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Purpose

Record details of prior radiation therapy related to the disease being studies by the protocol or when the details would be clinically significant for the evaluation of this study.

Prior Radiation Supplement 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

Date of First Dose^(m)^

Enter the date of the first dose of the radiation therapy. Partial dates are acceptable when the day is not known.

DD-MMM-YYYY or MMM-YYYY

Date of Last Dose

Enter the date of the last dose of the radiation therapy. Partial dates are acceptable when the day is not known. Leave it blank if the therapy is currently being received. “Ongoing’ will be reported to CTMS or CDS.

DD-MMM-YYYY, MMM-YYYY

Radiation Type^(m)^

Select the type of radiation therapy, e.g.: "proton beam", "external beam" or "implant".

Use pick list.

Other, Specify

Enter an explanation when ‘Other, Specify’ is selected as a ‘Radiation Type’

100 Characters

Radiation Extent^(m)^

Select the extent of the radiation therapy as follows:
Limited Radiation: therapy using ionizing radiation to a limited (<50%) portion of the body.
Extensive Radiation: therapy using ionizing radiation to a significant portion of the body (>50%), e.g. cardiospinal, pelvic, or total-body.
Radiation (NOS): Extent is not known.

Use pick list.

Site^(m)^

Select the site of the radiation therapy.

Use pick list.

Schedule

Select the radiation therapy schedule on which it was given.

24 characters

Total Dose

State the total radiation dose the patient received during the treatment period. Leave this field as well as the Total Dose UOM blank if the radiation therapy is ongoing.

8 characters

Total Dose UOM

Select the radiation dose units of measurement (e.g. cGy or rad, or cSv or rem).

Use pick list.

Best Response

Select the best response for the irradiated lesion. It applies to the type of therapy/intervation for which conventional response calls are appropriate. Leave this field blank if the radiation therapy is ongoing.
CR - Complete Response
PR - Partial Response
MR - Minimal/Marginal Response
SD - Stable Disease
PD - Progressive Disease
NE - Not Evaluable
NA - Not Assessed
UK - Unknown
NR - No Response

Use pick list.

NonResponse Therapy Type

Select the therapy type for which the conventional response calls are not appropriate.
AJ - Adjuvant Therapy
PA - Palliative Therapy
NJ - Neoadjuvant Therapy
PR - Prophylaxis

Use pick list.

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

Validations

Code

Description

Resolutions

PRD01

Date of First Dose is greater than Date of Last Dose.

Enter a Date of First Dose that is equal to or earlier than the Date of Last Dose.

PRD02,
PRD03

Date of First Dose and Date of Last Dose are in the future.

Enter a date that is equal to or earlier than the current date.

PRD04

Both Best Response and Nonresponse Therapy Type are present/absent.

One and only one fields should be entered.

PRD05

Prior Radiation Type 'Other Specify' and 'Other, Specify' field are not present together.

Enter ‘Other Specify’ if ‘Other Specify’ is selected as Prior Radiation Type.

Derivations

Code

Field Name

Description

PRD1001

Therapy Type

Derive Therapy Type Code based on matching Therapy Type