End-Stage Renal Disease

Illustrates Domains

Illustrates Variables

PRENRTPT
PRENTPT
PRSTDTC
RSDISC (NSV)
PRTRT
PRPRESP
PROCCUR

Content

Annotated CRF: Renal Replacement Therapy

No modification made.

This example shows a data collection form for renal replacement therapy, that is, for kidney transplant and chronic dialysis.

This CRF is only an example and is not meant to imply that any particular layout is preferable over another.

CRF annotated to show mapping. SDTM variables are in RED. If CDASH variable differs from SDTM, the CDASH variable is in GREY.

* Indicates variable is not approved in either CDASH or SDTM and will be submitted to the Governance Group for consideration.

Renal Replacement Therapy

Kidney Transplant PRTRT

Has the subject received a kidney transplant? PROCCUR	☐ Yes ☐ No
If yes, provide kidney transplant date (DD-MMM-YYYY) PRSTDTC PRSTDAT	_ _ / _ _ _ / _ _ _ _ (DD/MMM/YYYY)

Dialysis PRTRT

Has the subject received dialysis? PROCCUR	☐ Yes ☐ No
If yes, provide the following information:
Start Date (DD-MMM-YYYY) PRSTDTC PRSTDAT	_ _ / _ _ _ / _ _ _ _ (DD/MMM/YYYY)
Ongoing (if No, complete end date and reason discontinued) PRENRTPT="ONGOING" PRONGO	☐ Yes ☐ No
End Date (DD-MMM-YYYY) PRENDTC PRENDAT	_ _ / _ _ _ / _ _ _ _ (DD/MMM/YYYY)
Reason Discontinued Dialysis RSDISC RSDISC*	☐ No longer medically necessary ☐ Subject refused dialysis ☐ Dialysis is futile ☐ Received renal transplant ☐ Other

CDASH Metadata for this CRF can be found at: http://wiki.cdisc.org/x/ldrdAQ

Below are sample records for subjects who have undergone dialysis or a kidney transplant. Because, dialysis and kidney transplant are considered procedures, they are represented in the Procedures (PR) domain.

pr.xpt

Rows 1-3:	The first subject experienced AKI (acute kidney injury) two times, once in 2012 and once in 2013. After the AKI resolved, dialysis was no longer medically necessary. The subject started dialysis for a third time on 2014-06-23. On 2014-08-02 (PRENTPT) the subject was still undergoing dialysis (PRENRTPT="ONGOING").
Row 4:	The second subject had a kidney transplant.
Row 5:	The third subject started dialysis on 2014-08-05 (PRSTDTC). On 2014-08-25 (PRENTPT) the subject was still undergoing dialysis (PRENRTPT="ONGOING").
Row 6:	The fourth subject refused to continue dialysis a little more than a month after starting. The reason for discontinuation is represented using a non-standard variable.

pr.xpt

Row	STUDYID	DOMAIN	USUBJID	PRSEQ	PRTRT	PRSTDTC	PRENDTC	PRENRTPT	PRENTPT	RSDISC
1	XYZ	PR	XYZ-001	1	DIALYSIS	2012-05-01	2012-05-26			No longer medically necessary
2	XYZ	PR	XYZ-001	2	DIALYSIS	2013-06-01	2013-06-21			No longer medically necessary
3	XYZ	PR	XYZ-001	3	DIALYSIS	2014-06-23		ONGOING	2014-08-02
4	XYZ	PR	XYZ-002	1	KIDNEY TRANSPLANT	2014-06-17
5	XYZ	PR	XYZ-003	1	DIALYSIS	2014-08-05		ONGOING	2014-08-25
6	XYZ	PR	XYZ-004	1	DIALYSIS	2014-08-05	2014-09-10			Subject refused dialysis

PR NSV Metadata

Variable	Label	Type	Role	Origin
RSDISC	Reason for Discontinuation	text	Non-Standard Record Qualifier	CRF

Of the four subjects with records in PR above, the investigator felt that the first two had achieved ESRD, which is clinical endpoint in the study. Records for these two subjects are shown below.

ce.xpt

ce.xpt

Row	STUDYID	DOMAIN	USUBJID	CESEQ	CEGRPID	CETERM	CESTDTC
1	XYZ	CE	XYZ-001	1	001-1	END STAGE RENAL DISEASE	2014-06-23
2	XYZ	CE	XYZ-002	1	002-1	END STAGE RENAL DISEASE	2014-06-17