PrCa Tumor Response


This example shows a CRF used to collect information on tumor response.


RSCAT must be populated with the criteria and a version number (if appropriate) used in the assessment of response. This CRF may be used to collect response assessments based on PCWG SCHER PROSTATE CANCER 2008 or RECIST 1.1 The sponsor may default the appropriate value for RSCAT in collection or populate the appropriate value when the SDTM-based datasets are created. CDASH variables like _RSCAT (e.g., OVRLRESP_RSCAT) may be created to default the RSCAT associated with each response. This CRF only illustrates the use of OVRLRESP_RSCAT.


"Prostate Cancer Tumor Response [PrCa_Response]" Form Preview
Prostate Cancer Tumor Response
Prostate Cancer Disease Response
Response Criteria
Was the response assessment performed? Yes  No  
Why was the response assessment not performed?
Other, specify
Evaluator Investigator  Independent Assessor  
What is the evaluator identifier? Radiologist 1  Radiologist 2  Oncologist  
What was the Target Response?
Date of Procedure for Target Response
 01 Jan 2000
What was the Non-target Response?
Date of Procedure for Non-target Response
 01 Jan 2000
Was the Soft Tissue Response?
Date of Procedure for Soft Tissue Response
 01 Jan 2000
What was the Tumor Marker Response?
Date of assessment for Tumor Marker Response
 01 Jan 2000
What was the Bone Response? Non Progressive Disease (NON-PD)  Progressive Disease (PD)  
Date of Procedure for Bone Response
 01 Jan 2000
What was the Overall Response?
Date of Procedure for Overall Response
 01 Jan 2000
What was the Best Overall Response?
Date of Procedure for Best Overall Response
 01 Jan 2000
Did the patient experience Symptomatic Deterioration? Yes  No  
Date of Symptomatic Deterioration
 01 Jan 2000
* Mandatory field

Package(s)
PrCa_Tumor_Response_2023-01-31.zip