c Ceci
on

 

In my recent project, I have some early termination visits in the SDTM domain with SVUPDES = Early termination in SV. Since early termination is considered as unplanned visit, so I did not include that in TV. However, the checker is issuing warning "VISIT/VISITNUM values do not match TV domain data".

Rule SD1023 states that "Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain with the exception of Unscheduled and Unplanned visits."

How does the latest Pinnacle checker identify for the unscheduled and unplanned visits? I always think that any visit with SVUPDES populated will be considered as unplanned visits.

Thanks in advance for your help!

Ceci

Forums: General Discussion

j Jozef
on September 1, 2016

What visit number(s) did you assign to the termination visit(s)? Is it a non-integer (e.g. 5.1)?
Maybe the validator looks at the visit number and when it sees an integer, it regards the visit as a planned visit.

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