Contents

Purpose

 

 

Chronic GVHD - Activity Assessment Clinician eCRF

Field Name

Description / Instructions

Format

Visit Date

The Visit Date is required.

DD-MMM-YYYY

Data Collected? Indicate if data was collected or not. Use pick list.
Assessment Date Enter the Assessment Date.

DD-MMM-YYYY

Reason if Data Not Collected Enter the reason data was not collected. 200 characters 
Skin- erythematous rash of any sort (%BSA)   Number (99.999)
Skin- Moveable sclerosis (%BSA)   Number (99.999)
Skin- Non-moveable sclerosis or subcutaneous   Number (99.999)
Skin- Ulcers (largest ulceration lesion) Location   100 characters
Skin- Ulcers (largest ulceration lesion) Dimension (cm)   Number (99.99)
Eye- Right

 

  • NOT APPLICABLE
  • NOT ASSESSED
  • NOT ASSESSED DUE TO AGE RESTRICTION
  • PARTIALLY ASSESSED DUE TO AGE RESTRICTION
 Use pick list
Eye- Left  
  • NOT APPLICABLE
  • NOT ASSESSED
  • NOT ASSESSED DUE TO AGE RESTRICTION
  • PARTIALLY ASSESSED DUE TO AGE RESTRICTION
 Use pick list 
Mouth- Mucosal Change Erythema

 

  • 0 - None
  • 1 - Mild
  • 2 - Moderate
  • 3 - Severe
  • NOT APPLICABLE - Not Applicable
  • NOT ASSESSED - Not Assessed
  • PARTIALLY ASSESSED - Partial Assessment
  Use pick list
Mouth- Mucosal Change Lichenoid

 

  • 0 - None
  • 1 - Mild
  • 2 - Moderate
  • 3 - Severe
  • NOT APPLICABLE - Not Applicable
  • NOT ASSESSED - Not Assessed
  • PARTIALLY ASSESSED - Partial Assessment
 Use pick list
Mouth - Mucosal Change Ulcers

 

  • 0 - None
  • 1 - Mild
  • 2 - Moderate
  • 3 - Severe
  • NOT APPLICABLE - Not Applicable
  • NOT ASSESSED - Not Assessed
  • PARTIALLY ASSESSED - Partial Assessment
 Use pick list  
Mouth- Mucosal Change Mucoceles

 

  • 0 - None
  • 1 - Mild
  • 2 - Moderate
  • 3 - Severe
  • NOT APPLICABLE - Not Applicable
  • NOT ASSESSED - Not Assessed
  • PARTIALLY ASSESSED - Partial Assessment
 Use pick list
Mouth - Total Score   Number (99)
Upper GI

 

  • 0 - None
  • 1 - Occasional
  • 2 - Intermittent
  • 3 - Severe
  • NOT APPLICABLE - Not Applicable
  • NOT ASSESSED - Not Assessed
  • PARTIALLY ASSESSED - Partially Assessed
 Use pick list
Esophageal

 

  • 0 - None
  • 1 - Occasional
  • 2 - Intermittent
  • 3 - Severe
  • NOT APPLICABLE - Not Applicable
  • NOT ASSESSED - Not Assessed
  • PARTIALLY ASSESSED - Partially Assessed
 Use pick list
Lower GI- Diarrhea

 

  • 0 - None
  • 1 - Occasional
  • 2 - Intermittent
  • 3 - Severe
  • NOT APPLICABLE - Not Applicable
  • NOT ASSESSED - Not Assessed
  • PARTIALLY ASSESSED - Partially Assessed
 Use pick list
Health Care Provider Global Rating- Severity of cGVHD

 

  • 0 - None
  • 1 - Mild_
  • 2 - Moderate_
  • 3 - Severe_
 Use pick list
Health Care Provider Global Rating- Severity Scale Enter a number between 0 and 10. Number (99)
Health Care Provider Global Rating- Past Month Status

 

  • -1 - A Little Worse
  • -2 - Moderately Worse
  • -3 - Very Much Worse
  • 0 - About the Same
  • +1 - A Little Better
  • +2 - Moderately Better
  • +3 - Very Much Better

Use pick list

Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.

Validations

Code

Description

Resolutions

  There are no validations.  

Derivations

Code

Field Name

Description

  There are no derivations.  

 

 

 
Last updated by Fontinha, Marcelo (NIH/OD) [E] on Jul 30, 2013