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Neurological Assessment Screenshot.PNG

Contents

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:
YES - Yes
NO - No

 

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:
Y - Yes
N - No

 

Use pick list.

Change from Previous Evaluation?

Indicate whether the finding results were changed compared with that of previous evaluation:
Y - Yes
N - No

 

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.
0 - Dead
10 - Moribund
20 - Very Sick
30 - Hospitalized
40 - Disabled
50 - Frequent Assistance
60 - Occasional Assistance
70 - Self Care
80 - Effort
90 - Able
100 - Normal

Use pick list.

Status (Zubrod)

Select a value from the Zubrod/ECOG performance status scale.
0. Asymptomatic
1. Symptomatic, fully ambulatory
2. Symptomatic, in bed less than 50% of day
3. Symptomatic, in bed more than 50% of the day, but not bedridden
4. Bedridden

Use pick list.

Performance Status (Lansky)

Select a value from the Lansky performance status scale.
0 - Unresponsive
10 - No play; does not get out of bed
20 - Often sleeping; play entirely limited to very passive activities
30 - In bed; needs assistance even for quiet play
40 - Mostly in bed; participates in quiet activities
50 - Gets dressed but lies around much of the day; no active play; able to participate in all quiet play
60 - Up and around; but minimal active play; keeps busy with quieter activities
70 - Both greater restriction of and less time spent in play activity
80 - Active; but tires more quickly
90 - Minor restrictions in physically strenuous activity
100 - Fully active, normal

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.
The following simple approximation may be used for persons of "normal" height and weight:

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
YES - Yes
NO - No

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.

 

 

Last updated by Brown, Miranda (NIH/NCI) [C] on Apr 19, 2017