SD0052: Inconsistent value for VISITNUM within VISIT

w wanchi

on November 14, 2013

Dear all,

I have a question about SD0052: Inconsistent value for VISITNUM within VISIT.

There were at least two subjects had unscheduled visit, and I presented my SV dataset as following:

USUBJID VISITNUM VISIT VISITDY SVSTDTC SVENDTC

STUDYXX101 1.0 SCREENING -21 2013-07-12 2013-07-12

STUDYXX101 2.0 VISIT2 1 2013-07-25 2013-07-25

STUDYXX101 3.0 VISIT3 7 2013-07-31 2013-07-31

STUDYXX101 3.1 (Blank) 8 2013-08-01 2013-08-01

STUDYXX101 4.0 VISIT4 15 2013-08-08 2013-08-08

STUDYXX102 1.0 SCREENING -21 2013-07-12 2013-07-12

STUDYXX102 2.0 VISIT2 1 2013-07-25 2013-07-25

STUDYXX102 2.1 (Blank) 3 2013-07-28 2013-07-28

STUDYXX102 2.2 (Blank) 4 2013-07-29 2013-07-29

STUDYXX102 3.0 VISIT3 7 2013-07-31 2013-07-31

STUDYXX102 4.0 VISIT4 15 2013-08-08 2013-08-08

The SD0052 message was occurred due to I have many unscheduled visitnum, 3.1, 2.1, 2.2.

May I ask if you have any suggestion? Any feedback or any advise on this topic would be appreciated.

Thank you!

Forums: SDTM

s Sergiy

on November 21, 2013

Hi Wanchi, I think it's a

Hi Wanchi,

I think it's a bug in OpenCDISC definition of SD0052 check. It should be an exception for Unscheduled Visits where one option is to use missing value for VISIT variable. E.g., see SDTM IG 3.1.2 #4.1.4.5 (on page 41).

Thank you for reporting! We'll correct specs in the next release.

Kind Regards,

Sergiy

s Steve

on February 23, 2015

SD0052 issue exists in Enterprise as well

I continue to see this in Enterprise v 2.x. 3.01 UNSCHEDULED 4.01 UNSCHEDULED 4.02 UNSCHEDULED 4.03 UNSCHEDULED 4.04 UNSCHEDULED 4.05 UNSCHEDULED 7.02 UNSCHEDULED 7.03 UNSCHEDULED

s Sergiy

on February 24, 2015