Pancreatic Cancer Radiation Therapy aCRF

Illustrates Domains

Illustrates Variables

PRYN
PRCAT
PRTRTSTT
PRDSTXT
PRCPLDUIC

Content

In this example, information was collected about subjects who may have been previously treated with radiation therapy, possibly in different treatment settings (e.g., neoadjuvant, adjuvant, locally advanced, metastatic disease). The sponsor collected the treatment setting in which the radiation therapy was given.

	PRCAT Hidden/pre-populated	PANCREATIC CANCER RELATED RADIATION
Indicate if the subject was administered any radiation. If Yes, include the appropriate details where indicated on the CRF.	Was any radiation therapy administered for pancreatic cancer? PRYN Not submitted	Yes No <From NY codelist>
Select the most granular term that can be entered per site source documentation.	What was the name of the radiation therapy? PRTRT	Brachytherapy Stereotactic Body Radiation Therapy Intraoperative Radiation Therapy Intensity Modulated Radiation Therapy
	PRINDC Hidden/pre-populated	PANCREATIC CANCER
Select the appropriate treatment setting.	What was the treatment setting? PRTRTSTT NSPR.PRTRTSTT	NEO-ADJUVANT ADJUVANT LOCALLY ADVANCED METASTATIC
Record the anatomical location.	What was the anatomical location? PRLOC	_________________ <From LOC codelist>
Record the date the procedure was started or performed using this format (DD-MON-YYYY).	Start Date PRSTDAT PRSTDTC	_ _ / _ _ _ / _ _ _ _
Select Yes if the radiation has not resolved at the time of data collection; leave the end date blank.	Is the radiation still ongoing? PRONGO PRENRF/PRENRTPT PRENTPT	Yes No <From NY codelist>
Record the end date of the procedure using this format (DD-MON-YYYY). If the procedure has not ended, leave this field blank and populate PRONGO as "Y".	End Date PRENDAT PRENDTC	_ _ / _ _ _ / _ _ _ _
Record the amount of radiation administered.	What was the amount of radiation administered? PRDSTXT PRDOSE or PRDOSTXT	_________________
Record the unit for the amount of radiation administered.	What was the unit? PRDOSU	cGy Gy Rad <From UNIT codelist>
Record the frequency of radiation therapy.	What was the frequency of radiation therapy? PRDOSFRQ	DAILY 5 TIMES A WEEK WEEKLY <From FREQ codelist>
Record the collected planned duration of the radiation therapy.	If applicable, what was the planned duration of the radiation therapy? PRCPLDUIC NSPR.PRPLDUIC	5 DAYS 5 WEEKS 25 WEEKS

View CRF Metadata

Row	CDASH Variable	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target	SDTMIG Target Variable Mapping	Controlled Terminology Codelist Name	CRF Implementation notes	Permissible Values	Pre-specified Value	Query Display	List Style	Hidden
1	PRCAT	N/A	N/A	N/A	text	PRCAT		N/A	Sponsor-defined controlled terminology		PANCREATIC CANCER RELATED RADIATION	prompt		y
2	PRYN	Was any radiation therapy administered for pancreatic cancer?	Any Radiation Procedures	Indicate if the subject was administered any radiation. If Yes, include the appropriate details where indicated on the CRF.	text	N/A		(NY)	A sponsor may decide to represent that no radiation therapy was reported in the SDTM-based dataset.	Yes;No			Radio
3	PRTRT	What was the name of the radiation therapy?	Procedure Name	Select the most granular term that can be entered per site source documentation.	text	PRTRT			When radiation procedure terms are provided on the CRF, it is highly recommended that the sponsors use values from the (PROCEDUR) controlled terminology codelist.	Brachytherapy; Stereotactic Body Radiation Therapy; Intraoperative Radiation Therapy; Intensity Modulated Radiation Therapy			Radio
4	PRINDC	N/A	N/A	N/A	text	PRINDC		N/A			PANCREATIC CANCER			Y
5	PRTRTSTT	What was the treatment setting?	Treatment Setting	Select the appropriate treatment setting.	text	NSPR.PRTRTSTT				NEO-ADJUVANT; ADJUVANT; LOCALLY ADVANCED; METASTATIC
6	PRLOC	What was the anatomical location?	Anatomical Location	Record the anatomical location.	text	PRLOC		(LOC)	Sponsor-defined list of locations. If specific location are required, PRLAT, PRDIR can be added.
7	PRSTDAT	What was the radiation start date?	Start Date	Record the date the procedure was started or performed using this format (DD-MON-YYYY).	date	PRSTDTC		N/A
8	PRONGO	Is the radiation still ongoing?	Ongoing	Select Yes if the radiation has not resolved at the time of data collection; leave the end date blank.	text	PRENRF/PRENRTPT; PRENTPT		(NY)	Completed to indicate that the procedure has not stopped at the time of data collection.	Yes;No			Radio
9	PRENDAT	What was the radiation end date?	End Date	Record the end date of the procedure using this format (DD-MON-YYYY). If the procedure has not ended, leave this field blank and populate PRONGO as "Y".	date	PRENDTC		N/A
10	PRDSTXT	What was the amount of radiation administered?	[Dose/Amount]	Record the amount of radiation administered.	text	PRDOSE; PRDOSTXT;	PRDOSE or PRDOSTXT	N/A	The sponsor should provide detailed instruction on how to complete this field. Defining this data collection field as a dose text field allows for flexibility in capturing dose entries as numbers, text, or ranges. The data collected in this dose text-format field should be separated or mapped to either SDTMIG PRDOSE (if numeric) or PRDOSTXT (if text).
11	PRDOSU	What was the unit?	Unit	Record the unit for the amount of radiation administered.	text	PRDOSU		(UNIT)	For the Radiation CRF, a unit of cGy, Gy, or Rad may be used.	cGy; Gy; Rad			Radio
12	PRDOSFRQ	What was the frequency of radiation therapy?	Frequency	Record the frequency of radiation therapy.	text	PRDOSFRQ		(FREQ)		DAILY; 5 TIMES A WEEK; WEEKLY
13	PRCPLDUIC	If applicable, what was the planned duration of the radiation therapy?	Collected Planned Duration of Intervention Course	Record the collected planned duration of the radiation therapy.	text	NSPR.PRPLDUIC	NSPR.PRPLDUIC		The sponsor should convert the duration into the appropriate ISO 8601 duration format.	5 DAYS; 5 WEEKS; 25 WEEKS