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Study phases -> epoch. The label column holds 'Study Procedure' merged across both header rows, so the property name is synthesized." }, { "hierarchical_level": 2, "property_name": "Study Day", "property_type": "study_day", "property_comment": "Study day per column: '(D-42 to -2)' for Screening (lower line of the rotated col-2 cell), -1, 1-18 for the Treatment Period, and '24 (± 2 days)' for FU/ED. Values are protocol study days (the band header reads 'Study Days') -> study_day; the ± 2 day window is kept inside the FU/ED cell value as printed. Name synthesized (label column empty for this row)." } ] } ], "match_stats": { "exact": 0, "fuzzy_auto": 0, "fuzzy_cross_parent": 0, "fuzzy_review": 0, "decision": 0, "new": 24 }, "review_stats": { "total": 0, "open": 0, "decided": 0, "near_matches": 0 }, "source_activity_count": 24, "unified_activity_count": 24, "compression_percent": 0, "annotation_stats": { "source_annotation_count": 9, "unified_annotation_count": 9, "deduplicated_count": 0, "deduplication_percent": 0, "by_type": { "footnote": 7, "legend": 2 } } }, "property_hierarchy": [ { "property_id": "prop-001", "property_type": "epoch", "property_name": "Epoch", "hierarchical_level": 1, "property_comment": "Top header band: 'Screening' (upper line of the rotated col-2 cell, which spans header rows 1-2), 'Treatment Period (Study Days)' merged across cols 3-21, and 'FU/ED' (follow-up / early discontinuation) in col 22. Study phases -> epoch. 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[remainder redacted in source]", "display_markers": "T1:d", "source_occurrences": [ { "table_num": 1, "marker": "d", "annotation_id": "annot-004" } ], "referenced_xacts": [ "xact-014" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-005", "annotation_type": "footnote", "annotation_text": "Complete physical examination at check-in, discharge from CRU, and follow-up. Additional symptom-driven physical examinations may be performed at the discretion of the investigator.", "display_markers": "T1:e", "source_occurrences": [ { "table_num": 1, "marker": "e", "annotation_id": "annot-005" } ], "referenced_xacts": [ "xact-018" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-006", "annotation_type": "footnote", "annotation_text": "Definition not printed in the source: the footnote block on document page 12 lists a, b, c and e as text, while the positions where footnote 'f' would print are covered by redaction boxes labelled 'CCI'. [remainder redacted in source]", "display_markers": "T1:f", "source_occurrences": [ { "table_num": 1, "marker": "f", "annotation_id": "annot-006" } ], "referenced_xacts": [ "xact-020" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-020", "xcol_id": "xcol-008" } ], "occurrence_count": 1 }, { "xannot_id": "xannot-007", "annotation_type": "footnote", "annotation_text": "Definition not printed in the source: the footnote block on document page 12 lists a, b, c and e as text, while the positions where footnote 'g' would print are covered by redaction boxes labelled 'CCI'. [remainder redacted in source]", "display_markers": "T1:g", "source_occurrences": [ { "table_num": 1, "marker": "g", "annotation_id": "annot-007" } ], "referenced_xacts": [ "xact-020" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-008", "annotation_type": "legend", "annotation_text": "P = predose", "display_markers": "T1:P", "source_occurrences": [ { "table_num": 1, "marker": "P", "annotation_id": "annot-008" } ], "referenced_xacts": [ "xact-014", "xact-016", "xact-017", "xact-020" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-014", "xcol_id": "xcol-003" }, { "xact_id": "xact-014", "xcol_id": "xcol-008" }, { "xact_id": "xact-014", "xcol_id": "xcol-015" }, { "xact_id": "xact-016", "xcol_id": "xcol-003" }, { "xact_id": "xact-016", "xcol_id": "xcol-008" }, { "xact_id": "xact-016", "xcol_id": "xcol-015" }, { "xact_id": "xact-017", "xcol_id": "xcol-003" }, { "xact_id": "xact-017", "xcol_id": "xcol-008" }, { "xact_id": "xact-017", "xcol_id": "xcol-015" }, { "xact_id": "xact-020", "xcol_id": "xcol-003" }, { "xact_id": "xact-020", "xcol_id": "xcol-008" }, { "xact_id": "xact-020", "xcol_id": "xcol-015" } ], "occurrence_count": 1 }, { "xannot_id": "xannot-009", "annotation_type": "legend", "annotation_text": "h = hours postdose", "display_markers": "T1:h", "source_occurrences": [ { "table_num": 1, "marker": "h", "annotation_id": "annot-009" } ], "referenced_xacts": [ "xact-014", "xact-020" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-014", "xcol_id": "xcol-003" }, { "xact_id": "xact-014", "xcol_id": "xcol-004" }, { "xact_id": "xact-014", "xcol_id": "xcol-008" }, { "xact_id": "xact-014", "xcol_id": "xcol-009" }, { "xact_id": "xact-014", "xcol_id": "xcol-015" }, { "xact_id": "xact-014", "xcol_id": "xcol-016" }, { "xact_id": "xact-020", "xcol_id": "xcol-003" }, { "xact_id": "xact-020", "xcol_id": "xcol-004" }, { "xact_id": "xact-020", "xcol_id": "xcol-005" }, { "xact_id": "xact-020", "xcol_id": "xcol-006" }, { "xact_id": "xact-020", "xcol_id": "xcol-007" }, { "xact_id": "xact-020", "xcol_id": "xcol-008" }, { "xact_id": "xact-020", "xcol_id": "xcol-009" }, { "xact_id": "xact-020", "xcol_id": "xcol-010" }, { "xact_id": "xact-020", "xcol_id": "xcol-011" }, { "xact_id": "xact-020", "xcol_id": "xcol-012" }, { "xact_id": "xact-020", "xcol_id": "xcol-013" }, { "xact_id": "xact-020", "xcol_id": "xcol-015" }, { "xact_id": "xact-020", "xcol_id": "xcol-016" }, { "xact_id": "xact-020", "xcol_id": "xcol-017" }, { "xact_id": "xact-020", "xcol_id": "xcol-018" }, { "xact_id": "xact-020", "xcol_id": "xcol-019" }, { "xact_id": "xact-020", "xcol_id": "xcol-020" } ], "occurrence_count": 1 } ], "review_items": [ { "table_number": 1, "id": "D1", "severity": "high", "location": { "page": 11, "row_positions": [ 21, 22, 23 ] }, "call_made": "Two full-width black redaction bars labelled 'CCI' on page 11 (one between 'Genetic blood sample for screening' and 'Rosuvastatin PK samples', one between 'Rosuvastatin PK samples' and 'Adverse event review') are treated as hiding content, and no activity rows are created for them.", "alternative": "Each bar hides one (or more) activity row with its own marks; add placeholder activity rows (e.g. '[redacted row]') so the redacted procedures are represented in the schedule.", "report_section": "4" }, { "table_number": 1, "id": "D2", "severity": "medium", "location": { "page": 11, "row_position": 21 }, "call_made": "The label is transcribed as 'Genetic blood sample for screening' - the three visible lines of the cell, the last line partly clipped by the redaction bar below it.", "alternative": "Part of the label is hidden under the redaction bar (the text layer places the bar's 'CCI' label between 'for' and 'screening'); record the name as incomplete, e.g. 'Genetic blood sample for [redacted] screening'.", "report_section": "4" }, { "table_number": 1, "id": "D3", "severity": "low", "location": { "page": 10, "row_positions": [ 1, 2 ], "column_position": 2 }, "call_made": "The single rotated Screening header cell, which spans both header rows, is split by its two printed lines: 'Screening' goes on the epoch row and '(D-42 to -2)' on the study-day row.", "alternative": "Keep the whole cell text 'Screening (D-42 to -2)' as one value on the epoch row and leave the study-day row empty for the Screening column.", "report_section": "3" } ] }