Contents |
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Purpose
Record baseline physical exam results.
Physical Exams - Screening eCRF
Field Name | Description / Instructions | Format |
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Visit Date^(m)^ | Enter the date the physical examination took place. | DD-MM-YYYY |
PE Done?(m) | Indicate whether the physical examination was performed: Note: not applicable for CTMS. | Use pick list. |
Date of Examination | Enter the date the physical examination took place. | DD-MM-YYYY |
Body System | Predefined Body System. It cannot be changed. | text |
Finding Results | Indicate whether the finding results for the particular body system were either: Note: Do not select "Normal" if the body system was not specifically assessed during the physical exam (i.e.: not mentioned in the progress note in the medical record).
| Use pick list. |
Comments | Give a brief description for all abnormal finding results. | 200 characters (128 reported) |
Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.
Validations
Code | Description | Resolutions |
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PE01 | Finding Results is marked abnormal and a comment is not specified. | Enter a comment or change the Finding Results selection. |
PE04 | Date of Examination is in the future. | Enter an earlier date. |
PE06 | CTMS study has Comment length is greater than 128. | CTMS study should have comment no longer than 128. |
PE07 | PE is done but the Date of Examination is not provided. | Enter the Date of Examination. |
Physical Exams - Screening eCRF (Vital Signs tab)
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 | |
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. | |
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. |
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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. | 4 digit and 2 decimals | |
Temperature | Enter the patient's temperature only in Celsius, to one decimal place. See Appendix 1 for conversion factors. | 8 digits and 3 decimals | |
Pulse | Enter the patient's pulse rate. | 8 digits and 3 decimals | |
Respiration Rate | Enter the patient's respiration rate. | 8 digits and 3 decimals | |
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 |
---|---|---|
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. |