Check SD0065: VISIT, VISITNUM cross checked in SV with other domains

r Reema

on August 14, 2013

Is check SD0065 a bi-directional check? Does it check the presence of USUBJID, VISIT, VIISTNUM combination match between other domains and SV both the ways? To be precise, if a VISIT/VISITNUM combination exists in SDTM domains and does not exist in SV, it flags a warning message in the report. Does it hold true for the other way round too? If there exists a visit in SV but is not there in any other domain will it mark this as a warning too? This case is particularly for Screen Failure subjects.

Also, is it necessary to have all subjects in DM with a record in SV (even for screen failures)?

Forums: SDTM

s Sergiy

on August 14, 2013

Hi Reema, 1. No, SD0065

Hi Reema,

1. No, SD0065 check compares USUBJID/VISITNUM/VISIT values vs. SV domain records. It's a one-direction check.

2. Yes, there are no exceptions for Screen Failures in an algorithm of the SD0065 rule.

Kind Regards,

Sergiy

d Dhananjay

on August 18, 2013

Hi both, I have a doubt in

Hi both,

I have a doubt in populating VISIT and VISITNUM for Comment domain and would like to have suggestions from you all. I have some comments populated in CO domain which are related to EG domain which is coming from third part, however the CODTC does not match with any of the visits in EDC and does not even match with the EG domain visits. In this case if I slot the visits in CO domain as unscheduled 1, unscheduled 2 etc, then these VISIT and VISITNUM would not be present in SV domain as these comments were not provided on any visits.

What would be the solution in this case?

s Sergiy

on August 19, 2013

Hi Dhanajay, It's not clear

Hi Dhanajay,

It's not clear form your email if the comments are related to 1. some particular EG records or 2. to particular subjects in general. There are good examples how to handle the case #2 in SDTM IG v3.1.2 #5.2.1.2 on page 66.

Regards,

Sergiy