{
  "schema_name": "soa-table-resolved",
  "schema_version": "1.2",
  "resolution_metadata": {
    "resolved_at": "2026-10-03T15:50:56.854056+00:00",
    "resolver": "soa2usdm.steps.resolve v1.0",
    "source_extraction": {
      "schema_name": "soa-table-extraction",
      "schema_version": "1.0",
      "extraction_file": "NCT03637764_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:font_signal: 29",
        "marker_location:synthesized: 19"
      ]
    },
    "resolution_status": "resolved",
    "ready_for_integration": true,
    "resolution_notes": ""
  },
  "extraction_metadata": {
    "extracted_at": "2026-09-27T12:37:02Z",
    "extractor": "Claude, PDF_TO_JSON_PROMPT single-pass",
    "prompt_version": "3.8.1",
    "source_document": {
      "filename": "NCT03637764_soa.pdf",
      "document_type": "protocol",
      "document_version": "Amended Clinical Trial Protocol 05, Version number: 1",
      "document_date": "23-Nov-2020"
    },
    "extraction_status": "ready_for_resolution",
    "extraction_notes": "Single SoA table printed over document pages 18-21 with the header reprinted on each page (de-duplicated). Text-layer PDF; marks verified by pdftotext -bbox column binning; merged spans resolved from raster rule lines (200 dpi) because spans are drawn cell borders. Grey-shaded cells carry no content and are not emitted. Right-hand Notes column converted to annotations. Label columns L=1 (Evaluation); first data column position 2; Notes column (position 12) excluded from the grid. Pages 22-24 (PK/immunogenicity and biomarker flow charts) lie outside the declared SoA range and were not extracted (see review item D1).",
    "model": "claude-opus-5-5"
  },
  "table_metadata": {
    "table_id": "table-001",
    "table_number": 1,
    "table_type": "main_soa",
    "table_title": "SCHEDULE OF ACTIVITIES (SOA)",
    "table_purpose": "Main study schedule: screening, treatment cycles, end of treatment and post-treatment follow-up",
    "page_start": 18,
    "page_end": 21,
    "track_label": null,
    "column_count": 10,
    "row_count": 32,
    "header_row_count": 3,
    "activity_row_count": 29,
    "notes": "Primary anchor grid; one printed table running over four pages under a reprinted header (not continuations). Cross-references PK/ADA and biomarker flow charts on pages 22-24 which are outside the declared SoA range; they are extracted as subsidiary Tables 02 ('Pharmacokinetics and Immunogenicity Flow Chart', pp.22-23) and 03 ('Exploratory Biomarker Flow Chart', p.24)."
  },
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      "table_id": "table-001",
      "row_position": 1,
      "property_name": "Study Phase",
      "property_name_source": {
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        "column_position": 1,
        "cell_value": "",
        "synthesized": true
      },
      "property_type": "epoch",
      "property_comment": "Top header band naming the study phases: Screening (up to 28 days before Day 1), Treatment Phase, End of Treatment (EOT), Post Treatment Follow-up Phase. Major study phases -> epoch. Label column is empty (the 'Evaluation' activity-column header spans all header rows), 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": "Cycle / Follow-up Period",
      "property_name_source": {
        "row_position": 2,
        "column_position": 1,
        "cell_value": "",
        "synthesized": true
      },
      "property_type": "period",
      "property_comment": "Second header band sub-dividing the phases: Cycle 1, Cycle 2 and Beyond (treatment cycles of 21 days per footnote a), Safety follow-up Period, Survival follow-up; empty under Screening and EOT. Mixes treatment cycles with follow-up sub-periods, so classified as period (sub-phases) rather than cycle. Name synthesised (label column empty).",
      "hierarchical_level": 2,
      "parent_property_id": "prop-001",
      "child_property_ids": [
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      ],
      "annotation_markers": "",
      "linked_annotation_ids": []
    },
    {
      "property_id": "prop-003",
      "table_id": "table-001",
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      "property_name": "Study Day / Visit Timing",
      "property_name_source": {
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        "column_position": 1,
        "cell_value": "",
        "synthesized": true
      },
      "property_type": "study_day",
      "property_comment": "Lowest header band giving the day of each column with its window: D-28 to D-15, D-14 to D-1, D1 (±1), D8 (± 1), D15 (±1), D1 (± 2), and relative follow-up days (30 (±7) days after last IMPs admin, At 60/At 90 (±7) days after last IMPs admin, Every 90 days (±7) after last safety follow-up). Protocol day values -> study_day. Name synthesised (label column empty).",
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      "child_property_ids": [],
      "annotation_markers": "",
      "linked_annotation_ids": []
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          "is_merged": true,
          "annotation_markers": ""
        },
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          "is_merged": true,
          "annotation_markers": ""
        },
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          "is_merged": false,
          "annotation_markers": ""
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    },
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      "is_label_column": false,
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          "annotation_markers": ""
        },
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          "value": "Screening (up to 28 days before Day 1)",
          "is_merged": true,
          "annotation_markers": ""
        },
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          "is_merged": false,
          "annotation_markers": ""
        }
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      "linked_annotation_ids": []
    },
    {
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          "value": "Treatment Phase",
          "is_merged": true,
          "annotation_markers": "a"
        },
        {
          "property_id": "prop-002",
          "value": "Cycle 1",
          "is_merged": true,
          "annotation_markers": ""
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          "is_merged": false,
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      ],
      "composite_label": "Treatment Phase / Cycle 1 / D1 (±1)",
      "linked_annotation_ids": [
