Pancreatic Cancer Surgical History aCRF

Illustrates Domains

PR
DI

Illustrates Variables

PRYN
PRCAT

Content

This example CRF collects information about a subject's prior pancreatic cancer-related surgeries. Sponsors may also collect information on other procedures performed prior to study start using a standard Procedures CRF (not shown; an example of a standard Procedures CRF can be found in the CDASHIG, available at https://www.cdisc.org/standards/foundational/cdash).

CRF Instructions

Record 1 procedure per line.

Indicate if the subject had any prior surgeries related to pancreatic cancer. If Yes, include the appropriate details where indicated on the CRF.	Has the subject had any prior pancreatic cancer related surgery? PRYN Not submitted	Yes No <From NY codelist>
	PRCAT Hidden/pre-populated	PANCREATIC CANCER RELATED SURGERIES
Record only 1 procedure per line.	What was the procedure name? PRTRT	BILE DUCT STENT CHOLECYSTECTOMY EXPLORATORY LAPAROTOMY PANCREATECTOMY WITH PORTAL VEIN RESECTION TOTAL PANCREATECTOMY WHIPPLE RESECTION
Record the date the procedure was started or performed using this format (DD-MON-YYYY). Prior procedures that are exclusionary should have both a start and end date.	What was the procedure start date? PRSTDAT PRSTDTC	_________________
Record the date the procedure was ended using this format (DD-MON-YYYY). Prior procedures that are exclusionary should have both a start and end date.	What was the procedure end date? PRENDAT PRENDTC	_________________

View CRF Metadata

Order

Type

CDASHIG Variable

Question Text

Prompt

CRF Completion Instructions

SDTM Target

SDTMIG Target Variable Mapping

Controlled Terminology Codelist Name

CRF Implementation Notes

Permissible Values

Pre-populated Value

Query Display

List Style

Hidden

text

PRYN

Has the subject had any prior pancreatic cancer related surgery?

Any Procedures

Indicate if the subject had any prior surgeries related to pancreatic cancer. If Yes, include the appropriate details where indicated on the CRF.

(NY)

Yes; No

text

PRCAT

N/A

PRCAT

PANCREATIC CANCER RELATED SURGERIES

text

PRTRT

What was the procedure name?

Procedure Name

Record only 1 procedure per line.

PRTRT

BILE DUCT STENT; CHOLECYSTECTOMY; EXPLORATORY LAPAROTOMY; PANCREATECTOMY WITH PORTAL VEIN RESECTION; TOTAL PANCREATECTOMY; WHIPPLE RESECTION

radio button

text

PRSTDAT

What was the procedure start date?

Start Date

Record the date the procedure was started or performed using this format (DD-MON-YYYY). Prior procedures that are exclusionary should have both a start and end date.

PRSTDTC

text

PRENDAT

What was the procedure end date?

End Date

Record the date the procedure was ended using this format (DD-MON-YYYY). Prior procedures that are exclusionary should have both a start and end date.

PRENDTC