{
  "schema_name": "soa-table-resolved",
  "schema_version": "1.2",
  "resolution_metadata": {
    "resolved_at": "2026-10-03T15:51:00.430975+00:00",
    "resolver": "soa2usdm.steps.resolve v1.0",
    "source_extraction": {
      "schema_name": "soa-table-extraction",
      "schema_version": "1.0",
      "extraction_file": "NCT04557384_Table_02_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": [
        "activity_name:visual_transcription: 3",
        "annotation_text:visual_transcription: 4",
        "grid_cell:visual_read: 4",
        "indentation_level:assumed_flat: 3",
        "marker_location:synthesized: 3",
        "schedule_cell:raster_pixel_detection: 3"
      ]
    },
    "resolution_status": "resolved",
    "ready_for_integration": true,
    "resolution_notes": ""
  },
  "extraction_metadata": {
    "extracted_at": "2026-09-27T08:45:27Z",
    "extractor": "Claude, PDF_TO_JSON_PROMPT single-pass",
    "prompt_version": "3.8.1",
    "source_document": {
      "filename": "NCT04557384_soa.pdf",
      "document_type": "protocol",
      "document_version": "Protocol I4T-MC-JVDU(e)"
    },
    "extraction_status": "ready_for_resolution",
    "extraction_notes": "Image-only source PDF; text visually transcribed; cell geometry and marks from raster detection, validated visually.",
    "model": "claude-opus-5-5"
  },
  "table_metadata": {
    "table_id": "table-002",
    "table_number": 2,
    "table_type": "track",
    "table_title": "Continued Access Schedule of Activities",
    "table_purpose": "Schedule for participants in the continued-access period",
    "page_start": 23,
    "page_end": 23,
    "track_label": "Continued Access",
    "column_count": 2,
    "row_count": 7,
    "header_row_count": 2,
    "activity_row_count": 3,
    "notes": "track: genuinely separate phase/timeline (continued access after the main study) with its own visit numbering 501-5XX and 901, not the columns of Table 1. L=1 label column; data columns 2-3; right-hand Instructions column (col 4) captured as annotations i1-i3. Row 1 = title band, row 4 = 'Procedure' grey band (not an activity)."
  },
  "schedule_properties": [
    {
      "property_id": "prop-001",
      "table_id": "table-002",
      "row_position": 2,
      "property_name": "Epoch",
      "property_name_source": {
        "row_position": 2,
        "column_position": 1,
        "cell_value": "",
        "synthesized": true
      },
      "property_type": "epoch",
      "property_comment": "Phase labels 'Study Treatment' (col 2) and 'Follow-Up' with footnote a (col 3) of the continued-access period -> epoch. Label cell of rows 2-3 is one merged cell whose text 'Visit' sits on row 3; this row's 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-002",
      "row_position": 3,
      "property_name": "Visit",
      "property_name_source": {
        "row_position": 3,
        "column_position": 1,
        "cell_value": "Visit"
      },
      "property_type": "visit",
      "property_comment": "Visit numbers '501-5XX' (col 2, repeating study-treatment visits) and '901' (col 3, follow-up visit) -> visit. Name taken from the printed label 'Visit'.",
      "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-002",
      "column_position": 2,
      "is_label_column": false,
      "column_values": [
        {
          "property_id": "prop-001",
          "value": "Study Treatment",
          "is_merged": false,
          "annotation_markers": ""
        },
        {
          "property_id": "prop-002",
          "value": "501-5XX",
          "is_merged": false,
          "annotation_markers": ""
        }
      ],
      "composite_label": "Study Treatment / 501-5XX",
      "linked_annotation_ids": []
    },
    {
      "column_id": "col-003",
      "table_id": "table-002",
      "column_position": 3,
      "is_label_column": false,
      "column_values": [
        {
          "property_id": "prop-001",
          "value": "Follow-Up",
          "is_merged": false,
          "annotation_markers": "a"
        },
        {
          "property_id": "prop-002",
          "value": "901",
          "is_merged": false,
          "annotation_markers": ""
        }
      ],
      "composite_label": "Follow-Up / 901",
      "linked_annotation_ids": [
        "annot-001"
      ]
    }
  ],
  "activities": [
    {
      "activity_id": "act-001",
      "table_id": "table-002",
      "row_position": 5,
      "activity_name": "AE Collection",
      "activity_name_source": {
        "cell_text": "AE Collection",
        "indentation_level": 0,
        "method": "visual_transcription",
        "indentation_method": "assumed_flat"
      },
      "hierarchy_level": 0,
      "is_section_header": false,
      "parent_activity_id": null,
      "child_activity_ids": [],
      "has_schedule_data": true,
      "annotation_markers": "i1",
      "linked_annotation_ids": [
        "annot-002"
      ]
    },
    {
      "activity_id": "act-002",
      "table_id": "table-002",
      "row_position": 6,
      "activity_name": "PK, IG, and exploratory hypersensitivity",
      "activity_name_source": {
        "cell_text": "PK, IG, and exploratory hypersensitivity",
        "indentation_level": 0,
        "method": "visual_transcription",
        "indentation_method": "assumed_flat"
      },
      "hierarchy_level": 0,
      "is_section_header": false,
