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SE2326 message populated for 3.0 dataset
SergiyP21
Hi, A missing value in…
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…
Hi,
But I think for 3.0 study, there is no TSVALNFL applied? Thanks.
SergiyP21
FDA support for SEND-IG 3.0…
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…
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?
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!