Neurological Assessment Screenshot.PNG
Contents |
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Purpose
This CRF will record physical exam results during treatment. It will also record the vital signs data and neurological exam data obtained at time of the physical exam. Note: Some BTTC protocols will not require specific physical exam data to be captured.
Physical Exams - Courses eCRF
Field Name | Description / Instructions | Format |
---|---|---|
Visit Date(m) | Enter the date the physical examination took place. | DD-MM-YYYY |
PE Done?(m) | Indicate whether the physical examination was performed:
| Use pick list. |
Date of Examination | Enter the date the physical examination took place. | DD-MM-YYYY |
Day in Course(d) | Number of days since the beginning of the course is derived from the course initiation start date and examination date. | 5 digits |
Change from Baseline? | Indicate whether the finding results were changed compared with that of baseline:
| Use pick list. |
Change from Previous Evaluation? | Indicate whether the finding results were changed compared with that of previous evaluation:
| Use pick list. |
Course#(d) | Indicates the course number that this physical exam was performed as derived from the course initiation start date. | 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.
| 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. |
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 (C) | Enter the patient's temperature only in Celsius, to one decimal place. | 4 digits and 1 decimals |
Temperature (F) | Enter the patient's temperature only in Fahrenheit , to one decimal place. | 3 digits and 1 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 |
Data Collected | To indicate whether the data was collected for this assessment and time-point | Use pick list. |
Reason if No | If necessary, enter text reason that data is not collected for an identified assessment at this assessment and time point . | 200 characters |
Evaluation Date(m) | Enter the date the vital signs were taken. | DD-MMM-YYYY |
Legend: (d) derived field, (m) RDC mandatory
Validations TBD
Code | Description | Resolutions |
---|---|---|
PE01 | Finding Results is marked abnormal and a comment is not specified. | Enter a comment or change the Finding Results selection. |
PE03 | Finding Results has changed from baseline (either from N to A or A to N or X to A), but comment is missing. | Review the Finding Results or enter a comment. |
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. |
PE08 | PE is done and the response(s) to the change question(s) is/are ‘Y’, but the response to the evaluation section is absent. | Enter the evaluation section. |
Derivations TBD
Code | Field Name | Description |
---|---|---|
PE1001 | Day in Course | Number of days since the beginning of the course is derived from the course initiation start date and examination date. |