"Missing FWENDY variable, when FWENDTC variable is present" without FWDY present

m Matt

on August 10, 2016

Hi,

I'm validating with the latest version (2.1.2) and get the warning "Missing FWENDY variable, when FWENDTC variable is present" for my FW dataset. While I don't have the FWENDY column and do have the FWENDTC column, I don't have the FWDY column in the dataset. I think without the FWDY present, having the FWENDY wouldn't make sense and this rule should not report.

Thanks!

Forums: Troubleshooting and Problems

s Sergiy

on August 12, 2016

Hi Matt, …

Hi Matt,

Could you send your file for diagnostics. It may have 0 records.

Thank you,

Sergiy

ssirichenko at pinnacle 21 dot net

m Matt

on August 18, 2016

Unfortunately I can't send…

Unfortunately I can't send the file (client data). But it is not an empty file, it has 1260 records.

d Debra

on August 19, 2016

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The Tech Conf Guide indicates (Section 4.1.4.1, item 3) that if a DTC is there, a DY should also be there. I'm not sure if you are talking SEND or SDTM, but I know that v3.1 of the IG updated examples and clarified content to ensure this FDA desire was incorporated. So, if you have FWDTC, the TCG says you should have FWDY; and if FWENDTC is in the dataset, FWENDY should also be included.

m Matt

on September 8, 2016

I'm using SEND 3.0 currently…

I'm using SEND 3.0 currently.

I can see why you'd normally include the DY if you have a DTC, but this is for a pool record for the cage and the subjects where not necessarily started on the same day.