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Samples may be sent to central or local laboratory based on the type of test. A local laboratory must be qualified by local regulations.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-043" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 48, "method": "synthesized" } ] }, { "annotation_id": "annot-023", "table_id": "table-001", "annotation_marker": "c20", "annotation_type": "footnote", "annotation_text": "HCV RNA will be measured to confirm positive hepatitis C virus antibody.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-045" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 50, "method": "synthesized" } ] }, { "annotation_id": "annot-024", "table_id": "table-001", "annotation_marker": "c21", "annotation_type": "footnote", "annotation_text": "Includes testing for HBsAg and anti-HBc.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-046" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 51, "method": "synthesized" } ] }, { "annotation_id": "annot-025", "table_id": "table-001", "annotation_marker": "c22", "annotation_type": "footnote", "annotation_text": "Only for participants who are positive for anti-HBc at screening.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-047" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 52, "method": "synthesized" } ] }, { "annotation_id": "annot-026", "table_id": "table-001", "annotation_marker": "c23", "annotation_type": "footnote", "annotation_text": "Collect samples before dosing, if dosing is scheduled. Collect additional samples at specified times relative to onset of hypersensitivity events.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-048", "act-049" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 53, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 54, "method": "synthesized" } ] }, { "annotation_id": "annot-027", "table_id": "table-001", "annotation_marker": "c24", "annotation_type": "footnote", "annotation_text": "Blood sample for DNA pharmacogenetics can be obtained any time at or after V2.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-051" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 56, "method": "synthesized" } ] }, { "annotation_id": "annot-028", "table_id": "table-001", "annotation_marker": "c25", "annotation_type": "footnote", "annotation_text": "Screening endoscopy must occur ≤14 days prior to randomization. At screening, perform only for participants who are eligible for the study by all other study entry criteria.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-054" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 59, "method": "synthesized" } ] }, { "annotation_id": "annot-029", "table_id": "table-001", "annotation_marker": "c26", "annotation_type": "footnote", "annotation_text": "Performed at time of endoscopy. Instructions for collection are provided in the lab manual. Flexible sigmoidoscopy is recommended, except for protocol-specified reasons when a colonoscopy should be performed.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-055" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 60, "method": "synthesized" } ] }, { "annotation_id": "annot-030", "table_id": "table-001", "annotation_marker": "c27", "annotation_type": "footnote", "annotation_text": "Additional local stool testing (for example, for ova and parasites) is allowed at the investigator’s discretion.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-057" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 62, "method": "synthesized" } ] }, { "annotation_id": "annot-031", "table_id": "table-001", "annotation_marker": "c28", "annotation_type": "footnote", "annotation_text": "Additional C. difficile testing is allowed throughout the study at the investigator’s discretion.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-058" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 63, "method": "synthesized" } ] }, { "annotation_id": "annot-032", "table_id": "table-001", "annotation_marker": "c29", "annotation_type": "footnote", "annotation_text": "No dosing at V3.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-063" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 68, "method": "synthesized" } ] } ], "review_items": [ { "id": "D1", "severity": "high", "location": { "page": 17, "row_position": 5 }, "call_made": "The shaded 'Fasting visit' band (X at V2 and V9, reprinted on every page) is recorded as a header schedule_property, not as an activity row; the same treatment is applied in Tables 2-4.", "alternative": "Record 'Fasting visit' as a level-0 activity row carrying X marks at the fasting visits.", "report_section": "T1.3" }, { "id": "D2", "severity": "high", "location": { "page": 17, "row_position": 1, "annotation_marker": "t1" }, "call_made": "The title-cell instruction 'V1 and V9 procedures may be conducted over more than 1 day…' is bound to the V1 and V9 cells of the Visit number row (by the visits it names).", "alternative": "Treat it as a table-wide note bound to the Visit number property row as a whole.", "report_section": "T1.5" }, { "id": "D3", "severity": "low", "location": { "page": 17, "row_positions": [ 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 ] }, "call_made": "Rows printed above the first section header (Informed consent … Alcohol and caffeine use) are recorded at indentation level 0 as stand-alone activities with marks; the same convention is used for the ungrouped top rows of Tables 2-4.", "alternative": "Record them at level 1 as children of an implicit, unnamed general group.", "report_section": "T1.4" } ] }