CT0007 and similar Warnings: real or not?

m Michael

on June 13, 2012

We have 4,000 records in DA, with DATEST="Number Dispensed" or "Number Returned". These records are flagged with Warning CT0007 because these two terms don't match targeted controlled terminology "Dispensed Amount" and "Returned Amount".

The SDTM IG states that DATEST should be "Verbatim name, corresponding to the topic variable, of the test or examination used to obtain the drug accountability assessment. The value in DATEST cannot be longer than 40 characters. Example: Dispensed Amount, Returned Amount."

So, I don't think we're "breaking" SDTM with our DA, and my dilemna is what to do with the warning message. For external reasons, I can't change the DA contents, so: Should I ignore the warning? Should I try to explain it in a reviewer's guide? Should I modify define.xml to add a codelist for DATEST which includes these two terms?

If any reader has ideas or thoughts to share - please do! Thanks!

Forums: SDTM

s Sergiy

on June 18, 2012

Hi Mike, I think

Hi Mike,

I think technically you are safe. Yes, it is a good practice to use the CDISC Terminology codelist values by conversion/mapping of collected data. However in your case the (DATEST) is an extensible codelist and you may add your own values. Do not forget to include them into define.xml.

Best Regards,

Sergiy Sirichenko