SDTM

In example 3 (page 259, and RELREC on page 263) of the SDTM IG 3.4, relationships are established from one (parent) domain to another (related) domain while there not always records in the another (related) domain that will match with the parent domain:

Hi,

I've two versions of the protocols in my study where one of new the inclusion criteria was deleted in the last version of protocol. All other Inclusion criteria were exactly same in the last protocol only order is getting changed because of this deletion.

Here I will explain using an example.

IETEST   IETESTCD  TIVERS

Abc         INCL01         1.0

def          INCL02          1.0

ghi          INCL03          1.0

 

IETEST   IETESTCD  TIVERS

Abc         INCL01         2.0

ghi          INCL03          2.0

We usually enter explanations in excel report. Can this report directly uploaded to P21 to auto populate explainations on the individual issues page?

 

Hi, 

 

The information about Associated person captured as "Weight in (grams) at Birth". Please suggest, do we need to standardize the results in APxx domains as like we are doing in SDTM findings domains. 

Do we need to convert gram to Kilogram in APVS.VSSTRESC variable for the Weight assessment?

 

Thanks in Advance.

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.”