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

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

Why are there two rows to record height on each date?

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

Why is percentage difference from Screening Part 2 needed?

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

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

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

Questions? Comments? Concerns?

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