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      ]
    },
    {
      "column_id": "col-005",
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          "is_merged": true,
          "annotation_markers": "a"
        },
        {
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          "annotation_markers": ""
        },
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          "is_merged": false,
          "annotation_markers": ""
        }
      ],
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      "linked_annotation_ids": [
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      ]
    },
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          "annotation_markers": "a"
        },
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          "annotation_markers": ""
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          "annotation_markers": ""
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      "linked_annotation_ids": [
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    },
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          "is_merged": true,
          "annotation_markers": "a"
        },
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          "annotation_markers": ""
        },
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          "is_merged": false,
          "annotation_markers": ""
        }
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      "linked_annotation_ids": [
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      ]
    },
    {
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      "is_label_column": false,
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          "is_merged": false,
          "annotation_markers": ""
        },
        {
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          "value": "",
          "is_merged": false,
          "annotation_markers": ""
        },
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      "linked_annotation_ids": []
    },
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          "annotation_markers": ""
        },
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    },
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          "annotation_markers": ""
        },
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        }
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      "table_id": "table-001",
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  ],
  "review_items": [
    {
      "id": "D1",
      "severity": "high",
      "location": {
        "page": 22
      },
      "call_made": "Only the Schedule of Activities table on document pages 18-21 (the declared SoA range) was extracted. The 'Pharmacokinetics and Immunogenicity Flow Chart' (pages 22-23) and the 'Exploratory Biomarker Flow Chart' (page 24), which the SoA's PK / ADA / Tumor Biopsy rows point to, were not extracted.",
      "alternative": "Extract the two flow charts as additional tables (Table 02 PK/immunogenicity, Table 03 biomarkers), each typed 'subsidiary' because they give finer timing for the PK, ADA and biomarker activities of Table 01.",
      "report_section": "3.1"
    },
    {
      "id": "D2",
      "severity": "medium",
      "location": {
        "page": 21,
        "row_positions": [
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        ]
      },
      "call_made": "The merged text 'See Pharmacokinetics and immunogenicity Flow Chart' (PK, ADA rows) and 'See Biomarker Flow Chart' (Tumor Biopsy/Archival Tissue/Biomarker row) is kept as a cell value distributed across every data column 2-11 (source_range 2:11). The printed cell also runs into the Notes column, which is not a data column.",
      "alternative": "Treat each of these as a cross-reference (source_note annotation on the activity) and leave the grid cells of these three rows empty.",
      "report_section": "3.3"
    },
    {
      "id": "D3",
      "severity": "medium",
      "location": {
        "page": 18,
        "row_position": 2
      },
      "call_made": "Header row 2 (Cycle 1 / Cycle 2 and Beyond / Safety follow-up Period / Survival follow-up) is typed 'period' because it mixes treatment cycles with follow-up sub-periods.",
      "alternative": "Type it 'cycle' (the treatment-phase entries are cycles) or 'other'.",
      "report_section": "3.5"
    },
    {
      "id": "D4",
      "severity": "medium",
      "location": {
        "page": 20,
        "row_positions": [
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          19,
          24,
          25,
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        ]
      },
      "call_made": "Blood Typing Interference Test, Serology and Urinalysis (top of page 20) are placed under 'Laboratory Assessments' (indentation 1) across the page break; the bold rows Isatuximab Administration and Atezolizumab Administration and all page-21 rows are top level (indentation 0), not children of 'Disease Assessment'.",
      "alternative": "Treat the page-20 lab rows as top-level, and/or treat the rows after the Disease Assessment block as children of 'Disease Assessment'.",
      "report_section": "3.5"
    },
    {
      "id": "D5",
      "severity": "high",
      "location": {
        "page": 20,
        "row_position": 24,
        "annotation_marker": "c"
      },
      "call_made": "Footnote c ('evaluation not applicable for Cohort E') is printed in the Notes cell beside Isatuximab Administration but is bound to every cell carrying a printed superscript c (the D8 and D15 marks of 8 rows, 16 cells), not to the Isatuximab row alone.",
      "alternative": "Also bind footnote c to the Isatuximab Administration row as a whole (because its definition sits in that row's Notes cell), or restrict it to the Isatuximab Administration cells only.",
      "report_section": "3.4"
    },
    {
      "id": "D6",
      "severity": "medium",
      "location": {
        "page": 20,
        "row_positions": [
          17,
          21,
          22,
          23
        ]
      },
      "call_made": "Qualified entries in the 'Cycle 2 and Beyond D1' column - 'Cycle 2 Day 1 only' (Blood Typing) and 'X (Weeks 9, 18, 27, and then every 12 weeks)' / 'X (Weeks 6, 12, 18, 24, and then every 9 weeks)' (imaging, tumour markers) - are kept literally in that single column because the qualifiers name timings that are not separate columns of the table.",
      "alternative": "Normalise these to a bare 'X' and move the timing qualifier into a synthesised footnote on the cell.",
      "report_section": "3.3"
    }
  ]
}