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Contents

Purpose

Record baseline physical exam results.

Physical Exams - Screening 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

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:
N - Normal
A - Abnormal
X - Not Examined
L - Not Applicable
Comments are required for abnormal finding results.

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).


For CTMS reporting studies, L is reported as X.

Use pick list.

Comments

Give a brief description for all abnormal finding results.
If choosing "Other", indicate the body or organ system missing from the list in the comment and include this under both baseline and follow-up exams.

200 characters (128 reported)

Legend:  (m) RDC mandatory

Validations

Code

Description

Resolutions

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

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 adverse event started in as derived from the course initiation start date.Late adverse event (For CTMS and CDS monitored studies, it means the adverse event observed after the date of off treatment) have no associated Course #.5 digits

Day in Course(d)

Indicates the day since the beginning of course that this adverse event started as derived from the course initiation start date.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.
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

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.
The MIS BSA formula is:
BSA (m²) = Height(cm)^0.725 x Weight(kg)^0.425 / 139.315

VIT04

Entered BSA is not within 10% accuracy of the calculated BSA using the Mosteller formula.

Correct the BSA.
The Mosteller BSA formula is:
BSA (m²) = ( CCRClinicalIT2: Height(cm) x Weight(kg) / 3600 )^½

VIT05

Vitals Date is in the future.

Enter a date that is equal to or prior to the current date.

VIT06, VIT07,
VIT08, VIT09,
VIT10, VIT11,
VIT12, VIT13

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.

 

Physical Exams - Screening 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
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

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
DEFINETELY WORSE
POSSIBLY BETTER
POSSIBLY WORSE
STABLE
BASELINE

Use pick list.

Preference HandSelect 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:  (m) RDC mandatory

Validations

Code

Description

Resolutions

TBD

 

 

 

 

 

 

 

 

 

  
Last updated by Blackburn, Katie (NIH/NCI) [C] on Apr 18, 2017