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If measured more than once during a 12-hour period, the worst values (highest temperature, respiratory rate, and heart rate; lowest blood pressure, oxygen saturation, and consciousness level) during that period should be recorded on the eCRF. Following hospital discharge these parameters should be recorded once at each return visit to the clinic. Vital signs and oxygen saturation will not be recorded if follow-up visits are conducted by telephone.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-002", "act-004" ], "cell_references": [] }, "marker_locations": [ { "table_number": 2, "location_type": "activity_name", "row_position": 4 }, { "table_number": 2, "location_type": "activity_name", "row_position": 6 } ] }, { "annotation_id": "annot-004", "table_id": "table-002", "annotation_marker": "c", "annotation_type": "footnote", "annotation_text": "If arterial blood gases are measured.", "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": 5 } ] }, { "annotation_id": "annot-005", "table_id": "table-002", "annotation_marker": "d", "annotation_type": "footnote", "annotation_text": "Assessment of clinical status using the ordinal scale should be recorded at baseline on Day 1/Visit 1 then again daily every morning (between 8 am and 12 pm) for patients who remain hospitalized.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-005" ], "cell_references": [] }, "marker_locations": [ { "table_number": 2, "location_type": "activity_name", "row_position": 7 } ] }, { "annotation_id": "annot-006", "table_id": "table-002", "annotation_marker": "e", "annotation_type": "footnote", "annotation_text": "After informed consent has been obtained but prior to initiation of study drug, only serious adverse events caused by a protocol-mandated intervention should be reported. After initiation of study drug, all adverse events will be reported until 60 days after the final dose of study drug. After this period, the Sponsor should be notified if the investigator becomes aware of any serious adverse event that is believed to be related to prior study drug treatment (see Section 5.6).", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-006" ], "cell_references": [] }, "marker_locations": [ { "table_number": 2, "location_type": "activity_name", "row_position": 8 } ], "document_references": [ { "kind": "section", "target": "5.6" } ] }, { "annotation_id": "annot-007", "table_id": "table-002", "annotation_marker": "f", "annotation_type": "footnote", "annotation_text": "Medication (e.g., prescription drugs, over-the-counter drugs, vaccines, herbal or homeopathic remedies, nutritional supplements) used by a patient in addition to protocol-mandated treatment from 7 days prior to initiation of study drug to the study completion/discontinuation visit.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-007" ], "cell_references": [] }, "marker_locations": [ { "table_number": 2, "location_type": "activity_name", "row_position": 9 } ] }, { "annotation_id": "annot-008", "table_id": "table-002", "annotation_marker": "g", "annotation_type": "footnote", "annotation_text": "Hematology includes WBC count, RBC count, hemoglobin, hematocrit, platelet count, differential count (neutrophils, eosinophils, basophils, monocytes, lymphocytes), and lymphocyte subsets (T cells, B cells, and NK cells; if the test is available at the site).", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-008" ], "cell_references": [] }, "marker_locations": [ { "table_number": 2, "location_type": "activity_name", "row_position": 10 } ] }, { "annotation_id": "annot-009", "table_id": "table-002", "annotation_marker": "h", "annotation_type": "footnote", "annotation_text": "Chemistry panel (serum or plasma) includes bicarbonate or total carbon dioxide (if considered standard of care for the region), sodium, potassium, chloride, glucose, BUN or urea, creatinine, total protein, albumin, phosphorus, calcium, total bilirubin, ALP, ALT, and/or AST, uric acid, LDH, ferritin, and D-dimer.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-009" ], "cell_references": [] }, "marker_locations": [ { "table_number": 2, "location_type": "activity_name", "row_position": 11 } ] }, { "annotation_id": "annot-010", "table_id": "table-002", "annotation_marker": "i", "annotation_type": "footnote", "annotation_text": "Viral load will be assessed by nasopharyngeal swab. Patients who are intubated and undergo bronchoalveolar lavage will have samples taken for virological assessment. It may only be possible to access one nostril if a patient has a nasogastric tube in place, in which case sites may collect a sample from one nostril only and where possible the same nostril should be used.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-014" ], "cell_references": [] }, "marker_locations": [ { "table_number": 2, "location_type": "activity_name", "row_position": 16 } ] }, { "annotation_id": "annot-011", "table_id": "table-002", "annotation_marker": "j", "annotation_type": "footnote", "annotation_text": "For sites capable of sample collection for analysis of T cells by high-dimensional cytometry.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-016" ], "cell_references": [] }, "marker_locations": [ { "table_number": 2, "location_type": "activity_name", "row_position": 18 } ] }, { "annotation_id": "annot-012", "table_id": "table-002", "annotation_marker": "k", "annotation_type": "footnote", "annotation_text": "The first draw of blood should not be for PAXgene® tubes to avoid contact with RNA preservation reagent inside the tube.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-017" ], "cell_references": [] }, "marker_locations": [ { "table_number": 2, "location_type": "activity_name", "row_position": 19 } ] } ], "review_items": [ { "id": "D4", "severity": "medium", "location": { "page": 81 }, "call_made": "Appendix 2 (Days 3–28) and Appendix 3 (After Day 28) are each typed main_soa: sequential, independently structured schedules for the same participants, like separate Screening and Treatment tables.", "alternative": "Type Appendix 2 and/or Appendix 3 as track (same participants in a different study phase, own visit structure) with a short track_label such as 'Days 3–28' / 'After Day 28'.", "report_section": "5.1" }, { "id": "D5", "severity": "medium", "location": { "page": 81, "row_position": 1 }, "call_made": "The top header band ('Days 3–28' over the daily columns, 'Study Completion/Discontinuation' over the last column) is typed period with a synthesized name 'Period'.", "alternative": "Type the band as epoch (follow-up phase vs completion) or as visit (the last cell names a visit).", "report_section": "5.2" } ] }