No modification made.
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
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.
|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.|
|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|
|6||XYZ||PR||XYZ-004||1||DIALYSIS||2014-08-05||2014-09-10||Subject refused dialysis|
PR NSV Metadata
|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.
|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|