SDTM

We want to know how to define the NMPA Severity class. We think it is from the PMDA validation rules, But it is different.
Such as Rule ID SD0085 severity class is defined as Warning in PMDA, But Error in NMPA. 
Thanks.

 

Since controlled terminologys (PKUNIT), (PKUWG), (PKUWKG), (PKUDMG), (PKUDUG) can be used for PPORRESU & PPSTRESU, when I use the 'mg/mL/(mg/m2)' (C119384) which belongs to PK Units of Measure - Dose mg, the CT2002 issue is fired with describtion "PPORRESU/PPSTRESU value not found in 'PK Units of Measure' extensible codelist.". Please kindly help to clarify the issue here or should I explain in the cSDRG?

For all who get these false positive (SD0057) on LBSTREFC, some advice ...

Rule SD2239 with message "Inconsistent value for --TPT" and description "Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID) and Assessment Date/Time (--DTC)", is i.m.o. wrong.
It compares "planned" (-TPT) with "actual (-DTC)" and thus may lead to many false positives.

What is the best way to handle missed doses when the exact dates of the missed doses are unknown?

As for SDTM (–ENTPT), how should we define a reference time point? Is there a specify rule about these variables. Likes AEENTPT.

SDTM  IG 3.4 section 4.4.7 says “The variables --STRTPT and --ENRTPT contain values similar to --STRF and --ENRF, but may be anchored with any timing description or date/time value expressed in the respective --STTPT and --ENTPT variables, and are not limited to the study reference period.”

 

Hi Team,

 

Can we have a space in-between in STUDYID / USUBJID values? We don't have any specific restriction for providing with respect to spacing for STUDYID, USUBJID variables in IG.

Example: STUDYID = ABCSTDY-A 101  ;   USUBJID = ABCSTDY-A 101-001-101

 

Hi there,

I have a study with data collected with duplicated information. Is it mandatory to include all of the collected data in SDTM different domains even if they are duplicated?  

I added AETRTEM variable of which label is Treatment Emergent Flag in SUPPAE as per FDA rule.

However , still see the 'No Treatment Emergent info for Adverse Event' error after validation using FDA engine. 

Is it possible not to see this error?