) procedure dates occur within 4 days of Period 2 dosing. Period 2, Day 36 (±1) will also be considered as the final follow-up visit.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "schedule_cell",
          "row_position": 2,
          "column_position": 3
        },
        {
          "table_number": 1,
          "location_type": "schedule_cell",
          "row_position": 2,
          "column_position": 4
        },
        {
          "table_number": 1,
          "location_type": "schedule_cell",
          "row_position": 2,
          "column_position": 14
        }
      ]
    },
    {
      "annotation_marker": "c",
      "annotation_type": "footnote",
      "annotation_text": "Within 7 to 14 days upon confirmation of early discontinuation.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "schedule_cell",
          "row_position": 1,
          "column_position": 15
        }
      ]
    },
    {
      "annotation_marker": "n1",
      "annotation_type": "footnote",
      "annotation_text": "Study drug will be administered after an overnight fast of at least 8 hours.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 5,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n2",
      "annotation_type": "footnote",
      "annotation_text": "Subjects’ CRU stay may be extended at the investigator’s discretion for safety monitoring.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 6,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n3",
      "annotation_type": "footnote",
      "annotation_text": "Physical examination at screening. Thereafter, targeted reviews and medical assessments as appropriate.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 9,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n4",
      "annotation_type": "footnote",
      "annotation_text": "Single safety ECG will be collected. ECGs must be recorded before collecting any blood samples at each timepoint. Subjects must be supine for approximately 5 to 10 minutes before ECG collection, and remain supine but awake during ECG collection.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 13,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n5",
      "annotation_type": "footnote",
      "annotation_text": "Additional time points may be added, if warranted and agreed upon between Lilly and the investigator.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 14,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n6",
      "annotation_type": "footnote",
      "annotation_text": "See Appendix 2 for details. Day 1 predose sample is for baseline only.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 15,
          "method": "synthesized"
        }
      ]
    },
    {
      "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.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 16,
          "method": "synthesized"
        }
      ]
    },
    {
      "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.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 17,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n9",
      "annotation_type": "footnote",
      "annotation_text": "Single sample in Period 1 only.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 19,
          "method": "synthesized"
        }
      ]
    },
    {
      "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.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 20,
          "method": "synthesized"
        }
      ]
    },
    {
      "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.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 21,
          "method": "synthesized"
        }
      ]
    },
    {
      "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.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 22,
          "method": "synthesized"
        }
      ]
    },
    {
      "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.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "schedule_property",
          "row_position": 1,
          "method": "synthesized"
        }
      ]
    },
    {
      "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.",
      "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"
    }
  ]
}