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Purpose
Record the patient's Vital Signs while on study. Please note that if Vital Signs are taken as a part of protocol specific Physical Exam, record those Vital Signs on the Physical Exam eCRF.
Note: This eCRF is mandatory for all CTEP sponsored CTMS monitored studies.
Vital Signs eCRF
Field Name | Description / Instructions | Format | |
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Visit Date | The Visit Date is optional on this case report form. Hit the "Tab" key to leave it empty and move to the Date of Vitals field. | DD-MMM-YYYY | |
Course #(d) | Indicates the course number the vital signs are related to based on their date and time. | 5 digits | |
Day in Course(d) | Indicates the day since the beginning of course the vital signs are related to based on their date and time. | 5 digits | |
Date of Vitals(m) | Enter the date the vital signs were taken. | DD-MMM-YYYY | |
Time | Enter the time the vital signs were taken. | HH(24):MM | |
Notes | If necessary, enter some brief notes. Note: This information is not sent to the reporting agency. | 200 characters | |
Performance Status (Karnofsky) | Select a value from the Karnofsky performance status scale. | Use pick list. |
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Status (Zubrod) | Select a value from the Zubrod/ECOG performance status scale. | Use pick list. | |
Performance Status (Lansky) | Select a value from the Lansky performance status scale. | Use pick list. | |
Body Weight(m) | Enter the patient's weight only in kilograms. Use decimal places only for patients under 10kg. See Appendix 1 for conversion factors. | 5 digits and 2 decimals | |
Height(m) | Enter the patient's height only in centimeters, to one decimal place. See Appendix 1 for conversion factors. | 5 digits and 2 decimals | |
BSA(m) | Enter the patient's body surface area in m2 (to two decimal places) if needed for the calculation of study medication dose level. A nomogram for children's and adult's body surface area calculation can be found in Appendix 1. | 5 digit and 3 decimals | |
Temperature | Enter the patient's temperature only in Celsius, to one decimal place. See Appendix 1 for conversion factors. | 3 digits and 1 decimal | |
Pulse | Enter the patient's pulse rate. | 3 digits | |
Respiration Rate | Enter the patient's respiration rate. | 3 digits | |
Systolic Blood Pressure | Enter the patient's systolic blood pressure. | 8 digits and 3 decimals | |
Diastolic Blood Pressure | Enter the patient's diastolic blood pressure. | 8 digits and 3 decimals | |
Pulse Oximetry | Enter the patient's pulse oximetry reading. | 3 digits and 2 decimals |
Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.
Validations
Code | Description | Resolutions |
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VIT01 | Systolic Blood Pressure is less than Diastolic Blood Pressure. | Systolic Blood Pressure must be greater than Diastolic Blood Pressure. |
VIT02 | Two Vital Signs entries have the same Date and Time. | Correct the date and/or time. |
VIT03 | Entered BSA is not within 10% accuracy of the calculated BSA using the MIS formula. | Correct the BSA. |
VIT04 | Entered BSA is not within 10% accuracy of the calculated BSA using the Mosteller formula. | Correct the BSA. |
VIT05 | Vitals Date is in the future. | Enter a date that is equal to or prior to the current date. |
VIT06, VIT07, | Height, Weight, BSA, Temperature, Pulse, Respiration Rate, Systolic and/or Diastolic Blood Pressure are/is less than zero. | Height, Weight, BSA, Temperature, Pulse, Respiration Rate, Systolic Blood Pressure and Diastolic Blood Pressure must be greater than zero. |
VIT14 | Pulse Oximetry is out of range. | Pulse Oximetry must be an integer number between 0 and 100. |
VIT15 | Vitals (on cycle sections) have Date of Vitals outside the range of the cycle start and stop date. | Enter an appropriate date. Note: this does not apply for all protocol. |
Derivations
Code | Field Name | Description |
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VIT1001 | Course # | Course number is derived based on the course initiation start dates and the vital signs date. |
VIT1002 | Day in Course | Number of days since the beginning of the course is derived from the course initiation start date and the vital signs date. |