Neurological Assessment Screenshot.PNG
Contents |
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Purpose
This CRF will record physical exam results during treatment. Note: Some BTTC protocols will not require specific physical exam data to be captured.
Physical Exams - Courses 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 |
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: Note: not applicable for CTMS. | Use pick list. |
Change from Previous Evaluation? | Indicate whether the finding results were changed compared with that of previous evaluation: Note: not applicable for CTMS. | Use pick list. |
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). Any baseline body system with "Abnormal" Finding Results that remained unchanged must be re-entered in this case report form.
| Use pick list. |
Comments | If the finding results of a particular body system have changed from baseline, give a brief description of the change. | 200 characters (128 reported) |
Legend: (d) derived field, (m) RDC mandatory
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. |
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
Code | Field Name | Description |
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PE1001 | Day in Course | Number of days since the beginning of the course is derived from the course initiation start date and examination date. |
Physical Exams - Courses 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 |
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. 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. |
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
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. |
Derivations
Code | Field Name | Description |
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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. |
Physical Exams - Courses eCRF (Neurological Assessment tab)
Field Name | Description / Instructions | Format |
---|---|---|
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 |
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 |
Neurological Assessment | Select the patient's results or findings of neurological assessment. This determination must be adequately documented in the patient's medical record. DEFINITELY BETTER | Use pick list. |
Preference Hand | Select relating to the subject's identification of the preference or dominant hand. Preference hand can be defined as right, left, or both (bilateral). | Use pick list. |
Legend: (d) derived field, (m) RDC mandatory
Validations
Code | Description | Resolutions |
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TBD |
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