y yue
on

 

This warning (Invalid TSVAL value for STENDTC) populated  for 3.0 study when STENDTC is "NOT AVAILABLE" which I think cased by TSVAL variable is not in ISO 8601 format. 

I wonder what value should put in the TSVAL when Study End Date is not available that won't lead to val tool warnings, because removing STENDTC will cause another warning "Missing STENDTC Trial Summary Parameter". Thank you! 

Forums: SEND

Sergiy
on July 13, 2021

Hi, 

A missing value in TSVAL and 'NA' in TSVALNFL. Also, TSVCDREF='ISO 21090'.

Kind Regards,
Sergiy

y yue
on July 13, 2021

Hi,

But I think for 3.0 study, there is no TSVALNFL applied? Thanks.

 

Sergiy
on July 13, 2021

FDA support for SEND-IG 3.0 was ended 2 years ago. Why do you still need this old version of SEND?

y yue
on July 13, 2021

We still have some studies started before 2019-03-15. If p21 lists SEND 3.0 in the validation options, why it is a surprise seeing someone use it? So do you mean there is no way to get this right? 

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