SDTM

Hi, I am creating domains based on SDTMIG v3.3. Since Hepatitis C Virus Antibody (HCAB) has been removed from MBTEST (MBTESTCD) in the latest CT (version date 2023-12-15), with the reason for its removal being that in SDTMIG v3.4, antibody tests will be represented by the IS domain, this leads to a CT2002 issue during validation. Consequently, I would like to ask for advice on whether I should use the latest version of CT for validation and document this issue to the reviewer's guide, or use the previous version, which is more suitable for SDTMIG v3.3?

Kind regards,

John

Can we have partial dates in DM.RFPENDTC?

When reporting aCRF page numbers in the Define, should the page numbers be the PDF page numbers or the page numbers printed on the aCRF?

When creating the VLM for a domain (LB for example), to what extent do we need to report multiple origins for variables? To specify, say SUBJID, LBORRES, LBORRESU, LBMETHOD, LBDTC are all collected on the CRF and in an external for multiple LBTESTCDs. Do we need to create a row in the VLM for each variable, in relation to each LBTESTCD for each Origin, or is there a simpler way to report the multiple Origins for each variable without having to create a row in the VLM for each variable for each LBTESTCD from each source?

Hi~

We have no CT for QLABEL. But there are issues with "QLABEL value not found in user-defined codelist 'No Yes Response' when QNAM ==XXX" in VLM level. It is strange for this issue. Because we have no specify CT for QLABEL and only have specify CT for QVAL. Where does the CT for QLABEL from? Would you help to clarify?

Best Regards,

Maggie

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.