Pancreatic Cancer Stent Placement aCRF

Illustrates Domains

Illustrates Variables

DXPRESP
DXSTDAT
DXENDAT
DXONGO

Content

This example CRF shows information collected about stent placement.

Part 1 collects pre-study stent history and details on stents still in place at study start.
Part 2 collects information on the type of stent inserted during the study, including replacement stents.

The level of information collected for each stent inserted is determined by the sponsor. In this example, the sponsor only collected the generic name of the stent. These generic stents types are assigned a SPDEVID when the SDTM dataset is created.

Part 1. Stent History and Stents in Place at Study Entry

	Name of Device Exposure DXTRT Hidden/pre-populated	STENT
	Device Exposure Pre-specified DXPRESP DXPRESP where DXTRT = " STENT" Hidden/pre-populated	Y
Indicate if the subject has ever had a stent inserted, by checking Yes or No. If Yes, complete the remainder of the CRF for each stent still in place at study entry on a separate line.	Has the subject had a stent inserted for pancreatic cancer? DXOCCUR DXOCCUR where DXTRT = " STENT"	Yes No
Record the location where the stent was placed.	What was the anatomical location of the stent insertion? DXLOC	BILE DUCT DUODENAL DUCT
Record the date the stent was inserted.	What was the date of stent insertion? DXSTDAT DXSTDTC IF DXSTDTC is NULL then DXSTRTPT=" BEFORE" and DXSTTPT=" VISIT 1"	_________________
Check Yes if the subject still has this stent inserted at the end of the study	Ongoing DXONGO DXENRTPT where DXENRTPT=" ONGOING" and DXENTPT is assigned the subject' s last visit.	Yes
If the stent was removed during the study, record the date using this format (DD-MON-YYYY). If the subject has not had the stent removed, leave this field blank.	What was the date of stent removal? DXENDAT DXENDTC	_________________

View CRF Metadata

Row	CDASH Variable	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target Variable	SDTMIG Target Mapping	Controlled Terminology Code Name	Permissible Values	Pre-specified Value	Query Display	List Style	Hidden
1	DXTRT	N/A	Name of Device Exposure	N/A	Text	DXTRT				STENT			Yes
2	DXPRESP	N/A	Device Exposure Pre-specified	N/A	Text	DXPRESP	DXPRESP where DXTRT = "STENT"			Y			Yes
3	DXOCCUR	Has the subject had a stent inserted for pancreatic cancer?	Stent Insertion Occurrence	Indicate if the subject has ever had a stent inserted, by checking Yes or No. If Yes, complete the remainder of the CRF for each stent still in place at study entry on a separate line.	Text	DXOCCUR	DXOCCUR where DXTRT = "STENT"	(NY)	Yes; No			Radio
4	DXLOC	What was the anatomical location of the stent insertion?	Anatomical Location	Record the location where the stent was placed.	Text	DXLOC			BILE DUCT; DUODENAL DUCT			radio
5	DXSTDAT	What was the date of stent insertion?	Start Date	Record the date the stent was inserted.	Text	DXSTDTC	DXSTDTC; IF DXSTDTC is NULL then DXSTRTPT="BEFORE" and DXSTTPT="VISIT 1"
6	DXONGO	Is the stent still in place?	Ongoing	Check Yes if the subject still has this stent inserted at the end of the study	Text	DXENRTPT	DXENRTPT where DXENRTPT="ONGOING" and DXENTPT is assigned the subject's last visit.		Yes		prompt	checkbox
7	DXENDAT	What was the date of stent removal?	End Date	If the stent was removed during the study, record the date using this format (DD-MON-YYYY). If the subject has not had the stent removed, leave this field blank.	text	DXENDTC

Part 2. Stent Insertion During the Study (Including Replacement Stents)

	Name of Device Exposure DXTRT Hidden/pre-populated	STENT
	Device Exposure Pre-specified DXPRESP DXPRESP where DXTRT = " STENT" Hidden/pre-populated	Y
Indicate whether a stent was inserted during the study, by checking Yes or No. Include all replacement stents.	Has the subject had a stent inserted during the study? DXOCCUR DXOCCUR where DXTRT = " STENT"	Yes No <From NY codelist>
Indicate the type of stent inserted. Record the specific type of stent, if known. Otherwise, select "Pancreatic stent".	What was the device type? CDEVTYPE Not submitted	Pancreatic stent Bare-metal biliary stent Polymeric biliary stent, non-bioabsorbable Colonic/duodenal stent
Record the location where the stent was placed.	What was the anatomical location of the stent insertion? DXLOC	BILE DUCT DUODENAL DUCT
Record the date that the stent was inserted using this format (DD-MM-YYYY).	What was the date of stent insertion? DXSTDAT DXSTDTC	_________________
Check Yes if the subject has not had the stent removed. If Yes, the end date should be left blank.	Ongoing DXONGO DXENRTPT where DXENRTPT=" ONGOING" and DXENTPT is assigned the subject' s last visit.	Yes <From NY codelist>
Record the date the stent was removed using this format (DD-MON-YYYY). If the subject has not had the stent removed, leave this field blank.	What was the date of stent removal? DXENDAT DXENDTC	_________________

View CRF Metadata

Row	CDASH Variable	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target Variable	SDTMIG Target Mapping	Controlled Terminology Code List Name	CRF Implementation notes	Permissible Values	Pre-specified Value	Query Display	List Style	Hidden
1	DXTRT	N/A	Name of Device Exposure	N/A	Text	DXTRT					STENT			Yes
2	DXPRESP	N/A	Device Exposure Pre-specified	N/A	Text	DXPRESP	DXPRESP where DXTRT = "STENT"				Y			Yes
3	DXOCCUR	Has the subject had a stent inserted during the study?	Stent Insertion Occurrence	Indicate whether a stent was inserted during the study, by checking Yes or No. Include all replacement stents.	Text	DXOCCUR	DXOCCUR where DXTRT = "STENT"	(NY)		Yes; No			Radio
4	CDEVTYPE	What was the device type?	Device Type	Indicate the type of stent inserted. Record the specific type of stent, if known. Otherwise, select "Pancreatic stent".	Text				The sponsor assigns the appropriate SPDEVID based on the collected device type.	Pancreatic stent; Bare-metal biliary stent; Polymeric biliary stent, non-bioabsorbable; Colonic/duodenal stent
5	DXLOC	What was the anatomical location of the stent insertion?	Anatomical Location	Record the location where the stent was placed.	Text	DXLOC				BILE DUCT; DUODENAL DUCT
6	DXSTDAT	What was the date of stent insertion?	Start Date	Record the date that the stent was inserted using this format (DD-MM-YYYY).	Text	DXSTDTC
7	DXONGO	Is the stent still in place?	Ongoing	Check Yes if the subject has not had the stent removed. If Yes, the end date should be left blank.	Text	DXENRTPT	DXENRTPT where DXENRTPT="ONGOING" and DXENTPT is assigned the subject's last visit.	(NY)		Yes		prompt	checkbox
8	DXENDAT	What was the date of stent removal?	End Date	Record the date the stent was removed using this format (DD-MON-YYYY). If the subject has not had the stent removed, leave this field blank.	text	DXENDTC