      "parent_activity_id": null,
      "child_activity_ids": [],
      "has_schedule_data": false,
      "annotation_markers": "i2",
      "linked_annotation_ids": [
        "annot-003"
      ]
    },
    {
      "activity_id": "act-003",
      "table_id": "table-002",
      "row_position": 7,
      "activity_name": "Administer ramucirumab",
      "activity_name_source": {
        "cell_text": "Administer ramucirumab",
        "indentation_level": 0,
        "method": "visual_transcription",
        "indentation_method": "assumed_flat"
      },
      "hierarchy_level": 0,
      "is_section_header": false,
      "parent_activity_id": null,
      "child_activity_ids": [],
      "has_schedule_data": true,
      "annotation_markers": "i3",
      "linked_annotation_ids": [
        "annot-004"
      ]
    }
  ],
  "activity_schedule": [
    {
      "activity_id": "act-001",
      "column_id": "col-002",
      "row_position": 5,
      "column_position": 2,
      "cell_value": "X",
      "cell_value_type": "marker",
      "source_range": "",
      "annotation_markers": "",
      "linked_annotation_ids": []
    },
    {
      "activity_id": "act-001",
      "column_id": "col-003",
      "row_position": 5,
      "column_position": 3,
      "cell_value": "X",
      "cell_value_type": "marker",
      "source_range": "",
      "annotation_markers": "",
      "linked_annotation_ids": []
    },
    {
      "activity_id": "act-003",
      "column_id": "col-002",
      "row_position": 7,
      "column_position": 2,
      "cell_value": "X",
      "cell_value_type": "marker",
      "source_range": "",
      "annotation_markers": "",
      "linked_annotation_ids": []
    }
  ],
  "annotations": [
    {
      "annotation_id": "annot-001",
      "table_id": "table-002",
      "annotation_marker": "a",
      "annotation_type": "footnote",
      "annotation_text": "Continued-access follow-up begins when the participant and the investigator agree that the participant will no longer continue treatment in the continued-access period and lasts a minimum of 30 days following the last dose of study drug. In all cases, no follow-up procedures will be performed for a participant who withdraws informed consent unless he or she has explicitly provided permission and consent.",
      "annotation_scope": "column",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [
          "col-003"
        ],
        "activity_ids": [],
        "cell_references": []
      },
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 2,
          "column_position": 3
        }
      ]
    },
    {
      "annotation_id": "annot-002",
      "table_id": "table-002",
      "annotation_marker": "i1",
      "annotation_type": "footnote",
      "annotation_text": "Grading via CTCAE, Version 5.0. As part of AE collection, monitor vital signs and perform standard laboratory tests (hematology, chemistry, urinalysis, and pregnancy testing) at the same frequency as during the study treatment period. See Section 10.3 for AE grading for lab investigations. All laboratory tests during the continued access period will be performed in the local laboratories only.",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
          "act-001"
        ],
        "cell_references": []
      },
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 5,
          "method": "synthesized"
        }
      ],
      "document_references": [
        {
          "kind": "section",
          "target": "10.3"
        }
      ]
    },
    {
      "annotation_id": "annot-003",
      "table_id": "table-002",
      "annotation_marker": "i2",
      "annotation_type": "footnote",
      "annotation_text": "In the event of hypersensitivity, blood samples will be collected for PK, IG, and exploratory hypersensitivity analyses at the following time points, as close as possible to: (i) the onset of the hypersensitivity, (ii) the resolution of the hypersensitivity, and (iii) 30 (±3) days following the hypersensitivity.",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
          "act-002"
        ],
        "cell_references": []
      },
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 6,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_id": "annot-004",
      "table_id": "table-002",
      "annotation_marker": "i3",
      "annotation_type": "footnote",
      "annotation_text": "See Section 6.1. Participants must be closely monitored for a 1-hour observation period following the ramucirumab injection (see Section 6.1).",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
          "act-003"
        ],
        "cell_references": []
      },
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 7,
          "method": "synthesized"
        }
      ],
      "document_references": [
        {
          "kind": "section",
          "target": "6.1"
        }
      ]
    }
  ],
  "review_items": [
    {
      "id": "D8",
      "severity": "medium",
      "location": {
        "page": 23
      },
      "call_made": "Typed 'track' (track_label 'Continued Access'): a separate schedule for participants who continue study treatment in the continued-access period after the main study, with its own visit numbering (501-5XX, 901).",
      "alternative": "Type it 'main_soa' (an independent schedule table) rather than a separate timeline track.",
      "report_section": "4.1"
    }
  ]
}