Pancreatic Cancer Stent Placement aCRF

Illustrates Domains

DX

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

DXTRT Hidden/pre-populated
STENT
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"
Record the location where the stent was placed. What was the anatomical location of the stent insertion?
DXLOC
Record the date the stent was inserted.
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.
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.
DXENDAT DXENDTC
_________________
View CRF Metadata
RowCDASH VariableQuestion TextPromptCRF Completion  InstructionsTypeSDTMIG Target VariableSDTMIG Target  MappingControlled   Terminology Code NameCRF Implementation notesPermissible ValuesPre-specified ValueQuery DisplayList StyleHidden
1DXTRTN/AName of Device ExposureN/ATextDXTRT



STENT

Yes
2DXPRESPN/ADevice Exposure Pre-specifiedN/ATextDXPRESPDXPRESP where DXTRT =  "STENT"


Y

Yes
3DXOCCURHas 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.   

TextDXOCCURDXOCCUR where DXTRT = "STENT"(NY)
Yes; No

Radio
4DXLOCWhat was the anatomical location of the stent  insertion?Anatomical LocationRecord the location where the stent was placed.TextDXLOC


BILE DUCT; DUODENAL DUCT



radio
5DXSTDATWhat was the date of stent insertion? Start DateRecord the date the stent was inserted. TextDXSTDTCDXSTDTC; IF DXSTDTC is NULL then DXSTRTPT="BEFORE" and DXSTTPT="VISIT 1"   






6DXONGOIs the stent still in place? OngoingCheck Yes if the subject still has this stent inserted at the end of the study TextDXENRTPTDXENRTPT where DXENRTPT="ONGOING" and DXENTPT is assigned the subject's last visit. 

Yes
prompt checkbox
7DXENDATWhat 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.

textDXENDTC







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

DXTRT Hidden/pre-populated
STENT
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"

<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
Record the location where the stent was placed. What was the anatomical location of the stent insertion?
DXLOC
Record the date that the stent was inserted using this format (DD-MM-YYYY).
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.

<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.
DXENDAT DXENDTC
_________________
View CRF Metadata
RowCDASH VariableQuestion TextPromptCRF Completion   InstructionsTypeSDTMIG Target VariableSDTMIG Target MappingControlled   Terminology Code List NameCRF Implementation notesPermissible ValuesPre-specified ValueQuery DisplayList StyleHidden
1DXTRTN/AName of Device ExposureN/ATextDXTRT



STENT

Yes
2DXPRESPN/ADevice Exposure Pre-specifiedN/ATextDXPRESPDXPRESP where DXTRT = "STENT"


Y

Yes
3DXOCCURHas the subject had a  stent inserted during the study?Stent Insertion OccurrenceIndicate whether a stent was inserted during the study, by checking Yes or No. Include all replacement stents.TextDXOCCURDXOCCUR where DXTRT = "STENT"(NY)
Yes; No

Radio
4CDEVTYPEWhat 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



5DXLOCWhat was the anatomical location of the stent insertion?Anatomical LocationRecord the location where the stent was placed.   TextDXLOC


BILE DUCT; DUODENAL DUCT





6DXSTDATWhat was the date of stent insertion?Start DateRecord the date that the stent was inserted using this format (DD-MM-YYYY). TextDXSTDTC







7DXONGOIs 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.

TextDXENRTPTDXENRTPT where DXENRTPT="ONGOING" and DXENTPT is assigned the subject's last visit. (NY)
Yes
prompt checkbox
8DXENDATWhat was the date of stent removal?End DateRecord 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.textDXENDTC