Technical support questions about SDTM standard and validation rules

April 3, 2024

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,


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March 26, 2024

Can we have partial dates in DM.RFPENDTC?

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February 18, 2024

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?

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February 18, 2024

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?

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December 10, 2023


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,


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November 27, 2023

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:

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October 13, 2023


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.


Abc         INCL01         1.0

def          INCL02          1.0

ghi          INCL03          1.0



Abc         INCL01         2.0

ghi          INCL03          2.0

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August 8, 2023

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


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July 24, 2023



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.

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July 20, 2023

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. 


pinnacle 21 NMPA engine report screeshot

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