Rule SE0009 - Missing values for both --DTC and --DY variables

j Jozef

on August 16, 2019

I am puzzled about the FDA rule "SE0009 - Missing values for both --DTC and --DY variables".
According to the Excel worksheet published by the FDA, the rule applies to both SDTM and SEND, but it does not seem to be listed in Pinnacle21 SDTM validation reports.
Was this forgotten or is there an error in the FDA Excel and is it only applicable to SEND?

Secondly, the rule states: "Start Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated".
However "Start Date/Time of Observation" is --STDTC, not --DTC (which is date/time of collection which is something else).
So I wonder whether the rule is applicable to --DTC/--DY pairs and / or --STDTC/--STDY pairs.

Forums: SDTM

Sergiy

on August 29, 2019

P21

Hi Jozef, This is old rule…

Hi Jozef,

This is old rule published in the first version of FDA SEND rules ~ 6 years ago. It's applicable only for SEND. Usually SExxxx rules are SEND-specific.

Description of the rule should be corrected by removing a word "Start" as you suggested. Thank you for this catch!

Kind Regards,

Sergiy