SD0057: EXENDTC is permissible, yet flagged as expected (validator 2.0.1)

j Joan

on April 1, 2015

Hi,

The IG for 3.1.3 and 3.1.2 has EXENDTC as permissible. And that makes good sense for a per-instance recording scenario of an oral dose.

However, the validator is flagging an omitted EXENDTC column with the message, "SDTM Expected variable not found".

I recommend the configuration file be revised to treat EXENDTC as permissible. Thanks!

Regards,

Joan

Forums: SDTM

s Sergiy

on April 1, 2015

Hi Joan, Thank you for

Hi Joan,

Thank you for reporting this issue!

We fixed it by correcting EXENDTC Core to "Permissible" in 3.1.2 and 3.1.3 specifications.

Kind Regards,

Sergiy

m Michael

on August 5, 2015

Exposure End Date/Time of Treatment

Hi Joan. Serigy is right, but also consider this point once you start to move towards 3.2, which is already almost a 2 year old standard for which the FDA plans to add to the data catalog very soon.

http://www.opencdisc.org/forum/ct2022-exendtc-expected-however-its-permissible#comment-1797