Contents |
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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 |
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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 |
RT Reason | Select the term to explain the reason for the use of radiotherapy in a patient. | Use pick list. |
Radiation Type(m) | Select the type of radiation therapy, e.g.: "proton beam", "external beam" or "Palliative RT". | Use pick list. |
Other, Specify | Enter an explanation when ‘Other, Specify’ is selected as a ‘Radiation Type’ | 100 Characters |
RT Site | Select named and more specified location in the body that received radiation therapy. | Use pick list. |
RT Organ | Select named location with the central nervous system that received radiation therapy (RT). | Use pick list. |
RT Location | Select named location in the body that received radiation therapy. | Use pick list. |
Side of Body/ Organ | Select text term to identify the specified/detailed anatomic location of a malignant neoplasm that arises from or metastasize to structures within the cranium. | Use pick list. |
Side Detail | Select specification relating to the side or laterality of an anatomic location. | Use pick list. |
RT Field Site (Site 1, Site 2, Site 3) | Select term to identify the type of field used in the delivery of radiation therapy to a patient (up to 3 terms). | Use pick list. |
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. |
Number of Fractions | Enter the numeric value for the number of dose-portions or fractions of radiation therapy actually administered to a patient as treatment. | 4 digits |
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. | Use pick list. |
NonResponse Therapy Type | Select the therapy type for which the conventional response calls are not appropriate. | Use pick list. |
Relapse Date | Enter the calendar date of return of disease following radiation therapy with a period of improvement or complete remission. | DD-MMM-YYYY |
Legend: (m) RDC mandatory
Validations
Code | Description | Resolutions |
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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, | 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 |
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PRD1001 | Therapy Type | Derive Therapy Type Code based on matching Therapy Type |