Based on #SD0035 --DOSU must be populate when either --DOSE/--DOSTXT/--DOSTOT is not missing. But there are some exemptions for EC domain from SDTM IG: "Qualifier variables should be populated with equal granularity across Scheduled and Performed records when known. For example, if ECDOSU and ECDOSFRQ are known at scheduling and administration, then the variables would be populated on both records." I reckon this implies when ECDOSE/ECDOSTXT/ECDOSTOT is missing also. There are numerous scenarios in SDTM IG where you can see ECDOSU populated when dosing is missing (ECOCCUR="N").
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Hi,
Based on #SD0035 --DOSU must be populate when either --DOSE/--DOSTXT/--DOSTOT is not missing. But there are some exemptions for EC domain from SDTM IG: "Qualifier variables should be populated with equal granularity across Scheduled and Performed records when known. For example, if ECDOSU and ECDOSFRQ are known at scheduling and administration, then the variables would be populated on both records." I reckon this implies when ECDOSE/ECDOSTXT/ECDOSTOT is missing also. There are numerous scenarios in SDTM IG where you can see ECDOSU populated when dosing is missing (ECOCCUR="N").
For example:
ECTRT= "BOTTLE A", ECOCCUR="N", ECDOSE= "", ECDOSU="TABLET", ECDOSFRQ="QD".
Could you please provide your thoughts is this is a good idea to check for EC domain especially to have ECDOSU populated when dosing is missing.
Thanks!
Sai.