SD0052: Inconsistent value for VISITNUM within VISIT

Pinnacle 21 Support SDTM
1

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

2

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

3

Hi Steve,

Our SD0052 check is aligned with recent FDA Business Rules for SDTM data.

FDAC092: “All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT)”.

A simple solution in your case would be to add VISITNUM info into VISIT value. E.g., “UNSCHEDULED 3.01”.

Kind Regards,

Sergiy

4

The Condition for “FDAC091, FDAC092” is VISITNUM in TV.VISITNUM, which indicates that the check should only apply to planned visits.

5

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!