Physical Examination & Vital Signs

*The timeline requirements for this form are as follows:
Assessment Time Frame: Within 45 days prior to the anticipated start of the conditioning regimen.
Submission Time Frame: Within 5 business days of collection.

Assessment Date:
Enter the date the assessment was completed. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.

Per protocol a medical history review and physical exam including vital signs is required within 45 days prior to the anticipated start of the conditioning regimen. If the assessment date entered is outside of those parameters a protocol deviation should be logged in the EDC.

If the date entered is a future date, a query will appear in the EDC.

Was complete history and physical performed:
Indicate if a complete history and physical exam were completed as “Yes” or “No”. Per protocol a medical history review and physical exam including vital signs is required within 45 days prior to the anticipated start of the conditioning regimen. If a physical examination and collection of vital signs was not completed a protocol deviation should be logged in the EDC.

Height:
Report the subject’s documented height in centimeters or inches. Enter height in “XXX.X” format. This format allows for up to three digits prior to the decimal and up to one digit after the decimal.

Per protocol a physical exam including vital signs is required within 45 days prior to the anticipated start of the conditioning regimen. If this field is marked as “Intentionally Left Blank” a protocol deviation should be logged in the EDC.

Weight:
Report the subject’s documented weight in kilograms or pounds. Enter weight in “XXX.X” format. This format allows for up to three digits prior to the decimal and up to one digit after the decimal.

Per protocol a physical exam including vital signs is required within 45 days prior to the anticipated start of the conditioning regimen. If this field is marked as “Intentionally Left Blank” a protocol deviation should be logged in the EDC.

Blood Pressure Collected?:
Indicate if blood pressure was collected at screening as “Yes” or “No”. Per protocol a physical exam including vital signs is required within 45 days prior to the anticipated start of the conditioning regimen. If collection of blood pressure was not completed a protocol deviation should be logged in the EDC.

Heart Rate Collected?:
Indicate if heart rate was collected at screening as “Yes” or “No”. Per protocol a physical exam including vital signs is required within 45 days prior to the anticipated start of the conditioning regimen. If collection of heart rate was not completed a protocol deviation should be logged in the EDC.

Respiratory Rate Collected?:
Indicate if respiratory rate was collected at screening as “Yes” or “No”. Per protocol a physical exam including vital signs is required within 45 days prior to the anticipated start of the conditioning regimen. If collection of respiratory rate was not completed a protocol deviation should be logged in the EDC.

Temperature Collected?:
Indicate if temperature was collected at screening as “Yes” or “No”. Per protocol a physical exam including vital signs is required within 45 days prior to the anticipated start of the conditioning regimen. If collection of temperature was not completed a protocol deviation should be logged in the EDC.

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