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Use of Safety Monitoring Flow Sheets. Background. Flow sheets can serve as useful tools Not required but recommended Tailor for ease of use AND usefulness at your site When tailoring, consider staff roles and responsibilities AND other documentation requirements at your site. Flow Sheets. - PowerPoint PPT Presentation
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Background
Flow sheets can serve as useful tools Not required but recommended Tailor for ease of use AND usefulness at
your site When tailoring, consider staff roles and
responsibilities AND other documentation requirements at your site
Flow Sheets
Height and weight Vital signs Hematology Liver function: ALT and AST Renal function: phosphate and creatinine
Common Elements
Title Brief instructions/guidance Date and visit code Values being monitored
Shading indicates “not applicable”
Staff Initials
General Instructions for Use
Initiate use during screening File for “easy access” in participant study
notebook Update at or after each visit Continually review as part of ongoing safety
monitoring Initial and date to document reviews
Height
Because the protocol requires repeat measurement if a decrease of 3.8 cm or more is identified
Record NA if a second measurement is not required and therefore is not done
Severity grading is not required
Weight
Because the severity of unintentional weight loss must be graded in terms of percent decrease
01 JAN 2010 07 JAN 2010 15 APR 2010
6.0 (M3)
50 50 45
5
10%
50 – 45 = 5
5 ÷ 50 = 0.10 = 10%
Vital Signs Fever (oral temp), hypertension, and hypotension must
be graded For hypertension, grading requires repeat blood pressure
measurement at the same visit
Hematology
Hemoglobin, platelets, white blood cells, neutrophils, and lymphocytes must be graded
Hemoglobin is graded based on absolute values and difference from Screening Part 1
Neutrophils and lymphocytes are graded based on absolute counts
Although not recorded on flow sheet, abnormal differential counts should also be monitored for clinical significance
All results should be graded Grading is based on the site upper limit of
normal (record at top of flow sheet for ease of reference)
ALT and AST
Phosphate All results should be graded Grading is based on the site lower limit of normal
(record at top of flow sheet for ease of reference)
Creatinine
Absolute levels must be graded (based on site upper limit of normal)
Increases from baseline must be calculated to determine whether product hold is required
Creatinine clearance rate must be calculated to determine whether product hold is required
Creatinine: Relative Increase From Baseline
01 JAN 2010 15 APR 2010
6.0 (M3)
0.8 mg/dL 0.9 mg/dL
1.1
1.5 mg/dL
0.8 mg/dL
0 0
99 mL/min 87 mL/min
0.9 ÷ 0.8 = 1.1
Participant is a 23 year old, 57 kg woman, oral study product