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Purpose

Record details of prior surgery related to the disease being studied by the protocol or when the details would be clinically significant for the evaluation of this study. Note: Baseline Disease Assessment is using "Response Type- Lesion Size" and "Response Criteria Type- RANO"

Baseline Disease Assessment eCRF

Field Name

Description / Instructions

Format

Visit Date(m)

Enter the date the form was completed.

Note: If the information was obtained at multiple visits, please enter the date the form was completed.

DD-MMM-YYYY

Is pt NED?(m)

Indicate whether there is no evidence of disease (NED) at assessment.

  • Yes

  • No

  • Unknown

Use pick list.

Max Daily Corticosteroid Dose at assessment

Enter the numeric value for the largest daily corticosteroid dose taken by a patient at the time of an assessment.

8 digits and 2 decimals

Max Daily Corticosteroid Dose UOM

Select the total daily dose units of measurement.

Use pick list

Steroid dose status

Indicate the status that represents the steroid therapy dose.

  • None

  • Stable

  • Increase

  • Decrease

Use pick list.

Sum of Longest Diameters of all Measurable Lesions (cm)(m)Enter the numeric value to indicate the sum of the longest diameters of all measurable lesions captured in centimeters (cm).

6 digits and 2 decimals

Sum of TD x PD of all Measurable Lesions (cm2)(m)

Enter the numeric value for total sum of products (transverse diameter multiplied by perpendicular diameter) for all measurable lesions described in square centimeters (cm2).

10 digits and 2 decimals

Verifying physician(m)Enter the name of the doctor, a person who has been educated, trained, and licensed to practice the art and science of medicine; a practitioner of medicine, as contrasted with a surgeon, responsible for verification.

100 characters

Verified(m)

Select the term used primarily by a physician to confirm or indicate whether revision in a patient's disease evaluation assessment is needed.

•CONFIRMED
•NEEDS REVISION

Use pick list.

Date verified(m)Enter the calendar date on which a physician confirms or indicates whether revision in a patient's disease evaluation assessment is needed.

DD-MMM-YYYY

Legend: (m) RDC mandatory

Validations

Code

Description

Resolutions

 

 

 

   
   

Derivations

Code

Field Name

Description

 

 

 

   
   
Last updated by Karuppiah, Kanagaraja (NIH/NCI) [C] on Dec 04, 2017